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A multicenter randomized double-blind placebo-controlled clinical trial of Qinling granule in the treatment of hyperuricemia (damp heat accumulation syndrome)

A multicenter randomized double-blind placebo-controlled clinical trial of Qinling granule in the treatment of hyperuricemia (damp heat accumulation syndrome)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025002369
Enrollment
Unknown
Registered
2025-12-06
Start date
2025-08-18
Completion date
Unknown
Last updated
2026-01-12

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

Conditions

hyperuricemia

Interventions

control group:Sodium bicarbonate tablets+Qinling granules simulant
therapeutic group:Sodium bicarbonate tablets+Qinling granules

Sponsors

Xiyuan Hospital of China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) Patients with blood uric acid (UA) = 480umol/l and one of the following diseases: hypertension hyperlipidemia diabetes obesity cerebral infarction or coronary heart disease; (2) The syndrome differentiation of traditional Chinese medicine is damp heat type; (3) The age is between 18-70 years old and the gender is not limited; (4) Voluntarily participate in this study and sign the informed consent of enrolled patients.

Exclusion criteria

Exclusion criteria: (1) Taking uric acid lowering drugs in recent 2 weeks; (2) At the same time patients taking diuretics (including but not limited to hydrochlorothiazide furosemide torasemide bumetanide etc.) sglt-2 inhibitors GLP-1 receptor agonists and other drugs that will affect the blood uric acid level; (3) Patients with acute exacerbation of gout; (4) Those whose ALT and AST of liver function exceeded 50% of the upper limit of normal value and those whose SCR of renal function exceeded the upper limit of normal value were not enrolled; (5) Patients with active peptic ulcer; (6) Patients with secondary hyperuricemia (such as kidney disease bone marrow and lymphoproliferative disease diuretic drugs tumor chemotherapy drugs etc.); (7) Those who have serious primary cardiovascular disease liver disease kidney disease hematological disease lung disease or serious diseases that affect their survival such as tumor or AIDS and the investigator believes that they should not be selected; (8) Suspected or true history of alcohol and drug abuse or other diseases that reduce the possibility of enrollment or complicate enrollment according to the judgment of the investigator such as frequent changes in the working environment which are likely to cause loss to follow-up; (9) Patients with asthma angioedema urticaria or allergic reaction after taking diclofenac sodium or other non steroidal anti-inflammatory drugs; (10) Those who are participating in other clinical trials or are participating in other clinical trials; (11) Pregnant or lactating women or those who are allergic to this study drug.

Design outcomes

Primary

MeasureTime frame
Serum uric acid compliance rate(Blood uric acid compliance rate=(number of people with blood uric acid = 360 µ mol/L)/total number of people in the group);Decreased value of blood uric acid;Improvement rate of TCM syndrome score;Decreased values of inflammatory markers (hsCRP, TNF - a, IL6);

Countries

China

Contacts

Public ContactZou Benliang

Xiyuan Hospital of China Academy of Chinese Medical Sciences

forestzbl@163.com13522092745

Outcome results

None listed

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