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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)

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)

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2020/03/023787
Enrollment
200
Registered
2020-03-05
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K21- Gastro-esophageal reflux disease

Interventions

Intervention1: 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 Control Intervention1: NOT APPLICABLE:

Sponsors

SUNCARE FORMULATIONS PVT LTD
Lead Sponsor

Eligibility

Inclusion criteria

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

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).

Design outcomes

Primary

MeasureTime frame
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

Secondary

MeasureTime frame
Evaluate Efficacy of STOMAFITTimepoint: 1-3 weeks

Countries

India

Contacts

Public ContactDr Nimesh Patel

Sanjeevani Heart & Medical Hosptial

dr_nimesh_patel@yahoo.co.in27641742

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026