A clinical trial on ayurvedic formulation in the management of Garbhini Pandu w.s.r Anaemia in Pregnancy.

Phase 2

Not yet recruiting

• Conditions: Anemia complicating pregnancy, childbirth and the puerperium. Ayurveda Condition: GARBINIROGAH,

• Registration Number: CTRI/2022/04/042128
• Lead Sponsor: National Institute of Ayurveda Jaipur

Brief Summary

PRIMARY PURPOSE: Treatment

NEED OF STUDY:According to the WHO, anaemia affects 14% of pregnant women indeveloped and 51% in developing countries. It is painful to mentionthat India accounts for almost 80% of maternal fatalities in SouthAsia owing to anaemia.Anaemia during pregnancy has been linked to poor maternal andchild health, as well as a higher risk of maternal and perinatalmortality. Fatigue, poor work capacity, increased risk of cardiacdisease and mortality are all unfavourable health implications forthe mother.Preterm birth and low birth weight babies are associated to anaemiain pregnancy. It is also associated with increased risk of intrauterinedeaths, low APGAR score and intrauterine growth restriction(IUGR).[10] Anaemia is commonly due to dietary deficiency(nutrition, iron, folic acid, iodine and other micronutrients) orinfections.[11]Acharya Charaka has said that Raktadi dhatus get vitiated byDoshas, mainly by Pitta dosha and disease like Pandu appear.There is no direct formulations available for the management ofGarbhini Pandu in Ayurveda Samhitas. The line of treatment inPandu is Shodhana, but it is contraindicated during pregnancy.Therefore, appropriate Shamana Chikitsa has to be adopted. On thebasis of Pandughnata (antianaemic), Preenana (nourishing) andRaktaprasadana (blood toner) properties Punarnava Mandura isfound useful for the management of all types of Pandu. Hence toprevent various complications of anaemia in pregnancy, to provide asafe management to the pregnant lady and to study the efficacy ofindigenous compound this research work is undertaken.

AIM:ï‚· To assess the role of Punarnava Mandura with and withoutShatavari Avaleha in the management of Garbhini Pandu.

OBJECTIVES:Primary Objectives:• To assess and compare the efficacy of Punarnava Mandurawith and without Shatavari Avaleha in the management ofGarbhini Pandu.Secondary Objectives:1. To assess the improvement in quality of life.2. To assess the improvement in associated symptoms ofGarbhini 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).

HYPOTHESIS:

ï‚· NULL HYPOTHESIS (H0): There is no difference in theefficacy of Punarnava Mandura with and without ShatavariAvaleha in the management of Garbhini Pandu.

ï‚· ALTERNATIVE HYPOTHESIS (H1): There is significantdifference in the efficacy of Punarnava Mandura with andwithout Shatavari Avaleha in the management of GarbhiniPandu.

ï‚· RESEARCH QUESTION: Is there significant difference in theefficacy of Punarnava Mandura with and without ShatavariAvaleha in the management of Garbhini Pandu?

ASSESSMENT CRITERIA:During the trial and follow up study the patients will be assessedon the basis of following parameters before and after the treatment.ï‚· Shrama (fatigue), Panduta (pallor), Daurbalya (generalweakness), Shwasa (dyspnea), Hridspandana (palpitations),Aruchi (anorexia), Akshikuta Shoth (periorbital edema),Pindikodveshthana (leg cramps), Bhrama (giddiness).ï‚· Complete blood count (CBC), Haemoglobin percentage(Hb%), Serum iron, Total iron binding capacity (TIBC), Serumferritin.

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, TotalProtein• Other routine ANC investigations: Blood group with Rhesus factor (ABORH) Human Immunodeficiency Virus(HIV) Veneral disease research laboratory(VDRL) Hepatitis B Surface Antigen (HbsAg)• Ultrasonography (USG) for fetal well beingDuring Treatment:HaemoglobinAfter Treatment: Complete blood count (CBC) Serum iron Total iron binding capacity (TIBC) Serum ferritin

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-05
• Last Update Posted: 2022-04-24

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

• 1.A pregnant woman aged between 20-40 years with anaemia in between 13th to 28th week of pregnancy.
• Pregnant woman with haemoglobin percentage 7.0-10.00 gm/dl (moderate anaemia).

Exclusion Criteria

• 1.Anaemia other than iron deficiency anaemia.
• Patients having haemoglobin percentage less than 7.0 gm/dl.
• Patients suffering from any systemic disease.
• Patients suffering from pregnancy related complication such as pregnancy induced hypertensive disorders, hyperemesis gravidarum, gestational diabetes etc.
• Pregnancy associated with Rh Incompatibility, Jaundice,Ovarian tumour, Placenta Previa, abruptio Placenta, fibroid with pregnancy etc.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Achievement of more than 10gm/dl Haemoglobin	2 MONTHS

Secondary Outcome Measures

Name	Time	Method
1. Improvement in quality of life – SF 36.	2. Changes in Complete blood count (CBC), Serum iron, Total iron

Trial Locations

Locations (1)

National Institute of Ayurveda, Jaipur and associated hospitals; 🇮🇳 Jaipur, RAJASTHAN, India

National Institute of Ayurveda, Jaipur and associated hospitals

🇮🇳Jaipur, RAJASTHAN, India

Dr Sonia Sharma

Principal investigator

8005696282

sonia.sharmasog@gmail.com