Clinical study on PotatodaatÂ® in Healthy individuals

Phase 2

Registration Number: CTRI/2022/12/048064

Lead Sponsor: ODAAT PHARMA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1.Healthy Male and female participants, not taking any regular medications and who do not require continual/regular medical attention (healthy individuals will be considered as those who are not taking any medications and have a BMI between 21 kg/m2 to <28 kg/m2)

2.Participants having mild to moderate indigestion (occasional mild to moderate bothersome postprandial fullness and or early satiation, epigastric pain)

3.Participants willing to sign informed consent and to undergo all the study procedure.

Exclusion Criteria

1.Pregnant and Lactating females

2.Participants who have been confirmed of having COVID-19 and have been isolated for its treatment. Participants having recently ( <1 month) suffered and recovered of COVID-19 will also be excluded from the study

3.Known cases of Diabetes

4.Participants having any medical or surgical condition that would require immediate medical or surgical intervention at the time of screening

5.Participants having immune compromised status like HIV, Hepatitis, Tuberculosis and Cancer etc.

6.Participants taking steroid treatment and or any kind of immunosuppressive therapy

7.Participants participating in any other clinical study or having participated in any other study 3 months prior to screening in the present study.

8.Participants having a past history of allergy to potato starch, inulin and accessible corn starch.

9.Other conditions, which in the opinion of the investigators makes the participant unsuitable for enrollment or could interfere in adherence to of the study protocol

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1). Comparative changes in stool short-chain fatty acids- SCFA between three groups <br/ ><br>2). Comparative change in diversity and abundance of gut micro-biota (Ruminococcus bromii, Clostridium chartatabidum, Eubacterium rectale.) between three groupsTimepoint: Screening visit (up to day 3), Day 0, Day 15, and Day 30

Secondary Outcome Measures

Name	Time	Method
1). Comparative changes in symptoms like indigestion, appetite, bowel habits, constipation, flatulence, and fullness of abdomen on a graded scale. <br/ ><br>2). Comparative changes in consistency of stool on Bristol stool scale <br/ ><br>3). Comparative assessment of tolerability of study products by assessing Adverse Events/Adverse Drug Reactions <br/ ><br>4). Comparative changes in global evaluation for overall change by Investigator and participant at the end of study <br/ ><br>5). Comparative assessment of pre and post stool routine and microscopic <br/ ><br>Timepoint: Screening visit (up to day 3), Day 0, Day 15, and Day 30