Puerarin Versus Atorvastatin in Treating Metabolism Syndrome in Patients With Chronic Rheumatic Diseases

NCT ID: NCT02219191

Last Updated: 2017-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2018-12-31

Brief Summary

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To evaluate the Effect of Puerarin tablets versus statins in treating metabolism syndrome in patients with chronic rheumatic diseases

Detailed Description

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Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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puerarin tablet 50 mg

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.

Group Type EXPERIMENTAL

puerarin tablet 50 mg

Intervention Type DRUG

Atorvastatin tablet 20 mg

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.

Group Type ACTIVE_COMPARATOR

Atorvastatin tablet 20 mg

Intervention Type DRUG

Approval No.: H19990258

Interventions

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puerarin tablet 50 mg

Intervention Type DRUG

Atorvastatin tablet 20 mg

Approval No.: H19990258

Intervention Type DRUG

Other Intervention Names

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C15H10O4254.24 (3r,5rr)-7-[2-(4-fluorophenyl)-3-phenyl-4-(phenylcarbamoyl)-5-propan-2-yl-pyrrol-1-yl]-3,5-dihydroxy-heptanoic acid

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chengdu PLA General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yang Min

Ph.D

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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270 Rongdu street, Jin-niu district,Rheumatology Center of Integrated Medicine, General Hospital of Chengdu Military Area Command PLA,

Chengdu, Sichuan, China

Site Status

Countries

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China

Other Identifiers

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PTSTA20141102

Identifier Type: -

Identifier Source: org_study_id

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