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A Randomized Controlled Trial of Broken Cell Wall Ganoderma lucidum Spore Powder in Treating Asymptomatic Hyperuricemia with "Dampness Turbidity" Pattern

A Randomized Controlled Trial of Broken Cell Wall Ganoderma lucidum Spore Powder in Treating Asymptomatic Hyperuricemia with "Dampness Turbidity" Pattern

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025001752
Enrollment
Unknown
Registered
2025-09-15
Start date
2025-06-20
Completion date
Unknown
Last updated
2025-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asymptomatic Hyperuricemia with Dampness-Turbidity Accumulation Pattern

Interventions

Treatment Group:Ganoderma Spore Powder 2g per dose BID (twice daily) Intervention code
Control Group:placebo

Sponsors

Zhejiang Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: According to the Integrated Traditional Chinese and Western Medicine Guidelines for Diagnosis and Treatment of Gout and Hyperuricemia (2023) Chinese Guidelines for Diagnosis and Treatment of Hyperuricemia and Gout (2019) and the 2013 Chinese Expert Consensus on Management of Hyperuricemia and Gout the following criteria apply: Mandatory criteria: Items (1) (4) (5) (6) Inclusion requires meeting either (2) or (3) (1) Age 18–80 years; (2) Serum uric acid (SUA) =420 µmol/L on two separate occasions under normal purine diet and fasting conditions; (3) Meeting TCM diagnostic criteria for dampness-turbidity accumulation pattern; (4) No use of medications affecting SUA within the past month (e.g. thiazide diuretics aspirin losartan glucocorticoids urate-lowering drugs fenofibrate statins); (5) Capacity to comprehend the study and voluntarily provide signed informed consent.

Exclusion criteria

Exclusion criteria: Exclusion Criteria: (1) Presence of acute gout attack; (2) Diagnosis of gout-related nephropathy (e.g. uric acid nephrolithiasis chronic urate nephropathy acute uric acid nephropathy); (3) Requirement for regular use of antibiotics or other medications affecting uric acid levels; (4) Routine treatment with NSAIDs or corticosteroids; (5) Severe primary comorbidities involving cardiovascular cerebrovascular hepatic renal endocrine or hematopoietic systems; (6) Women who are planning pregnancy pregnant or lactating; (7) Known allergy to any component of the investigational product.

Design outcomes

Primary

MeasureTime frame
Liver Function;Serum Uric Acid Level;Plasma Metabolomic Differences;Renal Function;TCM Syndrome Score;

Countries

China

Contacts

Public ContactMinchun Yang

Zhejiang Hospital

zjyyymc@163.com15336522560

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026