CTRI/2018/02/011860
Completed
Phase 2
Clinical Study to Evaluate the Safety and Efficacy of Green Tea, Ginger Flavor for digestive wellbeing - Randomized Open Label Phase II Comparative Clinical Studyâ??
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- The Himalaya Drug Company
- Enrollment
- 40
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Both male and females in the age group of 18 \- 60 years
- •2\. Subjects who have mild occasional symptoms like abdominal discomfort, heartburn, flatulence, abdominal distension, belching, nausea, vomiting, sense of fullness/heaviness of stomach etc
- •3\. Subjects willing to give written informed consent
- •4\. Subjects who are willing to maintain their regular diet pattern and refrain from any other beverages known to relieve digestive disturbances
- •5\. Subjects who have not participated in similar kind of study in last 4 weeks
Exclusion Criteria
- •1\. Subjects with chronic gastrointestinal disorders and had undergone any surgery
- •2\. Subjects with chronic infection
- •3\. Subjects who are on anti\-allergic or anti\- inflammatory medications
- •4\. Subjects with established hypertension, renal, hepatic or cardiac failure
- •5\. Subjects with endocrine disorders
- •6\. Subjects currently using prescription medication to treat gastric problems
- •7\. Subjects who are pregnant \& lactating women.
- •8\. Subjects who are not willing to sign informed consent form
Outcomes
Primary Outcomes
Not specified
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