| CTRI Number |
CTRI/2020/03/023787 [Registered on: 05/03/2020] Trial Registered Prospectively |
| Last Modified On: |
02/08/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
A Prospective, Open-label, Non-comparative, Multi-centric Active PMS to evaluate efficacy and safety of STOMAFIT ORAL LIQUID containing Liquor Bismuth Ammonium Citrate 2.5ml, Belladonna Dry Extract 9mg, Thymol 0.15mg and Menthol 0.2 mg in Gastritis or Gastroesophageal Reflux Disease (GERD) |
|
Scientific Title of Study
|
A Prospective, Open-label, Non-comparative, Multi-centric Active PMS to evaluate
efficacy and safety of STOMAFIT ORAL LIQUID containing Liquor Bismuth Ammonium Citrate
2.5ml, Belladonna Dry Extract 9mg, Thymol 0.15mg and Menthol 0.2 mg in Gastritis or
Gastroesophageal Reflux Disease (GERD) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nimesh Patel |
| Designation |
M.D. General Medicine |
| Affiliation |
Sanjeevani Heart & Medical Hosptial |
| Address |
Snajeevani Complex, near Devasya Clinic, Opposite Mehsana Society, Vadaj Road, Ahmedabad
Ahmadabad
GUJARAT
380013
India |
| Phone |
27641742 |
| Fax |
|
| Email |
dr_nimesh_patel@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nimesh Patel |
| Designation |
M.D. General Medicine |
| Affiliation |
Sanjeevani Heart & Medical Hosptial |
| Address |
Snajeevani Complex, near Devasya Clinic, Opposite Mehsana Society, Vadaj Road, Ahmedabad
Ahmadabad
GUJARAT
380013
India |
| Phone |
27641742 |
| Fax |
|
| Email |
dr_nimesh_patel@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nimesh Patel |
| Designation |
M.D. General Medicine |
| Affiliation |
Sanjeevani Heart & Medical Hosptial |
| Address |
Snajeevani Complex, near Devasya Clinic, Opposite Mehsana Society, Vadaj Road, Ahmedabad
Ahmadabad
GUJARAT
380013
India |
| Phone |
27641742 |
| Fax |
|
| Email |
dr_nimesh_patel@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| SUNCARE FORMULATIONS PVT LTD |
|
|
Primary Sponsor
|
| Name |
SUNCARE FORMULATIONS PVT LTD |
| Address |
SUNCARE FORMULATIONS PVT. LTD.
E-20, UPSIDC, Selaqui, Dehradun-248011, Uttarakhand. |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Nimesh Patel |
Sanjeevani Heart and Medical Hospital |
Sanjeevani Complex, Opposite Mehsana Society, Nava Vadaj Road, Ahmedabad
Ahmadabad
GUJARAT |
7927641742
dr_nimesh_patel@yahoo.co.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Ashirwad Ethics Committee |
Approved |
| Ethics committe Sanjeevani Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K21||Gastro-esophageal reflux disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
| Intervention |
STOMAFIT ORAL LIQUID |
Treatment of Gastritis
DOSE: 5 to 10mL diluted in 30 mL water
Frequency 3 to 4 times daily
Route of administration: Oral |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Male and female subjects 18-60 years of age
2. Patients having gastrointestinal illness; signs and symptoms confirmed from clinical judgement
3. Patients willing to give informed consent for the Active PMS and willing to comply with all the study procedure and requiremnets |
|
| ExclusionCriteria |
| Details |
1. History of HIV positive patients
2. Chronic heart failure, respiratory failure or chronic liver and renal failure.
3. Patient with active cancer.
4. Female who is pregnant, planning a pregnancy (during the course of the study) or nursing a child
5. Certain medications that may interfere with the study medication (these will be identified by the study Investigator). |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief in signs and / or symptoms of patients’ disease. Each symptom or patient complaint will be given intensity score, to describe its intensity from mild to severe, on the Numeric Rating Scale of 01 to 10 starting mildest intensity from 01. Following is an indicative Numerical Rating Scale for measurement of pain intensity |
1-3 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Evaluate Efficacy of STOMAFIT |
1-3 weeks |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="200" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
09/03/2020 |
| Date of Study Completion (India) |
14/04/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Secondary objective is to provide preliminary
evidence of efficacy of STOMAFIT ORAL LIQUID in the treatment of Gastritis or
Gastroesophageal reflux disease (GERD). |