Post Marketing Surveillance Study (PMS) to generate safety and efficacy data of Gassanol
- Conditions
- Health Condition 1: K928- Other specified diseases of the digestive system
- Registration Number
- CTRI/2020/09/027636
- Lead Sponsor
- Aurio Pharma Laboratories Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1.Patients of either sex of age 18 to 60 years [both inclusive]
2.Willing to give written informed consent
3.All patients clinically manifesting with symptoms of Peptic Ulcer such as stomach upset, heartburn, and acid indigestion
1)Patients known, or thought to be hypersensitivity to study drug
2)History of auto-immune disease
3)Concurrent use of corticosteroids
4)Any medication or indication that might point to an increased risk, associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the study personnel, would make the subject inappropriate for inclusion
5)Participation in other clinical trials the last three months and during study participation
6)Patients with history of epilepsy, or those at risk for seizures or taking seizure drugs
7)Pregnant, lactating women or women of childbearing age who are not using an acceptable method of birth control
8)Patients with galactose or fructose intolerance
9)Patients with severe renal impairment, including those receiving dialysis.
10)Patients with active liver disease, including those with primary biliary cirrhosis and unexplained persistent liver function abnormalities.
11)Patients with preexisting gallbladder disease
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The aim of this prescriber based post marketing surveillance is to assess efficacy of Bismuth Citrate USP 252mg and Belladonna dry extract IP 18 mg in the actual field conditions of use.Timepoint: 14 days
- Secondary Outcome Measures
Name Time Method The aim of this prescriber based post marketing surveillance is to assess safety of Bismuth Citrate USP 252mg and Belladonna dry extract IP 18 mg in the actual field conditions of use.Timepoint: 14 days