Hyperuricemia
Conditions
Brief summary
To testify the efficacy and safety of traditional Chinese formulae, Wu-Ling San and Yin-Chen Wu-Ling San for patients with hyperuricemia.
Detailed description
The prevalence of hyperuricemia and gout is increasing in Taiwan. It is probably contributed by adapting to Western diet and lifestyle. Previous studies have demonstrated the relationship between hyperuricemia with hypertension, metabolic syndrome, cardiovascular disease and chronic renal disease. While Western medicine shows promising effects in treating hyperuricemia and gout, we are searching for an alternative in traditional Chinese medicine with both safety and efficacy in treating hyperuricemia. We conducted a randomized double-blinded placebo-controlled clinical trial in adults with hyperuricemia. Sixty patients with serum uric acid level more than 8 mg/dl were enrolled. Patients were then randomized into three arms: Traditional Chinese Medicine formulae: Wu-Ling San, Yin-Chen Wu-Ling San or placebo for 4 weeks. Efficacy and safety were evaluated at Week 2, 4 and 8. Primary endpoint was the serum uric acid\<6 mg/dL at Week 4. Secondary endpoints were the differences between groups in serum uric acid at Week 2 and 8, serum SGPT, SGOT, creatinine, total cholesterol, triglycerides, HDL, LDL, fasting blood glucose, body weight, blood pressures and frequency of gouty attack at Week 4.
Interventions
DRUGWu 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.
DRUGYin-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.
DRUGPlacebo
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.
Sponsors
Chung Shan Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* serum uric acid \> 8 mg/dL
Exclusion criteria
* 1\. gout attack within 2 weeks before baseline 2. drug for control urine acid must be stable dose within 2 weeks before baseline (e.g.allopurinol、benzbromarone、probenecid、sulfinpyrazone) 3. subject taking the drug involved azathioprine、aspirin (\>325 mg)、atorvastatin、fenofibrate、losartan、thiazide、systemic corticosteroid、estrogen、oral contraceptive pills 4. serum creatinine \> 3.0 mg/dL 5. GPT \> 100 mg/dL 6. Pregnant or breast-feeding women 7. Chemotherapy or radiation therapy in cancer patients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum Uric Acid<6 mg/dL at Week 4 | week 4 | The number of patient serum uric acid \<6 mg/dL at week 4 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline Serum Uric Acid at Week 2 | week 0, week 2 | The investigators use serum uric acid to compared the difference between the week 2 and week 0 |
| Change From Baseline Serum Uric Acid at Week 8 | week 0, week 8 | The investigators use serum uric acid to compared the difference between the week 8 and week 0 |
| Change From Baseline Blood Sugar at Week 4 | week 0, week 4 | The investigators use blood sugar to compared the difference between the week 4 and week 0 |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 20 |
| 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. | 20 |
| 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. | 20 |
| Total | 60 |
Baseline characteristics
| Characteristic | Wu Ling San | Yin-Chen Wu Ling San | Placebo | Total |
|---|---|---|---|---|
| Age, Continuous | 55.5 years STANDARD_DEVIATION 13.9 | 42.5 years STANDARD_DEVIATION 14.4 | 47.3 years STANDARD_DEVIATION 15.3 | 48.4 years STANDARD_DEVIATION 15.3 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 20 Participants | 20 Participants | 20 Participants | 60 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 2 Participants | 2 Participants | 1 Participants | 5 Participants |
| Sex: Female, Male Male | 18 Participants | 18 Participants | 19 Participants | 55 Participants |
| Uric Acid | 9.4 mg/dl STANDARD_DEVIATION 1.4 | 9.1 mg/dl STANDARD_DEVIATION 2.1 | 8.9 mg/dl STANDARD_DEVIATION 1.6 | 9.1 mg/dl STANDARD_DEVIATION 1.7 |
| Urine Uric Acid (24hr) | 161.6 gm/24hrs STANDARD_DEVIATION 174.7 | 109.2 gm/24hrs STANDARD_DEVIATION 74.6 | 430.1 gm/24hrs STANDARD_DEVIATION 1002.8 | 233.6 gm/24hrs STANDARD_DEVIATION 595.8 |
| Weight | 71.2 kg STANDARD_DEVIATION 13.3 | 73.0 kg STANDARD_DEVIATION 10.5 | 72.4 kg STANDARD_DEVIATION 10.5 | 72.2 kg STANDARD_DEVIATION 11.4 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 5 / 20 | 5 / 20 | 11 / 20 |
| serious Total, serious adverse events | 1 / 20 | 0 / 20 | 0 / 20 |
Outcome results
Primary
Serum Uric Acid<6 mg/dL at Week 4
The number of patient serum uric acid \<6 mg/dL at week 4
Time frame: week 4
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Wu Ling San | Serum Uric Acid<6 mg/dL at Week 4 | 0 Participants |
| Yin-Chen Wu Ling San | Serum Uric Acid<6 mg/dL at Week 4 | 1 Participants |
| Placebo | Serum Uric Acid<6 mg/dL at Week 4 | 1 Participants |
Secondary
Change From Baseline Blood Sugar at Week 4
The investigators use blood sugar to compared the difference between the week 4 and week 0
Time frame: week 0, week 4
Secondary
Change From Baseline Serum Uric Acid at Week 2
The investigators use serum uric acid to compared the difference between the week 2 and week 0
Time frame: week 0, week 2
Secondary
Change From Baseline Serum Uric Acid at Week 8
The investigators use serum uric acid to compared the difference between the week 8 and week 0
Time frame: week 0, week 8