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CTRI Number  CTRI/2012/01/002376 [Registered on: 25/01/2012] Trial Registered Retrospectively
Last Modified On:
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 mentally challenged children. 
Scientific Title of Study   Clinical Evaluation of Brahmi Ghrita and Jyotishmati Taila in the Management of Cognitive Deficit 
Trial Acronym  ACT- CD-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-110058
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-110058
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-110058
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-110058
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-110058
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-110058
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. Tilak Ayurved Mahavidyalaya, Pune. 3. Vaidyaratnam P. S. Varier Ayurved College, Kottakkal. 
 
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   
 
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 Dr Arun Parameshwar Kute   National Institute of Ayurveda (NIA), Jaipur   Department of Kaumarbhritya, Amer Road, Madhav Vilas Palace, Jaipur-302002
Jaipur
RAJASTHAN 		 9414779931
0141-2635709
ak_ayu@yahoo.co.in 
Dr Tanuja Nesari Dr Prajakta Patel   Tilak Ayurved Mahavidyalaya, Pune  Department of Dravyaguna and Office of the Principal, 583/2, Rasta Peth, Pune-411011
Pune
MAHARASHTRA 		 9423007988
020-26336428
tnesari@hotmail.com 
Dr AK Manoj kumar Dr Vimal Jyothi   Vaidyaratnam P. S. Varier Ayurved College, Kottakkal  Department of Manas Roga, Kottakkal, P.O. Edarikode, Mallapuram-676501
Malappuram
KERALA 		 9447184275
0483-2751851
manojkumarak@bsnl.in 
 
Details of Ethics Committee  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Institutional Ethics Committee, National Institute of Ayurveda (NIA), Jaipur  Approved 
Institutional Ethics Committee, Tilak Ayurved Mahavidyalaya, Pune  Approved 
Institutional Ethics Committee, VPSV Ayurved College, Kottakkal  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Cognitive Deficit,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Brahmi Ghrita  Dose – 10 gm twice daily Dosage form - Ghrita Route of Administration – Oral Time of Administration-Twice a day before food Anupana-Lukewarm Water Packing form- 300 gm pet jar Duration of therapy-12 weeks 
Intervention  Jyotishmati Taila  Dose – 2 drops twice daily Dosage form – Oil Route of Administration – Nasal Time of Administration-Twice a day Packing form- 15 ml plastic bottle with dropper Duration of therapy-12 weeks 
Comparator Agent  Not applicable  Not applicable 
 
Inclusion Criteria  
Age From  8.00 Year(s)
Age To  13.00 Year(s)
Gender  Both 
Details  1. Children of either sex aged between 8 to 13 years
2. Children with Intelligence Quotient 70 - 84 (Weschler’s-IQ Indian adaptation by Malin)
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. H/o hypersensitivity to any of the trial drug or their ingredients
5. Children who have completed participation in any other clinical trial during the past six (06) months.
6. 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 
• Symptomatic Improvement.  At Baseline, 14th day-28th day-42nd day-56th day-70th day-84th day and at the end of follow up after 16th week. 
 
Secondary Outcome  
Outcome  TimePoints 
• Change in Modified Child Mini Mental Scale Examination (MMMSE).  At Baseline, 14th day-28th day-42nd day-56th day-70th day-84th day and at the end of follow up after 16th week. 
 
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)   17/12/2010 
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.

Brahmi Ghrita is a poly herbal formulation containing Brahmi (Bacopa monnieri), Sunthi (Zingiber officinale), Marica (Piper nigrum), Pippali (Piper longum), Trivrta (Operculina turpethum), Danti (Baliospermum montanum), Shankhapushpi (Convolvulus pluricaulis), Aragvadha (Cassia fistula), Saptala (Euphorbia dracunculoides) and Vidanga (Embelia ribes).

Jyotismati Taila is oil obtained from a plant named Jyotishmati (Celastrus paniculatus).

The present study is being undertaken in three post graduate Ayurveda colleges to scientifically study and validate the clinical efficacy and safety of Brahmi Ghrita and Jyotishmati Taila- classical Ayurvedic formulations which have been in use since ages and found effective in treating Cognitive Deficit and promoting the health.

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 protocols), trial drugs and training to the researchers involved in the project. 
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