Effect of herbal formulation (Divya Cologrit Enteric-coated tablets) in inflammatory bowel disease.

Efficacy of Traditional Ayurvedic Formulation (Divya Cologrit Enteric Coated Tablets) in patients with Inflammatory Bowel Disease: a single-arm, open-label, prospective, observational study"

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/08/056244

Enrollment

Registered

2023-08-08

Start date

Unknown

Completion date

Unknown

Last updated

2023-08-21

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

Conditions

Health Condition 1: K509- Crohns disease, unspecified

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: Subject with known case of Inflammatory Bowel Disease (IBD). Male and female of 18 years to 65 years. Capability of complete compliance and completion of follow-up. Willingness to provide written informed consent.

Exclusion criteria

Exclusion criteria: The subject with complications and requires surgical intervention. The subject with a known history of any malignancy, uncontrolled diabetes mellitus, psychiatric disorders, or with complications of Cardiovascular disease, liver disease or Kidney disorders. Pregnancy or lactation, intention to pregnancy. History of alcoholism or substance abuse. The subject not willing to provide consent. The subject not willing to comply with the protocol.

Design outcomes

Primary

Measure	Time frame
To evaluate the benefit treatment regime on symptomatic improvement in IBD Symptom Inventory (IBDSI)-Long Form.Timepoint: Baseline to Day 60	—

Secondary

Measure	Time frame
To evaluate the benefit treatment regime on IBD Symptom Inventory (IBDSI)-Long Form and Short Form-12 (SF-12).Timepoint: Baseline to Day 60	—

Countries

India

Contacts

Public ContactDr Devika Balagopalan

Patanjali Research Institue

devika.balagopalan@patanjali.res.in7293549081

Outcome results