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

Prospective Open-label and Single-Center study for evaluation of efficacy and safety of Gutbio Capsule for Irritable Bowel Syndrome and its symptoms. - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/05/067532

Enrollment

100

Registered

2024-05-17

Start date

Unknown

Completion date

Unknown

Last updated

2025-08-18

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

Conditions

Health Condition 1: K582- Mixed irritable bowel syndrome

Interventions

Intervention1: GutBio Capsule: 1 Capsule after Breakfast and 1 capsule after Dinner with water or as prescribed by the physician.Total Duration is for 28 Days. Control Intervention1: NA: NA

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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

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

Measure

Time frame

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

—

Countries

India

Contacts

Public ContactDr Gajanan Bhagwat

Healing Hands Clinic Pvt Ltd.

drashwinporwal@healinghandsclinic.co.in9822347770

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026