Randomized comparative trial to evaluate the effect of punarnava mandura with and without shatavari avaleha in garbhini pandu w.s.r. to iron deficiency anaemia in pregnancy

Primary Purpose- Treatment

Need Of Study-

According to the WHO, Anemia affects 14% of pregnant women in developed nations and 51% in developing countries. Mentioning the fact that anemia is the primary cause of about 80% of maternal deaths in South Asia occurs in India.

Poor maternal and fetal health, as well as a higher risk of maternal and postnatal mortality etc. have been connected to anaemia during pregnancy. For the mother’s health, fatigue, diminished productivity, a higher risk of cardiac disease, and mortality are all problems.

Preterm birth and low birth weight babies are associated to anaemia in pregnancy. It is also associated with increased risk of intrauterine deaths, low APGAR score and intrauterine growth restriction (IUGR).Anaemia is commonly due to dietary deficiency (nutrition, iron,

folic acid, iodine and other micronutrients) or infections. Acharya Charaka has said that Raktadi dhatus get vitiated by Doshas, mainly by Pitta dosha and disease like Pandu appear.

There is no direct formulations available for the management of Garbhini Pandu in Ayurveda Samhitas. The line of treatment in Pandu is Shodhana, but it is contraindicated during pregnancy. Therefore, appropriate Shamana Chikitsa has to be adopted. On the basis of Pandughnata (antianaemic), Preenana (nourishing) and Raktaprasadana (blood toner) properties Punarnava Mandura is found useful for the management of all types of Pandu. Hence to prevent various complications of anaemia in pregnancy, to provide a safe management to the pregnant lady and to study the efficacy of indigenous compound this research work is undertaken.

Aim-

To evaluate the efficacy of punarnava mandura with and without shatavari avaleha in the management of garbhini pandu w.s.r. to iron deficiency anaemia in pregnancy.

Objectives-

Primary Objectives-

To evaluate and compare the efficacy of Punarnava mandura with and without shatavari

avaleha in the management of garbhini pandu w.s.r.to iron deficiency anaemia in

pregnancy.

Secondary Objectives-

1 To assess the quality of life.

2 To assess presence or absence of associated symptoms of Garbhini pandu such as Shrama (fatigue), Panduta (pallor), Daurbalya (general weakness), Shwasa (dyspnea), Hridspandana (palpitations), Aruchi (anorexia), Akshikuta Shoth (periorbital edema), Pindikodveshthana (leg cramps), Bhrama (giddiness).

Research Question- Is there any difference in the efficacy of Punarnava mandura with and without shatavari Avaleha in the management of garbhini pandu?

Hypothesis-

Null Hypothesis (H0)- There is no difference in the efficacy of Punarnava mandura with and without shatavari Avaleha in the management of garbhini pandu.

Alternative Hypothesis (H1)- There is difference in the efficacy of Punarnava mandura with and without shatavari Avaleha in the management of garbhini pandu.

Assessment Criteria-During the trial and follow up study the patients will be assessed on the basis of following parameters before and after the treatment.

1. Shrama (fatigue), Panduta (pallor), Daurbalya (general weakness), Shwasa (dyspnea),Hridspandana (palpitations), Aruchi (anorexia), Akshikuta Shoth (periorbital edema), Pindikodveshthana (leg cramps), Bhrama (giddiness).

2. Complete blood count (CBC), Haemoglobin percentage (Hb%), Serum iron, Total iron binding capacity (TIBC), Serum ferritin.

Laboratory Investigations-

Before Treatment- Complete blood count (CBC) ,Peripheral blood smear (PBS),Serum Iron ,Total iron binding capacity (TIBC), Serum Ferritin, RFT - Blood Urea, Serum Creatinine, LFT - Total Serum Bilirubin, Serum Albumin, Total Protein

Other routine ANC investigations- Blood group with Rhesus factor (ABO RH), Human Immunodeficiency Virus (HIV), Venereal disease research laboratory (VDRL), Hepatitis B Surface Antigen (HbsAg), Ultrasonography (USG) for fetal well being

During Treatment- (After follow–up of one month)- Complete blood count (CBC)

After Treatment- Complete blood count (CBC), Serum iron, Total iron binding capacity (TIBC), Serum ferritin, Peripheral blood smear (PBS)