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A randomized controlled study on the efficacy and safety of different doses of Qingrequshi granules compared with traditional decoctions in the treatment of gout

A randomized controlled study on the efficacy and safety of different doses of Qingrequshi granules compared with traditional decoctions in the treatment of gout

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000092
Enrollment
Unknown
Registered
2025-01-13
Start date
2025-01-25
Completion date
Unknown
Last updated
2025-02-03

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

Conditions

Gout

Interventions

SLFSN group:SLFSN group: SLFSN+QRQS simulated drug i.e. diclofenac sodium sustained-release tablets (trade name: Voltaren Beijing Novartis Pharmaceuticals Co. Ltd.) 1 tablet each time (75 mg) 1 time a
plus 1 dose of QRQS simulated drug (2L in total)/day taken frequently.
QRQS_K Medium dose group:QRQS_K medium-dose group: QRQS_K medium-dose + SLFSN simulation drug i.e. 1 dose (2L in total) of Qingrequshi formula granules (containing 50% Chinese medicine)/day taken fre
QRQS_K Low dose group:QRQS_K low-dose group: QRQS_K low-dose + SLFSN simulation drug i.e. 1 dose (2L in total) of Qingrequshi formula granules (containing 10% Chinese medicine)/day taken frequently pl
QRQS_K High dose group:QRQS_K high dose + SLFSN simulation drug i.e. 1 dose (2L in total) of Qingrequshi formula granules (containing 100% Chinese medicine)/day taken frequently plus 1 tablet (75mg) o
QRQS_T group:QRQS_T group: QRQS_T + SLFSN simulation drug i.e. 1 dose of traditional decoction for clearing away heat and removing dampness (2L in total)/day taken frequently plus 1 tablet of diclofen

Sponsors

Guangdong Provincial Hospital of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1)Meet the Western medical diagnosis criteria for gout; 2)3=VAS<7 points and the duration between gout attack and enrollment is =1 week; 3)Meet the TCM diagnosis criteria for damp-heat accumulation syndrome; 4)Age 18-70 years old; 5)Voluntarily participate in the study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1) Patients with secondary gout; 2) Oral contraceptives or hormone replacement therapy (prednisone dosage>10mg/d) within 3 months before the trial; 3) Patients with severe digestive tract diseases and digestive tract ulcers; 4) Patients with severe dysfunction of important organs such as heart brain liver and kidney and malignant tumors; 5) Patients with mental illness long-term alcohol abuse and drug abuse; 6) Pregnant or lactating patients; 7) Patients with allergic constitution or those who have been allergic to the components of this study's drugs; 8) Patients who are participating in other clinical trials that affect the evaluation of the results of this study.

Design outcomes

Primary

MeasureTime frame
(visual analogue scaleVAS);

Secondary

MeasureTime frame
ESR;UA;CRP;TCM Syndrome Score;

Countries

China

Contacts

Public ContactSunlu

Guangdong Provincial Hospital of Chinese Medicine

sunlu@gzucm.edu.cn+86 138 2605 5952

Outcome results

None listed

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