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A clinical study of GutBio Capsule for the treatment of chronic constipation.

"A prospective, open label, single contre & Placcbo controlled study for evaluation of efficacy & safety of Gutbio Plus capsule for chronic constipation & its symptoms." - Nil

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/02/063038
Enrollment
60
Registered
2024-02-22
Start date
Unknown
Completion date
Unknown
Last updated
2024-05-27

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

Conditions

Health Condition 1: K590- Constipation

Interventions

Intervention1: GutBio Plus Capsule: 1 Capsule after Breakfast and 1 Capsule after dinner with water for 29 days. Control Intervention1: Placebo Capsule (Glucose Capsule): 1 Capsule after Breakfast and

Sponsors

Healing Hands & Herbs Pvt.Ltd.
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients aged above 18 years of age. 2. Patient with a diagnosis of chronic constipation 3. Patient or Parents or legal guardian willing to give a written informed consent or parental consent or assent form. 4. Able to 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. Females who are not ready to use acceptable contraceptive methods during the course of study.

Design outcomes

Primary

MeasureTime frame
Overall Complete Spontaneous Bowel Movement Response.Timepoint: Upto fifth visit.

Secondary

MeasureTime frame
1. evaluate the Gastrointestinal Quality of Life Index of Patients suffering from Functional constipation, abdominal pain and bloating. 2. Number of Participants with Treatment-Related Treatment-Emergent Adverse Events. 3. Incidence of adverse events.Timepoint: Upto fifth visit.

Countries

India

Contacts

Public ContactDr Gajanan Bhagwat

Healing Hands Clinic

drashwinporwal@healinghandsclinic.co.in9822347770

Outcome results

None listed

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