| CTRI Number |
CTRI/2012/12/003229 [Registered on: 17/12/2012] Trial Registered Retrospectively |
| Last Modified On: |
10/12/2012 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Impaired digestion and its management |
|
Scientific Title of Study
|
Applied Concept of Panchavidha Vata in relation to their Panchabhautika Conjugation & Configuration |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Harshal Sampatrao Sabale |
| Designation |
MD Scholar |
| Affiliation |
INSTITUTE FOR POSTGRADUATE TEACHING AND RESEARCH IN AYURVEDA |
| Address |
OPD No 15
Basic Principles department
IPGT and RA
GAU Jammagar
Jamnagar
GUJARAT
361008
India |
| Phone |
9960446171 |
| Fax |
|
| Email |
drharshal1819s@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof R R Dwivedi |
| Designation |
Professor and Head Basic Principles department |
| Affiliation |
INSTITUTE FOR POSTGRADUATE TEACHING AND RESEARCH IN AYURVEDA |
| Address |
OPD No 15
Basic Principles department
IPGT and RA
GAU Jammagar
Jamnagar
GUJARAT
361008
India |
| Phone |
9426206906 |
| Fax |
|
| Email |
dwivedirb53@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr mahesh vyas |
| Designation |
Associate professor |
| Affiliation |
INSTITUTE FOR POSTGRADUATE TEACHING AND RESEARCH IN AYURVEDA |
| Address |
OPD No 15
Basic Principles department
IPGT and RA
GAU Jammagar
Jamnagar
GUJARAT
361008
India |
| Phone |
9426953118 |
| Fax |
|
| Email |
drmaheshvyas@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 POSTGRADUATE TEACHING AND RESEARCH IN AYURVEDA |
| Address |
OPD No 15
Basic Principles department
IPGT and RA
GAU Jammagar |
| 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 Harshal Sabale |
Department of Basic Principles |
OPD no.15 Department of Basic Principles Institute
for Post Graduate
Teaching and Research
in Ayurveda Gujarat
Ayurved University
Jamnagar – 361008
Jamnagar
GUJARAT
Jamnagar
GUJARAT |
09960446171
drharshal1819s@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University Jamnagar – 361008 Vide Ref- PGT/7-A/Ethi cs/2011-2012/2087 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Indigeston (Vaataj agnidushti), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
chitraka vati single drug |
Two tablets of 500mg (1 gm) twice in a day for 14 days as a ruksha deepan |
| Intervention |
Go Ghrita |
10 ml twice a day for 14 days as a snigdha deepan |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients having the symptoms of Vataja Agnidushti as per classics.
Assessment of Abhyavaharana & Jaranashakti of patients will be carried out.
Purisha of patient also be assessed for Samata & Niramata to get the status of Jaranashakti
|
|
| ExclusionCriteria |
| Details |
Patients having age less than 25 years and more than 60 years.
Patients suffering from any other systemic disease.
Patient having any established pathology of mahasrotas. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Goghrita Snigdha deepan group is more beneficial than Chitraka vati Ruksha deepan group |
till present study i.e. upto October 2012 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Lightness in body
increase in enthusiasm |
till present study |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
13/07/2012 |
| 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="0"
Months="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is Randomized parallel clinical study to evaluate the effect of Go ghrita and Chitraka vati as snigdha deepan and ruksha deepan respectively on vaataj agnidushti. Routine blood , Urine and stool exam will be performed to rule out other systematic pathology. Special scoring scale has been prepared based on information in Ayurvedic classical texts which will be utilized for assessment and evalution. Saama niraama condition of stool will be assessed as per Ayurveda.
|