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

Transcription

1 A CLINICAL STUDY OF PANDUGHNI VATI ON PANDU W.S.R. To IRON DEFICIENCY ANEMIA IN CHILDREN Dr. V. K. KORI Asst. Professor Prof.. K. S. PATEL HOD DEPARTMENT OF KAUMARABHRITYA Institute for Post Graduate Teaching And Research in Ayurveda Gujarat Ayurved University, Jamnagar

2 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 1/5 th 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, ****National Family Health Survey-III (NFHS-III) ,Delhi

3 Indian Govt. started a National Anemia Prophylaxis Programme in Recently Government of India in collaboration with WHO*, UNICEF* and FOGSI* launched the 12 by 12 initiative, on 23 April 2007**. 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 (Indian Medical Association) Anemia free India, as a Public Private Partnership and Anemia Chale Jao etc. However, most of these programmes have not had anticipated success 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

4 Anemia is defined as the reduction of hemoglobin concentration or the hematocrit below the range of values 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:

5 Faulty Diet Atisevena (excessive use): Kshara, Amla, Lavana, Katu, Kashaya, Tikshna, Ruksha, Ushna,Vidahi Ahara, Nishpava, Tila Taila, Pinyaka, Masha, Madya, Matsya, Mridbhakshana Sharirika Vyayama, Divaswapna etc (During digestion of food) Manasika Kama Krodha Bhaya Chinta Shoka

6 Krimiroga Grahaniroga Pratishyaya Jeerna Jwara

7 Panduta Gatramarda Hriddrava Akshikutashotha Gatrasada Kopanatva Aruchi Annadwesha Shishiradwesha Roma shata Agnisada Balakshaya Bhrama Dourbalya Gaurava Pindikodweshtana

8 Sanchaya Dosha Sanchaya Agni Dushti Prakopa Dhatusaithilya Pitta Pradhan Tridosha Prakopa Purvaroopa Agnimandya Prasara Samghatabheda Svarupatahaani & Svavyaparsaithilya Hridayaprapti Circulation through Dasa Dhamani Sadhak Pitta, Vyana Vayu Hridaya Spandana Shthivana Prekshanakoota Shotha Amotpatti Srotorodha Sthanasanshraya Tvakmasantara Ashrita Vyana Vayu Tvak Rukshata Kapha, Vata, Asrik, Tvak, Mamsa Dushti Svedabhava, Shrama Vyakti Dhatukshaya Rakta Poshak Bhaga Anutpada Bala, Varna, Sneha, Oja Kshaya Uttarottara Dhatukshaya Tvaksphotana, Gatrasada, Mrudabhakshana (Prabhavajanya) Bheda Vataja Pittaja Kaphaja Sannipataja Mrudabhakshanajanya

9 A) Kinetic approach B) Morphological approach 1. Blood Loss Acute: GI bleeding, Injuries, Childbirth, Surgery Chronic: Lesions of gastrointestinal tract, gynecological disturbances 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) abnormalities Antibody mediated Mechanical trauma to red cells Infections Chemical injury 3. Impaired Red Cell production (Ineffective hematopoiesis) Defective DNA synthesis: megaloblastic anaemias Defective haemoglobin synthesis Deficient heme synthesis: Iron deficiency Deficient globin synthesis: Thalassemias 1. Normocytic Normochromic Anaemias MCV, MCH and MCHC are within the normal range 2. Microcytic Hypochromic Anaemias MCV* (<approx. 80 fl.) MCH** (<approx. 27 pg) MCHC*** (<approx. 30 g/dl) Ex. iron deficiency and thalassemias 3. Macrocytic Anaemias MCV (>approx. 96fl) *MCV Mean Corpuscular Volume **MCH- Mean Corpuscular Hemoglobin ***MCHC- Mean Corpuscular Hemoglobin Concentration

10 Drug Review

11 Sr. no. Name of drug Botanical name Proporti on Part used 1. Amalki Emblica officinalis 1 Dry fruit Gaertn. 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 ex Benth. 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 Amalaki kwath Emblica officinalis Gaertn. 2

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13 Drugs Rasa Guna Virya Vipaka Doshag Karma Amalaki Bibhitaki Amla pradhan Panca Rasa. Kashaya Katu Punarnava Madhura, Tikta, Guru, Ruksha Shita Ruksha, Laghu, hnata Shita Madhura T Rasayana, Balya, Dipana, Medhya, Antioxidant Ushna Katu T Dhatuvardhaka, dipana, Anulomana, Antioxidant Laghu, Ruksha Ushna Madhura T Shothahara, Raktavardhaka, Mutral, Kashaya 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, Immunamodulator Kumari Katu Guru, Snigdha, Shita Tikta K P Vedanasthapana, Vrunaropana, Pichchhila hepatoprotective Gomutra Katu, Tikta, Tikshna, Laghu Ushna Katu K V Antioxidant, Antimicrobial Immunomodulator Kashaya

14 Clinical Study

15 To assess the efficacy of Pandughni Vati on various objective and subjective parameters among patients of Panduroga.

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

17 Patients of 2-16 age groups having classical symptomatology of Panduroga/Iron deficiency anemia. Hemoglobin <11.5 gm/dl Transferrin Saturation Index* <16 Patients with worms in stool were dewormed and included in study only after stool report become negative for worms. *T. Saturation= S. Iron TIBC X 100

18 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.

19 Pandughni Vati Form of drug Dose: : Tablate Age group(yr) Pandughni Vati Frequency gram three divided doses gram three divided doses gram three divided doses Time of Administration Anupana Duration of Treatment Follow up : After breakfast and meal : Luke warm water : 90 days : 60 days

20 : 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

21 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

22 Panduta No Pallor 0 Pallor hard palate 2 Pallor of hard palate, palms/tongue 4 Pallor of hard palate, palms/tongue, conjunctiva. 6 Pallor of hard palate, palms/tongue,conjunctiva 8,nails and skin Hriddrava No palpitation 0 Palpitation on heavy exertion 1 Palpitation on moderate exertion 2 Palpitation on mild exertion. 3 Akshikuta Shotha Edema occational. 1 Periorbital edema only in the morning hours. 2 Periorbital edema present throughout the day. 3

23 Pindikodveshtana No leg cramps 0 Mild leg cramps only at night. 1 Leg cramps present in night or on exertion. 2 Leg cramps present in night or on exertion, needs 3 medication. Leg cramps present throughout the day. 4 Shwasa No dyspnoea 0 Dyspnoea on heavy work or play. 2 Dyspnoea on moderate work or play. 4 Dyspnoea on light work or play. 6 Dyspnoea on routine activities. 8

24 Daurbalya No weakness. 0 Weakness present, routines not hampered. 1 Weakness present, routines hampered. 2 Weakness present, routines hampered, school 3 absenteeism Always sleepy. 4 Recurrent URTI No H/O RURTI 0 RURTI one episode /month. 1 RURTI two episode /month 2 RURTI three episodes /month. 3 RURTI > three episode /month 4 Weight Gain No Weight Gain 0 Weight Gain 1kg in three months. 2 Weight Gain 2 kg in three months 4 Weight Gain 3 kg in three months. 6 Weight Gain >3 kg in three months 8

25 Jarana Shakti Presence of all 0 (Utsah/Laghuta/Udgarshuddhi/Kshut/ Trishna/Yathochit malpravrutti) Any 4 2 Any 3 3 Any 2 4 Any 1 5 Abhyaharana Shakti Good quantity thrice a day 0 Reduction up to 25% 2 Reduction up to 50% 3 Reduction upto 75%, on IV fluids 4 Only on IV Fluids 5

26 Ruchi Aharakale Equally willing towards all the Bhojya 0 padarth(sarva rasa) Willing towards some specific Ahara/Rasavishesha 1 Willing towards only one among 2 Katu/Amla/Madhura food Only most liking, not to others 3 Unwilling for food but could take the meal 4 Totally unwilling for food 5 Vata Mutra Purisha Retasam mukti (esp. bowel) Easily in normal routine 0 In normal routine but with difficulty/after meals 1 Alternate day/1-2 times,not well formed 3 Every 2nd day/2-3 times, semi liquid, with food 4 particles Every 3rd day/3-4 times,liquid stools 5

27 Kopanatva No Irritability, always cheerful 0 Occasional irritability. 1 Frequent irritability 2 Irritability throughout the day 4 Nidra labho yathakalam Sound sleep (Deep, unbroken) 0 Delayed onset of sleep, gets disturbed at night 1 Sleep only for 3-4 hrs at night/day 2 No sleep at all at night/some hrs in day time only 3 Concentration and enthusiasm Enthusiastic and having concentration, interest in 0 routine Less enthusiastic, not able to concentrate but interested 1 in routine Less enthusiastic and not interested in work 2 Loss of enthusiasm and concentration 3

28 100% relief Cure (Complete remission) 76-99% relief Marked Improvement 51-75% relief Moderate Improvement 26-50% relief Mild Improvement < 25% relief Unchanged

29 Observations

30 1.97% Mild (Hb %) % % 33.33% 64.7% Moderate (Hb.<10-7%) Severe (Hb. <7%) Complete Discontinue 1.96% 17.64% 21.56% 43.13% 0-6months 6-12 months months months

31 %Observations n=

32 N= % 0 % Observations

33 % of Patients N= % % % Grahanidosha Krimiroga Pratishyaya

34 n= % of patients

35 N=51 % 0 % of patients

36 N= % 0 Dashavidha Pariksha

37 Results

38 Features n BT AT % of relief SD SE t p Panduta Daurbalya Shwasa Hriddrava Akshikutashotha <0.05 Pindikodweshtana

39 Features n BT AT % of relief SD SE t p Jwara <0.01 Shira Shula Gatramarda Kopanatva Agnisada Annadwesha Katipadaururuk ShirnaLomata <0.01 Chanchalatva <0.01 Smrutihras Suptata <0.01 Shishiradwesh Balakshaya

40 Parameters n BT AT % of relief SD SE t p Hb (g/dl) <0.01 PCV (%) >0.05 MCV (fl) >0.05 MCH (pg) <0.05 MCHC (g/dl) >0.05 TRBC (10 6 /µl) >0.05

41 Parameters N BT AT % of relief SD SE T p Blood urea (mg/dl) >0.05 S.Creatinine (mg/dl) >0.05 SGOT (IU/L) >0.05 SGPT (IU/L) >0.05 Total Protein (g/dl) >0.05 Albumin (g/dl) >0.05 Globulin (g/dl) >0.05 Alk. Phosphatase (IU/L) >0.05 S.Bilirubin (mg/dl) >0.05 Uric acid (mg/dl) >0.05 S. Calcium (mg/dl) >0.05

42 Parameters n BT AT % of relief SD SE t p S.Iron (IU/L) >0.05 S.Ferritin (IU/L) <0.05 S.TIBC (IU/L) >0.05 Transferrin Saturation (%) >0.05

43 Parameters n BT AT % of relief SD SE t p S.Iron (IU/L) >0.05 S. Ferritin (IU/L) >0.05 S.TIBC (IU/L) >0.05 Transferrin Saturation (%) >0.05

44 Parameters n BT AT % of relief SD SE t p Hb (g/dl) >0.05 S.Iron (IU/L) >0.05 S. Ferritin (IU/L) <0.01 S.TIBC (IU/L) >0.05 Transferrin Saturation (%) >0.05

45 100 Overall effect of therapy on various parameters of Pandu 87.03% 84.8% % % 0 Cardinal features Associated features Bala (Deha,Agni,Satva) Hematological Specific markers -7.87% -20

46 % 13.33% 0% 3.33% Cured Marked Imp. Moderate Imp. Mild Ipm.

47 Discussion

48 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:

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50 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

51 Maternal edu. Secondary (33.33%) Paternal edu. Secondary (35.29%) A study stated that poor education is the common cause of anemia. Because it is responsible for lack of knowledge about balanced and nutritious diet, faulty dietary habits etc. which may lead to nutritional anemia. Parents had little knowledge of the symptoms, causes and prevention of anemia. 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

52 Socioeconomic status 74.50% lower SES Dietary pattern 64.70% Vegetarian Various studies proved that patients from lower SES have higher grades of anemia than higher SES. Vegetarians are more likely to develop iron deficiency, it may be due to the fact that availability of iron in plants ranges from only 1-10%, while that in meet, fish etc, is 20-30%. Animal products are source of haem iron and its absorption is usually high compared to non haem iron. 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, pg Devidsons principle and practice of medicine, 20 th ed. 2006, Elsevier ltd., editors Nicholas Boon, Nicki college, Brain walker John Hunter, pg126.

53 PV revealed highly significant result on all cardinal and associated features. PV shown significant increase (P<0.01) in Hemoglobin level. MCH was significantly increased (P< 0.05) MCH, The absorption of iron and improvement in hematological parameters depends on availability of enhancers and quantity of iron*. *

54 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 Johns Hopkins University, Baltimore, Maryland 21205, USA.

55 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

56 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.

57 Appetizer, digestive and hepatoprotactive drugs (Kutaki, shunthi, Marich, Vi danga, Amalki, Bibhitaki ) Pippali and Shunthi: Increase the bioavailability & enhances absorption of the nutrients Amalaki, Bihitaki, Shunthi and Pippali: Antioxidant, Immunomod ulatory Correction of digestion & Iron deficiency Amalaki : Rich in Iron and Vitamin C

58 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.

59 No adverse effect was reported during study period

60