NCT06067698

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 15, 2023

Completed
16 days until next milestone

Study Start

First participant enrolled

October 1, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 5, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

February 6, 2025

Status Verified

February 1, 2025

Enrollment Period

1.5 years

First QC Date

September 15, 2023

Last Update Submit

February 3, 2025

Conditions

Ulcerative ColitisUlcerative Colitis (UC)

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • Change in "fecal calprotectin" as biological parameters

    3 months from start of treatment

  • Change in "reduced glutathione" as biological parameters

    3 months from start of treatment

  • Change in "interleukin-6" as biological parameters

    3 months from start of treatment

  • Change in "Transforming growth factor - beta 1" as biological parameters

    3 months from start of treatment

Study Arms (2)

Group (Placebo)

PLACEBO COMPARATOR

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

Drug: "Mesalamine" and "Placebo"

Group (Alpha lipoic acid)

ACTIVE COMPARATOR

(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"

Interventions

"Mesalamine" and "alpha-lipoic acid"DRUG

Mesalamine 1000 mg every 8 hrs. + alpha-lipoic acid 600 mg once daily for 3 months

Group (Alpha lipoic acid)
"Mesalamine" and "Placebo"DRUG

Mesalamine 1000 mg every 8 hrs. + Placebo once daily for 3 months

Group (Placebo)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanat university hospital

Tanta, Egypt

RECRUITING

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

MesalamineThioctic Acid

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesInflammatory Bowel DiseasesColonic DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

meta-AminobenzoatesAminobenzoatesBenzoatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsAminosalicylic AcidsSalicylatesHydroxybenzoatesHydroxy AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPhenolsThiophenesSulfur CompoundsCoenzymesEnzymes and CoenzymesFatty AcidsLipids

Central Study Contacts

Ahmed Farouk

CONTACT

+201067988063ahmed.farouk.pharmacist@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical pharmacy manager

Study Record Dates

First Submitted

September 15, 2023

First Posted

October 5, 2023

Study Start

October 1, 2023

Primary Completion

April 1, 2025

Study Completion

April 1, 2025

Last Updated

February 6, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)