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CTRI Number  CTRI/2012/01/002335 [Registered on: 12/01/2012] Trial Registered Retrospectively
Last Modified On: 12/01/2012
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   A clinical study to see the effect of some Ayurvedic formulations in the treatment of Anaemia 
Scientific Title of Study   Clinical Evaluation of Punarnavadi Madura and Dadimadi Ghrita in the Management of Iron Deficiency Anaemia 
Trial Acronym  ACT- IDA-2010 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Pradeep Dua 
Designation  Research Officer (co-ordinator ACT project) 
Affiliation  Central Council for Research in Ayurvedic Sciences (CCRAS) 
Address  Central Council for Research in Ayurvedic Sciences (CCRAS), Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opposite D Block, Janakpuri
Central Council for Research in Ayurvedic Sciences (CCRAS), Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opposite D Block, Janakpuri
West
DELHI
110058
India 
Phone  011-28525831  
Fax  011-28520748  
Email  duadrpradeep@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Pradeep Dua 
Designation  Research Officer (co-ordinator ACT project) 
Affiliation  Central Council for Research in Ayurvedic Sciences (CCRAS) 
Address  Central Council for Research in Ayurvedic Sciences (CCRAS), Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opposite D Block, Janakpuri
Central Council for Research in Ayurvedic Sciences (CCRAS), Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opposite D Block, Janakpuri
West
DELHI
110058
India 
Phone  011-28525831  
Fax  011-28520748  
Email  duadrpradeep@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Pradeep Dua 
Designation  Research Officer (co-ordinator ACT project) 
Affiliation  Central Council for Research in Ayurvedic Sciences (CCRAS) 
Address  Central Council for Research in Ayurvedic Sciences (CCRAS), Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opposite D Block, Janakpuri
Central Council for Research in Ayurvedic Sciences (CCRAS), Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opposite D Block, Janakpuri
West
DELHI
110058
India 
Phone  011-28525831  
Fax  011-28520748  
Email  duadrpradeep@gmail.com  
 
Source of Monetary or Material Support  
Support in terms of infrastructural facilities: 1. National Institute of Ayurveda (NIA), Jaipur. 2. Rajiv Gandhi Government Post-Graduate Ayurvedic College, Paprola. 3. Shri Dharmasthala Manjunatheswara (SDM) College of Ayurveda, Hassan. 
 
Primary Sponsor  
Name  Department of AYUSH Ministry of Health Family Welfare Government of India  
Address  Department of AYUSH, Ministry of Health & Family Welfare, Government of India, IRCS Building, Red Cross Road, New Delhi-110001. 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Prof Abhimanyu Kumar and Dr Sunil Kumar Jain  National Institute of Ayurveda (NIA)   Department of Kaumarbhritya, Amer Road, Madhav Vilas Palace, Jaipur-302002
Jaipur
RAJASTHAN 		 9414779931
0141-2635709
ak_ayu@yahoo.co.in 
Prof Chanchal Sharma and Dr Swati Sharma  Rajiv Gandhi Government Post-Graduate Ayurvedic College  Office of the Principal and Department of Kaumarbhritya, Paprola, District Kangra-176115
Kangra
HIMACHAL PRADESH 		 9418794064
01894242064
prof.c.k@gmail.com 
Dr Shailaja U and Dr Sarita  Shri Dharmasthala Manjunatheswara (SDM) College of Ayurveda  Department of Kaumabhritya, Thannirohalla, B.M. Road, P.B. No.-64, Hassan-573201
Hassan
KARNATAKA 		 9448816433
08172-256464
rao.shaila@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Institutional Ethics Committee, NIA, Jaipur  Approved 
Institutional Ethics Committee, RGGPG Ayurveda College, Paprola  Approved 
Institutional Ethics Committee, SDM College of Ayurveda, Hassan  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Iron Deficiency Anaemia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dadimadi Ghrita  Dose – 10 gm twice daily Dosage form - Ghrita Route of Administration – Oral Time of Administration-Twice a day before food Anupana-Lukewarm Water/Milk Packing form-300 gm pet jar Duration of therapy-12 weeks 
Comparator Agent  Not Applicable  Not Applicable 
Intervention  Punarnavadi Mandura  Dose – 500 mg twice daily Dosage form - tablet of 250 mg Route of Administration – oral Time of Administration-Twice a day before food Anupana-Lukewarm Water Packing form-Plastic jar containg 60 tablet Duration of therapy-12 weeks 
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  14.00 Year(s)
Gender  Both 
Details  1. 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. (Assent to be obtained from Parent(s) / Guardian(s). 
 
ExclusionCriteria 
Details  1. Children suffering from major systemic illness necessitating long term drug treatment.
2. Children with evidence of malignancy.
3. 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.
5. H/o hypersensitivity to any of the trial drugs or their ingredients.
6. Children who have completed participation in any other clinical trial during the past six (06) months.
7. Any other condition which the P.I. thinks may jeopardize the study 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
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  
Outcome  TimePoints 
1.Symptomatic relief.
2. Change in Serum ferritin level.
3. Change in Peripheral Blood Smear Picture. 		 1.Symptomatic relief.
At baseline, 14th day, 28th day, 42nd day, 56th day, 70th day, 84th day and at the end of follow up after 16 weeks.
2. Change in Serum ferritin level.
At Baseline, 42nd day and 84th day.
3. Change in Peripheral Blood Smear Picture.
At Baseline, 42nd day and 84th day. 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   14/01/2011 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   To be published after the completion of the clinical trials in all the three centers. 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

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.

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.

 
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