| CTRI Number |
CTRI/2024/08/072470 [Registered on: 13/08/2024] Trial Registered Prospectively |
| Last Modified On: |
09/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Trinapanchamula ghanvati in Hyperacidity |
|
Scientific Title of Study
|
A Study to Evaluate the Efficacy of Trina Panchamula Ghanvati in Urdhwaga Amlapitta - an open labelled single arm 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 |
PRIYA M SATHVARA |
| Designation |
PG Scholar |
| Affiliation |
Shree Swaminarayan Ayurvedic College, Kalol |
| Address |
Department of Kayachikitsa, Shree Swaminarayan Ayurvedic College,Opp.Kalol GIDC,Saij,Ahmedabad-Mehsana Highway,AT&PO,Ta,Saij,Kalol
Gandhinagar
GUJARAT
382725
India |
| Phone |
9904061923 |
| Fax |
|
| Email |
priyasathavara1999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrVishal N Solanki |
| Designation |
Associate professor |
| Affiliation |
Shree Swaminarayan Ayurvedic College, Kalol |
| Address |
Department of Kayachikitsa, Shree Swaminarayan Ayurvedic College,Opp.Kalol GIDC,Saij,Ahmedabad-Mehsana Highway,AT&PO,Ta,Saij,Kalol
Gandhinagar
GUJARAT
382725
India |
| Phone |
9558121886 |
| Fax |
|
| Email |
vishal12solanki@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Vd Tapankumar M |
| Designation |
Professor |
| Affiliation |
Shree Swaminarayan Ayurvedic College, Kalol |
| Address |
Department of Kayachikitsa, Shree Swaminarayan Ayurvedic College,Opp.Kalol GIDC,Saij,Ahmedabad-Mehsana Highway,AT&PO,Ta,Saij,Kalol
Gandhinagar
GUJARAT
382725
India |
| Phone |
9924304388 |
| Fax |
|
| Email |
vdtapankumar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shree Swaminarayan Ayurvedic College and hospital,Ahmedabad-Mehsana Highway,AT&PO.Saij,Ta,Kalol Dist.Gandhinagar-382725 |
|
|
Primary Sponsor
|
| Name |
Shree Swaminarayan Ayurvedic College |
| Address |
Faculty of Ayurved, Shree Swaminarayan Ayurvedic College,Ahmedabad-Mehsana Highway, AT&PO. Saij, Ta. Kalol, Dist.
Gandhinagar- 382725 |
| 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 Priya M Sathvara |
Premswarup Swami Ayurvedic Multispecialty Hospital |
OPD-004 Department of Kayachikitsa Premswarup Swami Ayurvedic Multispecialty Ahmedabad-Mehsana Highway,AT&PO.Saij,Ta,Kalol Dist.Gandhinagar-382725 Hospital
Gandhinagar
GUJARAT |
9904061923
priyasathavara1999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Shree Swaminarayan Ayurvedic College and Hospital, Kalol |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K30||Functional dyspepsia. Ayurveda Condition: AMLAPITTAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Trinapanchamula ghanvati, Reference: Dhanvantari nighantu Misrakadi varga ch 26, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1000(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: Jala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients presenting with classical signs and symptoms of the Amlapitta.
2.Uncomplicated cases with classical features of Amlapitta will be selected irrespective of Age, Sex, Religion, Caste and Occupation.
3.Patients between age group of 16 to 60 years.
4.Chronicity less than 1 years. |
|
| ExclusionCriteria |
| Details |
1.Patients having Age below 16 years and above 60 years.
2.Chronicity more than 1 years.
3.Patients suffering from Peptic ulcer, duodenal ulcer, Gastric ulcer, Intestinal T.B.
4.Uncontrolled D.M., HTN, Cardiac disorders, Paralysis, Parkinsonism
5.Patient having Acute Diarrhea, Hematemesis, Gastrointestinal infections
6.Patients of Carcinoma, Arsha, Malignancy of stomach, etc. serious condition of patient. This may leads to fatal condition for the patient at any time. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Efficacy of Trinapanchamula ghanvati in the Urdhwaga amlapitta.
|
14 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To devlop an understanding of Urdhwaga amlapitta based on the principles of Ayurveda.
To develop an understanding of Functional dyspepsia according to modern science.
To study the properties & effects of Trinapanchamula Ghanvati in Urdhwaga amlapitta |
28 Days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/10/2024 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Urdhwaga Amlapitta, also known as functional dyspepsia, is a common gastrointestinal problem characterized by symptoms such as heartburn, acid regurgitation, and dyspepsia. Trinapanchamula Ghanvati, an Ayurvedic formulation, has been traditionally used to manage digestive disorders. This study aims to evaluate the efficacy of Trinapanchamula Ghanvati in treating Urdhwaga Amlapitta. A single-arm study was conducted on 40 participants diagnosed with Urdhwaga Amlapitta. Participants were administered Trinapancamula Ghanvati orally, following the two ghanvati BD After food for a duration of 28 days. Baseline parameters including symptom severity were assessed before treatment initiation. Follow-up evaluations were performed at regular intervals during the treatment period. After 28 days of treatment with Trinapancamula Ghanvati, significant improvements were observed in the participants symptoms.
|