Trial Outcomes & Findings for Traditional Chinese Medicine in the Treatment of Patients With Hyperuricemia. (NCT NCT04144088)
NCT ID: NCT04144088
Last Updated: 2019-12-06
Results Overview
The number of patient serum uric acid \<6 mg/dL at week 4
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
60 participants
Primary outcome timeframe
week 4
Results posted on
2019-12-06
Participant Flow
Participant milestones
| Measure |
Wu Ling San
Drug : Wu Ling San Extract Granules "Sun-Ten"
Wu Ling San: assigned to Wu Ling San (n =20) and were instructed to take 4.5 gm 2 times per day of Wu Ling San for a period of 4 weeks.
|
Yin-Chen Wu Ling San
Drug : Yin-Chen-Wu-Ling-San Extract Power "SUN-TEN"
Yin-Chen Wu Ling San: assigned to Yin-Chen Wu Ling San (n =20) and were instructed to take 4.5 gm 2 times per day of Yin-Chen Wu Ling San for a period of 4 weeks.
|
Placebo
Drug : 1/10 Wu Ling San
Placebo: 1/10 Wu Ling San assigned to Placebo (n =20) and were instructed to take 4.5 gm 2 times per day of Placebo for a period of 4 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
20
|
|
Overall Study
COMPLETED
|
14
|
15
|
13
|
|
Overall Study
NOT COMPLETED
|
6
|
5
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Traditional Chinese Medicine in the Treatment of Patients With Hyperuricemia.
Baseline characteristics by cohort
| Measure |
Wu Ling San
n=20 Participants
Drug : Wu Ling San Extract Granules "Sun-Ten"
Wu Ling San: assigned to Wu Ling San (n =20) and were instructed to take 4.5 gm 2 times per day of Wu Ling San for a period of 4 weeks.
|
Yin-Chen Wu Ling San
n=20 Participants
Drug : Yin-Chen-Wu-Ling-San Extract Power "SUN-TEN"
Yin-Chen Wu Ling San: assigned to Yin-Chen Wu Ling San (n =20) and were instructed to take 4.5 gm 2 times per day of Yin-Chen Wu Ling San for a period of 4 weeks.
|
Placebo
n=20 Participants
Drug : 1/10 Wu Ling San
Placebo: 1/10 Wu Ling San assigned to Placebo (n =20) and were instructed to take 4.5 gm 2 times per day of Placebo for a period of 4 weeks.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
55.5 years
STANDARD_DEVIATION 13.9 • n=5 Participants
|
42.5 years
STANDARD_DEVIATION 14.4 • n=7 Participants
|
47.3 years
STANDARD_DEVIATION 15.3 • n=5 Participants
|
48.4 years
STANDARD_DEVIATION 15.3 • n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
55 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
60 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Uric Acid
|
9.4 mg/dl
STANDARD_DEVIATION 1.4 • n=5 Participants
|
9.1 mg/dl
STANDARD_DEVIATION 2.1 • n=7 Participants
|
8.9 mg/dl
STANDARD_DEVIATION 1.6 • n=5 Participants
|
9.1 mg/dl
STANDARD_DEVIATION 1.7 • n=4 Participants
|
|
Urine Uric Acid (24hr)
|
161.6 gm/24hrs
STANDARD_DEVIATION 174.7 • n=5 Participants
|
109.2 gm/24hrs
STANDARD_DEVIATION 74.6 • n=7 Participants
|
430.1 gm/24hrs
STANDARD_DEVIATION 1002.8 • n=5 Participants
|
233.6 gm/24hrs
STANDARD_DEVIATION 595.8 • n=4 Participants
|
|
Weight
|
71.2 kg
STANDARD_DEVIATION 13.3 • n=5 Participants
|
73.0 kg
STANDARD_DEVIATION 10.5 • n=7 Participants
|
72.4 kg
STANDARD_DEVIATION 10.5 • n=5 Participants
|
72.2 kg
STANDARD_DEVIATION 11.4 • n=4 Participants
|
PRIMARY outcome
Timeframe: week 4The number of patient serum uric acid \<6 mg/dL at week 4
Outcome measures
| Measure |
Wu Ling San
n=20 Participants
Drug : Wu Ling San Extract Granules "Sun-Ten"
Wu Ling San: assigned to Wu Ling San (n =20) and were instructed to take 4.5 gm 2 times per day of Wu Ling San for a period of 4 weeks.
|
Yin-Chen Wu Ling San
n=20 Participants
Drug : Yin-Chen-Wu-Ling-San Extract Power "SUN-TEN"
Yin-Chen Wu Ling San: assigned to Yin-Chen Wu Ling San (n =20) and were instructed to take 4.5 gm 2 times per day of Yin-Chen Wu Ling San for a period of 4 weeks.
|
Placebo
n=20 Participants
Drug : 1/10 Wu Ling San
Placebo: 1/10 Wu Ling San assigned to Placebo (n =20) and were instructed to take 4.5 gm 2 times per day of Placebo for a period of 4 weeks.
|
|---|---|---|---|
|
Serum Uric Acid<6 mg/dL at Week 4
|
0 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: week 0, week 2The investigators use serum uric acid to compared the difference between the week 2 and week 0
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: week 0, week 8The investigators use serum uric acid to compared the difference between the week 8 and week 0
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: week 0, week 4The investigators use blood sugar to compared the difference between the week 4 and week 0
Outcome measures
Outcome data not reported
Adverse Events
Wu Ling San
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Yin-Chen Wu Ling San
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Wu Ling San
n=20 participants at risk
Drug : Wu Ling San Extract Granules "Sun-Ten"
Wu Ling San: assigned to Wu Ling San (n =20) and were instructed to take 4.5 gm 2 times per day of Wu Ling San for a period of 4 weeks.
|
Yin-Chen Wu Ling San
n=20 participants at risk
Drug : Yin-Chen-Wu-Ling-San Extract Power "SUN-TEN"
Yin-Chen Wu Ling San: assigned to Yin-Chen Wu Ling San (n =20) and were instructed to take 4.5 gm 2 times per day of Yin-Chen Wu Ling San for a period of 4 weeks.
|
Placebo
n=20 participants at risk
Drug : 1/10 Wu Ling San
Placebo: 1/10 Wu Ling San assigned to Placebo (n =20) and were instructed to take 4.5 gm 2 times per day of Placebo for a period of 4 weeks.
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Traffic accident
|
5.0%
1/20 • Number of events 1
|
0.00%
0/20
|
0.00%
0/20
|
Other adverse events
| Measure |
Wu Ling San
n=20 participants at risk
Drug : Wu Ling San Extract Granules "Sun-Ten"
Wu Ling San: assigned to Wu Ling San (n =20) and were instructed to take 4.5 gm 2 times per day of Wu Ling San for a period of 4 weeks.
|
Yin-Chen Wu Ling San
n=20 participants at risk
Drug : Yin-Chen-Wu-Ling-San Extract Power "SUN-TEN"
Yin-Chen Wu Ling San: assigned to Yin-Chen Wu Ling San (n =20) and were instructed to take 4.5 gm 2 times per day of Yin-Chen Wu Ling San for a period of 4 weeks.
|
Placebo
n=20 participants at risk
Drug : 1/10 Wu Ling San
Placebo: 1/10 Wu Ling San assigned to Placebo (n =20) and were instructed to take 4.5 gm 2 times per day of Placebo for a period of 4 weeks.
|
|---|---|---|---|
|
Gastrointestinal disorders
fecal frequency increased but not diarrhea
|
5.0%
1/20
|
0.00%
0/20
|
0.00%
0/20
|
|
Gastrointestinal disorders
GI upset
|
5.0%
1/20
|
0.00%
0/20
|
0.00%
0/20
|
|
Gastrointestinal disorders
dyspepsia
|
0.00%
0/20
|
0.00%
0/20
|
5.0%
1/20
|
|
Hepatobiliary disorders
Elevated of GPT (GPT > 41 IU/L)
|
5.0%
1/20
|
5.0%
1/20
|
5.0%
1/20
|
|
Skin and subcutaneous tissue disorders
seborrheic dermatitis
|
5.0%
1/20
|
0.00%
0/20
|
0.00%
0/20
|
|
Renal and urinary disorders
gout attack
|
5.0%
1/20
|
5.0%
1/20
|
10.0%
2/20
|
|
Immune system disorders
Psoriatic arthritis
|
0.00%
0/20
|
5.0%
1/20
|
0.00%
0/20
|
|
Renal and urinary disorders
oliguria
|
0.00%
0/20
|
0.00%
0/20
|
10.0%
2/20
|
|
Renal and urinary disorders
Elevated of creatine ( Cr: 3.7mg/dl)
|
0.00%
0/20
|
0.00%
0/20
|
5.0%
1/20
|
|
Blood and lymphatic system disorders
Elevated of WBC (WBC: 12920/mm3)
|
0.00%
0/20
|
0.00%
0/20
|
5.0%
1/20
|
|
General disorders
muscle soreness
|
0.00%
0/20
|
5.0%
1/20
|
0.00%
0/20
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
|
0.00%
0/20
|
5.0%
1/20
|
0.00%
0/20
|
|
Skin and subcutaneous tissue disorders
Burns
|
0.00%
0/20
|
0.00%
0/20
|
5.0%
1/20
|
|
General disorders
Insomnia
|
0.00%
0/20
|
0.00%
0/20
|
5.0%
1/20
|
|
Respiratory, thoracic and mediastinal disorders
asthma attack
|
0.00%
0/20
|
0.00%
0/20
|
5.0%
1/20
|
Additional Information
Dr. Cheng Chung Wei
Chung Shan Medical University Hospital
Phone: +886-4-24739595
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place