NCT06187298

Effect of Oral Combined Berberine and Curcumin Pharmacological Therapy on IBS

The Adjuvant Synergistic Therapeutic Effect of Oral Berberine and Curcumin Alleviates Symptoms of Irritable Bowel Syndrome: Results From a Real-life Setting Clinical Intervention Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 146 (actual)
• Sponsor: Liaquat University of Medical & Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

Irritable bowel syndrome (IBS) is a prevalent, chronic functional gastrointestinal (GI) disorder, characterized by recurrent abdominal discomfort (pain) associated with altered bowel movements. IBS has a considerable negative impact on people's quality of life (QoL). There is currently no specific treatment available for IBS; most of the therapeutic management is symptomatic. Reported evidence suggest that BBR and CUR can alleviate symptoms of IBS through their multiple pharmacological effects including preventing stress-induced intestinal inflammation and visceral hypersensitivity, reducing bowel motility, and regulating intestinal permeability, gut microme and gut-brain axis.

Detailed description

Aim of the study: The present clinical study aimed to assess the synergestic therapeutic effect of a combined supplement of standardised extract of BBR and CUR (Enterophytol® PLUS, 200 mg BBR, 49 mg CUR) in the management of IBS. Method : This was an in real-life setting pragmatic, observational, retrospective, non-controlled and non-randomized clinical trial involving 146 patients with IBS, enrolled in General Practitioner clinics and Pharmacies in Belgium from Aug 2020 to May 2022. The supplement was used as two tablets daily for 2-months, alongside routine IBS care.

Conditions

• Irritable Bowel Syndrome

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	A combined supplement of Berberine and Curcumin (Enterophytol® PLUS) alongside standard of care	(Enterophytol® PLUS) alongside standard of care

Timeline

• Start date: 2020-08-25
• Primary completion: 2022-05-16
• Completion: 2023-12-15
• First posted: 2024-01-02
• Last updated: 2024-01-29

Locations

1 site across 1 country: Pakistan