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)
Phase 4
Completed
- Conditions
- Health Condition 1: K21- Gastro-esophageal reflux disease
- Registration Number
- CTRI/2020/03/023787
- Lead Sponsor
- SUNCARE FORMULATIONS PVT LTD
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
Inclusion Criteria
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
Exclusion Criteria
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).
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Relief in signs and / or symptoms of patientsâ?? 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 intensityTimepoint: 1-3 weeks <br/ ><br>
- Secondary Outcome Measures
Name Time Method Evaluate Efficacy of STOMAFITTimepoint: 1-3 weeks