| CTRI Number |
CTRI/2012/03/002536 [Registered on: 30/03/2012] Trial Registered Retrospectively |
| Last Modified On: |
28/03/2012 |
| Post Graduate Thesis |
No |
| 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 management of Mental Retardation. |
|
Scientific Title of Study
|
Clinical Evaluation of Brahmi Ghrita and Jyotishmati Taila in the Management of Cognitive Deficit. |
| Trial Acronym |
IMCRP-CD–2010-2011 |
|
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 (Project co-ordinator) |
| 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 (Project co-ordinator) |
| 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 (Project co-ordinator) |
| 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. Advanced Centre for Ayurveda in Mental Health and Neuro Sciences (ACAMHNS)Ayurvedic Research Unit,NIMHANS, Bengaluru |
|
|
Primary Sponsor
|
| Name |
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, New Delhi-110058, INDIA |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Srinivas Sahu |
Advanced Centre for Ayurveda in Mental Health and Neuro Sciences Ayurvedic Research Unit, Bengaluru |
Advanced Centre for Ayurveda in Mental Health and Neuro Sciences (ACAMHNS),Ayurvedic Research Unit,
NIMH&NS, Hosur Road,
Bengaluru-560029
Bangalore
KARNATAKA |
9448941203
080-26567546
drsrinibashsahoo@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, ACAMHNS, Bengaluru. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Cognitive Deficit, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Brahmi Ghrita along with Jyotishmati Taila |
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 AND 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 |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
13.00 Year(s) |
| Gender |
Both |
| Details |
1. Children with Intelligence Quotient 70 - 84 (Weschler’s-IQ Indian adaptation by Malin)
2. 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 14th 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 14th 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)
|
14/07/2011 |
| 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="0"
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 trial. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The Central Council for Research in Ayurvedic Sciences (CCRAS) is an autonomous body under the Department of AYUSH (Ayurveda, Yoga &Naturopathy, Unani, Siddha and Homeopathy), Ministry of Health & Family Welfare, Government of India. CCRAS is an apex body in India for the formulation, co-ordination, development and promotion of research on scientific lines in the Ayurveda system of medicine. Aimed at generating evidence for the scientific validation of the clinical efficacy and safety of twenty five classical Ayurvedic formulations, multicentre clinical trials have been initiated in sixteen disease areas across nineteen peripheral institutes of the Council as an activity under the Intra Mural Clinical Research (IMR) program. This initiative is basically a supplement to the similar venture being worked out as an activity under the Ayurveda Clinical Trials (A.C.T.) project of the Ayurvedic Pharmacopoeia Committee (APC) wherein, clinical trials on eighteen disease conditions are underway in eight post graduate Ayurveda colleges across the country. Brahmi Ghrita is a poly herbal formulation containing Brahmi (Bacopa monnieri), Shunthi (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 entitled “Clinical Evaluation of Brahmi Ghrita and Jyotishmati Taila in the Management of Cognitive Deficit†is being undertaken in one of the peripheral institutes of CCRAS. The cumulative evidence generated as an activity under the ACT project as well as IMR programme is expected to scientifically substantiate the claims regarding clinical efficacy and safety of these classical Ayurvedic formulations. |