| CTRI Number |
CTRI/2025/01/079655 [Registered on: 28/01/2025] Trial Registered Prospectively |
| Last Modified On: |
12/08/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Clinical Study Of Virecanakarma With Trivrt Curna In Amlapitta |
|
Scientific Title of Study
|
Effect Of Virecanakarma With Trivrt Curna In The Managment Of Amlapitta- A Single Arm Pre Post Design Clinical Study
|
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sonal B Bhimani |
| Designation |
Pg Scholar |
| Affiliation |
J S Ayurveda Mahavidyalaya, college road, Nadiad Kheda GUJARAT 387001 India |
| Address |
Department of Panchakarma, J S Ayurveda Mahavidyalaya, college
road, Nadiad 387001 Department of Panchakarma, J S Ayurveda
Mahavidyalaya, college road, Nadiad
Kheda
GUJARAT
387001
India
Kheda
GUJARAT
387001
India |
| Phone |
8160061620 |
| Fax |
|
| Email |
sonalbhimani12@icloud.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR MANSI M PATEL |
| Designation |
Reader Department of Panchkarma |
| Affiliation |
J S Ayurveda Mahavidyalaya, college road, Nadiad Kheda GUJARAT 387001 India |
| Address |
Department of Panchkarma J S Ayurveda
Mahavidyalaya, college road, Nadiad
Kheda
GUJARAT
387001
India
Kheda
GUJARAT
387001
India |
| Phone |
9638421735 |
| Fax |
|
| Email |
mansimpatel77@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mansi M Patel |
| Designation |
Reader Department of Panchkarma |
| Affiliation |
J S Ayurveda Mahavidyalaya, college road, Nadiad Kheda GUJARAT 387001 India |
| Address |
Department of Panchkarma J S Ayurveda
Mahavidyalaya, college road, Nadiad
Kheda
GUJARAT
387001
India
Kheda
GUJARAT
387001
India |
| Phone |
9638421735 |
| Fax |
|
| Email |
mansimpatel77@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sundar Ayurveda teaching pharmacy of J.S.Ayurveda Mahavidyalaya and P.D.Patel Ayurveda
Hospital,Nadiad, Gujarat, India.-387001 |
|
|
Primary Sponsor
|
| Name |
J S Ayurveda Mahavidyalaya |
| Address |
J.S.Ayurveda Mahavidyalaya and P.D.Patel Ayurveda
Hospital,Nadiad, Gujarat, India.-387001 |
| Type of Sponsor |
Private 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 Sonal B Bhimani |
P D Patel Ayurvedic hospital |
SUNDER AYURVEDA TEACHING PHARMCY
Kheda
GUJARAT |
8160061620
sonalbhimani12@icloud.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITEE FOR HUMAN RESEARCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K929||Disease of digestive system, unspecified. Ayurveda Condition: ADHOGATA-AMLAPITTAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient eligible for virechanakarma |
|
| ExclusionCriteria |
| Details |
Patient having any other clinical condition will be excluded |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improves Quality Of Life Of The Person |
2 Weeks (At Time Of Discharge)
4 Weeks (At Time Of Follow Up ) |
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
Final Enrollment numbers achieved (Total)= "25"
Final Enrollment numbers achieved (India)="25" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/02/2025 |
| Date of Study Completion (India) |
01/06/2026 |
| Date of First Enrollment (Global) |
10/02/2025 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This
chapter provided a concise summary of the entire research work, including the
objectives, methodology, observations, results, and discussion. The conclusions
drawn from the study regarding the efficacy and safety of Virecana Karma
in the management of Amlapitta were presented, along with the scope for
future research.
|