Rheumatoid ArthritisNCT06277635
Effect of Silymarin Against Methotrexate-induced Liver Injury in Rheumatic Diseases
A study testing Silymarin in people with Rheumatoid Arthritis and Psoriatic Arthritis, run by Phramongkutklao College of Medicine and Hospital at 1 site in Thailand.
Trial summary
To study the effect of silymarin against methotrexate-induced liver injury in rheumatic diseases including rheumatoid arthritis, psoriatric arthritis and psoriasis Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Rheumatoid Arthritis, Psoriatic Arthritis, Psoriasis
- What is being tested?
- Silymarin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteThailand
- Study dates
- 1 Feb 2024to Apr 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged > 20 years
- Diagnosis at least one of the following
- Rheumatoid arthritis according to American College of Rheumatology/ The European Alliance of Associations for Rheumatology 2010(ACR/EULAR2010) with at least one joint swelling or tenderness or
- Psoriatric arthritis according to CASPAR classification criteria with at least one joint swelling or tenderness, or at least one site dactylitis or enthesitis or Psoriasis by dermatologist with active skin lesion
- No previous treatment with methotrexate or treatment with methotrexate within 30 day before randomization
- No previous treatment with other conventional synthetic DMARDs other than methotrexate such as sulfasalazine, hydroxycholoquine, leflunomide
- No previous treatment with biologic DMARDs such as anti-TNF
- Can follow the treatment protocal
Who cannot join
- Pregnancy or planning for pregnancy
- Breastfeeding women
- Ongoing treatment with active malignancy
- GFR < 30 ml/min/1.73m2
- Previous documented of HIV infection
- Chronic alcohol drinking ≥ 3 times/wk or drug abuse within 6 months prior to randomization
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- Positive of HbsAg, anti HCV
- Previous documented of preexisting liver disease such as alcoholic liver disease, liver cirrhosis, autoimmune hepatitis
- AST or ALT > ULN ( 0-50 U/L )
- WBC < 3,000/ul or platelet < 100,000 /ul, ANC < 1,500/ul
- ILD diagnosed by rheumatologist and pulmonologist from chest X ray and HRCT
- History documented silymarin hypersensitivity or severe adverse effects diagnosed by physician or pharmacist from PMK hospital or from history drug allergy or symptoms such as rash, chest tightness, dyspnea, diarrhea and hypotension
- Cannot follow up on treatment protocal
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Rheumatic Disease Unit, Department of Internal Medicine, Phramongkutklao Hospital and College of Medicine
Bangkok, Thailand, 10400, Bangkok, 10400
Rattapol Pakchotanon, M.D., 66+23547980, rattapolpmk@gmail.com
Rattapol Pakchotanon, M.D.
About this study
Official title: Effect of Silymarin Against Methotrexate-induced Liver Injury in Rheumatic Diseases, a Double-blind Randomized Controlled Trial
To study the effect of silymarin against methotrexate-induced liver injury in rheumatic diseases including rheumatoid arthritis, psoriatric arthritis and psoriasis
Read the detailed description
- Methotrexate was indeed a common and effective treatment for rheumatoid arthritis, psoriatic arthritis and psoriasis. Methotrexate-related hepatotoxicity are common occur 1:1,100 persons. Liver abnormalities varies from asymptomatic liver enzyme elevation to fatal hepatic necrosis and liver fibrosis. Methotrexate was discontinued owing to liver dysfunction in 7.4%
- Conditions
- Rheumatoid Arthritis, Psoriatic Arthritis, Psoriasis
- Being tested
- Silymarin, Placebo
- Keywords
- Rheumatoid arthritis, Psoriatric arthritis, Psoriasis, Methotrexate, Silymarin
- Medical subject headings
- Arthritis, Rheumatoid, Arthritis, Psoriatic, Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SilymarinDrug
Also called Milk Thistle
Silymarin is randomly assigned to the participants for 12 weeks during study.
PlaceboDrug
Placebo is randomly assigned to the participants for 12 weeks during study.
| Study group | Role | What they receive |
|---|---|---|
| Silymarin group | Active comparator | Silymarin 140 mg oral tid pc + methotrexate weekly + folic acid 5 mg oral OD pc for 12 weeks Receives: Drug: Silymarin |
| Placebo group | Placebo comparator | Placebo + methotrexate weekly + folic acid 5 mg oral OD pc for 12 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
AST or ALT > 1X ULN ( normal AST and ALT 0-50 U/L)
elevation of AST or ALT more than 1X ULN (% participant)
Measured: 12 weeks
Secondary outcomes (9)
AST or ALT > 2X ULN ( normal AST and ALT 0-50 U/L) AST or ALT > 2X ULN AST or ALT > 2X ULN
elevation of AST or ALT more than 2X ULN (% participant)
Measured: 12 weeks
AST or ALT > 3X ULN ( normal AST and ALT 0-50 U/L)
elevation of AST or ALT more than 3X ULN (% participant)
Measured: 12 weeks
AST or ALT > 5X ULN or >3X ULN ( normal AST and ALT 0-50 U/L) with symptom of hepatitis such as Fatique, abdominal pain, nausea, vomiting or total bilirubin > 2X with jaundice
elevation of AST or ALT > 5X ULN or >3X ULN with symptom of hepatitis such as Fatique, abdominal pain, nausea, vomiting or total bilirubin > 2X with jaundice (% participant)
Measured: 12 weeks
Discontinuation rate of methotrexate
Rate of methotrexate discontinuation (%)
Measured: 12 weeks
Adverse events
Rate of any adverse events (%)
Measured: 12 weeks
Change of DAS-28 ESR or CRP Score
Change of DAS-28 ESR or CRP Score for patients with Rheumatoid arthritis and psoriatric arthritis (unit)
Measured: 12 weeks
Change of BASDAI Score
Change of BASDAI Score for AS (unit)
Measured: 12 weeks
Change of ASDAS ESR or CRP Score
Change of ASDAS ESR or CRP Score for AS (unit)
Measured: 12 weeks
Change of BSA for psoriasis
Change of BSA for psoriasis (unit)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start1 Feb 2024
- Primary completionApr 2025 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Phramongkutklao College of Medicine and Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rattapol Pakchotanon, M.D., Study director, Phramongkutklao College of Medicine and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06277635
- Sponsor's protocol ID
- TAPAC001
- Status last verified
- Feb 2024
- First submitted
- 12 Feb 2024
- Last updated
- 26 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Protocol is to be shared with others. Full data would become available by mid 2026.
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Silymarin Against Methotrexate-induced Liver Injury in Rheumatic Diseases, a Double-blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06277635
- Acronym / sponsor ID
- TAPAC001
- Conditions
- Rheumatoid Arthritis, Psoriatic Arthritis, Psoriasis
- Keywords
- Rheumatoid arthritis, Psoriatric arthritis, Psoriasis, Methotrexate, Silymarin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Phramongkutklao College of Medicine and HospitalUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 26 Feb 2024 (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.
To study the effect of silymarin against methotrexate-induced liver injury in rheumatic diseases including rheumatoid arthritis, psoriatric arthritis and psoriasis
Detailed description
- Methotrexate was indeed a common and effective treatment for rheumatoid arthritis, psoriatic arthritis and psoriasis. Methotrexate-related hepatotoxicity are common occur 1:1,100 persons. Liver abnormalities varies from asymptomatic liver enzyme elevation to fatal hepatic necrosis and liver fibrosis. Methotrexate was discontinued owing to liver dysfunction in 7.4%
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Silymarin group | Active comparator | Drug: SilymarinSilymarin 140 mg oral tid pc + methotrexate weekly + folic acid 5 mg oral OD pc for 12 weeks |
| Placebo group | Placebo comparator | Drug: PlaceboPlacebo + methotrexate weekly + folic acid 5 mg oral OD pc for 12 weeks |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Aged > 20 years
- Diagnosis at least one of the following
Key exclusion criteria (13 listed)
- Pregnancy or planning for pregnancy
- Breastfeeding women
- Ongoing treatment with active malignancy
- GFR < 30 ml/min/1.73m2
- Previous documented of HIV infection
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 |
|---|---|---|
| SilymarinAlso: Milk ThistleSilymarin is randomly assigned to the participants for 12 weeks during study. | Drug | Silymarin group |
| PlaceboPlacebo is randomly assigned to the participants for 12 weeks during study. | Drug | Placebo group |
Primary outcome
AST or ALT > 1X ULN ( normal AST and ALT 0-50 U/L)
Time frame: 12 weeks
elevation of AST or ALT more than 1X ULN (% participant)
9 secondary outcomes
AST or ALT > 2X ULN ( normal AST and ALT 0-50 U/L) AST or ALT > 2X ULN AST or ALT > 2X ULN
Time frame: 12 weeks
AST or ALT > 3X ULN ( normal AST and ALT 0-50 U/L)
Time frame: 12 weeks
AST or ALT > 5X ULN or >3X ULN ( normal AST and ALT 0-50 U/L) with symptom of hepatitis such as Fatique, abdominal pain, nausea, vomiting or total bilirubin > 2X with jaundice
Time frame: 12 weeks
Discontinuation rate of methotrexate
Time frame: 12 weeks
Adverse events
Time frame: 12 weeks
Change of DAS-28 ESR or CRP Score
Time frame: 12 weeks
Change of BASDAI Score
Time frame: 12 weeks
Change of ASDAS ESR or CRP Score
Time frame: 12 weeks
Change of BSA for psoriasis
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2024.
- Individual participant dataSharing planned: Yes. Study Protocol is to be shared with others. Full data would become available by mid 2026.
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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.
Rattapol Pakchotanon, M.D. study director
Phramongkutklao College of Medicine and Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Silymarin in people with Rheumatoid Arthritis and Psoriatic Arthritis, run by Phramongkutklao College of Medicine and Hospital at 1 site in Thailand.
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 8 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 26 Feb 2024. 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 Thailand. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rattapol Pakchotanon, M.D. (66+2 354 7980, rattapolpmk@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AST or ALT > 1X ULN ( normal AST and ALT 0-50 U/L) (time frame: 12 weeks). 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 26 Feb 2024.