| CTRI Number |
CTRI/2015/07/006041 [Registered on: 21/07/2015] Trial Registered Retrospectively |
| Last Modified On: |
05/04/2016 |
| 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
|
Effect of Chitraka on function of the Pachaka Pitta |
|
Scientific Title of Study
|
Study on Panchabhautika Conjugation and Configuration of Panchadha Pitta |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bharat Bhadiyadra |
| Designation |
MD Ayu scholar |
| Affiliation |
Institute for Post Graduate Teaching and Research in Ayurveda GAU Jamnagar |
| Address |
Room no 23 PG Boys Hostel Institute for Post Graduate Teaching and
Research in Ayurveda GAU Jamnagar Gujarat 361008
to nonghanvadar
ta palitana
via Sanosara
dist Bhavnagar
Bhavnagar
GUJARAT
361008
India |
| Phone |
9427559623 |
| Fax |
|
| Email |
dr.bharatbhadiyadra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR BHARAT L BHADIYADRA |
| Designation |
MD SCHOLAR |
| Affiliation |
INSTITUTE FOR POST GRADUATE TEACHING AND RESEARCH IN AYURVEDA GAU JAMNAGAR |
| Address |
OPD NO 18 BASIC PRINCIPLES DEPARTMENT IPGT AND RA GAU
JAMMAGAR JAMNAGAR GUJARAT 361008 INDIA
OPD NO 18 BASIC PRINCIPLES DEPARTMENT IPGT AND RA GAU
JAMMAGAR JAMNAGAR GUJARAT 361008 INDIA
Jamnagar
GUJARAT
361008
India |
| Phone |
09427559623 |
| Fax |
|
| Email |
dr.bharatbhadiyadra@mail.com |
|
Details of Contact Person
Public Query
|
| Name |
dr A S Baghel |
| Designation |
Associate Professor of Basic Principles department |
| Affiliation |
Institute for Post Graduate Teaching and Research in Ayurveda GAU Jamnagar |
| Address |
OPD No 18 Basic Principles department IPGT and RA GAU
Jammagar Jamnagar GUJARAT 361008 India
OPD No 18 Basic Principles department IPGT and RA GAU
Jammagar Jamnagar GUJARAT 361008 India
Jamnagar
GUJARAT
361008
India |
| Phone |
9426433575 |
| Fax |
|
| Email |
asbaghel2001@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 18 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 |
| Bharat Bhadiyadra |
I.P.G.T. & R.A. HOSPITAL |
OPD no.18 Department
of Basic Principles
Institute for Post
Graduate Teaching and
Research in Ayurveda
Gujarat Ayurved
University Jamnagar
361008
Jamnagar
GUJARAT |
09427559623
dr.bharatbhadiyadra@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 AYURVED GAU JAMNAGAR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
functionally disturbed Pachaka Pitta not more than 15 days history, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo tab 500mg 2 tab BD |
Anupana Luke warm water for 15 days with proper pathyapathya ORAL ROUTE |
| Intervention |
Group A Chitraka vati
500mg 2 vati BD ORAL ROUTE |
Anupana luke warm water
for 15 days with proper Pathyapathya ORAL ROUTE |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Patients having the symptoms of functionally disturbed Pachaka Pitta not more than 15 days history.
Patients having the symptoms of heaviness in abdomen and not appeared symptoms of Jirnahara.
|
|
| ExclusionCriteria |
| Details |
Patients having age between 20 -55 years.
Patients having the symptoms of functionally disturbed Pachaka Pitta not more than 15 days history.
Patients having the symptoms of heaviness in abdomen and not appeared symptoms of Jirnahara.
|
|
|
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 |
Improvement will be assessed on the basis of
relief found in cardinal symptoms and jirnaahara lakhshna
|
IMPROVEMENT SHOWS THAT CHITRAKA TAB HAVING DIPANA AND PACHANA PROPERTIES AND HAVING DOMINANCE OF VAYU AND AGNI MAHABHUTA IN THEIR CONFIGURATION
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement will be assessed on the basis of
relief found in cardinal symptoms and jirnaahara lakhshna
|
15 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
26/04/2014 |
| 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="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
not yet publish |
|
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 Chitraka vati on functionally disturbed Pachaka Pitta. 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.
In group A- Chitraka vati 500mg bd for 15 days.
anupan-luke warm water.
In group B-placebo tab=500 mg bd for 15 days.
anupan-luke warm water
Criteria for assessment-the efficacy of treatment will be assessed on the basis on jirna ahara lakshana.
patients will be redirected to regular OPD treatment after the stipulated time of research work
|