Traditional Chinese Medicine in the Treatment of Patients With Hyperuricemia.

NCT04144088 | Completed Phase 2 Results DMC

• 1 other identifier: CS05082
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hyperuricemia

Outcome Measures

Primary Outcomes (1)

• Serum Uric Acid<6 mg/dL at Week 4

  The number of patient serum uric acid \<6 mg/dL at week 4

  week 4

Secondary Outcomes (3)

• Change From Baseline Serum Uric Acid at Week 2

  week 0, week 2

• Change From Baseline Serum Uric Acid at Week 8

  week 0, week 8

• Change From Baseline Blood Sugar at Week 4

  week 0, week 4

Study Arms (3)

Wu Ling San

ACTIVE COMPARATOR

Drug : Wu Ling San Extract Granules "Sun-Ten"

Drug: Wu Ling San

Yin-Chen Wu Ling San

ACTIVE COMPARATOR

Drug : Yin-Chen-Wu-Ling-San Extract Power "SUN-TEN"

Drug: Yin-Chen Wu Ling San

Placebo

PLACEBO COMPARATOR

Drug : 1/10 Wu Ling San

Drug: Placebo

Interventions

Wu Ling San DRUG

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.

Wu Ling San

Yin-Chen Wu Ling San DRUG

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.

Yin-Chen Wu Ling San

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• serum uric acid \> 8 mg/dL

You may not qualify if:

• \. 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

Sponsors & Collaborators

• Chung Shan Medical University: lead

MeSH Terms

Conditions

Hyperuricemia

Interventions

Wen-pi-tang-Hab-Wu-ling-san

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Cheng Chung Wei
• Organization: Chung Shan Medical University Hospital

wei3228@gmail.com

+886-4-24739595

Study Officials

• Cheng Ching Wei, Ph. D.

  Chung Shan Medical University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 28, 2019
• First Posted: October 30, 2019
• Study Start: June 1, 2006
• Primary Completion: June 30, 2007
• Study Completion: June 30, 2007
• Last Updated: December 6, 2019
• Results First Posted: December 6, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share