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

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ClinicalTrials.gov Identifier: NCT02219191
Recruitment Status : Unknown
Verified March 2017 by Yang Min, Chengdu PLA General Hospital.
Recruitment status was:  Active, not recruiting
First Posted : August 18, 2014
Last Update Posted : April 4, 2017
Sponsor:
Information provided by (Responsible Party):
Yang Min, Chengdu PLA General Hospital

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

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: puerarin tablet 50 mg Drug: Atorvastatin tablet 20 mg Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Puerarin Tablets in Treating Metabolism Syndrome in Patients With Chronic Rheumatic Diseases
Study Start Date : August 2014
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Drug: puerarin tablet 50 mg
Other Name: C15H10O4254.24

Active Comparator: 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.
Drug: Atorvastatin tablet 20 mg
Approval No.: H19990258
Other Name: (3r,5rr)-7-[2-(4-fluorophenyl)-3-phenyl-4-(phenylcarbamoyl)-5-propan-2-yl-pyrrol-1-yl]-3,5-dihydroxy-heptanoic acid




Primary Outcome Measures :
  1. Change from baseline in homeostasis model assessment (HOMA-IR) [ Time Frame: At 0 week, 12 weeks, 24 weeks and 48 weeks ]

Secondary Outcome Measures :
  1. Fasting serum low-density lipoprotein cholesterol (LDL-C) [ Time Frame: at 0 week, 12 weeks, 24 weeks, 48 weeks ]
  2. Fasting serum high-density lipoprotein cholesterol (HDL-C) [ Time Frame: at 0 week, 12 weeks, 24 weeks, 48 weeks ]
  3. erythrocyte sedimentation rate (ESR) [ Time Frame: at 0 week, 12 weeks, 24 weeks, 48 weeks ]
  4. C reactive protein (CRP) [ Time Frame: at 0 week, 12 weeks, 24 weeks, 48 weeks ]
  5. Fasting serum total cholesterol (TC) [ Time Frame: at 0 week, 12 weeks, 24 weeks, 48 weeks ]
  6. Fasting serum triglycerides (TGs) [ Time Frame: at 0 week, 12 weeks, 24 weeks, 48 weeks ]
  7. tumor necrosis factor (TNFα) [ Time Frame: at 0 week, 12 weeks, 24 weeks, 48 weeks ]
  8. interleukin-8 (IL-8) [ Time Frame: at 0 week, 12 weeks, 24 weeks, 48 weeks ]
  9. interleukin-1 (IL-1) [ Time Frame: at 0 week, 12 weeks, 24 weeks, 48 weeks ]
  10. interleukin-6 (IL-6) [ Time Frame: at 0 week, 12 weeks, 24 weeks, 48 weeks ]
  11. Fasting serum insulin [ Time Frame: at 0 week, 12 weeks, 24 weeks, 48 weeks ]
  12. Fasting serum glucose [ Time Frame: at 0 week, 12 weeks, 24 weeks, 48 weeks ]
  13. Kidney function [ Time Frame: at 0 week, 12 weeks, 24 weeks, 48 weeks ]
  14. Liver function [ Time Frame: at 0 week, 12 weeks, 24 weeks, 48 weeks ]
  15. blood cell count [ Time Frame: at 0 week, 12 weeks, 24 weeks, 48 weeks ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02219191


Locations
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China, Sichuan
270 Rongdu street, Jin-niu district,Rheumatology Center of Integrated Medicine, General Hospital of Chengdu Military Area Command PLA,
Chengdu city, Sichuan, China, 610083
Sponsors and Collaborators
Chengdu PLA General Hospital
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Responsible Party: Yang Min, Ph.D, Chengdu PLA General Hospital
ClinicalTrials.gov Identifier: NCT02219191    
Other Study ID Numbers: PTSTA20141102
First Posted: August 18, 2014    Key Record Dates
Last Update Posted: April 4, 2017
Last Verified: March 2017
Keywords provided by Yang Min, Chengdu PLA General Hospital:
Puerarin tablet
rheumatoid arthritis
metabolism syndrome
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Rheumatic Diseases
Collagen Diseases
Joint Diseases
Musculoskeletal Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Puerarin
Atorvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Vasodilator Agents