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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

Tracking Information
First Submitted Date  ICMJE July 16, 2014
First Posted Date  ICMJE August 18, 2014
Last Update Posted Date April 4, 2017
Study Start Date  ICMJE August 2014
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 6, 2014)
Change from baseline in homeostasis model assessment (HOMA-IR) [ Time Frame: At 0 week, 12 weeks, 24 weeks and 48 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 15, 2014)
Changes from baseline in Agatston score at 24 weeks [ Time Frame: at 0 week, 24 weeks ]
All the patients underwent coronary artery calcium scanning (CAC) under Siemens Somatom Sensation Cardiac 64-slice spiral computed tomography (CT). Agatston score was defined as a hyperattenuating plaque of at 4 contiguous pixels with a CT density more than Hounsfield units. The Agatston score was calculated by multiplying the lesion area of each focus of detectable coronary calcium by a density factor derived from the maximal Hounsfield unit within this area, the total Agatston score was computed by summing the Agatston scores of all lesion foci in the epicardial coronary system .
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 6, 2014)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 15, 2014)
  • Changes from baseline in Carotid intima-media thickness at 24 weeks [ Time Frame: at 0 week, 24 weeks ]
    Carotid intima-media thickness (CIMT) was measured using a high-resolution B-mode ultrasound (US) machine (iU22 xMATRIX, Philips, Andover, Massachusetts, United States). Duplex carotid US was performed by an experienced cardiologist using an 11-MHz linear vascular probe. Offline QLab 6.0 analysis system (Philips, Andover, Massachusetts, United States) was applied to measure CIMT signals from the proximal internal carotid artery (the arterial segment 1 cm distal to the carotid bifurcation), the carotid bulb and the distal common carotid artery (the arterial segment 1 cm proximal to the carotid bulb). The investigator was blinded to all clinical information. The mean CIMT was calculated from the value of five arterial segments. All the measurement and analysis procedures were performed by a single ultra sonographer and a single investigator.
  • Changes from baseline in ankle brachial pressure index at 24 weeks [ Time Frame: at 0 week and 24 weeks ]
    Ankle brachial pressure index(ABI) was measured routinely by a physician. Systolic blood pressure measurements were detected with a cuff-type blood-pressure meter (REM016-A, Zhejiang, China) under a hand-held Doppler instrument with a 5-mHz probe (Philips, Andover, Massachusetts, United States). Systolic blood pressure measurements were examined on bilateral brachial, dorsalis pedis, and posterior tibial arteries. Brachial artery pressure of each side was detected for three times. The highest mean value was used as denominator and the highest pressure value from dorsalis pedis or posterior tibial was used as numerator to calculate ABI.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: August 15, 2014)
  • Total cholesterol (TC) [ Time Frame: at 0 week, 12 weeks, 24 weeks, 36 weeks and 48 weeks ]
  • triglycerides (TGs) [ Time Frame: at 0 week, 12 weeks, 24 weeks, 36 weeks and 48 weeks ]
  • low-density lipoprotein cholesterol (LDL-C) [ Time Frame: at 0 week, 12 weeks, 24 weeks, 36 weeks and 48 weeks ]
  • erythrocyte sedimentation rate (ESR) [ Time Frame: at 0 week, 12 weeks, 24 weeks, 36 weeks and 48 weeks ]
  • C reactive protein (CRP) [ Time Frame: at 0 week, 12 weeks, 24 weeks, 36 weeks and 48 weeks ]
  • tumor necrosis factor (TNFα) [ Time Frame: at 0 week, 12 weeks, 24 weeks, 36 weeks and 48 weeks ]
  • interleukin-8 (IL-8) [ Time Frame: at 0 week, 12 weeks, 24 weeks, 36 weeks and 48 weeks ]
  • interleukin-6 (IL-6) [ Time Frame: at 0 week, 12 weeks, 24 weeks, 36 weeks and 48 weeks ]
  • interleukin-1 (IL-1) [ Time Frame: at 0 week, 12 weeks, 24 weeks, 36 weeks and 48 weeks ]
  • Kidney function [ Time Frame: at 0 week, 12 weeks, 24 weeks, 36 weeks and 48 weeks, from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 weeks ]
  • Liver function [ Time Frame: at 0 week, 12 weeks, 24 weeks, 36 weeks and 48 weeks, from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 weeks ]
  • blood cell count [ Time Frame: at 0 week, 12 weeks, 24 weeks, 36 weeks and 48 weeks, from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 weeks ]
 
Descriptive Information
Brief Title  ICMJE Puerarin Versus Atorvastatin in Treating Metabolism Syndrome in Patients With Chronic Rheumatic Diseases
Official Title  ICMJE The Effect of Puerarin Tablets in Treating Metabolism Syndrome in Patients With Chronic Rheumatic Diseases
Brief Summary To evaluate the Effect of Puerarin tablets versus statins in treating metabolism syndrome in patients with chronic rheumatic diseases
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Rheumatoid Arthritis
Intervention  ICMJE
  • Drug: puerarin tablet 50 mg
    Other Name: C15H10O4254.24
  • 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
Study Arms  ICMJE
  • 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.
    Intervention: Drug: puerarin tablet 50 mg
  • 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.
    Intervention: Drug: Atorvastatin tablet 20 mg
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 6, 2014)
150
Original Actual Enrollment  ICMJE
 (submitted: August 15, 2014)
119
Estimated Study Completion Date  ICMJE December 2018
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02219191
Other Study ID Numbers  ICMJE PTSTA20141102
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yang Min, Chengdu PLA General Hospital
Study Sponsor  ICMJE Chengdu PLA General Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Chengdu PLA General Hospital
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP