| CTRI Number |
CTRI/2025/05/086844 [Registered on: 13/05/2025] Trial Registered Prospectively |
| Last Modified On: |
07/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
TO STUDY EFFECT OF ABHAYADI GHANAWATI COMPARED TO TABLET RANITIDINE IN MANAGEMENT OF URDHVAG AMLAPITTA |
|
Scientific Title of Study
|
A COMPARATIVE CLINICAL STUDY OF ABHAYADI GHANAWATI AND TABLET RANITIDINE IN MANAGEMENT OF URDHVAG AMLAPITTA |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
RUPALI KHOBRAGADE |
| Designation |
GUIDE |
| Affiliation |
COLLEGE OF AYURVEDA AND RESEARCH CENTRE NIGDI PUNE |
| Address |
COLLEGE OF AYURVEDA AND RESEARCH CENTRE,NIGDI PUNE
COLLEGE OF AYURVEDA AND RESEARCH CENTRE,NIGDI PUNE
Pune
MAHARASHTRA
411044
India |
| Phone |
8378929859 |
| Fax |
|
| Email |
khobragaderupali19@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
RUPALI KHOBRAGADE |
| Designation |
GUIDE |
| Affiliation |
COLLEGE OF AYURVEDA AND RESEARCH CENTRE NIGDI PUNE |
| Address |
COLLEGE OF AYURVEDA AND RESEARCH CENTRE,NIGDI PUNE
Pune
MAHARASHTRA
411044
India |
| Phone |
8378929859 |
| Fax |
|
| Email |
khobragaderupali19@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
PRANALI UGHADE |
| Designation |
STUDENT |
| Affiliation |
COLLEGE OF AYURVEDA AND RESEARCH CENTRE NIGDI PUNE |
| Address |
COLLEGE OF AYURVEDA AND RESEARCH CENTRE,NIGDI PUNE
COLLEGE OF AYURVEDA AND RESEARCH CENTRE,NIGDI PUNE
Pune
MAHARASHTRA
411044
India |
| Phone |
9619586664 |
| Fax |
|
| Email |
pranaliughade29@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
SELF |
| Address |
college of ayurveda and research centre nigdi pune |
| Type of Sponsor |
Research institution |
|
|
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 |
| RUPALI KHOBRAGADE |
Research Institute |
STERLING MULTISPECIALITY HOSPITAL AND RESEARCH CENTRE,NIGDI PUNE, Dept of Kayachikitsa OPDno.6
Pune
MAHARASHTRA |
08378929859
-
khobragaderupali19@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K290||Acute gastritis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NA |
NA |
| Intervention |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
patients having signs and symptoms of urdhvag amlapitta as described in ayurvedic samhitas that is chardi,amlodgar,hrullas,hruda kantadaha,udarda,shirashool,hastapada daha,aruchi,maddalotpatti |
|
| ExclusionCriteria |
| Details |
patients suffering gastric ulcers, duodenal ulcers
pregnant and lactating women
CA stomach,oesophagus,esophageal varices, hematemesis
patients having hepatic and renal disorders
immunocompromised patients,blood coagulation
systemic diseases like HTN,TB,DM |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 4 weeks |
ABHAYADI GHANAWATI IS EFFECTIVE IN URDHVAG AMLAPITTA |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
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)
|
19/05/2025 |
| 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="0"
Days="30" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A Randomised Comparative Clinical Trial will be done and patients will be selected in two groups as per the inclusion criteria Administration of the drug will be for 30 days for Group A and Group B Followup will be taken at an interval of 7days for 2 weeks |