Evaluation of a herbal formulation on symptoms of gastro esophageal reflux disease.

Phase 3

• Conditions: Health Condition 1: K219- Gastro-esophageal reflux disease without esophagitis

• Registration Number: CTRI/2023/07/055642
• Lead Sponsor: 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.Subjects of either sex in the age group of 18 to 60 years, both inclusive.

2.Subjects having average moderate reflux score (items 2 and 3) of Gastrointestinal symptoms rating scale (GSRS) [Appendix 2]

3.Subjects willing to follow the procedures as per the study protocol and voluntarily sign an informed consent form.

Exclusion Criteria

1.Known cases of diseases like gastric ulcer, duodenal ulcer, Gastric Ca etc.

2.Subjects who undergone abdominal surgeries.

3.Subjects with an anticipated need for concomitant medication with anticholinergics, promotility agents, prostaglandin analogs, sucralfate, nonsteroidal anti-inflammatory drugs (NSAIDs), or salicylates

4.Chronic alcoholics and Habitual Tobacco chewers.

5.Known cases of Severe/Chronic hepatic or renal disease.

6. Known subject of any active malignancy.

7.Subjects giving history of significant cardiovascular event < 12 weeks prior to recruitment.

8.Subjects having known chronic, contagious infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV.

9. Known subjects of having active metabolic or gastrointestinal diseases that may interfere with nutrient absorption, metabolism, or excretion, excluding diabetes.

10.Subjects using any other investigational drug within 1 month prior to recruitment or Subjects currently participating in any other Clinical study

11.Known hypersensitivity to any of the ingredients used in study drug

12.Pregnant and Lactating females.

13.Any other condition due to which patients are deemed to be unsuitable by the investigator for reason(s) not specifically started in the exclusion criteria

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assessment of time to onset of action & duration of action of DRDC/2022/040 with respect to relief from heartburn in subjects suffering from gastro oesophageal reflux diseaseTimepoint: Baseline & End of Study

Secondary Outcome Measures

Name	Time	Method
Changes in 8 symptoms of gastroesophageal reflex disease including 1. burning sensation in throat, 2. sour taste in the mouth, 3. burning sensation in the chest, 4. epigastric (upper abdomen) discomfort, 5. burning sensation in the stomach, 6. bitter taste in the mouth, 7. nausea & 8. bloating, as per subject assessment on VAS. <br/ ><br>2.Global assessment for overall change by subjects & investigator at the end of the study treatment <br/ ><br>3.Assessment of safety based on clinical adverse events and vitals <br/ ><br>Timepoint: Screening, Baseline & End of Study