Introduction to Ayurveda safety aspects of herbo … Session 2/pdf/Dr... · Rasa Aushadhi:...

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Introduction to Ayurveda Introduction to Ayurveda - - Safety Safety Aspects of Aspects of Herbo Herbo - - Metallic Metallic Compounds Compounds - - Rasa Aushadhi of Rasa Aushadhi of Ayurveda 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, BHU Deptt. 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, SASTRA, Thanjavur Thanjavur

Transcript of Introduction to Ayurveda safety aspects of herbo … Session 2/pdf/Dr... · Rasa Aushadhi:...

Page 1: Introduction to Ayurveda safety aspects of herbo … Session 2/pdf/Dr... · Rasa Aushadhi: Preparations containing metals, minerals ... (Rasa Tarangini ) human dose 125mg to 250mg/day

Introduction to AyurvedaIntroduction to Ayurveda--Safety Safety Aspects of Aspects of HerboHerbo--Metallic Metallic

CompoundsCompounds--Rasa Aushadhi of Rasa Aushadhi of AyurvedaAyurveda

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, SASTRA, Thanjavur Thanjavur

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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. gave to their science of medicine. AyuhAyuh means 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 Dharma (religion) is not decompartmentalizeddecompartmentalized; it ; it includes the adaptation of customs, traditions, includes the adaptation of customs, traditions, ethics, hygiene and medicine.ethics, hygiene and medicine.

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Subject Matter:Subject Matter:

The fundamental concept is mainly based on Samkhya and Nayaya Vaisheshikasystem 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.

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Ayurvedic concept of Health is based on Ayurvedic concept of Health is based on TridoshaTridosha Theory. Theory. TridosaTridosa is biological entity is biological entity responsible for structural, functional and responsible for structural, functional and

behavioral dimensions of the living organism.behavioral dimensions of the living organism.

DoshasDoshas are two types are two types --ManasikManasik (Psychic) (Psychic) –– SattvaSattva, Raja & Tama, Raja & TamaSharirikaSharirika (Somatic) (Somatic) –– VataVata, , PittaPitta & & KaphaKaphaSharirikaSharirika and and MansikaMansika dosasdosas are interacting 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.

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MIND BODY INTERACTION

S R T

P V K

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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

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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

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Ayurvedic approach of therapy Ayurvedic approach of therapy

PromotivePromotivePreventivePreventiveCurativeCurative

i.i. NonNon--Pharmacologic procedures: Diet, Pharmacologic procedures: Diet, exercise, yogicexercise, yogic--meditation relaxation meditation relaxation practices, observance of practices, observance of sadvrittasadvritta (socio(socio--cultural conduct) as per cultural conduct) as per doshikdoshik setup, and setup, and circadian and seasonal variation.circadian and seasonal variation.

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

HerboHerbo--metallic preparationsmetallic preparations::

BhasmaBhasma: Powder of a substance obtained by : Powder of a substance obtained by calcinationcalcination is is called called BhasmasBhasmas. It is applied to metals and minerals and . It is applied to metals and minerals and animal productsanimal products

RasaRasa--Yoga: Preparations containing minerals as main Yoga: Preparations containing minerals as main ingredients are called Rasaingredients are called Rasa--yoga. yoga. AbhrakAbhrak (Mica), (Mica), MakshikMakshik(copper(copper--pyrites) , pyrites) , SwarnaSwarna (gold), (gold), RajatRajat (silver), (silver), TamraTamra(copper), (copper), KamsyaKamsya (Bell metal) etc.(Bell metal) etc.

Rasa Aushadhi: Preparations containing metals, minerals Rasa Aushadhi: Preparations containing metals, minerals are considered are considered rasarasa--aushadhiaushadhi::

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Mercury, Arsenic, Lead, Zinc, Tin, Iron, Mercury, Arsenic, Lead, Zinc, Tin, Iron, SulphurSulphur & & 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 (Identification of new compound (herboherbo--metallic) 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.

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PhysicoPhysico--chemical characterizationchemical characterizationDistribution, BioDistribution, Bio--transformation and Eliminationtransformation and Elimination

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

DistributionDistribution :: Distributes widely to all Distributes widely to all tissue, kidney, liver spleen tissue, kidney, liver spleen and CNS.and CNS.

EliminationElimination : : Primarily by Urine and Primarily by Urine and fecal Interact with fecal Interact with different enzyme systems different enzyme systems in the body in Presence of in the body in Presence of sulphursulphur..

ActionAction : : Target organ system Target organ system

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WHO LimitNormal permissible concentration

Heavy Metals Heavy Metals BloodBloodMercuryMercury 0.20.2--3 3 ngng/ml/mlArsenicArsenic 1.1 µgm/Lit.1.1 µgm/Lit.LeadLead 0.020.02--1.0 µgm/Lit.1.0 µgm/Lit.CopperCopper 100100--200 µgm/dl200 µgm/dlAluminiumAluminium 11--10 10 ngng/ml/mlNickelNickel 0.050.05--1 1 ngng/ml/mlMagnisiumMagnisium 1.81.8--3 mg/dl3 mg/dlZincZinc 5050--150 µgm/Lit.150 µgm/Lit.IronIron 50.175 µgm/Lit.50.175 µgm/Lit.

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

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

Obtained ValueObtained Value Obtained ValueObtained Value

UrbanUrban Rural Rural UrbanUrban Rural Rural

Mercury Mercury 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

Normal Normal ValueValue

Normal Normal ValueValue

ElementElementss

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

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

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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.

250250 66 0/60/6300300 66 0/60/6

5050 66 0/60/6

100100 66 0/60/6150150 66 0/60/6200200 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

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Neurobehavioral toxicity following Makardhwaj(Dose 50 mg/kg)

ObservationsObservations

TestsTests 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 following No neurobehavioral abnormality was observed following oral administration of Makardhwajoral administration of Makardhwaj

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Chronic Toxicity of Makardhwaj:Chronic Toxicity of Makardhwaj:

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

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

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

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Normal Micro angiography of the Kidney

Right Kidney Left Kidney

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HgCl2 2.5 mg/kg body wt; Makardhwaj 12.50 mg/kg body wtDose 2.5 mg/kg body wt Dose 5.0 mg/kg body wt

Damage with HgCl2 (Low Dose) Damage with HgCl2

(High Dose)Makardhwaj +HgCl2

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Effect of Makardhwaj on serotonin level in experimental rats

Serotonin (Serotonin (µµ gm/gm tissue)gm/gm tissue)

Frontal CortexFrontal Cortex HippocampusHippocampusNo. No. of of

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

Normal Normal control control

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

1010

1010

0.4220.422±± 0.0880.088

0.4180.418±± 0.0750.075

0.3620.362±± 0.0920.092

0.3640.364±± 0.0840.084

Makardhwaj Makardhwaj 300 mg/kg300 mg/kg

****

0.3160.316±±0.0610.061

0.3640.364±±0.0540.054

0.2410.241±±0.0420.042

0.2010.201±±0.0640.064

MakardhwajMakardhwaj100 mg/kg100 mg/kg

******

0.4380.438±±0.0820.082

0.4560.456±±0.0720.072

0.3840.384±±0.0650.065

0.3960.396±±0.0750.075

Treated Treated GroupGroup

*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

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

nornor--adrenaline(µ gm/gm tissue)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

0.3680.368±0.067±0.067

0.2220.222±±0.0450.045

0.3840.384±±0.0850.085

Treated Treated GroupGroup

No. of No. of animalanimal

Normal Normal control (ACSF control (ACSF

5ml)*5ml)*1010 0.3760.376

± 0.058± 0.0580.6210.621

± 0.092± 0.0920.6310.631

± 0.085± 0.085Makardhwaj Makardhwaj 300 mg/kg300 mg/kg

****1010 0.2160.216

±±0.0510.0510.4080.408±±0.0390.039

0.4020.402±±0.0610.061

MakardhwajMakardhwaj100 mg/kg100 mg/kg

******1010 0.3880.388

±±0.0780.0780.6420.642±±0.0980.098

0.6500.650±±0.0900.090

*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

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

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

0.8360.836±0.082±0.082

0.6640.664±0.050±0.050

0.8410.841±0.101±0.101

Treated Treated GroupGroup

No. of No. of animalanimal

Normal Normal control (ACSF control (ACSF

5ml)*5ml)*1010 0.8420.842

±0.074±0.0741.2721.272

±0.092±0.0921.2081.208

±0.088±0.088Makardhwaj Makardhwaj 300 mg/kg300 mg/kg

****1010 0.6410.641

±0.033±0.0331.1561.156

±0.024±0.0241.1081.108

±0.052±0.052

MakardhwajMakardhwaj100 mg/kg100 mg/kg

******1010 0.8580.858

±0.104±0.1041.2891.289

±0.088±0.0881.2831.283

±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

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Effect of Makardhwaj on Effect of Makardhwaj on cholinecholine-- acetylacetyl--transferasetransferasein experimental ratsin experimental rats

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

Frontal cortexFrontal cortex HippocampusHippocampus

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

22.3422.34±2.85±2.85

18.2118.21±2.01±2.01

24.1424.14±3.02±3.02

Treated Treated GroupGroup

No. of No. of animalanimal

Normal Normal control (ACSF control (ACSF

5ml)*5ml)*1010 23.9723.97

±3.11±3.1120.2420.24±2.12±2.12

19.8819.88±2.75±2.75

Makardhwaj Makardhwaj 300 mg/kg300 mg/kg

****1010 16.1416.14

±2.11±2.1116.2216.22±3.01±3.01

14.0614.06±3.10±3.10

MakardhwajMakardhwaj100 mg/kg100 mg/kg

******1010 25.6825.68

±2.94±2.9421.9821.98±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

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

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

Lead : 37000 22000

Mercury : 22800 23800

Arsenic : 8100 6200

Presence of Organic materials

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Mahayogaraj Guggulu (with Silver and Makardhwaj)

Silver particle

MET. ENGG. IT- BHU & SASTRA, THANJAVUR

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SemSem of Mahayograj of Mahayograj guggulguggul (with silver (with silver and Makardhwaj)and Makardhwaj)

Tubular

particlesFlakes

Fused &

Solidification

cracks

Fine Spherical

particles

Particles sizes varies from 2-100 microns

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Acute toxicity of Mahayograj Acute toxicity of Mahayograj gugguluguggulu (with silver & Makardhwaj)(with silver & Makardhwaj)Animal model: Charles Animal model: Charles FoesterFoester Strain rats.Strain rats.

Dose LevelDose Level(mg/kg body wt.)(mg/kg body 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

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NeurobehaviouralNeurobehavioural acute toxicity following Mahayograj acute toxicity following Mahayograj GugguluGuggulu(with Silver & Makardhwaj)(with Silver & Makardhwaj)(Dose 250 (Dose 250 mg/kg body wt)

ObservationsObservationsTestsTests

InitialInitial After 24 hrs.After 24 hrs. After 48 hrs.After 48 hrs. After 72 hrs.After 72 hrs.

Flexing Flexing reflexreflex ++ ++ ++ ++

Grasping Grasping reflexreflex ++ ++ ++ ++

Corneal Corneal reflexreflex ++ ++ ++ ++

Body Body equilibriumequilibrium ++ ++ ++ ++

Head Head shakingshaking ++ ++ ++ ++

AuditoryAuditory ++ ++ ++ ++

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Chronic Toxicity of Mahayograj Chronic Toxicity of Mahayograj GugguluGuggulu (with silver & Makardhwaj)(with silver & Makardhwaj)

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

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

No adverse effects on No adverse effects on hemopoetichemopoetic GastroGastro--intestinal, intestinal, HepatictHepatict and kidney function test and kidney function test were noticed.were noticed.

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Changes in Acetylcholine concentration following oral Changes in Acetylcholine concentration following oral administration of administration of MahalaxmivilasMahalaxmivilas rasras with gold with gold

mahayograjmahayograj gugguluguggulu with gold & Mahayograj with gold & Mahayograj guggulugugguluwith silver & makardhwajwith silver & makardhwaj

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

MahalaxmiMahalaxmivilasvilas RasRas((SwarnaSwarnayuktayukta))

10 mg/10 mg/Kg body Kg body

wt.wt.---- 21.6221.62

±1.05±1.0522.3222.32±1.60±1.60 ---- 26.4526.45

±2.11±2.1125.7225.72±1.82±1.82

Mahayograj Mahayograj GugguluGugguluwith goldwith gold

50 mg/50 mg/Kg body Kg body

wt.wt.

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±2.7522.6022.60±2.13±2.13

Mahayograj Mahayograj GugguluGuggulu

with Silver with Silver & &

MakardhwajMakardhwaj

---- 18.6518.65±1.82±1.82

17.5217.52±1.61±1.61 ---- 20.7420.74

±1.20±1.2019.7519.75±3.95±3.95

FactorsFactors

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Changes in norChanges in nor--adrenaline following oral administration adrenaline following oral administration of of MahalaxmivilasMahalaxmivilas rasras with gold with gold mahayograjmahayograj gugguluguggulu

with gold & Mahayograj with gold & Mahayograj gugguluguggulu with silver & with silver & makardhwajmakardhwaj

NorNor--adrenaline (µg/gm tissue)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

MahalaxmiMahalaxmivilasvilas RasRas((SwarnaSwarnayuktayukta))

10 mg/10 mg/Kg body Kg body

wt.wt.---- 0.3520.352

±0.50±0.500.3420.342

±0.040±0.040 ---- 0.2690.269±0.052±0.052

0.6310.631±0.061±0.061

Mahayograj Mahayograj GugguluGugguluwith goldwith gold

50 mg/50 mg/Kg body Kg body

wt.wt.

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±0.0620.5250.525

±0.025±0.025

Mahayograj Mahayograj GugguluGuggulu

with Silver with Silver & &

MakardhwajMakardhwaj

---- 0.2400.240±0.071±0.071

0.2350.235±0.062±0.062 ---- 0.4250.425

±0.025±0.0250.4200.420

±0.021±0.021

FactorsFactors

Page 32: Introduction to Ayurveda safety aspects of herbo … Session 2/pdf/Dr... · Rasa Aushadhi: Preparations containing metals, minerals ... (Rasa Tarangini ) human dose 125mg to 250mg/day

Changes in Dopamine following oral administration of Changes in Dopamine following oral administration of MahalaxmivilasMahalaxmivilas rasras with gold with gold mahayograjmahayograj gugguluguggulu with with gold & Mahayograj gold & Mahayograj gugguluguggulu with silver & makardhwajwith silver & makardhwaj

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

MahalaxmiMahalaxmivilasvilas RasRas((SwarnaSwarnayuktayukta))

10 mg/10 mg/Kg body Kg body

wt.wt.---- 0.8320.832

±0.040±0.0400.8450.845

±0.056±0.056 ---- 1.2351.235±0.072±0.072

1.2301.230±0.062±0.062

Mahayograj Mahayograj GugguluGugguluwith goldwith gold

50 mg/50 mg/Kg body Kg body

wt.wt.

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±0.0951.0231.023

±0.102±0.102

Mahayograj Mahayograj GugguluGuggulu

with Silver with Silver & &

MakardhwajMakardhwaj

---- 0.6450.645±0.060±0.060

0.6300.630±0.042±0.042 ---- 0.9850.985

±0.072±0.0720.9800.980

±0.081±0.081

FactorsFactors

Page 33: Introduction to Ayurveda safety aspects of herbo … Session 2/pdf/Dr... · Rasa Aushadhi: Preparations containing metals, minerals ... (Rasa Tarangini ) human dose 125mg to 250mg/day

Clinical StudyClinical Study

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

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

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

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

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Toxicity studies of the subjectsToxicity studies of the subjectsEvaluation of Mahayograj guggulu (with silver & Makardhwaj)

on Hemopoetic system among rheumatoid arthritis cases.

ObservationsObservationsFactorsFactors

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

MonocyteMonocyte (%)(%) 0.950.95±0.42±0.42

0.860.86±0.48±0.48

0.920.92±0.45±0.45

HbHb (%)(%) 11.0511.05±2.35±2.35

10.8010.80±2.15±2.15

11.3511.35±2.32±2.32

Page 35: Introduction to Ayurveda safety aspects of herbo … Session 2/pdf/Dr... · Rasa Aushadhi: Preparations containing metals, minerals ... (Rasa Tarangini ) human dose 125mg to 250mg/day

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

rheumatoid arthritis cases.

ObservationsObservationsFactorsFactors

Initial Initial After 1 monthAfter 1 month After 3 monthsAfter 3 monthsAlkaline 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 … Session 2/pdf/Dr... · Rasa Aushadhi: Preparations containing metals, minerals ... (Rasa Tarangini ) human dose 125mg to 250mg/day

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

rheumatoid arthritis cases.ObservationsObservations

FactorsFactorsInitial 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 Serum CreatinineCreatinine(mg%)(mg%)

0.720.72±0.21±0.21

0.800.80±0.11±0.11

0.750.75±0.13±0.13

Serum Sodium (Serum Sodium (mEqmEq/L)/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 ((mEqmEq/L)/L)

3.863.86±0.98±0.98

4.504.50±0.81±0.81

3.963.96±0.78±0.78

CreatinineCreatinine clearance 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

inut

e

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Level of lead in blood and urine following oral Level of lead in blood and urine following oral administration of Mahayograj administration of Mahayograj gugguluguggulu (with silver (with silver

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

0

10

20

30

40

50

60

70

80

Initial After 1 month After 2 months After 3 months

BloodUrineµg

/dl

Normal range – In Blood <29 µgm/dlIn Urine < 2.3 µgm/dl

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

µg/d

l

Normal range – In Blood < 2.0 µgm/dlIn Urine < 2.3 µgm/dl

Page 39: Introduction to Ayurveda safety aspects of herbo … Session 2/pdf/Dr... · Rasa Aushadhi: Preparations containing metals, minerals ... (Rasa Tarangini ) human dose 125mg to 250mg/day

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

µg/d

l

Normal range – In Blood < 3.0 µgm/dlIn Urine < 8.4 µgm/dl

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

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

0

20

40

60

Initial After 7 days After 15 days

UrineBlood

µgm

/dl

Page 41: Introduction to Ayurveda safety aspects of herbo … Session 2/pdf/Dr... · Rasa Aushadhi: Preparations containing metals, minerals ... (Rasa Tarangini ) human dose 125mg to 250mg/day

ConclusionConclusionAyurveda has adopted holistic approach. It includes Ayurveda has adopted holistic approach. It includes the entire spectrum of life.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 nonThe non--pharmacologic procedures include pharmacologic procedures include observance of good conduct and practice of observance of good conduct and practice of relaxation, meditation and other yogic practices in relaxation, meditation and other yogic practices in order to maintain the positive health.order to maintain the positive health.In Ayurveda various metal and minerals are used In Ayurveda various metal and minerals are used for the prevention and management of various for the prevention and management of various diseases. The metals are modified in a new diseases. The metals are modified in a new compound which have therapeutic potentials.compound which have therapeutic potentials.

Page 42: Introduction to Ayurveda safety aspects of herbo … Session 2/pdf/Dr... · Rasa Aushadhi: Preparations containing metals, minerals ... (Rasa Tarangini ) human dose 125mg to 250mg/day