| CTRI Number |
CTRI/2017/05/008719 [Registered on: 31/05/2017] Trial Registered Retrospectively |
| Last Modified On: |
31/05/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
EFFECT OF GUDUCHYADICHURNA AND ELADICHURNA IN AMLAPITTA(HYPERACIDITY) |
|
Scientific Title of Study
|
A CLINICAL STUDY OF GUDUCHYADICHURNA AND ELADI CHURNA IN THE MANAGEMENT OF AMLAPITTA |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MOHIT PRAVINBHAI PAGHDAR |
| Designation |
MD |
| Affiliation |
GOVT AKHANDANAND AYURVED COLLEGE |
| Address |
GOVT AKHANDANAND AYURVED COLLEGE BHADRA ROOM NO 9 KAYACHIKITSAA DEPARTMENT AHMADABAD
Ahmadabad
GUJARAT
380001
India |
| Phone |
8866608559 |
| Fax |
|
| Email |
dr.mppaghdar273@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR BHARAT MUNGARA |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
GOVT AKHANDANAND AYURVED COLLEGE BHADRA AHMEDABAD |
| Address |
GOVT AKHANDANAND AYURVED COLLEGE BHADRA AHMEDABAD
Ahmadabad
GUJARAT
380001
India |
| Phone |
9426336822 |
| Fax |
|
| Email |
patanjaliayucare@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
MOHIT PRAVINBHAI PAGHDAR |
| Designation |
MD |
| Affiliation |
GOVT AKHANDANAND AYURVED COLLEGE |
| Address |
GOVT AKHANDANAND AYURVED COLLEGE BHADRA ROOM NO 9 KAYACHIKITSAA DEPARTMENT AHMADABAD
Ahmadabad
GUJARAT
360410
India |
| Phone |
8866608559 |
| Fax |
|
| Email |
dr.mppaghdar273@gmail.com |
|
|
Source of Monetary or Material Support
|
| GOVERNMENT AKHANDANAND AYURVED COLLEGE BHADRA AHMEDABAD |
|
|
Primary Sponsor
|
| Name |
GOVT AKHANDANAND AYURVED COLLEGE |
| Address |
GOVT AKHANDANAND AYURVED COLLEGE BHADRA AHMEDABAD |
| Type of Sponsor |
Government medical college |
|
|
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 MOHIT PAGHDAR |
AKHANDANAND AYURVED COLLEGE |
ROOM NO 9 KAYACHIKITSA DEPARTMENT AKHANDANAND AAYURVED COLLEGE BHADRA AHMEDABAD
Ahmadabad
GUJARAT |
8866608559
dr.mppaghdar273@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
PATIENT SUFFERING FROM AMLAPITTA., |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
A CLINICAL STUDY OF GUDUCHYADICHURNA IN THE MANAGEMENT OF AMLAPITTA |
15 patients will be taken in group A and will be treated with Guduchyadi churna in following dose and duration
Dose: 10gm/day two divided dose with water
Duration: 4 weeks
|
| Comparator Agent |
A CLINICAL STUDY OF ELADI CHURNA IN THE MANAGEMENT OF AMLAPITTA |
15 patients will be taken in group B and will be treated with ELADI CHURNA in following dose and duration Dose: 10gm/day two divided dose with water Duration: 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with classical signs & symptoms of Amlapitta.Avipaka (Indigestion), Klama(Lassitude), Utklesha (Nausea), Tiktodgara(Bitter eruction), Amlodgara(sour eruction),Gaurav(heaviness of body),Hrit Daha(Heart buru), Kantha Daha (Burning in throat), Aruchi (Anorexia). |
|
| ExclusionCriteria |
| Details |
Patients suffering from Hematemesis, Acute diarrhoea, Intestinal T.B, Gastric and Peptic ulcer, uncontrolled D.M. and HTN, Arsha, Carcinoma, cardiac disorders etc. serious condition of the patient. |
|
|
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 |
| Result will be assessed on the basis of relief in the Signs and symptoms of Amlapitta |
4 WEEKS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Result will be assessed on the basis of relief in the Signs and symptoms of Amlapitta |
4 weeks |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
23/05/2017 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a randomised, participants blinded, parallel group, active controlled trial to evaluate the efficacy of Guduchyadi Churna in a Dose of 10gm/day two divided dose with water Duration: 4 weeks in 15 patients with GROUP A and also to evaluate the efficacy of Eladi Churna in a Dose of 10gm/day two divided dose with water Duration: 4 weeks in 15 patients of GROUP B in Amlapitta.
|