Alpha Lipoic Acid in Ulcerative Colitis

Tanta University

Status: Enrolling

Conditions: Ulcerative Colitis (UC); Ulcerative Colitis

Treatments: Drug: "Mesalamine" and "alpha-lipoic acid"; Drug: "Mesalamine" and "Placebo"

Study type: Interventional

Funder types: Other

Identifiers

NCT06067698

36264MS206/6/23

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups, including a placebo group

Group (Placebo)

Placebo Comparator group

Description:

(Placepo group; n=30) which will receive mesalamine 1000 mg three times daily plus placebo once daily

Treatment:

Drug: "Mesalamine" and "Placebo"

Group (Alpha lipoic acid)

Active Comparator group

Description:

(Alpha-lipoic acid group; n=30) which will receive mesalamine 1000 mg three times daily plus alpha-lipoic acid 600 mg

Treatment:

Drug: "Mesalamine" and "alpha-lipoic acid"