Alpha Lipoic Acid in Ulcerative Colitis

Not Applicable

Recruiting

• Conditions: Ulcerative Colitis; Ulcerative Colitis (UC)
• Interventions: Drug: "Mesalamine" and "alpha-lipoic acid"; Drug: "Mesalamine" and "Placebo"

• Registration Number: NCT06067698
• Lead Sponsor: Tanta University

Brief Summary

This study aims at evaluating the efficacy and safety of alpha-lipoic acid as adjuvant therapy to mesalamine in patients with mild to moderate ulcerative colitis due to its effect as anti-oxidant and anti-inflammatory drug which can help to improve disease.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-15
• Study First Submitted QC: 2023-09-27
• Study Start: 2023-10-01
• Study First Posted: 2023-10-05
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-03
• Last Update Posted: 2025-02-06
• Primary Completion: 2025-04-01
• Study Completion: 2025-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Age ≥18 years old.
• Both male and female sex.
• Newly diagnosed patients with active mild and moderate ulcerative colitis according to American College of Gastroenterology (ACG) Clinical Guideline for diagnosing Ulcerative Colitis in Adults.26
• Patients treated with 5-aminosalisylic acid (mesalamine).

Exclusion Criteria

• Patients with severe ulcerative colitis.
• Patients with colorectal cancer.
• Patients on rectal or systemic steroids.
• Patients on immunosuppressants or biological therapies.
• Patients with previously failed treatment with sulphasalazine.
• Patients with known allergy to study medications.
• History of complete or partial colectomy.
• Patients with significant liver disease (fibrosis, cirrhosis, NASH, NAFLD).
• Patients with other inflammatory diseases.
• Patients with thyroid diseases.
• Patients with arrhythmia, ischemic heart disease, and heart failure.
• Patients with diabetes.
• Patients on antioxidants supplement (vitamin A, C, E), selenium, co-enzyme Q.
• Patients on amlodipine, levothyroxine, low strength aspirin, warfarin, atorvastatin, insulin, oral hypoglycemic, chemotherapy (drug-drug interaction).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group (Alpha lipoic acid)	"Mesalamine" and "alpha-lipoic acid"	(Alpha-lipoic acid group; n=30) which will receive mesalamine 1000 mg three times daily plus alpha-lipoic acid 600 mg
Group (Placebo)	"Mesalamine" and "Placebo"	(Placepo group; n=30) which will receive mesalamine 1000 mg three times daily plus placebo once daily

Primary Outcome Measures

Name	Time	Method
Change in both health related quality of life	3 months from start of treatment	The Short Inflammatory Bowel Disease Questionnaire to evaluate quality of life to the patient through score from 1 to 7 whether higher scores mean a better outcome and lower score mean a worse outcome
Change in disease severity	3 months from start of treatment	Partial Mayo Scoring Index which evaluate severity through total score whether higher scores mean a worse and lower score mean a better outcome.

Secondary Outcome Measures

Name	Time	Method
Change in "reduced glutathione" as biological parameters	3 months from start of treatment	measure reduced glutathione which lower result means a better outcome
Change in "interleukin-6" as biological parameters	3 months from start of treatment	measure interleukin-6 which lower result mean better outcome.
Change in "Transforming growth factor - beta 1" as biological parameters	3 months from start of treatment	measure Transforming growth factor - beta 1 which lower result mean better outcome.
Change in "fecal calprotectin" as biological parameters	3 months from start of treatment	measure Fecal calprotectin which lower result means a better outcome

Trial Locations

Locations (1)

Tanat university hospital; 🇪🇬 Tanta, Egypt