Clinical Study on AGS/WEL01 Capsule in Functional Dyspepsia

Phase 2

Completed

• Conditions: Health Condition 1: null- Functional Dyspepsia

• Registration Number: CTRI/2018/04/012986
• Lead Sponsor: Welex Laboratories Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2018-11-12
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

1. Subject with Functional Dyspepsia as defined by Rome III criteria having one or more of following symptoms:

a). Bothersome postprandial fullness,

b). Early satiation, epigastric pain,

c). Epigastric burning with no evidence of structural disease.

Subjects should have these symptoms for the last three months.

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

Exclusion Criteria

1.Subjects having a history of structural disease of Oesophagus, Stomach, duodenum.

2.Subjects having a history of previous abdominal surgery (in last 6 months).

3.Subjects having a history of organic deformity or malignancy of the GI tract.

4.Subjects with any active GI Bleeding, epigastric mass, peptic ulcer.

5.Pregnant or lactating women.

6.Chronic alcoholics and Habitual Tobacco chewers.

7.Subjects participating in any other Clinical study within 1 month prior to screening visit.

8.Subjects having known hypersensitivity to any ingredient of the study drug.

9.Any other condition due to which subjects 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 gastrointestinal symptoms on Gastrointestinal Symptom Rating Scale (GSRS) (Epigastric pain/upper abdominal pain, Bloating, loss of appetite, retrosternal discomfort Acidic eructation/ heartburn, Nausea, sickness, vomiting, abdominal cramps and early satietyTimepoint: Day-7, Day 0, Day 10, Day 20, Day 30

Secondary Outcome Measures

Name	Time	Method
1. Assessment of postprandial fullness and flatulence <br/ ><br>2. Assessment of frequency of Bowel movements <br/ ><br>3. Assessment of requirement of rescue medications uses <br/ ><br>4. Global assessment for overall change by subject and Investigator <br/ ><br>5. Assessment of tolerability of AGS/WEL01 capsule <br/ ><br>6. Assessment of changes in vitals. <br/ ><br>7. Assessment of laboratory parameters <br/ ><br>Timepoint: Day-7, Day 0, Day 10, Day 20, Day 30