A clinical study to see the effect of some Ayurvedic formulations in the treatment of Anaemia

Phase 2

Recruiting

• Conditions: Iron Deficiency Anaemia

• Registration Number: CTRI/2012/01/002335
• Lead Sponsor: Department of AYUSH Ministry of Health Family Welfare Government of India

Brief Summary

Aimed at scientific validation of the clinical efficacy and safety of twenty nine (29) classical Ayurvedic pharmacopoeial formulations, multicentre clinical trials have been initiated as an activity under the Ayurveda Clinical Trials (ACT) project of the Ayurvedic Pharmacopoeia committee (APC) during August 2010 in eighteen (18) disease conditions involving fifty four (54) M.D/PhD (Ay.) research scholars in eight (08) postgraduate Ayurveda colleges across the country.xml:namespace prefix = o /

**Punarnavadi Madura**, is a classical polyherbal Ayurvedic formulation containing Punarnava (Boerhaavia diffusa), Trivrta (Ipomoea turpethum), Sunthi (Zingiber officinale), Marica (Piper nigrum), Pippali (Piper longum), Vidanga (Embelia ribes), Devdaru (Cedrus deodara), Citraka (Plumbago zeylanica), Kustha (Saussurea lappa), Haridra (Curcuma longa), Daruharidra (Berberis aristata), Haritaki (Terminalia chebula), Bibhitaka (Terminalia bellirica), Amlaki (Emblica officinalis), Danti (Baliospermum montanum), Cavya (Piper chaba), Indrayava (Holarrhena antidysenterica), Musta (Cyperus rotundus), Mandura Bhasma (Calcined Mandura), Gomutra (Cow urine).

**Dadimadi Ghrita** is a medicated ghrita containing Dadima (Punica granatum), Dhanyaka (Coriandrum sativum), Citraka (Plumbago zeylanica), Sunthi (Zingiber officinale), Pippali (Piper longum) and Ghrita.

**Punarnavadi Madura** and **Dadimadi Ghrita** have been in use since ages and found to be useful in treating Iron Deficiency Anaemia and promoting the health. The present study is being undertaken in three post graduate Ayurveda colleges involving the post graduate scholars who would be doing the clinical trials to scientifically study and validate the clinical efficacy and safety of these Ayurvedic formulations as a part of their Post Graduate (PG) Thesis.

The **Central Council for Research in Ayurvedic Sciences (CCRAS)** is the nodal organization to co-ordinate and monitor these trials. CCRAS has provided the necessary infrastructure to the participating colleges, technical inputs (including the clinical trial protocol), trial drugs and training to the researchers involved in the project.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01-14
• Last Update Posted: 2012-12-01

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Children of either sex aged between 10 to 14 years 2.
• Children with iron deficiency anemia (Hb 8gm-10gm.%), 3.
• Willing and able to participate for 16 weeks.

Exclusion Criteria

• Children suffering from major systemic illness necessitating long term drug treatment.
• Children with evidence of malignancy.
• Children with concurrent serious Hepatic Dysfunction (defined as AST and/or ALT 3 times of the upper normal limit) or Renal Dysfunction (defined as S.
• creatinine 1.2mg/dl) Uncontrolled Pulmonary Dysfunction (asthmatic and COPD patients) 4.
• Co-morbidities like Tuberculosis, Chronic urinary tract infection, Bleeding disorders etc.
• H/o hypersensitivity to any of the trial drugs or their ingredients.
• Children who have completed participation in any other clinical trial during the past six (06) months.
• Any other condition which the P.I. thinks may jeopardize the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Hb%	At baseline, 14th day, 28th day, 42nd day, 56th day, 70th day, 84th day and at the end of follow up after 16 weeks.

Secondary Outcome Measures

Name	Time	Method
1.Symptomatic relief.	2. Change in Serum ferritin level.

Trial Locations

Locations (3)

National Institute of Ayurveda (NIA); 🇮🇳 Jaipur, RAJASTHAN, India

Rajiv Gandhi Government Post-Graduate Ayurvedic College; 🇮🇳 Kangra, HIMACHAL PRADESH, India

Shri Dharmasthala Manjunatheswara (SDM) College of Ayurveda; 🇮🇳 Hassan, KARNATAKA, India

National Institute of Ayurveda (NIA)

🇮🇳Jaipur, RAJASTHAN, India

Prof Abhimanyu Kumar and Dr Sunil Kumar Jain

Principal investigator

9414779931

ak_ayu@yahoo.co.in