A CLINICAL STUDY OF PANDUGHNI VATI ON PANDU W.S.R. To IRON DEFICIENCY ANEMIA IN CHILDREN

Prof.. K. S. PATELHODDr. V. K. KORI

Asst. Professor

Institute for Post Graduate Teaching And Research in AyurvedaGujarat Ayurved University,

Jamnagar-361008

DEPARTMENT OF KAUMARABHRITYA

• With a global population of 6,700 million, at least 3,600

million people have iron deficiency and 2000 million out of

these suffer from iron deficiency anemia.

• South East Asia contributes to 1/5th of population living with

Iron deficiency anemia*.

• Prevalence of anemia in India to be higher than other south

Asian countries**.

• The Third National Family Health Survey (NFHS 3)

reported that prevalence of anemia to be 70-80% in

children. ****GBD 2000 WHO estimates.

** Lancet study rings alarm over anaemia prevalence in India, Indian Express, August 11, 2011.

****National Family Health Survey-III (NFHS-III) 2005-06,Delhi

• Indian Govt. started a National Anemia Prophylaxis Programme in1970.

• Recently Government of India in collaboration with WHO*,UNICEF* and FOGSI* launched the 12 by 12 initiative, on 23 April2007**.

• Several other programmes focusing on issue of anemia include:

1. Mid-day meal programme

2. Kishori Swasthya Yojna,

3. Matri Suraksha Abhiyan

4. ICDS (Integrated Child Development Services), IMA (IndianMedical Association) Anemia free India, as a Public PrivatePartnership and Anemia Chale Jao etc.

• However, most of these programmes have not had anticipatedsuccess and anemia prevalence goes on increasing.

*World Health Organization, United Nations Children’s Fund, Federation of obstetric and Gynecology Society of India**Suneeta Mittal , FCH news and workshop 12 by 12 initiative booklet, , July, 2007, All India Institute of Medical Sciences, New Delhi

Anemia is defined as the reduction of hemoglobinconcentration or the hematocrit below the range ofvalues occurring in healthy persons.*

IRON DEFICIENCY ANEMIA (IDA)

Iron deficiency anemia (IDA) is defined as the depletion of

iron stores in the body where iron loss exceeds iron intake

for a long time and insufficient iron is available for normal

hemoglobin production.

*Bertil Glader, The Anemias. In Nelson Text Book of Pediatrics, Ed Behrman RE et al. 17th Edition, Saunders, Philadelphia, 2004: 1604-1632.

Faulty DietAtisevena (excessive

use):

Kshara, Amla, Lavana,

Katu, Kashaya,

Tikshna, Ruksha,

Ushna,Vidahi Ahara,

Nishpava, Tila Taila,

Pinyaka, Masha, Madya,

Matsya, Mridbhakshana

Sharirika Manasika

Vyayama, Divaswapna

etc

(During digestion of

food)

Kama

Krodha

Bhaya

Chinta

Shoka

Krimiroga

Grahaniroga

Pratishyaya

Jeerna Jwara

Panduta

Gatramarda

Hriddrava

Akshikutashotha

Gatrasada

Kopanatva

Aruchi

Annadwesha

Shishiradwesha

Roma shata

Agnisada

Balakshaya

Bhrama

Dourbalya

Gaurava

Pindikodweshtana

Pitta PradhanTridosha Prakopa

Agni DushtiSanchaya

DhatusaithilyaAgnimandya

Amotpatti

Srotorodha

Dosha Sanchaya

Hridayaprapti

UttarottaraDhatukshaya

Prakopa

Sadhak Pitta,Vyana Vayu

Circulation through Dasa DhamaniPrasara

Tvakmasantara AshritaSthanasanshraya

Kapha, Vata, Asrik, Tvak, Mamsa Dushti

Rakta Poshak BhagaAnutpada

Bala, Varna, Sneha, Oja Kshaya

Purvaroopa

Hridaya Spandana

Shthivana

Prekshanakoota Shotha

Vyana Vayu Tvak Rukshata

Svedabhava, Shrama

Tvaksphotana, Gatrasada,Mrudabhakshana (Prabhavajanya)

SamghatabhedaSvarupatahaani & Svavyaparsaithilya

Dhatukshaya

Vyakti

Bheda Vataja Pittaja Kaphaja Sannipataja Mrudabhakshanajanya

A) Kinetic approach B) Morphological approach

1. Blood LossAcute: GI bleeding, Injuries, Childbirth, SurgeryChronic: Lesions of gastrointestinal tract, gynecologicaldisturbances

2. Increased Rate of Destruction(Haemolytic anaemias)•Intrinsic (intracorpuscular) abnormalities of RBC

Red cell membrane disorders Red cell enzyme deficiencies Disorders of haemoglobin synthesis

• Extrinsic (extra corpuscular) abnormalitiesAntibody mediated Mechanical trauma to red cells InfectionsChemical injury

3. Impaired Red Cell production(Ineffective hematopoiesis)

• Defective DNA synthesis: megaloblastic anaemias• Defective haemoglobin synthesis

Deficient heme synthesis: Iron deficiencyDeficient globin synthesis: Thalassemias

1. Normocytic Normochromic AnaemiasMCV, MCH and MCHC are within the normal range

2. Microcytic Hypochromic AnaemiasMCV* (<approx. 80 fl.) MCH** (<approx. 27 pg)MCHC*** (<approx. 30 g/dl)

Ex. iron deficiency and thalassemias

3. Macrocytic AnaemiasMCV (>approx. 96fl)

*MCV – Mean Corpuscular Volume**MCH- Mean Corpuscular Hemoglobin***MCHC- Mean Corpuscular Hemoglobin Concentration

Drug Review

Sr. no. Name of drug Botanical name Proporti

on

Part used

1. Amalki Emblica officinalisGaertn.

1 Dry fruit

2. Bibhitaki Terminalia belerica Roxb. 1 Dry fruit

3. Punarnava Boerhaavia diffusa Linn. 1 Whole plant (dry)

4. Vidanga Embelia ribes Burm. f. 1 Dry fruit

5. Shunthi Zingiber officinale Rosc. 1 Dry Rhizome

6. Maricha Piper nigrum Linn. 1 Dry fruit

7. Pippali Piper longum Linn. 1 Dry fruit

8. Katuki Picrorhiza kurroa Royle exBenth.

1 Dry Rhizome

Sr. no. Name of drug Latin name No. of Bhavana

9 Kumari swaras Aloe barbadensis Mill 1

10 Gomutra Cow’s urine 1

11 Punarnava kwath Boerhaavia diffusa Linn. 2

12 Amalaki kwath Emblica officinalis Gaertn. 2

Drugs Rasa Guna Virya Vipaka Doshag

hnata

Karma

Amalaki Amla pradhan

Panca Rasa.

Guru, Ruksha

Shita

Shita Madhura T Rasayana, Balya, Dipana, Medhya,

Antioxidant

Bibhitaki Kashaya

Katu

Ruksha,

Laghu,

Ushna Katu T Dhatuvardhaka, dipana, Anulomana,

Antioxidant

Punarnava Madhura, Tikta,

Kashaya

Laghu, Ruksha Ushna Madhura T Shothahara, Raktavardhaka, Mutral,

Antioxidant

Vidanga Katu, Kashaya Laghu,Ruksha Ushna Katu K V Dipana, Anuloman, krimighna,

Raktashodhak, Varnya, Rasayana

Shunthi Katu Laghu, Snigdha Ushna Madhura K V Deepana, Rochana, Pachana,

Antioxidant

Maricha Katu Laghu, Tikshna Ushna Katu K V Deepana, Pachana,

Srotoshodhana, Antioxidant

Pippali Katu Snigdha, Ushna,Tikshna Shita Madhura V K Raktavardhaka, Yakriduttejaka,

Bioavaibility enhancer

Katuki Tikta Ruksha, Laghu Shita Katu K P Deepana, Yakriduttejaka

Bhedana, antioxidant,

ImmunamodulatorKumari Katu Guru, Snigdha,

Pichchhila

Shita Tikta K P Vedanasthapana, Vrunaropana,

hepatoprotective

Gomutra Katu, Tikta,

Kashaya

Tikshna, Laghu Ushna Katu K V Antioxidant, Antimicrobial

Immunomodulator

Clinical Study

To assess the efficacy of Pandughni Vati on various

objective and subjective parameters among patients

of Panduroga.

• Patients attending the OPD of Kaumarbhritya Dept, IPGT

& RA, Jamnagar from age 2 to 16 of either sex fulfilling

the inclusion criteria were selected for the study.

• Clinical study cleared by Institutional Ethics Committee:

Ref-PGT/Ethics/2008-9/2520 dated 24-11-2008

• Clinical study registered in CTRI: CTRI/2011/12/002310

Patients of 2-16 age groups having classical symptomatologyof Panduroga/Iron deficiency anemia.

Hemoglobin <11.5 gm/dl

Transferrin Saturation Index* <16

Patients with worms in stool were dewormed and included instudy only after stool report become negative for worms.

*T. Saturation=S. Iron

TIBCX 100

Age <2 years and >16 years

Hemoglobinopathies especially Thalassemia.

Associated Cardiac Complaints.

Hemoglobin below 6.5% g/dl.

Patients with conditions causing chronic blood loss.

Chronic debilitating illness like TB, Juvenile Diabetes.

Regular/ irregular menstrual cycle with heavy blood loss in

adolescent girls.

Pandughni Vati

Form of drug : Tablate

Dose:

Time of Administration : After breakfast and meal

Anupana : Luke warm water

Duration of Treatment : 90 days

Follow up : 60 days

Age group(Yr) Pandughni Vati Frequency

2-6 3.0 gram three divided doses

7-11 6.5 gram three divided doses

12-16 10.5 gram three divided doses

: S. iron, S. ferritin,

Total Iron Binding Capacity (TIBC)

:Total Protein, A/G ratio, SGOT,

SGPT, Alk. Phosphatase, S.Bilirubin

:S. Urea, S. Creatinine

:Routine and microscopic

:Routine and microscopic

• Subjective Parameters:1. Roga Bala-Cardinal and Associated Symptoms of Pandu

Roga.

2. Dehabala, Agnibala and Satvabala Pariksha.

• Objective Parameters:1. Haematology-Hb%, PCV, MCV, MCH, MCHC, TRBC

2. Marker Compounds- S. Iron, S. ferritin, TIBC, Transferrin

Saturation

No Pallor 0Pallor hard palate 2Pallor of hard palate, palms/tongue 4Pallor of hard palate, palms/tongue, conjunctiva. 6Pallor of hard palate, palms/tongue ,conjunctiva ,nails and skin

8

Panduta

No palpitation 0Palpitation on heavy exertion 1Palpitation on moderate exertion 2Palpitation on mild exertion. 3

Hriddrava

Edema occational. 1Periorbital edema only in the morning hours. 2Periorbital edema present throughout the day. 3

Akshikuta Shotha

No leg cramps 0Mild leg cramps only at night. 1Leg cramps present in night or on exertion. 2Leg cramps present in night or on exertion, needs medication.

3

Leg cramps present throughout the day. 4

Pindikodveshtana

No dyspnoea 0Dyspnoea on heavy work or play. 2Dyspnoea on moderate work or play. 4Dyspnoea on light work or play. 6Dyspnoea on routine activities. 8

Shwasa

No weakness. 0Weakness present, routines not hampered. 1Weakness present, routines hampered. 2Weakness present, routines hampered, school absenteeism

3

Always sleepy. 4

Daurbalya

No H/O RURTI 0RURTI one episode /month. 1RURTI two episode /month 2RURTI three episodes /month. 3RURTI > three episode /month 4

Recurrent URTI

No Weight Gain 0Weight Gain 1kg in three months. 2Weight Gain 2 kg in three months 4Weight Gain 3 kg in three months. 6Weight Gain >3 kg in three months 8

Weight Gain

Presence of all (Utsah/Laghuta/Udgarshuddhi/Kshut/Trishna/Yathochit malpravrutti)

0

Any 4 2Any 3 3Any 2 4Any 1 5

Jarana Shakti

Good quantity thrice a day 0Reduction up to 25% 2Reduction up to 50% 3Reduction upto 75%, on IV fluids 4Only on IV Fluids 5

Abhyaharana Shakti

Equally willing towards all the Bhojyapadarth(sarva rasa)

0

Willing towards some specific Ahara/Rasavishesha 1Willing towards only one among Katu/Amla/Madhura food

2

Only most liking, not to others 3Unwilling for food but could take the meal 4Totally unwilling for food 5

Ruchi Aharakale

Easily in normal routine 0In normal routine but with difficulty/after meals 1Alternate day/1-2 times ,not well formed 3Every 2nd day/2-3 times, semi liquid, with food particles

4

Every 3rd day/3-4 times ,liquid stools 5

Vata Mutra Purisha Retasam mukti (esp. bowel)

No Irritability , always cheerful 0Occasional irritability. 1Frequent irritability 2Irritability throughout the day 4

Kopanatva

Sound sleep (Deep, unbroken) 0Delayed onset of sleep, gets disturbed at night 1Sleep only for 3-4 hrs at night/day 2No sleep at all at night/some hrs in day time only 3

Nidra labho yathakalam

Enthusiastic and having concentration, interest in routine

0

Less enthusiastic, not able to concentrate but interested in routine

1

Less enthusiastic and not interested in work 2Loss of enthusiasm and concentration 3

Concentration and enthusiasm

• Cure (Complete remission) 100% relief

• Marked Improvement76-99% relief

• Moderate Improvement51-75% relief

• Mild Improvement26-50% relief

• Unchanged< 25% relief

Observations

58.82%

41.18%

Complete

Discontinue

64.7%

33.33%

1.97% Mild (Hb. 11.5-10%)

Moderate (Hb.<10-7%)

Severe (Hb. <7%)

43.13%21.56%

17.64%

1.96%

0-6months

6-12 months

12-24 months

24-36 months

0

20

40

60

80 74.5

64.770.5

64.7 64.7

33.33 35.29

74.5

%Observations n=51

0

20

40

60

80

100

64.7 64.7

29.41

90.19 92.15

58.82

% Observations

N=51

%

0102030405060708090

35.2943.13

76.4766.6762.74

47.05

88.23% of Patients N=51

23.08 %

41.76 %

52.75 %

Grahanidosha Krimiroga Pratishyaya

0

20

40

60

80

100100

96.07

43.13

25.49

13.7229.41

% of patients

n=51

0

20

40

60

80

60.78

47.05

39.21

70.5864.7

31.3739.21

62.74

23.52

% of patients

N=51

%

0

20

40

60

80

100

47.05

82.27

54.9

60.78

49.01

45.09

50.98

52.94

52.94

72.54

100

Dashavidha Pariksha

N=51

%

Results

Features n BT AT% of

reliefSD SE t p

Panduta 30 4.53 0.73 83.82 1.10 0.20 19.00

Daurbalya 29 1.86 0.34 81.48 0.63 0.12 12.90

Shwasa 13 3.15 0.15 95.12 1.41 0.39 7.65

Hriddrava 10 1.80 0.30 83.33 0.71 0.22 6.71

Akshikutashotha 4 2.00 0.25 87.50 0.96 0.48 3.66 <0.05

Pindikodweshtana 7 1.57 0.14 90.91 0.53 0.20 7.07

Features n BT AT% of

reliefSD SE t p

Jwara 7 1.43 0.00 100 0.79 0.16 4.80 <0.01

Shira Shula 10 1.40 0.20 85.71 0.42 0.13 9.00

Gatramarda 12 1.50 0.17 88.89 0.49 0.14 9.38

Kopanatva 21 2.14 0.48 77.78 0.66 0.14 11.60

Agnisada 17 1.65 0.06 96.43 0.62 0.15 10.59

Annadwesha 20 1.75 0.15 91.43 0.88 0.20 8.11

Katipadaururuk 11 1.55 0.18 88.24 0.67 0.20 6.71

ShirnaLomata 10 1.80 0.50 72.22 0.95 0.30 4.33 <0.01

Chanchalatva 5 1.80 0.40 77.78 0.55 0.24 5.72 <0.01

Smrutihras 10 1.30 0.20 84.62 0.32 0.10 11

Suptata 8 1.75 0.50 71.43 0.89 0.31 3.99 <0.01

Shishiradwesh 7 1.00 0.14 85.71 0.38 0.14 6.00

Balakshaya 18 1.56 0.28 82.14 0.57 0.14 9.44

Parameters n BT AT% of

reliefSD SE t p

Hb (g/dL) 30 10.16 10.54 3.75 0.69 0.13 3.02 <0.01

PCV (%) 30 32.22 32.84 1.9 1.95 0.36 1.72 >0.05

MCV (fl) 30 70.01 70.53 0.74 1.70 0.31 1.67 >0.05

MCH (pg) 30 22.22 22.53 1.43 0.70 0.13 2.46 <0.05

MCHC (g/dL) 30 31.51 31.74 0.75 1.16 0.21 1.12 >0.05

TRBC (106/µL) 30 4.66 4.76 2.10 0.29 0.05 1.84 >0.05

Parameters N BT AT% of

reliefSD SE T p

Blood urea (mg/dL) 30 19.63 19.70 0.34 6.59 1.20 0.06 >0.05

S.Creatinine (mg/dL) 30 0.57 0.53 7.56 0.14 0.03 1.69 >0.05

SGOT (IU/L) 30 28.83 29.07 0.81 7.56 1.38 0.17 >0.05

SGPT (IU/L) 30 12.47 12.33 1.07 7.19 1.31 0.10 >0.05

Total Protein (g/dL) 30 6.99 6.99 0.05 0.33 0.06 0.06 >0.05

Albumin (g/dL) 30 4.06 4.09 0.74 0.31 0.06 0.53 >0.05

Globulin (g/dL) 30 2.93 2.91 0.91 0.42 0.08 0.35 >0.05

Alk. Phosphatase (IU/L) 30 144.63 150.13 3.8 53.58 9.78 0.56 >0.05

S.Bilirubin (mg/dL) 30 0.56 0.58 4.79 0.26 0.05 0.57 >0.05

Uric acid (mg/dL) 30 3.19 3.35 5.12 1.17 0.21 0.77 >0.05

S. Calcium (mg/dL) 30 9.58 9.79 2.26 0.65 0.12 1.83 >0.05

Parameters n BT AT% of

reliefSD SE t p

S.Iron (IU/L) 30 36.41 38.02 ↑4.42 7.44 1.36 1.18 >0.05

S.Ferritin (IU/L) 30 25.77 15.46 39.99 20.53 3.75 2.75 <0.05

S.TIBC (IU/L) 30 382.47 389.20 ↑1.76 67.09 12.25 0.55 >0.05

TransferrinSaturation (%) 30 9.65 9.88 ↑2.32 1.23 0.22 0.99 >0.05

Parameters n BT AT% of

reliefSD SE t p

S.Iron (IU/L) 15 36.87 39.67 7.58 6.38 1.65 1.70 >0.05

S. Ferritin (IU/L) 15 24.46 14.55 40.53 21.72 5.61 1.77 >0.05

S.TIBC (IU/L) 15 358.73 378.73 5.58 78.18 20.19 0.99 >0.05

TransferrinSaturation (%)

15 10.38 10.64 2.50 1.26 0.32 0.80 >0.05

Parameters n BT AT% of

reliefSD SE t p

Hb (g/dL) 13 9.91 9.94 0.31 0.77 0.21 0.14 >0.05

S.Iron (IU/L) 13 36.32 36.60 0.76 9.07 2.52 0.11 >0.05

S. Ferritin (IU/L) 13 28.58 14.84 48.07 19.30 5.35 2.57 <0.01

S.TIBC (IU/L) 13403.6

9397.00 1.66 57.50 15.95 0.42 >0.05

TransferrinSaturation (%)

13 9.08 9.23 1.65 1.33 0.37 0.41 >0.05

Overall effect of therapy on various parameters of Pandu

87.03%84.8%

61.62%

1.82%

-7.87%

-20

0

20

40

60

80

100

Cardinal features Associated features

Bala (Deha,Agni,Satva)

Hematological Specific markers

0% 3.33%

80%

13.33%

0

10

20

30

40

50

60

70

80

90

Cured Marked Imp. Moderate Imp. Mild Ipm.

Discussion

Basic difference in the management – Pandu / IDA

• Correction of Metabolism Vs Nutritional Deficiency

• Pandu – A Santarpanottha Vyadhi

• Correctors of Agni Vs Role of iron containing compounds

• Charaka Samhita: 108 preparations are indicated but only 13 preparations

contain iron.

• AFI:102 preparations are indicated but only 30 preparations contain iron.

• Administration of metallic preparations require special cautions in children.*

• * Masawe MJ. The adverse effect of iron retention on the course of certain infections. British medical journal, 1987, 2:1113–15.

Discontinued patients = 21

8 : Non-cooperative (fear of injection)

2 : laboratory personal were unable to take sample even after several pricks

6 : Irregular

1 : URTI Infections

1 : vomiting

1 : diarrhea

1 : Refusal of intake due to Heavy dose of PV

1 : Move other place

• A study stated that pooreducation is the common cause ofanemia. Because it is responsiblefor lack of knowledge aboutbalanced and nutritiousdiet, faulty dietary habits etc.which may lead to nutritionalanemia.

• Parents had little knowledge ofthe symptoms, causes andprevention of anemia.

Maternal edu. Secondary (33.33%)

Paternal edu. Secondary (35.29%)

www.jiag org, www.ijag.org,

Lillian Mwanri, Anthony W, Joseph M, School and anaemia prevention: current reality and opportunities—a Tanzanian case study, Oxford

Journal, health promotion International, Vol 16, issue4, pg 321-331.

• Various studies proved that patients fromlower SES have higher grades of anemiathan higher SES.

Socio-economic

status

74.50% lower SES

• Vegetarians are more likely to developiron deficiency, it may be due to the factthat availability of iron in plants rangesfrom only 1-10%, while that in meet, fishetc, is 20-30%. Animal products aresource of haem iron and its absorption isusually high compared to non haemiron.

Dietary pattern 64.70%

Vegetarian

Sanjeev M Chaudhry, Vasant R Dhage, A study of anemia among adolescent female in the urban area of Nagpur , IJCM, Vol33, issue

4, oct.2008, pg243-245.

Devidsons principle and practice of medicine, 20th ed. 2006, Elsevier ltd., editors Nicholas Boon, Nicki college, Brain walker John Hunter, pg126.

• PV shown significant increase (P<0.01) in Hemoglobin level.

• MCH was significantly increased (P< 0.05) MCH, Theabsorption of iron and improvement in hematologicalparameters depends on availability of enhancers and quantityof iron*.

*http://www.who.int/nutrition/publications/micronutrients/guidelines_for_Iron_supplementation.pdf

• PV revealed highly significant result on all cardinal andassociated features.

PV, All biochemical parameters shown insignificant result

Finding are suggestive of normal functioning of liver and

kidney and normal metabolism of body. Various studies

revealed that vitamin C may lower the serum uric acid level*.

*Arthritis Rheum. 2005. Johns Hopkins University, Baltimore, Maryland 21205, USA.

• S. ferritin was significantly decreased (P<0.05) High

S. ferritin reflects high stores of iron in the body.

• S. iron and Transferrin saturation shown insignificant

result. Iron is transported in blood by the protein

transferrin High iron intake may increase S. iron and

transferrin saturation and helpful in correcting IDA

because *.*Centers for Disease Control and Prevention (CDC), Recommendations to Prevent and Control Iron Deficiency in the United States, MMWR, April 3, 1998 / Vol. 47 / No. RR-3

• increase in hemoglobin level was highly significantly

in 2-6 yrs children, but insignificant change was

noticed in 7-11yrs aged children

• Some dissimilarity was noted between the present study and

the previous research. Previous research work on Pandughni

Vati shown insignificant result in adult*. But in present

research work insignificant result was noticed in 7-11yrs aged

children while highly significant result shown in 2-6yrs aged

children.

Appetizer, digestive and hepatoprotactive drugs

(Kutaki, shunthi, Marich, Vidanga, Amalki, Bibhitaki )

Pippali and Shunthi: Increase the bioavailability &

enhances absorption of the nutrients

Amalaki : Rich in

Iron and Vitamin C

Amalaki, Bihitaki, Shunthiand Pippali:

Antioxidant, Immunomodulatory

Correction of digestion

& Iron deficiency

Pandu includes Various types of Anemias

Kapha Dominant variety of Pandu has more resemblance with IDA

More emphasis given for the correction of Metabolism as well as

supplementation of Iron in treatment of Pandu.

Presence of Grahanidosha (23.52%), Krimiroga (43.13%) and Pratishyaya

(62.74%) show strong evidence between anemia and these conditions.

On subjective parameters shown Highly Significant result.

Pandughni Vati prevents anemia enhances the hemoglobin level in this

clinical trial.

No adverse effect was reported

during study period