Clinical study on gastrointestinal health.

A randomized, double blind, placebo controlled, study to evaluate the effects of a Herbal formulation (GP/PROD/2021/003)on gastrointestinal health - Nil

Status

Recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/01/039174

Enrollment

Registered

2022-01-05

Start date

Unknown

Completion date

Unknown

Last updated

2022-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Herbal formulation (GP/PROD/2021/003)on gastrointestinal health: 1 tablets twice a day after meals for 90 days Control Intervention1: Placebo Tablets: 1 tablets twice a day after meals

Eligibility

Inclusion criteria

Inclusion criteria: Males and Females between 18-60 years of age Subjects must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent. Subjects self-described any of the gastrointestinal symptoms like epigastric discomfort, heartburn, nausea, vomiting, belching, flatulence, fullness in stomach, abdominal distension. Not consuming probiotics, prebiotics, etc.

Exclusion criteria

Exclusion criteria: Not having a major critical illness. Pregnant & lactating women Not willing to sign an informed consent form. Actively having a gut infection As per the discretion of the investigator

Design outcomes

Primary

Measure	Time frame
Clinical improvement in the overall health as assessed by clinical examination of signs and symptoms such as epigastric discomfort, heartburn, nausea, vomiting, belching, flatulence, fullness in stomach, abdominal distension, etc on a 5 point Linkert scale.Timepoint: Baseline Day, Day 7, Day 14, Day 30, 60 and 90 days	—

Secondary

Measure	Time frame
% responders compared to placebo. Compliance of the subject to the drug treatment. Adverse effects profile. Reduction in requirement of rescue medication. Biochemical parameters for safety consideration. Laboratory Parameters like LFT,RFT and Lipid profileTimepoint: Baseline Day to end of the study.	—

Countries

India

Contacts

Public ContactMr Chetan savaliya

Gplife Healthcare Pvt Ltd

gplifehealthcare@gmail.com

Outcome results