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Clinical Trials/CTRI/2023/08/056221
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.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Sponsor
Dabur Research Development Centre Dabur India Limited

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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