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

Primary Purpose

Rheumatoid Arthritis

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
puerarin tablet 50 mg
Atorvastatin tablet 20 mg
Sponsored by
Chengdu PLA General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Puerarin tablet, rheumatoid arthritis, metabolism syndrome

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

puerarin tablet 50 mg

Atorvastatin tablet 20 mg

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change from baseline in homeostasis model assessment (HOMA-IR)

Secondary Outcome Measures

Fasting serum low-density lipoprotein cholesterol (LDL-C)
Fasting serum high-density lipoprotein cholesterol (HDL-C)
erythrocyte sedimentation rate (ESR)
C reactive protein (CRP)
Fasting serum total cholesterol (TC)
Fasting serum triglycerides (TGs)
tumor necrosis factor (TNFα)
interleukin-8 (IL-8)
interleukin-1 (IL-1)
interleukin-6 (IL-6)
Fasting serum insulin
Fasting serum glucose
Kidney function
Liver function
blood cell count

Full Information

First Posted
July 16, 2014
Last Updated
March 31, 2017
Sponsor
Chengdu PLA General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02219191
Brief Title
Puerarin Versus Atorvastatin in Treating Metabolism Syndrome in Patients With Chronic Rheumatic Diseases
Official Title
The Effect of Puerarin Tablets in Treating Metabolism Syndrome in Patients With Chronic Rheumatic Diseases
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 2014 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chengdu PLA General Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Puerarin tablet, rheumatoid arthritis, metabolism syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
puerarin tablet 50 mg
Arm Type
Experimental
Arm Description
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.
Arm Title
Atorvastatin tablet 20 mg
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
puerarin tablet 50 mg
Other Intervention Name(s)
C15H10O4254.24
Intervention Type
Drug
Intervention Name(s)
Atorvastatin tablet 20 mg
Other Intervention Name(s)
(3r,5rr)-7-[2-(4-fluorophenyl)-3-phenyl-4-(phenylcarbamoyl)-5-propan-2-yl-pyrrol-1-yl]-3,5-dihydroxy-heptanoic acid
Intervention Description
Approval No.: H19990258
Primary Outcome Measure Information:
Title
Change from baseline in homeostasis model assessment (HOMA-IR)
Time Frame
At 0 week, 12 weeks, 24 weeks and 48 weeks
Secondary Outcome Measure Information:
Title
Fasting serum low-density lipoprotein cholesterol (LDL-C)
Time Frame
at 0 week, 12 weeks, 24 weeks, 48 weeks
Title
Fasting serum high-density lipoprotein cholesterol (HDL-C)
Time Frame
at 0 week, 12 weeks, 24 weeks, 48 weeks
Title
erythrocyte sedimentation rate (ESR)
Time Frame
at 0 week, 12 weeks, 24 weeks, 48 weeks
Title
C reactive protein (CRP)
Time Frame
at 0 week, 12 weeks, 24 weeks, 48 weeks
Title
Fasting serum total cholesterol (TC)
Time Frame
at 0 week, 12 weeks, 24 weeks, 48 weeks
Title
Fasting serum triglycerides (TGs)
Time Frame
at 0 week, 12 weeks, 24 weeks, 48 weeks
Title
tumor necrosis factor (TNFα)
Time Frame
at 0 week, 12 weeks, 24 weeks, 48 weeks
Title
interleukin-8 (IL-8)
Time Frame
at 0 week, 12 weeks, 24 weeks, 48 weeks
Title
interleukin-1 (IL-1)
Time Frame
at 0 week, 12 weeks, 24 weeks, 48 weeks
Title
interleukin-6 (IL-6)
Time Frame
at 0 week, 12 weeks, 24 weeks, 48 weeks
Title
Fasting serum insulin
Time Frame
at 0 week, 12 weeks, 24 weeks, 48 weeks
Title
Fasting serum glucose
Time Frame
at 0 week, 12 weeks, 24 weeks, 48 weeks
Title
Kidney function
Time Frame
at 0 week, 12 weeks, 24 weeks, 48 weeks
Title
Liver function
Time Frame
at 0 week, 12 weeks, 24 weeks, 48 weeks
Title
blood cell count
Time Frame
at 0 week, 12 weeks, 24 weeks, 48 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
270 Rongdu street, Jin-niu district,Rheumatology Center of Integrated Medicine, General Hospital of Chengdu Military Area Command PLA，
City
Chengdu city
State/Province
Sichuan
ZIP/Postal Code
610083
Country
China

12. IPD Sharing Statement

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

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