Ulcerative ColitisNCT06067698
Alpha Lipoic Acid in Ulcerative Colitis
A study testing "Mesalamine" and "alpha-lipoic acid" in people with Ulcerative Colitis and Ulcerative Colitis (UC), run by Tanta University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis, Ulcerative Colitis (UC)
- What is being tested?
- "Mesalamine" and "alpha-lipoic acid"
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2023to 1 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Ulcerative Colitis, Ulcerative Colitis (UC)
- Being tested
- "Mesalamine" and "alpha-lipoic acid", "Mesalamine" and "Placebo"
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Mesalamine" and "alpha-lipoic acid"Drug
Mesalamine 1000 mg every 8 hrs. + alpha-lipoic acid 600 mg once daily for 3 months
"Mesalamine" and "Placebo"Drug
Mesalamine 1000 mg every 8 hrs. + Placebo once daily for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Group (Placebo) | Placebo comparator | (Placepo group; n=30) which will receive mesalamine 1000 mg three times daily plus placebo once daily Receives: 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 Receives: Drug: "Mesalamine" and "alpha-lipoic acid" |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 3 months from start of treatment
Secondary outcomes (4)
Change in "fecal calprotectin" as biological parameters
measure Fecal calprotectin which lower result means a better outcome
Measured: 3 months from start of treatment
Change in "reduced glutathione" as biological parameters
measure reduced glutathione which lower result means a better outcome
Measured: 3 months from start of treatment
Change in "interleukin-6" as biological parameters
measure interleukin-6 which lower result mean better outcome.
Measured: 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.
Measured: 3 months from start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2023
- Study start1 Oct 2023
- Primary completion1 Apr 2025
- Study completion1 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Elsayed Farouk, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06067698
- Sponsor's protocol ID
- 36264MS206/6/23
- Status last verified
- Sep 2026
- First submitted
- 15 Sep 2023
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study Evaluating the Efficacy and Safety of Alpha-lipoic Acid in Patients With Ulcerative Colitis Treated With Mesalamine
- ClinicalTrials.gov ID
- NCT06067698
- Acronym / sponsor ID
- 36264MS206/6/23
- Conditions
- Ulcerative Colitis, Ulcerative Colitis (UC)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 1 Aug 2025 (actual)
- First posted
- 5 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group (Placebo) | Placebo comparator | Drug: "Mesalamine" and "Placebo"(Placepo group; n=30) which will receive mesalamine 1000 mg three times daily plus placebo once daily |
| Group (Alpha lipoic acid) | Active comparator | Drug: "Mesalamine" and "alpha-lipoic acid"(Alpha-lipoic acid group; n=30) which will receive mesalamine 1000 mg three times daily plus alpha-lipoic acid 600 mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| "Mesalamine" and "alpha-lipoic acid"Mesalamine 1000 mg every 8 hrs. + alpha-lipoic acid 600 mg once daily for 3 months | Drug | Group (Alpha lipoic acid) |
| "Mesalamine" and "Placebo"Mesalamine 1000 mg every 8 hrs. + Placebo once daily for 3 months | Drug | Group (Placebo) |
Primary outcome
Change in both health related quality of life
Time frame: 3 months from start of treatment
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
Time frame: 3 months from start of treatment
Partial Mayo Scoring Index which evaluate severity through total score whether higher scores mean a worse and lower score mean a better outcome.
4 secondary outcomes
Change in "fecal calprotectin" as biological parameters
Time frame: 3 months from start of treatment
Change in "reduced glutathione" as biological parameters
Time frame: 3 months from start of treatment
Change in "interleukin-6" as biological parameters
Time frame: 3 months from start of treatment
Change in "Transforming growth factor - beta 1" as biological parameters
Time frame: 3 months from start of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "Mesalamine" and "alpha-lipoic acid" in people with Ulcerative Colitis and Ulcerative Colitis (UC), run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in both health related quality of life (time frame: 3 months from start of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.