A comparative study on the effect of Pandughnivati and Dhatrilauhavati in the management of Garbhinipandu (Iron Deficiency Anemia).

The desire to have a healthy progeny is innate and very intense in every livingbeing. The hectic life and tremendous stress in daily life has made the conception and continuation of pregnancy till term very difficult. Anemia is one of the common disease conditions, which affects a pregnant woman. In Ayurvedic classics anemia in pregnancy is taken under the Rasa Pradoshajavikara. It is clear that Garbhavasthajanyapandu occurs due to the fetal demands and improper functioning of the Rasadhatu leading to malnourishment of the body. A total of 26 patients were registered from out-patient department of Streeroga and Prasutitantra, out of which four patients discontinued. The remaining 22 patients were randomly divided into two groups; Group A (n-12) Pandughnivati two tablets of 500 mg tds and Group B (n-10) Dhatrilauhavati one tablet of 500 mg tds. Dhatrilauhavati was selected for the present study due to its Pandughna, Prinana, Raktaprasadana properties. In the present study, Pandughnivati a compound formulation developed by AYUSH department was administered for patients of group A. The results revealed that the over all clinical improvement was better in patients of Group B when compared to Group A. Hence it was concluded that Dhatrilauhavati was effective in treating anemia during pregnancy.

RCT Entities:   Population Interventions Outcomes

Introduction

Acharya Harita has described eight Garbhopadravas in Harita Samhita[1] and included Vivarnatva, which appears to be pallor that accompanies anemia. In the context of Raktagulma, Acharya Kashyapa has described furnished similar description during with Garbhavastha (pregnancy) which refres to Garbhavasthajanya Pandu.[2] The growing fetus is nourished by the Rasa of mother.[3] So, mother needs a better and more nutritious diet. Kashyapa Acharya has described that Ahara Rasa of the mother is divided into three parts. First part nourishes her own body, second part nourishes the Garbha (fetus) and the third part is utilized for the nourishment of Stana (breast).[4] Acharya Charaka has also described “Pandutva” (pallor) as a Rasapradoshaja Vikara.[5] It is clear that Garbhavasthajanya Pandu occurs due to the fetal demands and improper functioning of the Rasadhatu leading to malnourishment of the body.

Maternal diet and maternal tissues store supply nutrients to the fetus. No mother will be able to meet the extra demand of nutrients by diet alone. This leads to certain pathological conditions in a pregnant woman. Among these, iron deficiency anemia is very common.

When the hemoglobin percentage (Hb%) decreases to less than 11 g/dl in 1st trimester and 3rd trimester or less than 10.5 g/ dl in 2nd trimester in peripheral blood the condition is called anemia[6] (Center for Disease Control and Prevention). In Asia and South Africa about 20% pregnant females die due to iron deficiency anemia[7] (UNICEF, 1997). In India anemia in pregnancy is the most common high risk pregnancy having incidence of 40-80%. In western countries, this incidence is 10-20%.[8]

The analysis of the formulations mentioned in the context of Pandu (anemia) indicates that they contain herbal ingredients like Shunthi, Maricha etc., which are known correctors of metabolism and enhancers of bio-availability of nutrients irrespective of the factor whether they contain metallic iron or not. Though metallic and non-metallic preparations are indicated in the management of Pandu, Pandughnivati had been selected, which can improve the metabolism and Agni and thus improve the Pandu. Dhatrilauhavati contains Lauha Bhasma, which is iron supplementation and Deepana which leads to proper metabolism and Dhatuposhana and other ingredients are Rasayana and Shonitasthapana, so, Dhatrilauhavati[9] had been selected as a metallic preparation. The drugs were prepared in Vati form for easy administration.

Aims and Objective

To study the etiopathogenesis of Garbhinipandu (anemia in pregnancy).

To evaluate and compare the efficacy of Pandughnivati and Dhatrilauhavati in Garbhinipandu (anemia in pregnancy).

Materials and Methods

Patients

Patients attending the out-patient department of Streeroga and Prasootitantra, those fulfilling the criteria for the selection were selected for the study. A detailed history was taken according to the proforma specially prepared for this purpose.

Drugs

Pandughnivati and Dhatrilauhavati were prepared in pharmacy of Gujarat Ayurved University, Jamnagar.

Pandughnivati contains Amalaki, Bibhitaki, Punarnava, Vidanga, Shunthi, Maricha, Pippali and Katuki in an equal amount. Bhavana of Kumari Swarasa (one time), Gomutra (one time), Punarnava (two times) and Amalaki (two times) Swarasa was given during preparing the Vati.

Dhatrilauhavati contains four parts Dhatri, two parts Lauha Bhasma and one part Yastimadhu. Bhavana with Amruta Kwatha for seven times was given during preparing the Vati.

Criteria for selection of patients

Inclusion criteria

Patients with clinical signs and symptoms of Pandu (anemia) described in Ayurvedic classics and modern medicine

Patients of 2nd or 3rd trimester of pregnancy

Patients having Hb% equal to or less than 10 gm% but more than 6.5 gm%

Microcytic hypochromic appearance of red blood cell in peripheral smear.

Exclusion criteria

Patients suffering from pregnancy related complications such as pregnancy induced hypertension pregnancy induced hypertension (PIH), hyperemesis gravidarum, pre-eclampsia etc

1st trimester of pregnancy

Patients having with high risk pregnancy

Patients having Hb% count less than 6.5 gm% and more than 10 gm%.

Criteria for assessment

Increase in Hb%

Improvement in signs and symptoms of the disease

Improvement in other biological parameters.

Ethical clearance

The study was cleared by the Institutional Ethics Committee. Prior to initiation of the study, written consent was taken from each patient. Patients were asked to withdraw their name from the study at any time without giving any reason if they wish.

Investigation

Hematological investigations like Hb (Hemoglobin) %, total red blood cell((TRBC), total leucocyte count (TLC), differential leucocyte count (DLC), platelet count, erythrocyte sedimentation rate (ESR), packed cell volume (PCV), mean cell volume (MCV), Mean corpuscular hemoglobin (MCH), Mean corpuscular hemoglobin concentration (MCHC), peripheral smear, serum ferritin, serum iron, total iron binding capacity (TIBC) and routine and microscopic urine investigations were done.

Posology

Group A: Patients were given two tablets of Pandughnivati (500 mg) tds, before the meal with luke warm water for 90 days.

Group B: Patients were given one tablet of Dhatrilauhavati (500 mg) tds, before the meal with luke warm water for 90 days.

Statistical test

Based on observations, the data obtained were statistically analyzed in terms of mean, standard deviation, standard error and unpaired t-test was considered at the level of P < 0.001 as highly significant, P < 0.05 or P < 0.01 as significant and P > 0.05 as insignificant to assess the result.

Assessment for overall effect of therapy

Complete remission: 100% relief in the signs and symptoms

Marked Improvement: Above 76%

Moderate Improvement: 51-75% relief in the signs and symptoms

Mild improvement: 26-50% relief in the signs and symptoms

Unchanged: Up to 25% relief.

Observations

In this clinical study, total 14 patients were registered in Group A, out of which 12 patients completed the treatment, whereas two patients discontinued. Out of 12 patients registered in Group B, 10 patients completed the treatment, whereas two patients discontinued.

In the present study, maximum number of patients, i.e., 46.15% belonged to age group of 23-27 years, 46.15% were between 13 and 16 weeks of gestation, 69.23% were multipara, 53.85% patients belonged to urban area, 100% were housewives, 65.38% were vegetarian, 88.46% patients were addicted of tea, 73.07% patients had Vata-Pitta Prakriti and 84.62% had Mandagni.

Results

Group A provided relief in all the cardinal features of Garbhinipandu. The result observed in Shwasa (dyspnea) (60%) and Hridrava (palpitation) (53.33%) were highly significant statistically (<0.001). Daurbalya (general weakness) (33.33%), Shrama (fatigue) (40%), Aruchi (anorexia) (28.57%) and Pindikodvestana (leg cramps) (55.55%) were decreased which were found statistically significant (P < 0.05) [Table 1]. No response was seen in objective parameters in this study [Table 2]. In Group B, results observed were highly significant statistically (P < 0.001) in Panduta (pallor) (50%) and Shwasa (dyspnea) (56.25%). The results in Shrama (fatigue) (61.54%), Hridrava (palpitation) (55.55%), Aruchi (anorexia) (42.85%), Pindikodvestan (leg cramps) (49.49%) were significant statistically (<0.05) [Table 3]. Hb%, TRBC, PCV were slightly increased and TIBC was decreased in Group B whereas no result was found in other objective parameters [Table 4].

Table 1

Effect on cardinal features-Group A

Table 2

Effects on laboratory investigations-Group A

Table 3

Effect on cardinal features-Group B

Table 4

Effects on laboratory investigations-Group B

Total effect of therapy

On subjective parameters, in Group A, none of the patient had got complete remission, 8.33% of patients got marked improvement, and 33.33% patients got moderate improvement. 41.67% of patients had got mild improvement and 16.67% remained unchanged. In Group B none of the patients had got complete remission, 10% patients got marked improvement, 50% patients got moderate improvement, 30% patients had got mild improvement and 10% remained unchanged [Figure 1].

Figure 1

Overall effect of therapy on subjective parameters

On objective parameters, in Group A, none of the patients had got complete remission, marked improvement and moderate improvement. Nearly 16.67% of patients had got mild improvement and 83.33% patients remained unchanged. In Group B, Nearly 10% patients got mild improvement and 90% patients remained unchanged [Figure 2].

Figure 2

Overall effect of therapy on objective parameters

Discussion

Gabhinipandu (anemia in pregnancy) may be taken as a Rasapradoshajavyadhi and it is a Santarpanothavikara, which is common in Garbhavastha (pregnancy). The consumable objects having excessive Amla, Lavana, Katu etc., Rasa, Abhojana, Pramitabhojana etc., is consumed abundantly by the pregnant women during pregnancy due to Dauhridavastha and Manasika Bhava like Chinta, Shoka, Krodha etc., and other condition like multiple and repeated pregnancy were found as etiological factors for Garbhini Pandu.

In the present study, majority of patients (69.23%) were Multi Para. This observation indicates that repeated pregnancies and due to excessive blood loss they become Anemic. 65.38% patients were having a vegetarian diet. As iron supplied from Veg. diet is mainly non-Haem iron and its bioavailability is only about 1-10%.[10] That is why vegetarians are more prone for iron deficiency anemia. Almost 84.62% had Mandagni. Mandagni creates Ama production and improper Rasa Dhatu formation, which is the foremost step in development of Pandu. 88.46% were habituated to tea. Tannins in tea can cause iron absorption to drop by 60%.

In Group A, result was observed statistically significant improvement in a maximum of the cardinal features of Garbhinipandu. These results were observed due to efficacy of drugs of Pandughnivati such as Raktavardhaka, Amapachana and Srotoshodhaka. The decrease in Hb% can be due to the combined effect of increased demand and raised hemo-dilution which is physiological in pregnancy state. Dhatrilauhavati provided relief in all the cardinal features of Garbhinipandu. Hb%, TRBC, PCV were increased in percentage. Dhatrilauhavati contains Lauha Bhasma, which is iron supplementation and Deepana which leads to proper metabolism and Dhatuposhana. Amalaki and Amruta are Rasayana which leads to Dhatuposhana as well as supportive for the iron absorption. Yastimadhu has Shonitasthapana property. Thus, all cumulative effect leads to correction of metabolism, iron absorption, improved blood formation and correction of disease.

On comparing the effect of therapy on objective and subjective parameters of both groups there was not significant results. It means that both the therapies have more or less same effect and any one of them cannot be claimed as superior to other statistically. However, the better result was obtained in Group B than Group A. This may be attributed to the presence of Lauha Bhasma in Dhatrilauhavati.

Probable mode of action of Pandughnivati in Pandu

Pandughnivati contains Trikatu, which is Deepana Pachana and has Srotoshodhaka property, which leads to proper metabolism and formation of proper Dhatus. Amalaki, which is a rich source of Vitamin C, is known enhancer of iron absorption. It also contains Katuki which is Pitta Virechaka, thus corrects Pitta and Rakta. Punarnava has Srotoshodhaka and Raktavardhaka properties. Thus, the cumulative effects of all the drugs lead to correction of metabolism, iron absorption, improved blood formation and correction of disease.

Probable mode of action of Dhatrilauhavati in Pandu

Dhatrilauhavati contains Lauha Bhasma, which is iron supplement and has Deepana property which leads to proper metabolism and Dhatuposhana. Amalaki and Amruta are Rasayana which lead to Dhatuposhana as well as are supportive for the iron absorption. Yastimadhu has Shonitasthapana property. Thus, cumulative effects of all the drugs lead to correction of metabolism, iron absorption, improved blood formation and correction of disease.

Conclusion

Garbhinipandu may be correlated with iron deficiency anemia in pregnancy, which is commonly seen. In the present study on comparison a better percentage of improvement was noted in group B (Dhatrilauhavati) in terms of subjective and objective parameters than group A (Pandughnivati).