HyperuricemiaPhase 2NCT04144088
Traditional Chinese Medicine in the Treatment of Patients With Hyperuricemia.
A Phase 2 study testing Wu Ling San and Yin-Chen Wu Ling San in people with Hyperuricemia, run by Chung Shan Medical University.
Trial summary
To testify the efficacy and safety of traditional Chinese formulae, "Wu-Ling San" and "Yin-Chen Wu-Ling San" for patients with hyperuricemia. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hyperuricemia
- What is being tested?
- Wu Ling San and Yin-Chen Wu Ling San
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2006to 30 Jun 2007
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- serum uric acid > 8 mg/dL
Who cannot join
- 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
About this study
Official title: Traditional Chinese Medicine in the Treatment of Patients With Hyperuricemia. A Randomized Placebo-Controlled Double-Blinded Clinical Trial.
To testify the efficacy and safety of traditional Chinese formulae, "Wu-Ling San" and "Yin-Chen Wu-Ling San" for patients with hyperuricemia.
Read the 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.
- Conditions
- Hyperuricemia
- Being tested
- Wu Ling San, Yin-Chen Wu Ling San, Placebo
- Medical subject headings
- Hyperuricemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wu Ling SanDrug
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 SanDrug
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Wu Ling San | Active comparator | Drug : Wu Ling San Extract Granules "Sun-Ten" Receives: Drug: Wu Ling San |
| Yin-Chen Wu Ling San | Active comparator | Drug : Yin-Chen-Wu-Ling-San Extract Power "SUN-TEN" Receives: Drug: Yin-Chen Wu Ling San |
| Placebo | Placebo comparator | Drug : 1/10 Wu Ling San Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Uric Acid<6 mg/dL at Week 4
The number of patient serum uric acid <6 mg/dL at week 4
Measured: week 4
Secondary outcomes (3)
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
Measured: week 0, week 2
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
Measured: week 0, week 8
Change From Baseline Blood Sugar at Week 4
The investigators use blood sugar to compared the difference between the week 4 and week 0
Measured: week 0, week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2019
- Study start1 Jun 2006
- Primary completion30 Jun 2007
- Study completion30 Jun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HyperuricemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chung Shan Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cheng-Chung Wei, Chung Shan Medical University
- Investigators
- Cheng Ching Wei, Ph. D., Study director, Chung Shan Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04144088
- Sponsor's protocol ID
- CS05082
- Status last verified
- Oct 2019
- First submitted
- 28 Oct 2019
- Last updated
- 6 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Traditional Chinese Medicine in the Treatment of Patients With Hyperuricemia. A Randomized Placebo-Controlled Double-Blinded Clinical Trial.
- ClinicalTrials.gov ID
- NCT04144088
- Acronym / sponsor ID
- CS05082
- Conditions
- Hyperuricemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Chung Shan Medical UniversityUniversity, hospital or other
- Study start
- 1 Jun 2006 (actual)
- Primary completion
- 30 Jun 2007 (actual)
- Study completion
- 30 Jun 2007 (actual)
- First posted
- 30 Oct 2019 (actual)
- Results
- Posted 6 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Wu Ling San | Active comparator | Drug: Wu Ling SanDrug : Wu Ling San Extract Granules "Sun-Ten" |
| Yin-Chen Wu Ling San | Active comparator | Drug: Yin-Chen Wu Ling SanDrug : Yin-Chen-Wu-Ling-San Extract Power "SUN-TEN" |
| Placebo | Placebo comparator | Drug: PlaceboDrug : 1/10 Wu Ling San |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- serum uric acid > 8 mg/dL
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wu Ling Sanassigned 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. | Drug | Wu Ling San |
| Yin-Chen Wu Ling Sanassigned 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. | Drug | Yin-Chen Wu Ling San |
| Placebo1/10 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. | Drug | Placebo |
Primary outcome
Serum Uric Acid<6 mg/dL at Week 4
Time frame: week 4
The number of patient serum uric acid <6 mg/dL at week 4
3 secondary outcomes
Change From Baseline Serum Uric Acid at Week 2
Time frame: week 0, week 2
Change From Baseline Serum Uric Acid at Week 8
Time frame: week 0, week 8
Change From Baseline Blood Sugar at Week 4
Time frame: week 0, week 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cheng Ching Wei, Ph. D. study director
Chung Shan Medical University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Wu Ling San and Yin-Chen Wu Ling San in people with Hyperuricemia, run by Chung Shan Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum Uric Acid<6 mg/dL at Week 4 (time frame: week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2019; AzTrials last refreshed its copy on 8 Nov 2026.