Serum Uric Acid<6 mg/dL at Week 4
Primary
· week 4
The number of patient serum uric acid \<6 mg/dL at week 4
| Group | Value | 95% CI |
|---|---|---|
| Wu Ling San | 0 | |
| Yin-Chen Wu Ling San | 1 | |
| Placebo | 1 |
Last reviewed · How we verify
NCT04144088
Traditional Chinese Medicine in the Treatment of Patients With Hyperuricemia.
Completed
Phase 2
Results posted
Last updated 6 December 2019
What this trial tests
Phase 2 trial testing Wu Ling San in Hyperuricemia in 60 participants. Completed in 30 June 2007.
Timeline
1 June 2006
Primary endpoint
30 June 2007
30 June 2007
30 June 2007
Quick facts
| Lead sponsor | Chung Shan Medical University |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | basic science |
| Enrollment | 60 |
| Start date | 1 June 2006 |
| Primary completion | 30 June 2007 |
| Estimated completion | 30 June 2007 |
Drugs / interventions tested
- Wu Ling San — full drug profile →
- Yin-Chen Wu Ling San — full drug profile →
- Placebo
Conditions studied
- Hyperuricemia — all drugs for Hyperuricemia →
Sponsor
Chung Shan Medical University
Who can join
Adults 18 to 80, any sex, with Hyperuricemia. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Adverse events — posted to ClinicalTrials.gov
Reporting threshold: 1%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Wu Ling San
Serious: 1/20 (5%)
Deaths: 0/20
Yin-Chen Wu Ling San
Serious: 0/20 (0%)
Deaths: 0/20
Placebo
Serious: 0/20 (0%)
Deaths: 0/20
Serious adverse events (1 terms)
| Reaction | System | Wu Ling San | Yin-Chen Wu Ling San | Placebo |
|---|---|---|---|---|
| Traffic accident | Injury, poisoning and procedural complications | — | — | — |
Other adverse events (15 terms — click to expand)
| Reaction | System | Wu Ling San | Yin-Chen Wu Ling San | Placebo |
|---|---|---|---|---|
| gout attack | Renal and urinary disorders | — | — | — |
| oliguria | Renal and urinary disorders | — | — | — |
| fecal frequency increased but not diarrhea | Gastrointestinal disorders | — | — | — |
| GI upset | Gastrointestinal disorders | — | — | — |
| dyspepsia | Gastrointestinal disorders | — | — | — |
| Elevated of GPT (GPT > 41 IU/L) | Hepatobiliary disorders | — | — | — |
| seborrheic dermatitis | Skin and subcutaneous tissue disorders | — | — | — |
| Psoriatic arthritis | Immune system disorders | — | — | — |
| Elevated of creatine ( Cr: 3.7mg/dl) | Renal and urinary disorders | — | — | — |
| Elevated of WBC (WBC: 12920/mm3) | Blood and lymphatic system disorders | — | — | — |
| muscle soreness | General disorders | — | — | — |
| Upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Burns | Skin and subcutaneous tissue disorders | — | — | — |
| Insomnia | General disorders | — | — | — |
| asthma attack | Respiratory, thoracic and mediastinal disorders | — | — | — |
Most-reported serious reactions: Traffic accident.
Data from ClinicalTrials.gov NCT04144088 adverse events section.
Sponsor's own description
To testify the efficacy and safety of traditional Chinese formulae, "Wu-Ling San" and "Yin-Chen Wu-Ling San" for patients with hyperuricemia.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04144088
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Currently open trials in the same condition.
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- NCT06463561 — CPAP Effect on Lipid Profile and Hyperuricemia in Patients With Dyslipidemia and Moderate-severe Obstructive Sleep Apnea · Phase 4 · recruiting
- NCT06729853 — PK and Safety Evaluation Study of SAP-001 in Adult Subjects With Normal and Impaired Renal Function · Phase 1, PHASE2 · active not recruiting
Other Chung Shan Medical University trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT04144088 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Chung Shan Medical University
- Last refreshed: 6 December 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04144088.
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