| CTRI Number |
CTRI/2013/06/003779 [Registered on: 24/06/2013] Trial Registered Retrospectively |
| Last Modified On: |
22/06/2013 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Impaired digestion and its management |
|
Scientific Title of Study
|
An Applied study of Samavaya as Karana / Padartha in Ayurveda Chikitsa and Darshana |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anil D Avhad |
| Designation |
MD Scholar |
| Affiliation |
INSTITUTE FOR POST GRADUATE TEACHIND AND RESEARCH IN AYURVEDA |
| Address |
OPD NO 15 Basic principles Department IPGT and RA GAU, Jamnagar Gujarat
Jamnagar
GUJARAT
361008
India |
| Phone |
9510176085 |
| Fax |
|
| Email |
anilavhad4u@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof R R Dwivedi |
| Designation |
Professor and Head Basic Principles Department |
| Affiliation |
INSTITUTE FOR POST GRADUATE TEACHIND AND RESEARCH IN AYURVEDA |
| Address |
OPD NO 15 Basic principles Department IPGT and RA GAU, Jamnagar Gujarat
Jamnagar
GUJARAT
361008
India |
| Phone |
9426206906 |
| Fax |
|
| Email |
dwivedirb53@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof R R Dwivedi |
| Designation |
Professor and Head Basic Principles Department |
| Affiliation |
INSTITUTE FOR POST GRADUATE TEACHIND AND RESEARCH IN AYURVEDA |
| Address |
OPD NO 15 Basic principles Department IPGT and RA GAU, Jamnagar Gujarat
Jamnagar
GUJARAT
361008
India |
| Phone |
9426206906 |
| Fax |
|
| Email |
dwivedirb53@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| INSTITUTE FOR POST GRADUATE TEACHING AND RESEARCH IN AYURVEDA GAU Jamnagar 361008 |
|
|
Primary Sponsor
|
| Name |
INSTITUTE FOR POST GRADUATE TEACHING AND RESEARCH IN AYURVEDA |
| Address |
OPD NO 15 Basic principles department IPGT and RA GAU Jamnagar |
| 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 Anil D Avhad |
Department of Basic Principles |
OPD No 15 IPGT and RA GAU JAmnagar
Jamnagar
GUJARAT |
09510176085
anilavhad4u@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee institute for post graduate teaching and Research in Ayurved Gujarat Ayurved University Jamnagar 361008 Ref - PGT/7-A/Ethics/2010-11/1858 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Indigestion (Ama), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Pippalimula (Piper longum radix) |
Two tablets of 500 mg four times in a day for 10 ten days along with luke warm water |
| Comparator Agent |
Placebo (rice flour) tablet |
Two tablets of 500 mg four times in a day for 10 days along with luke warm water |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients suffering from the state of Ama having the classical symptoms like Aruchi Avipaka Udaragaurava agnimandya etc |
|
| ExclusionCriteria |
| Details |
Patients having age less than 20 years and more than 60 years
patients having any major systemic disease
Patients having the dominancy of pittaprakriti |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pippalimula tablet is more beneficial than the placebo group |
Till present study i.e. upto february 2012 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Lightness and Enthusiasm in the body |
February 2012 |
|
|
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)
|
01/08/2011 |
| 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="0"
Months="9"
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 placebo control clinical study to evaluate the efficacy of Pippalimula on the Patients suffering from Ama. Routine blood, urine and stool examinations will be carried out to assess the status of Ama and also to rule out any other systemic pathology. Special scoring scale has been prepared based on the information in Ayurvedic classics which will be utilized for assessment and evaluation. |