A Clinical study to evaluate the effect of ASFP001/21 and SMXP001/22 on improvement in quality of life in healthy volunteers with mild to moderate functional dyspepsia symptoms.

Not Applicable

Not yet recruiting

• Registration Number: CTRI/2022/07/044075
• Lead Sponsor: Akay Natural Ingredients Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2 August 2022

Recruitment & Eligibility

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

Inclusion Criteria

1.Fulfilling Rome IV diagnostic criteria for functional dyspepsia

2.Female subjects who are non-pregnant, non-lactating, postmenopausal, surgically sterilized, or using a medically acceptable form of birth control, as determined by the investigator

3. Must be willing and able to give informed consent and comply with the study procedures.

Exclusion Criteria

1.History of peptic ulcer, gastro oesophageal reflux disease, gastro intestinal surgery or any other clinically significant gastro intestinal disease, gastrointestinal bleeding, mechanical obstruction, perforation, gastrointestinal cancer.

2.Subjects who have taken antibiotics or any other drugs in last 2 weeks with primary site of action in the gastro intestinal tract

3.History of psychiatric illness

4.History of congestive heart failure or uncontrolled hypertension

5.Subjects with abnormal haematological or biochemical parameters

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in quality of life in mild to moderate functional dyspepsia symptomsTimepoint: Day 0, Day 2, Day 3, Day 7 and Day 14

Secondary Outcome Measures

Name	Time	Method
Change in cognitive functionsTimepoint: Day 0 and Day 14;Change in Gastro Intestinal SymptomsTimepoint: Day 0, Day 2, Day 3, Day 7 and Day 14;Change in gut microbiotaTimepoint: Day 0 and Day 14