Introduction to Ayurveda-Safety Aspects of Herbo-Metallic Compounds-Rasa Aushadhi of Ayurveda Prof....

42
Introduction to Ayurveda- Introduction to Ayurveda- Safety Aspects of Herbo- Safety Aspects of Herbo- Metallic Compounds-Rasa Metallic Compounds-Rasa Aushadhi of Ayurveda Aushadhi of Ayurveda Prof. G.P. Dubey, Dr. Aruna Agrawal, Prof. G.V. Rajamanickam Centre for psychosomatic & Biofeedback Medicine & Deptt. Of Basic Principles, Faculty of Ayurveda, IMS, Deptt. Of Basic Principles, Faculty of Ayurveda, IMS, BHU BHU & & Centre for Advanced Research in Indian System of Centre for Advanced Research in Indian System of Medicine, Medicine,

Transcript of Introduction to Ayurveda-Safety Aspects of Herbo-Metallic Compounds-Rasa Aushadhi of Ayurveda Prof....

Page 1: Introduction to Ayurveda-Safety Aspects of Herbo-Metallic Compounds-Rasa Aushadhi of Ayurveda Prof. G.P. Dubey, Dr. Aruna Agrawal, Prof. G.V. Rajamanickam.

Introduction to Ayurveda-Introduction to Ayurveda-Safety Aspects of Herbo-Safety Aspects of Herbo-Metallic Compounds-Rasa Metallic Compounds-Rasa

Aushadhi of AyurvedaAushadhi of Ayurveda

Prof. G.P. Dubey, Dr. Aruna Agrawal,

Prof. G.V. Rajamanickam

Centre for psychosomatic & Biofeedback Medicine&

Deptt. Of Basic Principles, Faculty of Ayurveda, IMS, BHUDeptt. Of Basic Principles, Faculty of Ayurveda, IMS, BHU& &

Centre for Advanced Research in Indian System of Medicine,Centre for Advanced Research in Indian System of Medicine,SASTRA, Thanjavur SASTRA, Thanjavur

Page 2: Introduction to Ayurveda-Safety Aspects of Herbo-Metallic Compounds-Rasa Aushadhi of Ayurveda Prof. G.P. Dubey, Dr. Aruna Agrawal, Prof. G.V. Rajamanickam.

Ayurvedic approach of HealthAyurvedic approach of Health

Ayurveda is a name which the Ancient Indians Ayurveda is a name which the Ancient Indians gave to their science of medicine. Ayuh means gave to their science of medicine. Ayuh means life and Veda means knowledge. Therefore life and Veda means knowledge. Therefore Ayurveda is a science by the knowledge of Ayurveda is a science by the knowledge of which life can be prolonged and its nature can be which life can be prolonged and its nature can be understood. In a broader sense, Ayurveda like understood. In a broader sense, Ayurveda like Dharma (religion) is not decompartmentalized; it Dharma (religion) is not decompartmentalized; it includes the adaptation of customs, traditions, includes the adaptation of customs, traditions, ethics, hygiene and medicine.ethics, hygiene and medicine.

Page 3: Introduction to Ayurveda-Safety Aspects of Herbo-Metallic Compounds-Rasa Aushadhi of Ayurveda Prof. G.P. Dubey, Dr. Aruna Agrawal, Prof. G.V. Rajamanickam.

The fundamental concept is mainly based on Samkhya and Nayaya Vaisheshika system of Indian philosophy. Subject matter is scattered in Vedas, Upanishads and other Classical literature.

Charaka Samhita, Sushruta Samhita and Ashtanga Samgrah are three important Medical Texts.

Subject Matter:Subject Matter:

Page 4: Introduction to Ayurveda-Safety Aspects of Herbo-Metallic Compounds-Rasa Aushadhi of Ayurveda Prof. G.P. Dubey, Dr. Aruna Agrawal, Prof. G.V. Rajamanickam.

Ayurvedic concept of Health is based on Ayurvedic concept of Health is based on Tridosha Theory. Tridosa is biological Tridosha Theory. Tridosa is biological entity responsible for structural, entity responsible for structural, functional and behavioral dimensions of functional and behavioral dimensions of

the living organism.the living organism. Doshas are two types -Doshas are two types - Manasik (Psychic) – Sattva, Raja & TamaManasik (Psychic) – Sattva, Raja & Tama Sharirika (Somatic) – Vata, Pitta & KaphaSharirika (Somatic) – Vata, Pitta & Kapha

Sharirika and Mansika dosas are interacting Sharirika and Mansika dosas are interacting each other therefore, psychosomatic each other therefore, psychosomatic interaction is responsible for maintenance of interaction is responsible for maintenance of physiological homeostasis.physiological homeostasis.

Page 5: Introduction to Ayurveda-Safety Aspects of Herbo-Metallic Compounds-Rasa Aushadhi of Ayurveda Prof. G.P. Dubey, Dr. Aruna Agrawal, Prof. G.V. Rajamanickam.

MIND BODY INTERACTION

S R T

P V K

Page 6: Introduction to Ayurveda-Safety Aspects of Herbo-Metallic Compounds-Rasa Aushadhi of Ayurveda Prof. G.P. Dubey, Dr. Aruna Agrawal, Prof. G.V. Rajamanickam.

SIGNIFICANCE OF PRAKRITI IN CLINICAL MEDICINE

1) Promotive Health

2) Preventive Health

a) Clinical application of constitution study (Prakriti)

b) Identification of Risk Factors

c) Course, Complication and Ultimate prognosis of the disease.

d) Drug body interaction

Page 7: Introduction to Ayurveda-Safety Aspects of Herbo-Metallic Compounds-Rasa Aushadhi of Ayurveda Prof. G.P. Dubey, Dr. Aruna Agrawal, Prof. G.V. Rajamanickam.

FACTORS RESPONSIBLE FOR HEALTH AND DISEASE

1) Society at risk

a) Rural urban differences

b) Economic status

c) Education & Profession

2) Family at risk

a) Structure of Family

b) Familial diseases

c) Social stress (marital tension , Strained inter- personal relationship, Poor religious affiliation )

3) Individual at risk

a) Psychosomatic constitution

b) Individual habits

Page 8: Introduction to Ayurveda-Safety Aspects of Herbo-Metallic Compounds-Rasa Aushadhi of Ayurveda Prof. G.P. Dubey, Dr. Aruna Agrawal, Prof. G.V. Rajamanickam.

Ayurvedic approach of therapy Ayurvedic approach of therapy

PromotivePromotive PreventivePreventive CurativeCurative

i.i. Non-Pharmacologic procedures: Diet, Non-Pharmacologic procedures: Diet, exercise, yogic-meditation relaxation exercise, yogic-meditation relaxation practices, observance of sadvritta (socio-practices, observance of sadvritta (socio-cultural conduct) as per doshik setup, and cultural conduct) as per doshik setup, and circadian and seasonal variation.circadian and seasonal variation.

Page 9: Introduction to Ayurveda-Safety Aspects of Herbo-Metallic Compounds-Rasa Aushadhi of Ayurveda Prof. G.P. Dubey, Dr. Aruna Agrawal, Prof. G.V. Rajamanickam.

ii. ii. PharmacologicPharmacologic: plant based single and poly : plant based single and poly herbal preparations.herbal preparations.

Herbo-metallic preparationsHerbo-metallic preparations::

Bhasma: Powder of a substance obtained by Bhasma: Powder of a substance obtained by calcination is called Bhasmas. It is applied to calcination is called Bhasmas. It is applied to metals and minerals and animal productsmetals and minerals and animal products

Rasa-Yoga: Preparations containing minerals as Rasa-Yoga: Preparations containing minerals as main ingredients are called Rasa-yoga. Abhrak main ingredients are called Rasa-yoga. Abhrak (Mica), Makshik (copper-pyrites) , Swarna (gold), (Mica), Makshik (copper-pyrites) , Swarna (gold), Rajat (silver), Tamra (copper), Kamsya (Bell metal) Rajat (silver), Tamra (copper), Kamsya (Bell metal) etc.etc.

Rasa Aushadhi: Preparations containing metals, Rasa Aushadhi: Preparations containing metals, minerals are considered rasa-aushadhi:minerals are considered rasa-aushadhi:

Page 10: Introduction to Ayurveda-Safety Aspects of Herbo-Metallic Compounds-Rasa Aushadhi of Ayurveda Prof. G.P. Dubey, Dr. Aruna Agrawal, Prof. G.V. Rajamanickam.

Mercury, Arsenic, Lead, Zinc, Tin, Iron, Sulphur & Mercury, Arsenic, Lead, Zinc, Tin, Iron, Sulphur & Copper are mainly utilized for the preparation of Copper are mainly utilized for the preparation of Ayurvedic formulations. Metals are generally toxic in Ayurvedic formulations. Metals are generally toxic in its native form.its native form.

Several methods have been described for Several methods have been described for detoxification of metals & minerals in classical detoxification of metals & minerals in classical literature of Ayurveda. literature of Ayurveda.

Documentation of the classical preparation along with Documentation of the classical preparation along with their ingredients including history of use.their ingredients including history of use.

Identification of new compound (herbo-metallic) Identification of new compound (herbo-metallic) showing therapeutic efficacy.showing therapeutic efficacy.

Standardization of classical procedure by following Standardization of classical procedure by following objective parameters.objective parameters.

Biological standardization of the product along with Biological standardization of the product along with evaluation of safety and efficacy profile.evaluation of safety and efficacy profile.

Page 11: Introduction to Ayurveda-Safety Aspects of Herbo-Metallic Compounds-Rasa Aushadhi of Ayurveda Prof. G.P. Dubey, Dr. Aruna Agrawal, Prof. G.V. Rajamanickam.

Physico-chemical Physico-chemical characterizationcharacterization

Distribution, Bio-transformation and Distribution, Bio-transformation and EliminationElimination

Route of AbsorptionRoute of Absorption :: Inhalation of Inhalation of Vapor, sub-Vapor, sub-cutaneous and oral.cutaneous and oral.

DistributionDistribution ::Distributes widely to all Distributes widely to all

tissue, kidney, liver tissue, kidney, liver spleen spleen and CNS.and CNS.

EliminationElimination : : Primarily Primarily by Urine and by Urine and fecal Interact with fecal Interact with

different enzyme different enzyme systems systems in the in the body in Presence of body in Presence of sulphur.sulphur.

ActionAction : : Target Target organ system organ system

Page 12: Introduction to Ayurveda-Safety Aspects of Herbo-Metallic Compounds-Rasa Aushadhi of Ayurveda Prof. G.P. Dubey, Dr. Aruna Agrawal, Prof. G.V. Rajamanickam.

WHO LimitNormal permissible

concentrationHeavy Metals Heavy Metals BloodBlood

MercuryMercury 0.2-3 ng/ml0.2-3 ng/ml

ArsenicArsenic 1.1 µgm/Lit.1.1 µgm/Lit.

LeadLead 0.02-1.0 µgm/Lit.0.02-1.0 µgm/Lit.

CopperCopper 100-200 µgm/dl100-200 µgm/dl

AluminiumAluminium 1-10 ng/ml1-10 ng/ml

NickelNickel 0.05-1 ng/ml0.05-1 ng/ml

MagnisiumMagnisium 1.8-3 mg/dl1.8-3 mg/dl

ZincZinc 50-150 µgm/Lit.50-150 µgm/Lit.

IronIron 50.175 µgm/Lit.50.175 µgm/Lit.

Page 13: Introduction to Ayurveda-Safety Aspects of Herbo-Metallic Compounds-Rasa Aushadhi of Ayurveda Prof. G.P. Dubey, Dr. Aruna Agrawal, Prof. G.V. Rajamanickam.

Normal and obtained level of Normal and obtained level of elements in blood and urine elements in blood and urine

ElemenElementsts

Blood (µg/dl)Blood (µg/dl) Urine (µg/dl)Urine (µg/dl)

NormaNormal Valuel Value

Obtained Obtained ValueValue NormNorm

al al ValueValue

Obtained ValueObtained Value

UrbanUrban Rural Rural UrbanUrban Rural Rural

MercurMercury y 2.02.0 3.103.10 0.960.96 2.32.3 2.92.9 1.01.0

LeadLead 2.92.9 6.56.5 3.53.5 2.32.3 5.85.8 2.92.9

ArsenicArsenic 3.103.10 3.983.98 1.961.96 8.48.4 9.29.2 5.45.4

Page 14: Introduction to Ayurveda-Safety Aspects of Herbo-Metallic Compounds-Rasa Aushadhi of Ayurveda Prof. G.P. Dubey, Dr. Aruna Agrawal, Prof. G.V. Rajamanickam.

Dose of Makardhwaj

Makardhwaj: (i) 50 mg/kg daily

Preparation of Makardhwaj as per classical method (Rasa Tarangini ) human dose 125mg to 250mg/day

Gold - 1 partMercury - 4 partSulphur - 8 part

Experimental Animal Study

Maximum Human Dose= 250mg/day ; Average Human Maximum Human Dose= 250mg/day ; Average Human Wt=50kgWt=50kg

Per Kg Dose=250/50=5mg ; Animal Dose ten Times morePer Kg Dose=250/50=5mg ; Animal Dose ten Times more

Page 15: Introduction to Ayurveda-Safety Aspects of Herbo-Metallic Compounds-Rasa Aushadhi of Ayurveda Prof. G.P. Dubey, Dr. Aruna Agrawal, Prof. G.V. Rajamanickam.

ACUTE TOXICITY OF MAKARDHWAJAnimal model - Charles foster strain rats

Dose level Dose level (mg/ kg)(mg/ kg) Sample sizeSample size Mortality after Mortality after

24 hrs.24 hrs.

5050 66 0/60/6

100100 66 0/60/6

150150 66 0/60/6

200200 66 0/60/6

250250 66 0/60/6

300300 66 0/60/6

No lethality was found at the highest dose of No lethality was found at the highest dose of 300mg/kg/day 300mg/kg/day

Page 16: Introduction to Ayurveda-Safety Aspects of Herbo-Metallic Compounds-Rasa Aushadhi of Ayurveda Prof. G.P. Dubey, Dr. Aruna Agrawal, Prof. G.V. Rajamanickam.

Neurobehavioral toxicity following Makardhwaj

(Dose 50 mg/kg)

TestsTests

ObservationsObservations

InitialInitial After 6 After 6 hrshrs

After 12 After 12 hrshrs

After 24 After 24 hrshrs

Flexing Flexing reflexreflex ++ ++ ++ ++

GraspingGrasping ++ ++ ++ ++

Corneal Corneal reflexreflex ++ ++ ++ ++

EquilibriumEquilibrium ++ ++ ++ ++

Head Head shakingshaking ++ ++ ++ ++

AuditoryAuditory ++ ++ ++ ++

No neurobehavioral abnormality was observed No neurobehavioral abnormality was observed following oral administration of Makardhwajfollowing oral administration of Makardhwaj

Page 17: Introduction to Ayurveda-Safety Aspects of Herbo-Metallic Compounds-Rasa Aushadhi of Ayurveda Prof. G.P. Dubey, Dr. Aruna Agrawal, Prof. G.V. Rajamanickam.

Chronic Toxicity of Chronic Toxicity of Makardhwaj:Makardhwaj:

Chronic toxicity of studies were carried Chronic toxicity of studies were carried out among albino rabbits of Holland out among albino rabbits of Holland strain with average body weight of strain with average body weight of 1.86±0.58kg upto 3 months. 1.86±0.58kg upto 3 months.

The dose of Makardhwaj was The dose of Makardhwaj was 50mg/kg/day50mg/kg/day

No adverse effect on hemopoetic, No adverse effect on hemopoetic, Gastro-intestinal, Hepatic & kidney Gastro-intestinal, Hepatic & kidney function test were noticed.function test were noticed.

Page 18: Introduction to Ayurveda-Safety Aspects of Herbo-Metallic Compounds-Rasa Aushadhi of Ayurveda Prof. G.P. Dubey, Dr. Aruna Agrawal, Prof. G.V. Rajamanickam.

Right Kidney

Normal Micro angiography of the Kidney

Left Kidney

Page 19: Introduction to Ayurveda-Safety Aspects of Herbo-Metallic Compounds-Rasa Aushadhi of Ayurveda Prof. G.P. Dubey, Dr. Aruna Agrawal, Prof. G.V. Rajamanickam.

Damage with HgCl2

(High Dose)

Damage with HgCl2 (Low Dose)

Dose 5.0 mg/kg body wtDose 2.5 mg/kg body wt

Makardhwaj +HgCl2

HgCl2 2.5 mg/kg body wt; Makardhwaj 12.50 mg/kg body wt

Page 20: Introduction to Ayurveda-Safety Aspects of Herbo-Metallic Compounds-Rasa Aushadhi of Ayurveda Prof. G.P. Dubey, Dr. Aruna Agrawal, Prof. G.V. Rajamanickam.

Treated Treated GroupGroup

No. No.

of of animaanima

ll

Serotonin (µ gm/gm tissue)Serotonin (µ gm/gm tissue)

Frontal CortexFrontal Cortex HippocampusHippocampus

7 days7 days 14 days14 days 7 days7 days 14 days14 days

Normal Normal control control

(ACSF 5ml)*(ACSF 5ml)*1010

0.4220.422

±± 0.088 0.0880.4180.418

±± 0.075 0.0750.3620.362

±± 0.092 0.0920.3640.364

±± 0.084 0.084

MakardhwMakardhwaj 300 aj 300 mg/kgmg/kg ****

10100.3160.316

±0.061±0.0610.3640.364

±0.054±0.0540.2410.241

±0.042±0.0420.2010.201

±0.064±0.064

MakardhwMakardhwajaj

100 mg/kg100 mg/kg ******

10100.4380.438

±0.082±0.0820.4560.456

±0.072±0.0720.3840.384

±0.065±0.0650.3960.396

±0.075±0.075

Effect of Makardhwaj on serotonin level in experimental rats

*vs** P>0.05 P>0.05 P>0.05 P>0.05

*vs*** P<0.01 P<0.001 P<0.001 P<0.001

Page 21: Introduction to Ayurveda-Safety Aspects of Herbo-Metallic Compounds-Rasa Aushadhi of Ayurveda Prof. G.P. Dubey, Dr. Aruna Agrawal, Prof. G.V. Rajamanickam.

Beneficial effect of Makardhwaj on nor-Beneficial effect of Makardhwaj on nor-adrenaline in experimental rats adrenaline in experimental rats

Treated Treated GroupGroup

No. of No. of animalanimal

nor-adrenaline(µ gm/gm tissue)nor-adrenaline(µ gm/gm tissue)

Total brain Total brain Mid brainMid brain

7 days 7 days 14 days14 days 7 days 7 days 14 days14 days

Normal Normal control (ACSF control (ACSF

5ml)*5ml)*1010 0.3680.368

±0.067±0.067

0.3760.376± ±

0.0580.058

0.6210.621± 0.092± 0.092

0.6310.631± 0.085± 0.085

Makardhwaj Makardhwaj 300 mg/kg300 mg/kg ****

1010 0.2220.222±0.045±0.045

0.2160.216±0.051±0.051

0.4080.408±0.039±0.039

0.4020.402±0.061±0.061

MakardhwajMakardhwaj100 mg/kg100 mg/kg ******

1010 0.3840.384±0.085±0.085

0.3880.388±0.078±0.078

0.6420.642±0.098±0.098

0.6500.650±0.090±0.090*vs** P>0.05 P>0.05 P>0.05 P>0.05

*vs*** P<0.01 P<0.001 P<0.001 P<0.001

Page 22: Introduction to Ayurveda-Safety Aspects of Herbo-Metallic Compounds-Rasa Aushadhi of Ayurveda Prof. G.P. Dubey, Dr. Aruna Agrawal, Prof. G.V. Rajamanickam.

Effect of Makardhwaj on Dopamine level in Effect of Makardhwaj on Dopamine level in experimental ratsexperimental rats

Treated Treated GroupGroup

No. of No. of animalanimal

Dopamine (µ gm/gm tissue)Dopamine (µ gm/gm tissue)

Total brainTotal brain Mid brain Mid brain

7 days 7 days 14 days14 days 7 days 7 days 14 days14 days

Normal Normal control (ACSF control (ACSF

5ml)*5ml)*1010 0.8360.836

±0.082±0.0820.8420.842

±0.074±0.0741.2721.272

±0.092±0.0921.2081.208

±0.088±0.088

Makardhwaj Makardhwaj 300 mg/kg300 mg/kg ****

1010 0.6640.664±0.050±0.050

0.6410.641±0.033±0.033

1.1561.156±0.024±0.024

1.1081.108±0.052±0.052

MakardhwajMakardhwaj100 mg/kg100 mg/kg ******

1010 0.8410.841±0.101±0.101

0.8580.858±0.104±0.104

1.2891.289±0.088±0.088

1.2831.283±0.098±0.098

*vs** P>0.05 P>0.05 P>0.05 P>0.05

*vs*** P<0.001 P<0.001 P<0.001 P<0.001

Page 23: Introduction to Ayurveda-Safety Aspects of Herbo-Metallic Compounds-Rasa Aushadhi of Ayurveda Prof. G.P. Dubey, Dr. Aruna Agrawal, Prof. G.V. Rajamanickam.

Effect of Makardhwaj on choline- acetyl-Effect of Makardhwaj on choline- acetyl-transferase in experimental ratstransferase in experimental rats

Treated Treated GroupGroup

No. of No. of animalanimal

ChAT activity (n mol/mg ChAT activity (n mol/mg protein/hour)protein/hour)

Frontal cortexFrontal cortex HippocampusHippocampus

7 days 7 days 14 days14 days 7 days 7 days 14 days14 days

Normal Normal control (ACSF control (ACSF

5ml)*5ml)*1010 22.3422.34

±2.85±2.8523.9723.97±3.11±3.11

20.2420.24±2.12±2.12

19.8819.88±2.75±2.75

Makardhwaj Makardhwaj 300 mg/kg300 mg/kg ****

1010 18.2118.21±2.01±2.01

16.1416.14±2.11±2.11

16.2216.22±3.01±3.01

14.0614.06±3.10±3.10

MakardhwajMakardhwaj100 mg/kg100 mg/kg ******

1010 24.1424.14±3.02±3.02

25.6825.68±2.94±2.94

21.9821.98±3.94±3.94

23.4223.42±4.82±4.82*vs** P>0.05 P>0.05 P>0.05 P>0.05

*vs*** P<0.001 P<0.001 P<0.001 P<0.001

Page 24: Introduction to Ayurveda-Safety Aspects of Herbo-Metallic Compounds-Rasa Aushadhi of Ayurveda Prof. G.P. Dubey, Dr. Aruna Agrawal, Prof. G.V. Rajamanickam.

Heavy Metals µg/gm of the product (JAMA) (SASTRA & BHU)

Lead : 37000 22000

Mercury : 22800 23800

Arsenic : 8100 6200

Mahayograj guggulu (with silver & makardhwaj) is an Ayurvedic herbo - metallic preparation mainly advocated in the management of Rheumatoid and Osteo-arthritis.

Presence of Organic materials

Page 25: Introduction to Ayurveda-Safety Aspects of Herbo-Metallic Compounds-Rasa Aushadhi of Ayurveda Prof. G.P. Dubey, Dr. Aruna Agrawal, Prof. G.V. Rajamanickam.

MET. ENGG. IT- BHU & SASTRA, THANJAVUR

Mahayogaraj Guggulu (with Silver and Makardhwaj)

Silver particle

Page 26: Introduction to Ayurveda-Safety Aspects of Herbo-Metallic Compounds-Rasa Aushadhi of Ayurveda Prof. G.P. Dubey, Dr. Aruna Agrawal, Prof. G.V. Rajamanickam.

Sem of Mahayograj guggul (with Sem of Mahayograj guggul (with silver and Makardhwaj)silver and Makardhwaj)

Tubular

particles

Fused &

Solidification

cracks

Fine Spherical

particles

Flakes

Particles sizes varies from 2-100 microns

Page 27: Introduction to Ayurveda-Safety Aspects of Herbo-Metallic Compounds-Rasa Aushadhi of Ayurveda Prof. G.P. Dubey, Dr. Aruna Agrawal, Prof. G.V. Rajamanickam.

Acute toxicity of Mahayograj guggulu (with silver & Acute toxicity of Mahayograj guggulu (with silver & Makardhwaj)Makardhwaj) Animal model: Charles Foester Strain Animal model: Charles Foester Strain

rats.rats.

Dose LevelDose Level

(mg/kg body (mg/kg body wt.)wt.)

Sample SizeSample SizeMortality after Mortality after

72 hrs.72 hrs.

250250 66 0/60/6

500500 66 0/60/6

10001000 66 0/60/6

15001500 66 0/60/6

20002000 66 0/60/6

Page 28: Introduction to Ayurveda-Safety Aspects of Herbo-Metallic Compounds-Rasa Aushadhi of Ayurveda Prof. G.P. Dubey, Dr. Aruna Agrawal, Prof. G.V. Rajamanickam.

Neurobehavioural acute toxicity following Mahayograj Neurobehavioural acute toxicity following Mahayograj Guggulu (with Silver & Makardhwaj)Guggulu (with Silver & Makardhwaj)

(Dose 250 (Dose 250 mg/kg body wt)

TestsTestsObservationsObservations

InitialInitial After 24 After 24 hrs.hrs.

After 48 After 48 hrs.hrs.

After 72 After 72 hrs.hrs.

Flexing Flexing reflexreflex ++ ++ ++ ++

Grasping Grasping reflexreflex ++ ++ ++ ++

Corneal Corneal reflexreflex ++ ++ ++ ++

Body Body equilibriumequilibrium ++ ++ ++ ++

Head Head shakingshaking ++ ++ ++ ++

AuditoryAuditory ++ ++ ++ ++

Page 29: Introduction to Ayurveda-Safety Aspects of Herbo-Metallic Compounds-Rasa Aushadhi of Ayurveda Prof. G.P. Dubey, Dr. Aruna Agrawal, Prof. G.V. Rajamanickam.

Chronic Toxicity of Mahayograj Chronic Toxicity of Mahayograj Guggulu (with silver & Guggulu (with silver &

Makardhwaj)Makardhwaj)Chronic toxicity of studies were carried Chronic toxicity of studies were carried out among albino rabbits of Holland out among albino rabbits of Holland strain with average body weight of strain with average body weight of 1.90±0.55kg upto 3 months. 1.90±0.55kg upto 3 months.

The dose of Mahayograj Guggulu (with The dose of Mahayograj Guggulu (with silver & Makardhwaj) was silver & Makardhwaj) was 250mg/kg/day250mg/kg/day

No adverse effects on hemopoetic No adverse effects on hemopoetic Gastro-intestinal, Hepatict and kidney Gastro-intestinal, Hepatict and kidney function test were noticed.function test were noticed.

Page 30: Introduction to Ayurveda-Safety Aspects of Herbo-Metallic Compounds-Rasa Aushadhi of Ayurveda Prof. G.P. Dubey, Dr. Aruna Agrawal, Prof. G.V. Rajamanickam.

Changes in Acetylcholine concentration following Changes in Acetylcholine concentration following oral administration of Mahalaxmivilas ras with oral administration of Mahalaxmivilas ras with

gold mahayograj guggulu with gold & Mahayograj gold mahayograj guggulu with gold & Mahayograj guggulu with silver & makardhwajguggulu with silver & makardhwaj

FactorsFactors

Acetylcholine Concentration (n mol/g)Acetylcholine Concentration (n mol/g)

Frontal CortexFrontal Cortex HippocampusHippocampus

Initial Initial After 14 After 14 daysdays

After 28 After 28 daysdays Initial Initial After 14 After 14

daysdaysAfter 28 After 28

daysdays

Normal ControlNormal Control 24.8224.82±1.32±1.32

23.4223.42±1.02±1.02

24.3224.32±2.10±2.10

28.8228.82±1.96±1.96

27.4227.42±1.42±1.42

28.6228.62±2.05±2.05

MahalaxmMahalaxmii

vilas Ras vilas Ras (Swarna (Swarna yukta)yukta)

10 mg/10 mg/Kg body Kg body

wt.wt.----

21.6221.62±1.05±1.05

22.3222.32±1.60±1.60 ----

26.4526.45±2.11±2.11

25.7225.72±1.82±1.82

MahayogrMahayograj aj

Guggulu Guggulu with goldwith gold

50 mg/50 mg/Kg body Kg body

wt.wt.----

19.7519.75±2.01±2.01

18.6218.62±1.62±1.62 ----

23.6523.65±2.75±2.75

22.6022.60±2.13±2.13

MahayogrMahayograj aj

Guggulu Guggulu with Silver with Silver

& & MakardhwMakardhw

ajaj

50 mg/50 mg/Kg body Kg body

wt.wt.----

18.6518.65±1.82±1.82

17.5217.52±1.61±1.61 ----

20.7420.74±1.20±1.20

19.7519.75±3.95±3.95

Page 31: Introduction to Ayurveda-Safety Aspects of Herbo-Metallic Compounds-Rasa Aushadhi of Ayurveda Prof. G.P. Dubey, Dr. Aruna Agrawal, Prof. G.V. Rajamanickam.

Changes in nor-adrenaline following oral Changes in nor-adrenaline following oral administration of Mahalaxmivilas ras with gold administration of Mahalaxmivilas ras with gold mahayograj guggulu with gold & Mahayograj mahayograj guggulu with gold & Mahayograj

guggulu with silver & makardhwajguggulu with silver & makardhwaj

FactorsFactors

Nor-adrenaline (µg/gm tissue)Nor-adrenaline (µg/gm tissue)

Frontal CortexFrontal Cortex HippocampusHippocampus

Initial Initial After 14 After 14 daysdays

After 28 After 28 daysdays Initial Initial After 14 After 14

daysdaysAfter 28 After 28

daysdays

Normal ControlNormal Control 0.3750.375±0.042±0.042

0.3720.372±0.059±0.059

0.3860.386±0.062±0.062

0.6710.671±0.025±0.025

0.6890.689±0.043±0.043

0.6490.649±0.030±0.030

MahalaxmMahalaxmii

vilas Ras vilas Ras (Swarna (Swarna yukta)yukta)

10 mg/10 mg/Kg body Kg body

wt.wt.----

0.3520.352±0.50±0.50

0.3420.342±0.040±0.040 ----

0.2690.269±0.052±0.052

0.6310.631±0.061±0.061

MahayogrMahayograj aj

Guggulu Guggulu with goldwith gold

50 mg/50 mg/Kg body Kg body

wt.wt.----

0.2620.262±0.035±0.035

0.2710.271±0.041±0.041 ----

0.5200.520±0.062±0.062

0.5250.525±0.025±0.025

MahayogrMahayograj aj

Guggulu Guggulu with Silver with Silver

& & MakardhwMakardhw

ajaj

50 mg/50 mg/Kg body Kg body

wt.wt.----

0.2400.240±0.071±0.071

0.2350.235±0.062±0.062 ----

0.4250.425±0.025±0.025

0.4200.420±0.021±0.021

Page 32: Introduction to Ayurveda-Safety Aspects of Herbo-Metallic Compounds-Rasa Aushadhi of Ayurveda Prof. G.P. Dubey, Dr. Aruna Agrawal, Prof. G.V. Rajamanickam.

Changes in Dopamine following oral Changes in Dopamine following oral administration of Mahalaxmivilas ras with gold administration of Mahalaxmivilas ras with gold mahayograj guggulu with gold & Mahayograj mahayograj guggulu with gold & Mahayograj

guggulu with silver & makardhwajguggulu with silver & makardhwaj

FactorsFactors

Dopamine (µg/gm tissue)Dopamine (µg/gm tissue)

Frontal CortexFrontal Cortex HippocampusHippocampus

Initial Initial After 14 After 14 daysdays

After 28 After 28 daysdays Initial Initial After 14 After 14

daysdaysAfter 28 After 28

daysdays

Normal ControlNormal Control 0.8600.860±0.025±0.025

0.8720.872±0.035±0.035

0.9050.905±0.065±0.065

1.2451.245±0.120±0.120

1.2651.265±0.112±0.112

1.2821.282±0.102±0.102

MahalaxmMahalaxmii

vilas Ras vilas Ras (Swarna (Swarna yukta)yukta)

10 mg/10 mg/Kg body Kg body

wt.wt.----

0.8320.832±0.040±0.040

0.8450.845±0.056±0.056 ----

1.2351.235±0.072±0.072

1.2301.230±0.062±0.062

MahayogrMahayograj aj

Guggulu Guggulu with goldwith gold

50 mg/50 mg/Kg body Kg body

wt.wt.----

0.7250.725±0.062±0.062

0.7150.715±0.032±0.032 ----

1.0251.025±0.095±0.095

1.0231.023±0.102±0.102

MahayogrMahayograj aj

Guggulu Guggulu with Silver with Silver

& & MakardhwMakardhw

ajaj

50 mg/50 mg/Kg body Kg body

wt.wt.----

0.6450.645±0.060±0.060

0.6300.630±0.042±0.042 ----

0.9850.985±0.072±0.072

0.9800.980±0.081±0.081

Page 33: Introduction to Ayurveda-Safety Aspects of Herbo-Metallic Compounds-Rasa Aushadhi of Ayurveda Prof. G.P. Dubey, Dr. Aruna Agrawal, Prof. G.V. Rajamanickam.

Clinical StudyClinical Study

Procedure:Procedure:27 cases (14 male & 13 female) 27 cases (14 male & 13 female)

receiving Mahayogaraj Guggulu with receiving Mahayogaraj Guggulu with silver & Makardhwaj in the dose of 2 tab silver & Makardhwaj in the dose of 2 tab twice in a day prescribed by qualified twice in a day prescribed by qualified Ayurvedic physicians were selected.Ayurvedic physicians were selected.

The cases receiving the therapy The cases receiving the therapy were carefully monitored for adverse were carefully monitored for adverse reaction on different system.reaction on different system.

Three successive follow-up studies Three successive follow-up studies were carried out.were carried out.

Page 34: Introduction to Ayurveda-Safety Aspects of Herbo-Metallic Compounds-Rasa Aushadhi of Ayurveda Prof. G.P. Dubey, Dr. Aruna Agrawal, Prof. G.V. Rajamanickam.

Toxicity studies of the subjectsToxicity studies of the subjects

FactorsFactorsObservationsObservations

Initial Initial After 1 monthAfter 1 month After 3 monthsAfter 3 months

RBC RBC

(millions/cu mm)(millions/cu mm)3.383.38±0.52±0.52

3.653.65±0.62±0.62

3.403.40±0.78±0.78

WBCWBC

(Thousand/cu mm)(Thousand/cu mm)7.427.42±0.98±0.98

6.856.85±1.12±1.12

7.387.38±1.02±1.02

Polymorph (%)Polymorph (%)64.3864.38±3.85±3.85

65.7265.72±4.01±4.01

63.0163.01±3.48±3.48

Lymphocytes (%)Lymphocytes (%)29.4629.46±5.42±5.42

28.7828.78±4.03±4.03

27.3227.32±5.62±5.62

Eosinophils (%)Eosinophils (%)4.924.92±1.72±1.72

5.425.42±1.65±1.65

3.823.82±1.35±1.35

Monocyte (%)Monocyte (%)0.950.95±0.42±0.42

0.860.86±0.48±0.48

0.920.92±0.45±0.45

Hb (%)Hb (%)11.0511.05±2.35±2.35

10.8010.80±2.15±2.15

11.3511.35±2.32±2.32

Evaluation of Mahayograj guggulu (with silver & Makardhwaj) on Hemopoetic system among rheumatoid arthritis cases.

Page 35: Introduction to Ayurveda-Safety Aspects of Herbo-Metallic Compounds-Rasa Aushadhi of Ayurveda Prof. G.P. Dubey, Dr. Aruna Agrawal, Prof. G.V. Rajamanickam.

Evaluation of Mahayograj guggulu (with silver & Makardhwaj) on Liver function tests among

rheumatoid arthritis cases.

FactorsFactorsObservationsObservations

Initial Initial After 1 monthAfter 1 month After 3 monthsAfter 3 months

Alkaline Alkaline phosphates phosphates

(kings (kings Au/100ml)Au/100ml)

8.828.82±2.75±2.75

10.1310.13±3.08±3.08

9.189.18±1.75±1.75

GGTP (IU)GGTP (IU)29.0129.01±4.34±4.34

28.6428.64±3.40±3.40

26.6226.62±5.01±5.01

SGOT (IU)SGOT (IU)48.8548.85±4.98±4.98

49.7549.75±3.02±3.02

46.6246.62±5.20±5.20

SGPT (IU)SGPT (IU)38.8338.83±3.25±3.25

40.6340.63±3.01±3.01

44.0144.01±3.98±3.98

Serum Billirubin Serum Billirubin (mg%)(mg%)

0.850.85±0.25±0.25

0.960.96±0.16±0.16

0.830.83±0.20±0.20

Total Protein Total Protein (gm%)(gm%)

5.205.20±1.10±1.10

4.604.60±1.70±1.70

5.655.65±1.85±1.85

Page 36: Introduction to Ayurveda-Safety Aspects of Herbo-Metallic Compounds-Rasa Aushadhi of Ayurveda Prof. G.P. Dubey, Dr. Aruna Agrawal, Prof. G.V. Rajamanickam.

Evaluation of Mahayograj guggulu (with silver & makardhwaj) on Renal function tests among

rheumatoid arthritis cases.

FactorsFactorsObservationsObservations

Initial Initial After 1 monthAfter 1 month After 3 monthsAfter 3 months

Blood Urea (mg%)Blood Urea (mg%)25.7225.72±3.01±3.01

27.2527.25±3.42±3.42

23.2823.28±4.96±4.96

Serum Creatinine (mgSerum Creatinine (mg%)%)

0.720.72±0.21±0.21

0.800.80±0.11±0.11

0.750.75±0.13±0.13

Serum Sodium (mEq/L)Serum Sodium (mEq/L)139.65139.65±12.62±12.62

132.82132.82±15.01±15.01

137.62137.62±16.92±16.92

Serum Potassium Serum Potassium (mEq/L)(mEq/L)

3.863.86±0.98±0.98

4.504.50±0.81±0.81

3.963.96±0.78±0.78

Creatinine clearance Creatinine clearance (ml/min)(ml/min)

117.82117.82±11.64±11.64

121.65121.65±12.95±12.95

118.86118.86±13.76±13.76

115

116

117

118

119

120

121

122

Initial After 1months

After 3months

Creatinine clearance

ml/m

inu

te

Page 37: Introduction to Ayurveda-Safety Aspects of Herbo-Metallic Compounds-Rasa Aushadhi of Ayurveda Prof. G.P. Dubey, Dr. Aruna Agrawal, Prof. G.V. Rajamanickam.

Level of lead in blood and urine following Level of lead in blood and urine following oral administration of Mahayograj guggulu oral administration of Mahayograj guggulu (with silver & makardhwaj) in rheumatoid (with silver & makardhwaj) in rheumatoid

arthritis casesarthritis cases

0

10

20

30

40

50

60

70

80

Initial After 1 month After 2 months After 3 months

BloodUrineg

/dl

Normal range – In Blood <29 gm/dl In Urine < 2.3 gm/dl

Page 38: Introduction to Ayurveda-Safety Aspects of Herbo-Metallic Compounds-Rasa Aushadhi of Ayurveda Prof. G.P. Dubey, Dr. Aruna Agrawal, Prof. G.V. Rajamanickam.

Level of mercury in blood and urine following oral Level of mercury in blood and urine following oral administration of Mahayograj guggulu (with silver administration of Mahayograj guggulu (with silver

& makardhwaj) in rheumatoid arthritis cases& makardhwaj) in rheumatoid arthritis cases

0

5

10

15

20

25

Initial After 1 month After 2 months After 3 months

BloodUrine

g/d

l

Normal range – In Blood < 2.0 gm/dl In Urine < 2.3 gm/dl

Page 39: Introduction to Ayurveda-Safety Aspects of Herbo-Metallic Compounds-Rasa Aushadhi of Ayurveda Prof. G.P. Dubey, Dr. Aruna Agrawal, Prof. G.V. Rajamanickam.

Level of Arsenic in blood and urine following oral Level of Arsenic in blood and urine following oral administration of Mahayograj guggulu (with silver administration of Mahayograj guggulu (with silver

& makardhwaj) in rheumatoid arthritis cases& makardhwaj) in rheumatoid arthritis cases

0

2

4

6

8

10

12

14

16

18

Initial After 1 month After 2 months After 3 months

BloodUrine

g/d

l

Normal range – In Blood < 3.0 gm/dl In Urine < 8.4 gm/dl

Page 40: Introduction to Ayurveda-Safety Aspects of Herbo-Metallic Compounds-Rasa Aushadhi of Ayurveda Prof. G.P. Dubey, Dr. Aruna Agrawal, Prof. G.V. Rajamanickam.

Elimination of lead after withdrawal Elimination of lead after withdrawal of Mahayograj guggulu of Mahayograj guggulu

with silver and makardhwaj :-with silver and makardhwaj :-

0

20

40

60

Initial After 7 days After 15 days

UrineBlood

gm

/dl

Page 41: Introduction to Ayurveda-Safety Aspects of Herbo-Metallic Compounds-Rasa Aushadhi of Ayurveda Prof. G.P. Dubey, Dr. Aruna Agrawal, Prof. G.V. Rajamanickam.

ConclusionConclusion Ayurveda has adopted holistic approach. It Ayurveda has adopted holistic approach. It

includes the entire spectrum of life.includes the entire spectrum of life. The object is to enhance longevity.The object is to enhance longevity. The application of fundamental principles of The application of fundamental principles of

Ayurveda is helpful in the prevention and Ayurveda is helpful in the prevention and management of various mental and physical management of various mental and physical disorders.disorders.

The non-pharmacologic procedures include The non-pharmacologic procedures include observance of good conduct and practice of observance of good conduct and practice of relaxation, meditation and other yogic practices relaxation, meditation and other yogic practices in order to maintain the positive health.in order to maintain the positive health.

In Ayurveda various metal and minerals are In Ayurveda various metal and minerals are used for the prevention and management of used for the prevention and management of various diseases. The metals are modified in a various diseases. The metals are modified in a new compound which have therapeutic new compound which have therapeutic potentials.potentials.

Page 42: Introduction to Ayurveda-Safety Aspects of Herbo-Metallic Compounds-Rasa Aushadhi of Ayurveda Prof. G.P. Dubey, Dr. Aruna Agrawal, Prof. G.V. Rajamanickam.