To Evaluate the Safety and Efficacy of HODT101510A in Indigestion: Open Label Clinical Study
- Conditions
- Health Condition 1: K00-K95- Diseases of the digestive system
- Registration Number
- CTRI/2019/02/017532
- Lead Sponsor
- The Himalaya Drug Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Adult male and female subjects aged >=18 years presenting with either one or more of the following indigestion symptoms like Loss of appetite, nausea, bloating, belching, abdominal discomfort, flatulence.
Subjects who are willing to withdraw from any other medication taken for indigestion.
Subjects willing to sign informed consent and follow the study procedure.
Subjects who has not participated in any similar kind of clinical study in the last one month.
Patients who took any other medications to relieve these symptoms within 2 weeks. Subjects with cardiac, neurological, renal or hepatic dysfunction. A known history or present condition of allergic response to products its components or to any of the ingredients in the test product. Pre-existing systemic disease requiring long-term medications. Pregnant & breast-feeding women.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method â?¢To clinically evaluate â??HODT101510Aâ?? in reducing the symptoms of indigestion in subjects with Loss of appetite, nausea, bloating, belching, abdominal discomfort, flatulence etc.Timepoint: The whole study duration is for 4 days with follow up visit at day 1, day 3 and day 5
- Secondary Outcome Measures
Name Time Method â?¢To assess the incidence of adverse events during the study period and overall compliance to the study intervention.Timepoint: The whole study duration is for 4 days with follow up visit at day 1, day 3 and day 5