A Clinical Study of GutBio Capsule for the treatment of Irritable Bowel Syndrome and its symptoms.

Phase 4

• Conditions: Health Condition 1: K582- Mixed irritable bowel syndrome

• Registration Number: CTRI/2024/05/067532
• Lead Sponsor: Healing Hands &Herbs Pvt Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 27 May 2024

Recruitment & Eligibility

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

Inclusion Criteria

1.Patients aged 18 years & above.

2.Patient with a diagnosis of irritable bowel syndrome.

3.Patient or Parent or legal guardian willing to give a written informed consent or parental consent or assent form.

4.Able to or Willing to strictly adhere to the investigator’s prescription.

Exclusion Criteria

1.Individuals were excluded if they had taken any medications that might interfere with the action of the study medications prior to the start of the study or during the study.

2.Subjects with a history of coeliac disease, Inflammatory Bowel disease, bowel cancer, bariatric surgery or surgical resection of the stomach, small intestine, or large intestine.

3.Subjects with a history of unexplained weight loss or rectal bleeding.

4.Female subjects who are pregnant or lactating or planning to become pregnant during the study period.

5.Females who are not ready to use acceptable contraceptive methods during the course of study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluate the improvement in the Irritable Bowel Syndrome- Symptom Severity Score, IBS-Adequate relief, Gastrointestinal symptom rating scale, Complete Spontaneous Bowel Movement and Stool consistency of GutBio capsule.Timepoint: Upto Visit 5 (Day-43)

Secondary Outcome Measures

Name	Time	Method
1.Evaluate the improvement in the Hamilton Anxiety Rating Scale, Hamilton Depression,Rating Scale and IBS-QoL Questionnaire. <br/ ><br> <br/ ><br>2.Number of Participants with Treatment-Related Treatment-Emergent Adverse Events(TEAEs). <br/ ><br> <br/ ><br>3.Safety evaluation of GutBio capsule. <br/ ><br>Impact of GutBio capsule on overall quality of life of patients suffering from IBS. <br/ ><br> <br/ ><br>4.Incidence of Adverse events. <br/ ><br>Timepoint: Upto Visit 5 (Day 43)