Alpha Lipoic Acid in Ulcerative Colitis

Ulcerative Colitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06067698
• Other study ID #: 36264MS206/6/23
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: October 1, 2024

Study information

• Verified date: October 2023
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: October 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• "Mesalamine" and "alpha-lipoic acid"
Mesalamine 1000 mg every 8 hrs. + alpha-lipoic acid 600 mg once daily for 3 months
• "Mesalamine" and "Placebo"
Mesalamine 1000 mg every 8 hrs. + Placebo once daily for 3 months

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Change in "fecal calprotectin" as biological parameters	measure Fecal calprotectin which lower result means a better outcome	3 months from start of treatment
Secondary	Change in "reduced glutathione" as biological parameters	measure reduced glutathione which lower result means a better outcome	3 months from start of treatment
Secondary	Change in "interleukin-6" as biological parameters	measure interleukin-6 which lower result mean better outcome.	3 months from start of treatment
Secondary	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