A clinical study of a herbal formulation DRDC/2022/040 on symptoms of Gastroesophageal reflux disease (GERD)

Phase 2

• Registration Number: CTRI/2023/08/056221
• Lead Sponsor: Dabur Research Development Centre Dabur India Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 21 August 2023

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time required for study products to induce statistically significant acid neutralization effect after a single dose administration.Timepoint: Baseline, End of Study

Secondary Outcome Measures

Name	Time	Method
<br/ ><br>1. Time needed for subjects to demonstrate a one pH unit change after a single dose administration <br/ ><br>2. Time needed to achieve a pH of 3.5 or greater after a single dose <br/ ><br>administration <br/ ><br>3. Safety evaluation through assessment of AE & concomitant medications <br/ ><br>during the study <br/ ><br>Timepoint: Baseline, End of Study