Rheumatoid ArthritisNCT02219191
Puerarin Versus Atorvastatin in Treating Metabolism Syndrome in Patients With Chronic Rheumatic Diseases
A study testing puerarin tablet 50 mg and Atorvastatin tablet 20 mg in people with Rheumatoid Arthritis, run by Chengdu PLA General Hospital at 1 site in China.
Trial summary
To evaluate the Effect of Puerarin tablets versus statins in treating metabolism syndrome in patients with chronic rheumatic diseases Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- puerarin tablet 50 mg and Atorvastatin tablet 20 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- Aug 2014to Dec 2018
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with a definite diagnose with rheumatic disease
- patients with metabolic Syndrome
- without conflict to the written, informed consent signed prior to the enrollment
- no severe hepatic or renal disorders
- no known carotid artery stenosis
- no coagulation disorders
- no hypertension
Who cannot join
- being in pregnancy, lactation period or under a pregnancy plan
- being allergic to the test drug
- not compatible for the trial medication
- without full legal capacity
Trial locations and contacts
1 site in 1 country.
China1 site
270 Rongdu street, Jin-niu district,Rheumatology Center of Integrated Medicine, General Hospital of Chengdu Military Area Command PLA，
Chengdu, Sichuan, 610083
About this study
Official title: The Effect of Puerarin Tablets in Treating Metabolism Syndrome in Patients With Chronic Rheumatic Diseases
To evaluate the Effect of Puerarin tablets versus statins in treating metabolism syndrome in patients with chronic rheumatic diseases
- Conditions
- Rheumatoid Arthritis
- Being tested
- puerarin tablet 50 mg, Atorvastatin tablet 20 mg
- Keywords
- Puerarin tablet, rheumatoid arthritis, metabolism syndrome
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
puerarin tablet 50 mgDrug
Also called C15H10O4254.24
Atorvastatin tablet 20 mgDrug
Also called (3r,5rr)-7-[2-(4-fluorophenyl)-3-phenyl-4-(phenylcarbamoyl)-5-propan-2-yl-pyrrol-1-yl]-3,5-dihydroxy-heptanoic acid
Approval No.: H19990258
| Study group | Role | What they receive |
|---|---|---|
| puerarin tablet 50 mg | Experimental | Patients were orally administrated with 50 mg puerarin tablet three times a day for 24 weeks. Furthermore, patients receive stable treatment with oral anti-rheumatic agents and/or non-steroidal anti-inflammatory drugs, prednisone, aspirin, bone metabolism regulators and gastric mucosal protective agents on as-needed basis. Receives: Drug: puerarin tablet 50 mg |
| Atorvastatin tablet 20 mg | Active comparator | Patients were orally administrated with 20 mg Atorvastatin tablet once a day for 24 weeks. Furthermore, patients receive stable treatment with oral anti-rheumatic agents and/or non-steroidal anti-inflammatory drugs, prednisone, aspirin, bone metabolism regulators and gastric mucosal protective agents on as-needed basis. Receives: Drug: Atorvastatin tablet 20 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in homeostasis model assessment (HOMA-IR)
Measured: At 0 week, 12 weeks, 24 weeks and 48 weeks
Secondary outcomes (15)
Fasting serum low-density lipoprotein cholesterol (LDL-C)
Measured: at 0 week, 12 weeks, 24 weeks, 48 weeks
Fasting serum high-density lipoprotein cholesterol (HDL-C)
Measured: at 0 week, 12 weeks, 24 weeks, 48 weeks
erythrocyte sedimentation rate (ESR)
Measured: at 0 week, 12 weeks, 24 weeks, 48 weeks
C reactive protein (CRP)
Measured: at 0 week, 12 weeks, 24 weeks, 48 weeks
Fasting serum total cholesterol (TC)
Measured: at 0 week, 12 weeks, 24 weeks, 48 weeks
Fasting serum triglycerides (TGs)
Measured: at 0 week, 12 weeks, 24 weeks, 48 weeks
tumor necrosis factor (TNFα)
Measured: at 0 week, 12 weeks, 24 weeks, 48 weeks
interleukin-8 (IL-8)
Measured: at 0 week, 12 weeks, 24 weeks, 48 weeks
interleukin-1 (IL-1)
Measured: at 0 week, 12 weeks, 24 weeks, 48 weeks
interleukin-6 (IL-6)
Measured: at 0 week, 12 weeks, 24 weeks, 48 weeks
Fasting serum insulin
Measured: at 0 week, 12 weeks, 24 weeks, 48 weeks
Fasting serum glucose
Measured: at 0 week, 12 weeks, 24 weeks, 48 weeks
Kidney function
Measured: at 0 week, 12 weeks, 24 weeks, 48 weeks
Liver function
Measured: at 0 week, 12 weeks, 24 weeks, 48 weeks
blood cell count
Measured: at 0 week, 12 weeks, 24 weeks, 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chengdu PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yang Min, Chengdu PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02219191
- Sponsor's protocol ID
- PTSTA20141102
- Status last verified
- Mar 2017
- First submitted
- 16 Jul 2014
- Last updated
- 4 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Puerarin Tablets in Treating Metabolism Syndrome in Patients With Chronic Rheumatic Diseases
- ClinicalTrials.gov ID
- NCT02219191
- Acronym / sponsor ID
- PTSTA20141102
- Conditions
- Rheumatoid Arthritis
- Keywords
- Puerarin tablet, rheumatoid arthritis, metabolism syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Chengdu PLA General HospitalUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 18 Aug 2014 (estimated)
- 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 evaluate the Effect of Puerarin tablets versus statins in treating metabolism syndrome in patients with chronic rheumatic diseases
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| puerarin tablet 50 mg | Experimental | Drug: puerarin tablet 50 mgPatients were orally administrated with 50 mg puerarin tablet three times a day for 24 weeks. Furthermore, patients receive stable treatment with oral anti-rheumatic agents and/or non-steroidal anti-inflammatory drugs, prednisone, aspirin, bone metabolism regulators and gastric mucosal protective agents on as-needed basis. |
| Atorvastatin tablet 20 mg | Active comparator | Drug: Atorvastatin tablet 20 mgPatients were orally administrated with 20 mg Atorvastatin tablet once a day for 24 weeks. Furthermore, patients receive stable treatment with oral anti-rheumatic agents and/or non-steroidal anti-inflammatory drugs, prednisone, aspirin, bone metabolism regulators and gastric mucosal protective agents on as-needed basis. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- patients with a definite diagnose with rheumatic disease
- patients with metabolic Syndrome
- without conflict to the written, informed consent signed prior to the enrollment
- no severe hepatic or renal disorders
- no known carotid artery stenosis
Key exclusion criteria (4 listed)
- being in pregnancy, lactation period or under a pregnancy plan
- being allergic to the test drug
- not compatible for the trial medication
- without full legal capacity
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 |
|---|---|---|
| puerarin tablet 50 mgAlso: C15H10O4254.24 | Drug | puerarin tablet 50 mg |
| Atorvastatin tablet 20 mgAlso: (3r,5rr)-7-[2-(4-fluorophenyl)-3-phenyl-4-(phenylcarbamoyl)-5-propan-2-yl-pyrrol-1-yl]-3,5-dihydroxy-heptanoic acidApproval No.: H19990258 | Drug | Atorvastatin tablet 20 mg |
Primary outcome
Change from baseline in homeostasis model assessment (HOMA-IR)
Time frame: At 0 week, 12 weeks, 24 weeks and 48 weeks
15 secondary outcomes
Fasting serum low-density lipoprotein cholesterol (LDL-C)
Time frame: at 0 week, 12 weeks, 24 weeks, 48 weeks
Fasting serum high-density lipoprotein cholesterol (HDL-C)
Time frame: at 0 week, 12 weeks, 24 weeks, 48 weeks
erythrocyte sedimentation rate (ESR)
Time frame: at 0 week, 12 weeks, 24 weeks, 48 weeks
C reactive protein (CRP)
Time frame: at 0 week, 12 weeks, 24 weeks, 48 weeks
Fasting serum total cholesterol (TC)
Time frame: at 0 week, 12 weeks, 24 weeks, 48 weeks
Fasting serum triglycerides (TGs)
Time frame: at 0 week, 12 weeks, 24 weeks, 48 weeks
tumor necrosis factor (TNFα)
Time frame: at 0 week, 12 weeks, 24 weeks, 48 weeks
interleukin-8 (IL-8)
Time frame: at 0 week, 12 weeks, 24 weeks, 48 weeks
interleukin-1 (IL-1)
Time frame: at 0 week, 12 weeks, 24 weeks, 48 weeks
interleukin-6 (IL-6)
Time frame: at 0 week, 12 weeks, 24 weeks, 48 weeks
Fasting serum insulin
Time frame: at 0 week, 12 weeks, 24 weeks, 48 weeks
Fasting serum glucose
Time frame: at 0 week, 12 weeks, 24 weeks, 48 weeks
Kidney function
Time frame: at 0 week, 12 weeks, 24 weeks, 48 weeks
Liver function
Time frame: at 0 week, 12 weeks, 24 weeks, 48 weeks
blood cell count
Time frame: at 0 week, 12 weeks, 24 weeks, 48 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2017.
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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 puerarin tablet 50 mg and Atorvastatin tablet 20 mg in people with Rheumatoid Arthritis, run by Chengdu PLA General Hospital at 1 site in China.
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 7 inclusion and 4 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 4 Apr 2017. 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 China. 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. 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?
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 from baseline in homeostasis model assessment (HOMA-IR) (time frame: At 0 week, 12 weeks, 24 weeks and 48 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 4 Apr 2017.