| CTRI Number |
CTRI/2018/07/015068 [Registered on: 26/07/2018] Trial Registered Prospectively |
| Last Modified On: |
26/07/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A CLINICAL STUDY OF AMLAPITTA WITH DRAKSHADI VATI AND PATOLADI GHANVATI |
|
Scientific Title of Study
|
A CLINICO COMPARATIVE STUDY ON DRAKSHADIVATI AND PATOLADIGHANVATI 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 |
JAYANTI PRAJAPATI |
| Designation |
PG SCHOLAR |
| Affiliation |
GOVERNMENT AKHANDANAND AYURVED MAHAVIDHYALAYA |
| Address |
UPGRADED DEPARTMENT OF KAYACHIKITSA OPD NO. 9 GOVERNMENT AKHANDANAND AYURVED MAHAVIDHYALAYA BHADRA AHEMEDABAD
38-K KUMBHARVASS AT-SABA POST-GADSISAR TA-THARAD DIST-BANASKANTHA GUJRAT
Banas Kantha
GUJARAT
380006
India |
| Phone |
9925799795 |
| Fax |
|
| Email |
dr.jayprajapati93@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR VIBHA JANI |
| Designation |
HOD AND PROFFESSOR |
| Affiliation |
GOVERNMENT AKHANDANAND AYURVED MAHAVIDHYALAYA |
| Address |
UPGRADED DEPARTMENT OF KAYACHIKITSA OPD NO. 9 GOVERNMENT AKHANDANAND AYURVED MAHAVIDHYALAYA BHADRA AHEMEDABAD
Ahmadabad
GUJARAT
380006
India |
| Phone |
9426222941 |
| Fax |
|
| Email |
diptipandya73@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
DR VIBHA JANI |
| Designation |
HOD AND PROFFESSOR |
| Affiliation |
GOVERNMENT AKHANDANAND AYURVED MAHAVIDHYALAYA |
| Address |
UPGRADED DEPARTMENT OF KAYACHIKITSA OPD NO. 9 GOVERNMENT AKHANDANAND AYURVED MAHAVIDHYALAYA BHADRA AHEMEDABAD
Ahmadabad
GUJARAT
380006
India |
| Phone |
9426222941 |
| Fax |
|
| Email |
diptipandya73@yahoo.in |
|
|
Source of Monetary or Material Support
|
| GOVERNMENT AKHANDANAND AYURVEDA COLLEGE BHADRA AHEMEDABAD GUJARAT |
|
|
Primary Sponsor
|
| Name |
GOVERNMENT AKHANDANAND AYURVED MAHAVIDHYALAYA |
| Address |
UPGRADED DEPARTMENT OF KAYACHIKITSA OPD NO. 9 GOVERNMENT AKHANDANAND AYURVED MAHAVIDHYALAYA BHADRA AHEMEDABAD |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| GOVERNMENT AKHANDANAND AYURVED MAHAVIDHYALAYA |
UPGRADED DEPARTMENT OF KAYACHIKITSA OPD NO. 9 GOVERNMENT AKHANDANAND AYURVED MAHAVIDHYALAYA BHADRA AHEMEDABAD |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr JAYANTI PRAJAPATI |
Akhandanad Ayurveda Collage Bhadra Ahmedabad |
ROOM NO 9 UPGRADED DEPARTMENT OF KAYACHIKITSA GOVERNMENT AKHANDANAND AYURVED MAHAVIDHYALAYA BHADRA AHEMEDABAD
Ahmadabad
GUJARAT |
9925799795
drjayprajapati93@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 |
AMLAPITTA (HYPER ACIDITY), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
MANAGEMENT OF AMLAPITTA WITH PATOLADI GHANVATI |
15 PATIENTS TAKEN IN GROUP B AND WILL BE TREATED WITH PATOLADI GHANVATI FOLLOWING DOSE AND DURATION
DOSE (1tab of 500mg) 4tab two times a day.
DURATION 4 WEEKS |
| Intervention |
MANAGMENT OF AMLAPITTA WITH DRAKSHADIVATI |
15 PATIENTS TAKEN IN GROUP A AND WILL BE TREATED WITH DRAKSHADIVATI FOLLOWING DOSE AND DURATION
DOSE (1tab of 500mg) 4tab two times a day.
DURATION 4 WEEKS |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
(2) Patients with classical signs & symptoms of Urdhvag Amlapitta.
Avipaka (Indigestion), Klama(Lassitude),Utklesha (Nausea), Tiktodgara(Bitter eruction),Amlodgara(sour eruction), Gaurav(heaviness of body), HritDaha (Heart burn), KanthaDaha (Burning in throat),Aruchi (Anorexia).
|
|
| ExclusionCriteria |
| Details |
(1) Patients having age < 18 years and > 60 years.
(2) Patients suffering from Hematemesis, Acute diarrhea, 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
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| ALL THE SIGN AND SYMPTOMS OF AMLAPITTA WILL BE ASSIGNED SCORE DEPENDING UPON THEIR SEVERITY TO ASSESS THE EFFECT OF THE DRUGS AT THE TIME OF BEFORE AND AFTER TREATMENT |
4 WEEKS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| ALL THE SIGN AND SYMPTOMS OF AMLAPITTA WILL BE ASSIGNED SCORE DEPENDING UPON THEIR SEVERITY TO ASSESS THE EFFECT OF THE DRUGS AT THE TIME OF BEFORE AND AFTER TREATMENT |
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)
|
30/07/2018 |
| 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) |
Not Yet Recruiting |
|
Publication Details
|
NOT YET PUBLISHED |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
AIM OF THIS STUDY IS TO KNOW EFFICACY OF AMLAPITTA IN TRIAL GROUP. THIS STUDY IS RANDOMISED, PATIENTS SELECTION IS BLINDED. DRAKSHADI VATI AND PATOLADI GHANVATI WILL BE GIVEN AS PER TEXT. |