Trial Outcomes & Findings for The Effect of XueZhiKang on Fatigue：Comparing With Simvastatin (NCT NCT01686451)
NCT ID: NCT01686451
Last Updated: 2014-05-19
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
60 participants
Primary outcome timeframe
Measured at baseline and week 4
Results posted on
2014-05-19
Participant Flow
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.
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.
Participant milestones
| Measure |
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.
|
|---|---|---|
|
Overall Study
STARTED
|
33
|
27
|
|
Overall Study
COMPLETED
|
33
|
27
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Effect of XueZhiKang on Fatigue：Comparing With Simvastatin
Baseline characteristics by cohort
| Measure |
Simvastatin
n=33 Participants
Participants will receive 20mg of simvastatin daily for 4 weeks.
simvastatin : Participants will receive 20mg of simvastatin daily for 4 weeks.
|
XueZhiKang
n=27 Participants
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
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
33 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
46.18 years
STANDARD_DEVIATION 7.00 • n=5 Participants
|
47.04 years
STANDARD_DEVIATION 5.83 • n=7 Participants
|
46.57 years
STANDARD_DEVIATION 6.46 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Region of Enrollment
China
|
33 participants
n=5 Participants
|
27 participants
n=7 Participants
|
60 participants
n=5 Participants
|
|
Current cigarette smoker, Categorical
Current cigarette smoker
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Current cigarette smoker, Categorical
Not Current cigarette smoker
|
30 participants
n=5 Participants
|
25 participants
n=7 Participants
|
55 participants
n=5 Participants
|
|
Arterial hypertension, Categorical
Arterial hypertension
|
26 participants
n=5 Participants
|
16 participants
n=7 Participants
|
42 participants
n=5 Participants
|
|
Arterial hypertension, Categorical
Not Arterial hypertension
|
7 participants
n=5 Participants
|
11 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
Arterial blood pressure, Continuous
Systolic blood pressure
|
148.06 mmHg
STANDARD_DEVIATION 18.51 • n=5 Participants
|
147.89 mmHg
STANDARD_DEVIATION 17.03 • n=7 Participants
|
147.98 mmHg
STANDARD_DEVIATION 17.71 • n=5 Participants
|
|
Arterial blood pressure, Continuous
Diastolic blood pressure
|
84.18 mmHg
STANDARD_DEVIATION 6.95 • n=5 Participants
|
83.00 mmHg
STANDARD_DEVIATION 8.82 • n=7 Participants
|
83.65 mmHg
STANDARD_DEVIATION 7.80 • n=5 Participants
|
|
Fasting blood glucose, Continuous
|
5.10 mmol/L
STANDARD_DEVIATION 0.36 • n=5 Participants
|
5.33 mmol/L
STANDARD_DEVIATION 0.52 • n=7 Participants
|
5.20 mmol/L
STANDARD_DEVIATION 0.45 • n=5 Participants
|
|
Triglyceride, Continuous
|
1.76 mmol/L
STANDARD_DEVIATION 1.00 • n=5 Participants
|
1.61 mmol/L
STANDARD_DEVIATION 0.65 • n=7 Participants
|
1.69 mmol/L
STANDARD_DEVIATION 0.86 • n=5 Participants
|
|
Total cholesterol, Continuous
|
5.91 mmol/L
STANDARD_DEVIATION 0.71 • n=5 Participants
|
5.82 mmol/L
STANDARD_DEVIATION 0.73 • n=7 Participants
|
5.87 mmol/L
STANDARD_DEVIATION 0.72 • n=5 Participants
|
|
High-density lipoprotein-cholesterol, Continuous
|
1.27 mmol/L
STANDARD_DEVIATION 0.25 • n=5 Participants
|
1.23 mmol/L
STANDARD_DEVIATION 0.25 • n=7 Participants
|
1.26 mmol/L
STANDARD_DEVIATION 0.25 • n=5 Participants
|
|
Low-density lipoprotein-cholesterol, Continuous
|
3.72 mmol/L
STANDARD_DEVIATION 0.48 • n=5 Participants
|
3.74 mmol/L
STANDARD_DEVIATION 0.55 • n=7 Participants
|
3.73 mmol/L
STANDARD_DEVIATION 0.50 • n=5 Participants
|
|
Alanine aminotransferase, Continuous
|
28.58 U/L
STANDARD_DEVIATION 10.55 • n=5 Participants
|
30.33 U/L
STANDARD_DEVIATION 13.30 • n=7 Participants
|
29.37 U/L
STANDARD_DEVIATION 11.79 • n=5 Participants
|
|
Aspartate aminotransferase, Continuous
|
24.12 U/L
STANDARD_DEVIATION 7.00 • n=5 Participants
|
25.63 U/L
STANDARD_DEVIATION 7.53 • n=7 Participants
|
24.80 U/L
STANDARD_DEVIATION 7.22 • n=5 Participants
|
|
Creatine phosphate kinase, Continuous
|
80.82 U/L
STANDARD_DEVIATION 24.91 • n=5 Participants
|
91.65 U/L
STANDARD_DEVIATION 23.71 • n=7 Participants
|
85.69 U/L
STANDARD_DEVIATION 24.78 • n=5 Participants
|
|
Creatinine, Continuous
|
72.57 μmol/L
STANDARD_DEVIATION 14.44 • n=5 Participants
|
75.59 μmol/L
STANDARD_DEVIATION 17.20 • n=7 Participants
|
73.93 μmol/L
STANDARD_DEVIATION 15.68 • n=5 Participants
|
|
Fatigue score, Continuous
|
19.58 units on a scale
STANDARD_DEVIATION 2.55 • n=5 Participants
|
19.26 units on a scale
STANDARD_DEVIATION 1.85 • n=7 Participants
|
19.43 units on a scale
STANDARD_DEVIATION 2.25 • n=5 Participants
|
|
Physical activity level, Categorical
Low level
|
14 participants
n=5 Participants
|
3 participants
n=7 Participants
|
17 participants
n=5 Participants
|
|
Physical activity level, Categorical
Moderate level
|
10 participants
n=5 Participants
|
12 participants
n=7 Participants
|
22 participants
n=5 Participants
|
|
Physical activity level, Categorical
High level
|
9 participants
n=5 Participants
|
12 participants
n=7 Participants
|
21 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Measured at baseline and week 4At 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.
Outcome measures
| Measure |
Simvastatin/Baseline
n=33 Participants
Participants will receive 20mg of simvastatin daily for 4 weeks.
simvastatin : Participants will receive 20mg of simvastatin daily for 4 weeks.
|
Simvastatin/Week 4
n=33 Participants
Participants will receive 20mg of simvastatin daily for 4 weeks.
simvastatin : Participants will receive 20mg of simvastatin daily for 4 weeks.
|
XueZhiKang/Baseline
n=27 Participants
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.
|
XueZhiKang/Week 4
n=27 Participants
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.
|
|---|---|---|---|---|
|
Comparison Between XueZhiKang and Simvastatin on Fatigue Scores
|
19.58 units on a scale
Standard Deviation 2.55
|
21.58 units on a scale
Standard Deviation 2.75
|
19.26 units on a scale
Standard Deviation 1.85
|
19.33 units on a scale
Standard Deviation 1.90
|
SECONDARY outcome
Timeframe: Measured at baseline and week 4Treatment 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.
Outcome measures
| Measure |
Simvastatin/Baseline
n=33 Participants
Participants will receive 20mg of simvastatin daily for 4 weeks.
simvastatin : Participants will receive 20mg of simvastatin daily for 4 weeks.
|
Simvastatin/Week 4
n=33 Participants
Participants will receive 20mg of simvastatin daily for 4 weeks.
simvastatin : Participants will receive 20mg of simvastatin daily for 4 weeks.
|
XueZhiKang/Baseline
n=27 Participants
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.
|
XueZhiKang/Week 4
n=27 Participants
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.
|
|---|---|---|---|---|
|
Treatment Efficacy
TG level at baseline and week 4
|
1.76 mmol/L
Standard Deviation 1.00
|
1.54 mmol/L
Standard Deviation 1.01
|
1.61 mmol/L
Standard Deviation 0.65
|
1.36 mmol/L
Standard Deviation 0.69
|
|
Treatment Efficacy
TC level at baseline and week 4
|
5.91 mmol/L
Standard Deviation 0.71
|
4.73 mmol/L
Standard Deviation 1.08
|
5.82 mmol/L
Standard Deviation 0.73
|
4.72 mmol/L
Standard Deviation 1.16
|
|
Treatment Efficacy
HDL level at baseline and week 4
|
1.27 mmol/L
Standard Deviation 0.25
|
1.32 mmol/L
Standard Deviation 0.36
|
1.23 mmol/L
Standard Deviation 0.25
|
1.37 mmol/L
Standard Deviation 0.44
|
|
Treatment Efficacy
LDL level at baseline and week 4
|
3.72 mmol/L
Standard Deviation 0.48
|
2.54 mmol/L
Standard Deviation 0.72
|
3.74 mmol/L
Standard Deviation 0.55
|
2.45 mmol/L
Standard Deviation 0.71
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Measured at baseline and week 4At 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.
Outcome measures
| Measure |
Simvastatin/Baseline
n=33 Participants
Participants will receive 20mg of simvastatin daily for 4 weeks.
simvastatin : Participants will receive 20mg of simvastatin daily for 4 weeks.
|
Simvastatin/Week 4
n=33 Participants
Participants will receive 20mg of simvastatin daily for 4 weeks.
simvastatin : Participants will receive 20mg of simvastatin daily for 4 weeks.
|
XueZhiKang/Baseline
n=27 Participants
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.
|
XueZhiKang/Week 4
n=27 Participants
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.
|
|---|---|---|---|---|
|
Comparison of XueZhiKang With Simvastatin of Physical Activity Level
Low level at baseline and week 4
|
14 participants
|
25 participants
|
3 participants
|
3 participants
|
|
Comparison of XueZhiKang With Simvastatin of Physical Activity Level
Moderate level at baseline and week 4
|
10 participants
|
8 participants
|
12 participants
|
15 participants
|
|
Comparison of XueZhiKang With Simvastatin of Physical Activity Level
High level at baseline and week 4
|
9 participants
|
0 participants
|
12 participants
|
9 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Measured at baseline and week 4Fasting blood samples were collected at weeks 0 (randomization) and 4 (end of study) for clinical chemistry.
Outcome measures
| Measure |
Simvastatin/Baseline
n=33 Participants
Participants will receive 20mg of simvastatin daily for 4 weeks.
simvastatin : Participants will receive 20mg of simvastatin daily for 4 weeks.
|
Simvastatin/Week 4
n=33 Participants
Participants will receive 20mg of simvastatin daily for 4 weeks.
simvastatin : Participants will receive 20mg of simvastatin daily for 4 weeks.
|
XueZhiKang/Baseline
n=27 Participants
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.
|
XueZhiKang/Week 4
n=27 Participants
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.
|
|---|---|---|---|---|
|
Comparison of Safety Laboratory Testings (ALT,AST,CPK) Between Simvastatin- and Xuezhikang-groups
AST level at baseline and week 4
|
24.12 U/L
Standard Deviation 6.99
|
24.42 U/L
Standard Deviation 6.89
|
25.63 U/L
Standard Deviation 7.53
|
25.85 U/L
Standard Deviation 7.24
|
|
Comparison of Safety Laboratory Testings (ALT,AST,CPK) Between Simvastatin- and Xuezhikang-groups
ALT level at baseline and week 4
|
28.58 U/L
Standard Deviation 10.55
|
28.73 U/L
Standard Deviation 13.10
|
30.33 U/L
Standard Deviation 13.30
|
28.67 U/L
Standard Deviation 14.73
|
|
Comparison of Safety Laboratory Testings (ALT,AST,CPK) Between Simvastatin- and Xuezhikang-groups
CPK level at baseline and week 4
|
80.82 U/L
Standard Deviation 24.91
|
82.76 U/L
Standard Deviation 33.80
|
91.65 U/L
Standard Deviation 23.71
|
90.92 U/L
Standard Deviation 24.36
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Measured at baseline and week 4Fasting blood samples were collected at weeks 0 (randomization) and 4 (end of study) for clinical chemistry.
Outcome measures
| Measure |
Simvastatin/Baseline
n=33 Participants
Participants will receive 20mg of simvastatin daily for 4 weeks.
simvastatin : Participants will receive 20mg of simvastatin daily for 4 weeks.
|
Simvastatin/Week 4
n=33 Participants
Participants will receive 20mg of simvastatin daily for 4 weeks.
simvastatin : Participants will receive 20mg of simvastatin daily for 4 weeks.
|
XueZhiKang/Baseline
n=27 Participants
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.
|
XueZhiKang/Week 4
n=27 Participants
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.
|
|---|---|---|---|---|
|
Comparison of Safety Laboratory Testing (Cr) Between Simvastatin- and Xuezhikang-group
|
72.57 mmol/L
Standard Deviation 14.44
|
71.95 mmol/L
Standard Deviation 14.34
|
75.59 mmol/L
Standard Deviation 17.20
|
76.51 mmol/L
Standard Deviation 16.39
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Measured at baseline and week 4We 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.
Outcome measures
| Measure |
Simvastatin/Baseline
n=33 Participants
Participants will receive 20mg of simvastatin daily for 4 weeks.
simvastatin : Participants will receive 20mg of simvastatin daily for 4 weeks.
|
Simvastatin/Week 4
n=33 Participants
Participants will receive 20mg of simvastatin daily for 4 weeks.
simvastatin : Participants will receive 20mg of simvastatin daily for 4 weeks.
|
XueZhiKang/Baseline
n=27 Participants
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.
|
XueZhiKang/Week 4
n=27 Participants
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.
|
|---|---|---|---|---|
|
Treatment Adherence at Week 4 in Simvastatin- and Xuezhikang-group
|
462 number of pills
|
462 number of pills
|
3024 number of pills
|
3024 number of pills
|
Adverse Events
Simvastatin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
XueZhiKang
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. JiFei Tang
Department of Cardiology, the Second Affiliated Hospital, Wenzhou Medical University, Zhejiang province, Wenzhou, 325000, China
Phone: +8615968766021
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60