Back to resultsAlpha Lipoic Acid in Ulcerative Colitis
Primary Purpose
Ulcerative Colitis
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
"Mesalamine" and "alpha-lipoic acid"
"Mesalamine" and "Placebo"
Sponsored by
About this trial
This is an interventional treatment trial for Ulcerative Colitis
Eligibility Criteria
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).
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Group (Placebo)
Group (Alpha lipoic acid)
Arm Description
(Placepo group; n=30) which will receive mesalamine 1000 mg three times daily plus placebo once daily
(Alpha-lipoic acid group; n=30) which will receive mesalamine 1000 mg three times daily plus alpha-lipoic acid 600 mg
Outcomes
Primary Outcome Measures
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
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.
Secondary Outcome Measures
Change in "fecal calprotectin" as biological parameters
measure Fecal calprotectin which lower result means a better outcome
Change in "reduced glutathione" as biological parameters
measure reduced glutathione which lower result means a better outcome
Change in "interleukin-6" as biological parameters
measure interleukin-6 which lower result mean better outcome.
Change in "Transforming growth factor - beta 1" as biological parameters
measure Transforming growth factor - beta 1 which lower result mean better outcome.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06067698
Brief Title
Alpha Lipoic Acid in Ulcerative Colitis
Official Title
Clinical Study Evaluating the Efficacy and Safety of Alpha-lipoic Acid in Patients With Ulcerative Colitis Treated With Mesalamine
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
July 1, 2024 (Anticipated)
Study Completion Date
October 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group (Placebo)
Arm Type
Placebo Comparator
Arm Description
(Placepo group; n=30) which will receive mesalamine 1000 mg three times daily plus placebo once daily
Arm Title
Group (Alpha lipoic acid)
Arm Type
Active Comparator
Arm Description
(Alpha-lipoic acid group; n=30) which will receive mesalamine 1000 mg three times daily plus alpha-lipoic acid 600 mg
Intervention Type
Drug
Intervention Name(s)
"Mesalamine" and "alpha-lipoic acid"
Intervention Description
Mesalamine 1000 mg every 8 hrs. + alpha-lipoic acid 600 mg once daily for 3 months
Intervention Type
Drug
Intervention Name(s)
"Mesalamine" and "Placebo"
Intervention Description
Mesalamine 1000 mg every 8 hrs. + Placebo once daily for 3 months
Primary Outcome Measure Information:
Title
Change in both health related quality of life
Description
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
Time Frame
3 months from start of treatment
Title
Change in disease severity
Description
Partial Mayo Scoring Index which evaluate severity through total score whether higher scores mean a worse and lower score mean a better outcome.
Time Frame
3 months from start of treatment
Secondary Outcome Measure Information:
Title
Change in "fecal calprotectin" as biological parameters
Description
measure Fecal calprotectin which lower result means a better outcome
Time Frame
3 months from start of treatment
Title
Change in "reduced glutathione" as biological parameters
Description
measure reduced glutathione which lower result means a better outcome
Time Frame
3 months from start of treatment
Title
Change in "interleukin-6" as biological parameters
Description
measure interleukin-6 which lower result mean better outcome.
Time Frame
3 months from start of treatment
Title
Change in "Transforming growth factor - beta 1" as biological parameters
Description
measure Transforming growth factor - beta 1 which lower result mean better outcome.
Time Frame
3 months from start of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Alpha Lipoic Acid in Ulcerative Colitis
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