| CTRI Number |
CTRI/2023/03/050976 [Registered on: 22/03/2023] Trial Registered Prospectively |
| Last Modified On: |
18/07/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical study on Ampop tablet in healthy participants. |
|
Scientific Title of Study
|
An open label, multi-center, non-comparative, interventional, prospective clinical study to evaluate efficacy and safety of Ampop tablet in healthy participants. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| AMPOP/INDIGE/TLS/2022/1, Version 1.0, 24th DEC 2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Chetan Neelnath Mhaske |
| Designation |
Director |
| Affiliation |
Dr. Mhaske Hospital and Research Centre |
| Address |
Dr. Mhaske Hospital and Research Centre, Department of Surgery, OPD no. 1, ground floor, Jiyaji Mention
Building, Near UCO Bank, Solapur - Pune
Hwy, next to Old Post Office, Gadital, Hadapsar,
Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
9923010890 |
| Fax |
|
| Email |
seemhaske@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Satyendra Kumar |
| Designation |
Senior Manager |
| Affiliation |
Transformative Learning Solutions Pvt Ltd |
| Address |
Transformative Learning Solutions Pvt Ltd
3rd Floor, 301B, 302-304, Veritas Business Suite, Sec-53, Gurugram –, Haryana
Gurgaon
HARYANA
122002
India |
| Phone |
9891253516 |
| Fax |
|
| Email |
satyendra.kumar@transformative.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjay Tamoli |
| Designation |
Director |
| Affiliation |
Target Institute of Medical Education and Research Pvt. Ltd. |
| Address |
Target Institute of Medical Education and Research Pvt. Ltd
A wing 402 A/B/C, Jaswanti Allied Business Center, Ramchandra Lane Extension, Kachpada, Malad West, Mumbai
Mumbai (Suburban)
MAHARASHTRA
400064
India |
| Phone |
09322522252 |
| Fax |
|
| Email |
targetinstitute@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Transformative Learning Solutions Private Limited
1 G, Bharat Nagar, New Friends Colony,
New Delhi-110025
|
|
|
Primary Sponsor
|
| Name |
Transformative Learning Solutions Private Limited |
| Address |
1 G, Bharat Nagar, New Friends Colony,
New Delhi-110025
|
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Kanchan Khond |
Ashakiran JHC Hospital |
Department of Ayurvedic Medicine
OPD No. 1, Ground Floor, Ashakiran JHC Hospital, Sr. No. 138, Chinchwad East, Behind St. Andrew’s High School, Pune 411019
Pune
MAHARASHTRA |
9766192921
kanchanskhond@gmail.com |
| Dr Chetan Neelnath Mhaske |
Dr. Mhaske Hospital and Research Centre |
Department of Surgery,
OPD no. 1, ground floor, Jiyaji Mention Building, Near UCO
Bank, Solapur – Pune, Highway, next to Old Post
Office, Gadital, Hadapsar, Pune, Maharashtra 411028
Pune
MAHARASHTRA |
9923010890
seemhaske@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Independent Ethics Committee, Dr. Mhaske Hospital and Research Centre, Pune |
Approved |
| Independent Ethics Committee, for Ashakiran JHC Hospital, Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Mild to moderate symptoms of Hyperacidity |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ampop Tablet |
Subjects will be asked to take Ampop tablet in a dose of 1 tablet twice daily orally after meals with water for 1 month. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthy males and females with any of the mild to moderate symptoms including bloating, feeling of acid reflux, early fullness during a meal, pain, or discomfort in the upper abdomen, burning in the upper abdomen, pain/burning in the center of chest, nausea, vomiting, burping, flatulence, indigestion, and appetite. (Healthy individuals will be defined as those who are not taking any medications and do not require continuous medical care and monitoring)
2. Subjects must be suffering from any of the above symptoms at least from last six months.
3. Ready to provide written consent and follow all the study procedure
|
|
| ExclusionCriteria |
| Details |
1. Subjects with known tuberculosis, hepatitis B and C, HIV, ischemic heart disease, cancer, kidney failure, chronic liver diseases,
2. Subjects having jaundice or any other symptom of active hepatitis
3. Subjects with any other investigational product within 1 month prior to randomization
4. Subject suffering from any other functional dyspepsia, or any other functional gastrointestinal disorder
5. Subjects with diabetes mellitus and hypertension taking regular medications
6. Pregnant and lactating women
7. Subjects with any significant abnormal laboratory parameters
8. Known hypersensitivity to any of the ingredients of Ampop Tablet
9. Other conditions, which in the opinion of the investigators, make subject unsuitable for enrolment or could interfere with his/her participation in, and completion of the study
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1). Changes in duration, number of episodes and severity of symptoms including bloating, feeling of acid reflux, early fullness during a meal, pain or discomfort in the upper abdomen, burning in the upper abdomen, pain/burning in the center of chest, nausea, vomiting, burping, and flatulence
2). Time to get relief from flatulence, bloating, acidity whenever it occurs during study based on subject diary.
|
Day 0, Day 15, Day 30 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Changes in indigestion and appetite on graded scale
2. Changes in bowel movements
3. Changes in consistency of stool on Bristol stool scale
4. Change in quality of life assessed on WHO QOL BREF
5. Global assessment for overall change by investigator and subject
6. Global assessment of tolerability of study product by assessing ADRs, vitals and clinical symptoms by investigator and subject
7. Assessment of adverse events
|
Day 0, Day 15, Day 30 |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
24/03/2023 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not yet done |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
It
is an open label, multi-center, non-comparative, interventional, prospective
clinical study to evaluate efficacy and safety of Ampop tablet in healthy
participants. The study will be carried out
at two centers in India. Subjects will be asked to take Ampop tablet in a
dose of 1 tablet twice daily orally after meals with water for 1 month. Primary
objective of the study will be to assess changes in duration, number of episodes and severity
of symptoms including bloating, feeling of acid reflux, early fullness during a
meal, pain or discomfort in the upper abdomen, burning in the upper abdomen,
pain/burning in the center of chest, nausea, vomiting, burping, and flatulence
and time to get relief from flatulence, bloating, acidity whenever it occurs
during study based on subject diary.
Secondary objectives of the study will be to assess changes in indigestion and appetite on graded scale, changes in bowel movements,
changes in consistency of stool on Bristol stool scale, change in quality of
life assessed on WHO QOL BREF, global assessment for overall change by
investigator and subject, global assessment of tolerability of study product by
assessing ADRs, vitals and clinical symptoms by investigator and subject and
adverse events on day 0,
day 15, day 30 |