CTRI/2023/08/056221
Not yet recruiting
Phase 2
Clinical study to evaluate effect and safety of herbal formulation DRDC/2022/040 on Intragastric pHâ?? A randomized, open label, comparative, cross over, interventional, prospective study - NI
Dabur Research Development Centre Dabur India Limited0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Dabur Research Development Centre Dabur India Limited
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Healthy male and female subjects
- •2\.Clinically normal physical findings at the time of screening visit
- •3\.Laboratory values (CBC, CT, BT, Liver profile) within the normal range
- •4\.Negative Urine pregnancy test at the time of screening for female participants
- •5\.Ready to sign informed consent form and follow study procedure
Exclusion Criteria
- •1\. Immunocompromised subjects or those suffering from any serious or debilitating medical condition;
- •2\. Subjects with current drug, tobacco or alcohol abuse;
- •3\. Subjects with diabetes/hypertension;
- •4\. Subjects with presence of any disease/condition or physical defect which could preclude subjects from complying with study procedures.
- •5\. Subjects receiving treatment with any medication which could alter or influence stomach acidity or study drug/placebo activity;
- •6\. Subjects who investigator feels may be unreliable or unsuitable to participate in a clinical trial
- •7\. Subject having participated in a clinical trial in the previous 30 days
- •8\. Pregnant and Lactating females
Outcomes
Primary Outcomes
Not specified
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