| CTRI Number |
CTRI/2013/10/004100 [Registered on: 25/10/2013] Trial Registered Retrospectively |
| Last Modified On: |
11/01/2016 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of Yoga on memory power |
|
Scientific Title of Study
|
PHILOSOPHICAL AND APPLIED AYURVEDIC ASPECTS OF MANAS W.S.R. TO SMRITI |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Hetal Amin |
| Designation |
M.D. Scholar |
| Affiliation |
Institute for Post Graduate Teaching and Research in Ayurveda |
| Address |
PG Scholar – Department of Basic Principles,
Institute for Post Graduate Teaching and Research in Ayurveda
Gujarat Ayurved University
Jamnagar – 361008
Jamnagar
GUJARAT
361008
India |
| Phone |
09924194660 |
| Fax |
|
| Email |
dr.hetal1985@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hitesh A Vyas |
| Designation |
MD(Ayu) Ph.D |
| Affiliation |
Assistant Professor, Institute for Post Graduate Teaching and Research in Ayurveda |
| Address |
Guide
Department of Basic Principles,
Institute for Post Graduate Teaching and Research in Ayurveda
Gujarat Ayurved University
Jamnagar – 361008
Basic Principles,
Assistant Professor
Institute for Post Graduate Teaching and Research in Ayurveda
Gujarat Ayurved University
Jamnagar – 361008
Jamnagar
GUJARAT
361008
India |
| Phone |
09924194660 |
| Fax |
|
| Email |
drhavyas@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Hetal Amin |
| Designation |
M.D. Scholar |
| Affiliation |
Institute for Post Graduate Teaching and Research in Ayurveda |
| Address |
PG Scholar – Department of Basic Principles,
Institute for Post Graduate Teaching and Research in Ayurveda
Gujarat Ayurved University
Jamnagar – 361008
Jamnagar
GUJARAT
361008
India |
| Phone |
09924194660 |
| Fax |
|
| Email |
dr.hetal1985@gmail.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 and Research in Ayurveda Gujarat Ayurved University |
| Address |
Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University Jamnagar – 361008 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 HITESH VYAS |
OPD OF BASIC PRINCIPLES DEPARTMENT |
GUJARAT AYURVED UNIVERSITY
JAMNAGAR
Jamnagar
GUJARAT |
09426433231
drhavyas@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IPGT and RA Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Normal Values of routine Haematological and Urine investigation before treatment |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Shankhapushpi Tablet |
Group A received Shankhapushpi tablet 4 tablet of 500 mg each
Anupana- milk
Dose- 4 tablet after meal with milk twice a day
Time- 2 time per day after meal (Udanakala)orally
Duration- 2 montha |
| Comparator Agent |
trial group B yoga and placebo |
tablet 500mg each
Drug Dose- 4 tablet after meal with milk orally
Duration- 2 months
Anupana- milk
Time- 4 tablet after meal at Udanakala
Duration- 2 months |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Healthy volunteers between 15-25 yrs age group will be selected from the surrounding area of research place without any bar of race, religion and sex. |
|
| ExclusionCriteria |
| Details |
Volunteers younger than 15 years and older than 25 years age,Patients with any type of listed psychiatric disorders like A.D.H.D.,G.A.D. etc., Patients of old age memory loss (senile dementia),Patients with systemic diseases like carcinoma, H.I.V .etc or where memory loss is a symptom of other diseases.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Scoring of Weschslers memory Scale |
Scoring of Weschslers memory Scale before and after of two months duration |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to get good memory |
after 2 months
|
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
07/06/2010 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="2"
Days="15" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Hetal et al Global J Res Med Plants and Indigenous Med Volume 2 Issue 8 August 2013 605 612 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This study is an Randomized controlled single blind Clinical study to evaluate the efficacy of Yogic procedure as Sattvavajaya Chikitsa and Shankhapushpi tablet in the management of Smriti. The primary outcome measures are Changes in scoring of Weschsler’s Memory Scale measured at baseline and after 2 months, |