Alpha Lipoic Acid in Ulcerative Colitis

Clinical Study Evaluating the Efficacy and Safety of Alpha-lipoic Acid in Patients With Ulcerative Colitis Treated With Mesalamine

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.

Study Overview

• Status: Recruiting
• Conditions: Ulcerative Colitis; Ulcerative Colitis (UC)
• Intervention / Treatment: Drug: "Mesalamine" and "Placebo"; Drug: "Mesalamine" and "alpha-lipoic acid"

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ahmed Farouk; Phone Number: +201067988063; Email: ahmed.farouk.pharmacist@gmail.com

Study Locations

• Egypt
  • Tanta, Egypt
    • Recruiting
    • Tanat university hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Group (Placebo); (Placepo group; n=30) which will receive mesalamine 1000 mg three times daily plus placebo once daily	Drug: "Mesalamine" and "Placebo"; Mesalamine 1000 mg every 8 hrs. + Placebo once daily for 3 months
Active Comparator: Group (Alpha lipoic acid); (Alpha-lipoic acid group; n=30) which will receive mesalamine 1000 mg three times daily plus alpha-lipoic acid 600 mg	Drug: "Mesalamine" and "alpha-lipoic acid"; Mesalamine 1000 mg every 8 hrs. + alpha-lipoic acid 600 mg once daily for 3 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in both health related quality of life	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	3 months from start of treatment
Change in disease severity	Partial Mayo Scoring Index which evaluate severity through total score whether higher scores mean a worse and lower score mean a better outcome.	3 months from start of treatment

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2023
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: September 15, 2023
• First Submitted That Met QC Criteria: September 27, 2023
• First Posted (Actual): October 5, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 3, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Colitis; Colitis, Ulcerative; Ulcer; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Peripheral Nervous System Agents; Antirheumatic Agents; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Anti-Inflammatory Agents, Non-Steroidal; Micronutrients; Antioxidants; Protective Agents; Vitamin B Complex; Vitamins; Thioctic Acid; Mesalamine
• Other Study ID Numbers: 36264MS206/6/23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No