| CTRI Number |
CTRI/2013/10/004059 [Registered on: 14/10/2013] Trial Registered Retrospectively |
| Last Modified On: |
26/08/2013 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Diet therapy in indigestion |
|
Scientific Title of Study
|
A study on Dwadasha Ashana Pravichara and its applied assessment in mandagni patients |
| Trial Acronym |
DAPIM |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bhadarva Abdeli S |
| Designation |
PG Scholar Department of Basic Principles |
| Affiliation |
Institute for Post Graduate Teaching and Research in Ayurveda |
| Address |
Institute for Post Graduate Teaching and Research in Ayurveda
Gujarat Ayurved University Jamnagar
Jamnagar
GUJARAT
361008
India
Jamnagar
GUJARAT
361008
India |
| Phone |
09974059434 |
| Fax |
|
| Email |
abdelibhadarva@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hitesh Vyas |
| Designation |
Asst. Prof., Department of Basic Principles |
| Affiliation |
Institute for Post Graduate Teaching and Research in Ayurveda |
| Address |
Institute for Post Graduate Teaching and Research in Ayurveda
Gujarat Ayurved University Jamnagar
Jamnagar
GUJARAT
361008
India
Jamnagar
GUJARAT
361008
India |
| Phone |
09426433231 |
| Fax |
|
| Email |
drhavyas@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Prof RR Dwivwdi |
| Designation |
HOD, Department of Basic Principles |
| Affiliation |
Institute for Post Graduate Teaching and Research in Ayurveda |
| Address |
Institute for Post Graduate Teaching and Research in Ayurveda
Gujarat Ayurved University Jamnagar
Jamnagar
GUJARAT
361008
India
Jamnagar
GUJARAT
361008
India |
| Phone |
|
| Fax |
|
| Email |
dwivedirb53@rediffmail.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 |
| Address |
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 |
| Bhadarva Abdeli S |
Department of Basic Principles |
OPD no.18 Institute
for Post Graduate
Teaching and Research
in Ayurveda Gujarat
Ayurved University
Jamnagar – 361008
Jamnagar
GUJARAT
Jamnagar
GUJARAT |
09974059434
abdelibhadarva@yahoo.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/2012-2013/1964 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Indigestion and related symptoms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Placebo tablet |
Group B was advised to take meal only once a day preferably a lunch and was given two placebo tab. 500 mg 2 times a day with luke warm water for 10 days. |
| Comparator Agent |
Trikatu tablet |
Group A was given two Trikatu tab. 500 mg 2 times a day with luke warm water for 10 days. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients suffering from classical signs and symptoms of Mandagni |
|
| ExclusionCriteria |
| Details |
Patients suffering from any major systemic disease, pregnant lady, conditions where Trikatu or Ekkala bhojana is contraindicated |
|
|
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
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| signs and symptoms of indigestion will improve with ekkala bhojana (one time meal) |
after ten days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| functions of digestive symptoms will improve and patient will get health, strength and complexion. |
after one month |
|
|
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)
|
20/10/2012 |
| 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="2"
Months="0"
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 a randomized parallel clinical study to evaluate the efficacy of restricted diet in terms of quality, quantity and frequency. Patients of indigestion will be advised to take diet only one time as indicated in classics of Ayurved. In one group, patients will be advised for ekkala bhojana (diet at one time only) along with two placebo tablet of 500 mg orally for 10 days, while in other group two Trikatu tablet (Zingiber
officinale Roscoe., Piper
nigrum Linn. and Piper
longum Linn. in equal quantity)
of 500 mg orally for 10 days. Patients were assessed before and after treatment by assessment criteria. |