| CTRI Number |
CTRI/2012/03/002469 [Registered on: 02/03/2012] Trial Registered Retrospectively |
| Last Modified On: |
29/02/2012 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Role of Brahmi Ghrita,an ayurved drug in treatment of senile dementia (jarajanya Smritibhramsha) |
|
Scientific Title of Study
|
Etiopathological study on Senile dementia(Jarajanya - Smritibhramsha) and Evaluation of Brahmi Ghrita in its Samprapti-Vighatana |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jyoti S Gubbannavar |
| Designation |
BAMS MD |
| Affiliation |
Institute for Post Graduate Teaching & Research in Ayurveda |
| Address |
2 nd year M.D.(Ayu)
Dept of Roga Nidana Vikriti Vijnana
Institute for Post Graduate Teaching & Research in Ayurveda
Gujarat Ayurveda University,
Jamnagar 361008,Gujarat
2 nd year M.D.(Ayu)
Dept of Roga Nidana Vikriti Vijnana
Institute for Post Graduate Teaching & Research in Ayurveda
Gujarat Ayurveda University,
Jamnagar 361008,Gujarat
Jamnagar
GUJARAT
361008
India |
| Phone |
09016892472 |
| Fax |
|
| Email |
jyoti.gubbannavar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
ProfHMChandola |
| Designation |
MD(Ay.)PhD |
| Affiliation |
Institute for Post Graduate Teaching & Research in Ayurveda |
| Address |
Prof.H M Chandola Professor and Head Kayachikitsa
Executive Editor -AYU
Institute for Post Graduate Teaching & Research in Ayurveda
Gujarat Ayurveda University
Jamnagar
Prof.H.M.Chandola Professor & Head- Kayachikitsa
Executive Editor -AYU
Institute for Post Graduate Teaching & Research in Ayurveda
Gujarat Ayurveda University
Jamnagar -Gujarat
Jamnagar
GUJARAT
361 008
India |
| Phone |
09426208877 |
| Fax |
|
| Email |
drhmchandola@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
ProfHMChandola |
| Designation |
MD(Ay.)PhD |
| Affiliation |
Institute for Post Graduate Teaching & Research in Ayurveda |
| Address |
Prof.H M Chandola Professor and Head Kayachikitsa
Executive Editor -AYU
Institute for Post Graduate Teaching & Research in Ayurveda
Gujarat Ayurveda University
Jamnagar
Prof.H.M.Chandola Professor & Head- Kayachikitsa
Executive Editor -AYU
Institute for Post Graduate Teaching & Research in Ayurveda
Gujarat Ayurveda University
Jamnagar -Gujarat
GUJARAT
361 008
India |
| Phone |
09426208877 |
| Fax |
|
| Email |
drhmchandola@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Institute for Post Graduate Teaching and Research in Ayurveda
Gujarat Ayurved University
Jamnagar – 361008
|
|
|
Primary Sponsor
|
| Name |
Institute for Post Graduate Teaching Research in Ayurveda |
| Address |
Institute for Post Graduate Teaching & Research in Ayurveda
Gujarat Ayurveda University,
Jamnagar 361008,Gujarat |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Prof H M Chandola |
Prof.H.M.Chandola MD(Ay.)PhD
Professor & Head- Kayachikitsa
Executive Editor -AYU
I.P.G.T. & R.A.
Gujarat Ayurved University
Jamnagar -361 008
Gujarat (India) |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| dr jyoti s gubbannavar |
Institute of postgraduate teaching and research in ayurveda |
opd no 16 gujarat ayurveda university jamnagar
Jamnagar
GUJARAT |
9016892472
jyoti.gubbannavar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Senile dementia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
BRAMHI GHRITA |
10 ml twice a day with warm milk for 60 days |
| Comparator Agent |
go ghrita
|
10 ml twice a day with warm milk for 60 days,
|
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients between 60 to 80 years of age group attending the OPD of Kayachikitsa & RNVV Department I.P.G.T. & R.A, Jamnagar will be screened for presence of any neuropsychiatric disorders. Those fulfilling the diagnostic criteria of ICD -10 for Dementia will be selected for the present study. |
|
| ExclusionCriteria |
| Details |
Patients below 60 years and above 80 years
Psychiatric and neuropsychiatric conditions like Schizophrenia Parkinsonism Huntington’s disease Picks disease etc
Persons taking psychotropic drug including alcohol
Persons suffering from persistent endocrine disorder
CV Stroke (past and present)
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
CHANGES IN Mini-mental state examination (questionnaires)
Bender Gestalt Motor Visual Test.
Hamilton Anxiety Rating Scale
Hamilton Depression Rating Scale.
Improvement in clinical features
|
60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| IMPROVEMENT IN MEMORY AND GENERAL HEALTH |
60 days |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
05/11/2011 |
| 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
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The present study will be a randomized, open, comparative clinical research.There are 2 groups in this study.Group A-Brahmi ghrita which contain Vacha,Brahmi,Shankapushpi,kushta and in group B-Goghrita i.e plane cow ghee will be given. The result will be asessed by following parameters • Mini-mental state examination (questionnaires) *Bender Gestalt Motor Visual Test. Hamilton Anxiety Rating Scale• Hamilton Depression Rating Scale.• Improvement in clinical features ,Serum AcetyleCholine Esterase estimation * Urine formaldehyde estimation.The study period is for 2 months,and 10 ml of Brahmi ghrita will be given with warm milk in group A, 10 ml of Goghrita will be given with warm milk in group B.Secondary outcome measures are changes in general health conditions and improvement in memory. |