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The Effect of XueZhiKang on Fatigue:Comparing With Simvastatin

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
JiFei Tang, Wenzhou Medical University
ClinicalTrials.gov Identifier:
NCT01686451
First received: September 3, 2012
Last updated: April 20, 2014
Last verified: April 2014
Results First Received: October 8, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label
Condition: Dyslipidemias
Interventions: Drug: XueZhiKang
Drug: simvastatin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
From August 10, 2012, through September 15, 2013, 243 patients were screened and 60 patients who met the inclusion criteria were enrolled and randomly assigned to either simvastatin (33 patients) or xuezhikang (27 patients) at medical clinic.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
183 eligible patients were excluded with 160 patients declined to participate while 19 patients were currently using lipid-lowering medications, 3 patients were suffering from chronic kidney disease or active liver disease and 1 was of currently childbearing.

Reporting Groups
  Description
Simvastatin

Participants will receive 20mg of simvastatin daily for 4 weeks.

simvastatin : Participants will receive 20mg of simvastatin daily for 4 weeks.

XueZhiKang

Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.

XueZhiKang : Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.


Participant Flow:   Overall Study
    Simvastatin     XueZhiKang  
STARTED     33     27  
COMPLETED     33     27  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
A total of 60 patients with dyslipidemia and moderate to low cardiovascular disease (CVD) risk were randomly assigned in an open label fashion to receive either simvastatin (n=33) 20 mg daily or xuezhikang (n=27) 600 mg twice daily. All 60 patients were included in baseline analysis.

Reporting Groups
  Description
Simvastatin

Participants will receive 20mg of simvastatin daily for 4 weeks.

simvastatin : Participants will receive 20mg of simvastatin daily for 4 weeks.

XueZhiKang

Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.

XueZhiKang : Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.

Total Total of all reporting groups

Baseline Measures
    Simvastatin     XueZhiKang     Total  
Number of Participants  
[units: participants]
  33     27     60  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     33     27     60  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  46.18  ± 7.00     47.04  ± 5.83     46.57  ± 6.46  
Gender  
[units: participants]
     
Female     15     13     28  
Male     18     14     32  
Region of Enrollment  
[units: participants]
     
China     33     27     60  
Current cigarette smoker, Categorical  
[units: participants]
     
Current cigarette smoker     3     2     5  
Not Current cigarette smoker     30     25     55  
Arterial hypertension, Categorical  
[units: participants]
     
Arterial hypertension     26     16     42  
Not Arterial hypertension     7     11     18  
Arterial blood pressure, Continuous  
[units: mmHg]
Mean ± Standard Deviation
     
Systolic blood pressure     148.06  ± 18.51     147.89  ± 17.03     147.98  ± 17.71  
Diastolic blood pressure     84.18  ± 6.95     83.00  ± 8.82     83.65  ± 7.80  
Fasting blood glucose, Continuous  
[units: mmol/L]
Mean ± Standard Deviation
  5.10  ± 0.36     5.33  ± 0.52     5.20  ± 0.45  
Triglyceride, Continuous  
[units: mmol/L]
Mean ± Standard Deviation
  1.76  ± 1.00     1.61  ± 0.65     1.69  ± 0.86  
Total cholesterol, Continuous  
[units: mmol/L]
Mean ± Standard Deviation
  5.91  ± 0.71     5.82  ± 0.73     5.87  ± 0.72  
High-density lipoprotein-cholesterol, Continuous  
[units: mmol/L]
Mean ± Standard Deviation
  1.27  ± 0.25     1.23  ± 0.25     1.26  ± 0.25  
Low-density lipoprotein-cholesterol, Continuous  
[units: mmol/L]
Mean ± Standard Deviation
  3.72  ± 0.48     3.74  ± 0.55     3.73  ± 0.50  
Alanine aminotransferase, Continuous  
[units: U/L]
Mean ± Standard Deviation
  28.58  ± 10.55     30.33  ± 13.30     29.37  ± 11.79  
Aspartate aminotransferase, Continuous  
[units: U/L]
Mean ± Standard Deviation
  24.12  ± 7.00     25.63  ± 7.53     24.80  ± 7.22  
Creatine phosphate kinase, Continuous  
[units: U/L]
Mean ± Standard Deviation
  80.82  ± 24.91     91.65  ± 23.71     85.69  ± 24.78  
Creatinine, Continuous  
[units: μmol/L]
Mean ± Standard Deviation
  72.57  ± 14.44     75.59  ± 17.20     73.93  ± 15.68  
Fatigue score, Continuous [1]
[units: units on a scale]
Mean ± Standard Deviation
  19.58  ± 2.55     19.26  ± 1.85     19.43  ± 2.25  
Physical activity level, Categorical [2]
[units: participants]
     
Low level     14     3     17  
Moderate level     10     12     22  
High level     9     12     21  
[1] The fatigue score was assessed by a fatigue questionnaire named as Fatigue Assessment Scale (FAS) which used 10-item fatigue measure with the fatigue score ranged from 10-50. The higher score was meaning of higher level of fatigue.
[2] We estimated physical activity level by short version of international physical activity questionnaire (IPAQ) with categorical score ranged from low to high. The higher score was meaning of lower physical activity level.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Comparison Between XueZhiKang and Simvastatin on Fatigue Scores   [ Time Frame: Measured at baseline and week 4 ]

2.  Secondary:   Treatment Efficacy   [ Time Frame: Measured at baseline and week 4 ]

3.  Other Pre-specified:   Comparison of XueZhiKang With Simvastatin of Physical Activity Level   [ Time Frame: Measured at baseline and week 4 ]

4.  Other Pre-specified:   Comparison of Safety Laboratory Testings (ALT,AST,CPK) Between Simvastatin- and Xuezhikang-groups   [ Time Frame: Measured at baseline and week 4 ]

5.  Other Pre-specified:   Comparison of Safety Laboratory Testing (Cr) Between Simvastatin- and Xuezhikang-group   [ Time Frame: Measured at baseline and week 4 ]

6.  Other Pre-specified:   Treatment Adherence at Week 4 in Simvastatin- and Xuezhikang-group   [ Time Frame: Measured at baseline and week 4 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
There are some limitations to this research. First, the sample size was relative small. Second, the follow-up period was short (4 weeks).


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. JiFei Tang
Organization: Department of Cardiology, the Second Affiliated Hospital, Wenzhou Medical University, Zhejiang province, Wenzhou, 325000, China
phone: +8615968766021
e-mail: jiftang@126.com


No publications provided


Responsible Party: JiFei Tang, Wenzhou Medical University
ClinicalTrials.gov Identifier: NCT01686451     History of Changes
Other Study ID Numbers: Wenzhou
Study First Received: September 3, 2012
Results First Received: October 8, 2013
Last Updated: April 20, 2014
Health Authority: China: Ethics Committee