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The Effect of XueZhiKang on Fatigue:Comparing With Simvastatin

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ClinicalTrials.gov Identifier: NCT01686451
Recruitment Status : Completed
First Posted : September 18, 2012
Results First Posted : May 19, 2014
Last Update Posted : May 19, 2014
Sponsor:
Information provided by (Responsible Party):
JiFei Tang, Wenzhou Medical University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label)
Condition Dyslipidemias
Interventions Drug: XueZhiKang
Drug: simvastatin
Enrollment 60
Recruitment Details 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 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.
Arm/Group Title Simvastatin XueZhiKang
Hide Arm/Group Description

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

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

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.

Period Title: Overall Study
Started 33 27
Completed 33 27
Not Completed 0 0
Arm/Group Title Simvastatin XueZhiKang Total
Hide Arm/Group Description

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

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

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 of all reporting groups
Overall Number of Baseline Participants 33 27 60
Hide Baseline Analysis Population Description
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.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 27 participants 60 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
33
 100.0%
27
 100.0%
60
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 33 participants 27 participants 60 participants
46.18  (7.00) 47.04  (5.83) 46.57  (6.46)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 27 participants 60 participants
Female
15
  45.5%
13
  48.1%
28
  46.7%
Male
18
  54.5%
14
  51.9%
32
  53.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
China Number Analyzed 33 participants 27 participants 60 participants
33 27 60
Current cigarette smoker, Categorical  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 33 participants 27 participants 60 participants
Current cigarette smoker 3 2 5
Not Current cigarette smoker 30 25 55
Arterial hypertension, Categorical  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 33 participants 27 participants 60 participants
Arterial hypertension 26 16 42
Not Arterial hypertension 7 11 18
Arterial blood pressure, Continuous  
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 33 participants 27 participants 60 participants
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  
Mean (Standard Deviation)
Unit of measure:  mmol/L
Number Analyzed 33 participants 27 participants 60 participants
5.10  (0.36) 5.33  (0.52) 5.20  (0.45)
Triglyceride, Continuous  
Mean (Standard Deviation)
Unit of measure:  mmol/L
Number Analyzed 33 participants 27 participants 60 participants
1.76  (1.00) 1.61  (0.65) 1.69  (0.86)
Total cholesterol, Continuous  
Mean (Standard Deviation)
Unit of measure:  mmol/L
Number Analyzed 33 participants 27 participants 60 participants
5.91  (0.71) 5.82  (0.73) 5.87  (0.72)
High-density lipoprotein-cholesterol, Continuous  
Mean (Standard Deviation)
Unit of measure:  mmol/L
Number Analyzed 33 participants 27 participants 60 participants
1.27  (0.25) 1.23  (0.25) 1.26  (0.25)
Low-density lipoprotein-cholesterol, Continuous  
Mean (Standard Deviation)
Unit of measure:  mmol/L
Number Analyzed 33 participants 27 participants 60 participants
3.72  (0.48) 3.74  (0.55) 3.73  (0.50)
Alanine aminotransferase, Continuous  
Mean (Standard Deviation)
Unit of measure:  U/L
Number Analyzed 33 participants 27 participants 60 participants
28.58  (10.55) 30.33  (13.30) 29.37  (11.79)
Aspartate aminotransferase, Continuous  
Mean (Standard Deviation)
Unit of measure:  U/L
Number Analyzed 33 participants 27 participants 60 participants
24.12  (7.00) 25.63  (7.53) 24.80  (7.22)
Creatine phosphate kinase, Continuous  
Mean (Standard Deviation)
Unit of measure:  U/L
Number Analyzed 33 participants 27 participants 60 participants
80.82  (24.91) 91.65  (23.71) 85.69  (24.78)
Creatinine, Continuous  
Mean (Standard Deviation)
Unit of measure:  μmol/L
Number Analyzed 33 participants 27 participants 60 participants
72.57  (14.44) 75.59  (17.20) 73.93  (15.68)
Fatigue score, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 33 participants 27 participants 60 participants
19.58  (2.55) 19.26  (1.85) 19.43  (2.25)
[1]
Measure Description: 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.
Physical activity level, Categorical   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 33 participants 27 participants 60 participants
Low level 14 3 17
Moderate level 10 12 22
High level 9 12 21
[1]
Measure Description: 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.
1.Primary Outcome
Title Comparison Between XueZhiKang and Simvastatin on Fatigue Scores
Hide Description At baseline and week 4, 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.
Time Frame Measured at baseline and week 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Simvastatin/Baseline Simvastatin/Week 4 XueZhiKang/Baseline XueZhiKang/Week 4
Hide Arm/Group Description:

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

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

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

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

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.

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.

Overall Number of Participants Analyzed 33 33 27 27
Mean (Standard Deviation)
Unit of Measure: units on a scale
19.58  (2.55) 21.58  (2.75) 19.26  (1.85) 19.33  (1.90)
2.Secondary Outcome
Title Treatment Efficacy
Hide Description Treatment efficacy was estimated on the basis of triglyceride (TG), total cholesterol (TC), high-density lipoprotein-cholesterol (HDL-C), as well as LDL-C levels obtained at baseline and week 4.
Time Frame Measured at baseline and week 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Simvastatin/Baseline Simvastatin/Week 4 XueZhiKang/Baseline XueZhiKang/Week 4
Hide Arm/Group Description:

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

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

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

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

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.

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.

Overall Number of Participants Analyzed 33 33 27 27
Mean (Standard Deviation)
Unit of Measure: mmol/L
TG level at baseline and week 4 1.76  (1.00) 1.54  (1.01) 1.61  (0.65) 1.36  (0.69)
TC level at baseline and week 4 5.91  (0.71) 4.73  (1.08) 5.82  (0.73) 4.72  (1.16)
HDL level at baseline and week 4 1.27  (0.25) 1.32  (0.36) 1.23  (0.25) 1.37  (0.44)
LDL level at baseline and week 4 3.72  (0.48) 2.54  (0.72) 3.74  (0.55) 2.45  (0.71)
3.Other Pre-specified Outcome
Title Comparison of XueZhiKang With Simvastatin of Physical Activity Level
Hide Description At baseline and week 4, 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.
Time Frame Measured at baseline and week 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Simvastatin/Baseline Simvastatin/Week 4 XueZhiKang/Baseline XueZhiKang/Week 4
Hide Arm/Group Description:

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

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

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

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

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.

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.

Overall Number of Participants Analyzed 33 33 27 27
Measure Type: Number
Unit of Measure: participants
Low level at baseline and week 4 14 25 3 3
Moderate level at baseline and week 4 10 8 12 15
High level at baseline and week 4 9 0 12 9
4.Other Pre-specified Outcome
Title Comparison of Safety Laboratory Testings (ALT,AST,CPK) Between Simvastatin- and Xuezhikang-groups
Hide Description Fasting blood samples were collected at weeks 0 (randomization) and 4 (end of study) for clinical chemistry.
Time Frame Measured at baseline and week 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Simvastatin/Baseline Simvastatin/Week 4 XueZhiKang/Baseline XueZhiKang/Week 4
Hide Arm/Group Description:

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

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

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

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

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.

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.

Overall Number of Participants Analyzed 33 33 27 27
Mean (Standard Deviation)
Unit of Measure: U/L
ALT level at baseline and week 4 28.58  (10.55) 28.73  (13.10) 30.33  (13.30) 28.67  (14.73)
AST level at baseline and week 4 24.12  (6.99) 24.42  (6.89) 25.63  (7.53) 25.85  (7.24)
CPK level at baseline and week 4 80.82  (24.91) 82.76  (33.80) 91.65  (23.71) 90.92  (24.36)
5.Other Pre-specified Outcome
Title Comparison of Safety Laboratory Testing (Cr) Between Simvastatin- and Xuezhikang-group
Hide Description Fasting blood samples were collected at weeks 0 (randomization) and 4 (end of study) for clinical chemistry.
Time Frame Measured at baseline and week 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Simvastatin/Baseline Simvastatin/Week 4 XueZhiKang/Baseline XueZhiKang/Week 4
Hide Arm/Group Description:

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

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

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

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

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.

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.

Overall Number of Participants Analyzed 33 33 27 27
Mean (Standard Deviation)
Unit of Measure: mmol/L
72.57  (14.44) 71.95  (14.34) 75.59  (17.20) 76.51  (16.39)
6.Other Pre-specified Outcome
Title Treatment Adherence at Week 4 in Simvastatin- and Xuezhikang-group
Hide Description We counted the total number of pills that were dispensed to the participants at baseline and the total number of pills that were taken by participants at week 4.
Time Frame Measured at baseline and week 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Simvastatin/Baseline Simvastatin/Week 4 XueZhiKang/Baseline XueZhiKang/Week 4
Hide Arm/Group Description:

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

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

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

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

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.

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.

Overall Number of Participants Analyzed 33 33 27 27
Measure Type: Number
Unit of Measure: number of pills
462 462 3024 3024
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Simvastatin XueZhiKang
Hide Arm/Group Description

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

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

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.

All-Cause Mortality
Simvastatin XueZhiKang
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Simvastatin XueZhiKang
Affected / at Risk (%) Affected / at Risk (%)
Total   0/33 (0.00%)   0/27 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Simvastatin XueZhiKang
Affected / at Risk (%) Affected / at Risk (%)
Total   0/33 (0.00%)   0/27 (0.00%) 
There are some limitations to this research. First, the sample size was relative small. Second, the follow-up period was short (4 weeks).
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.
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
Responsible Party: JiFei Tang, Wenzhou Medical University
ClinicalTrials.gov Identifier: NCT01686451     History of Changes
Other Study ID Numbers: Wenzhou
First Submitted: September 3, 2012
First Posted: September 18, 2012
Results First Submitted: October 8, 2013
Results First Posted: May 19, 2014
Last Update Posted: May 19, 2014