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Efficacy and safety of Tibetan medicine Qingpeng ointment for patients with acute gouty arthritis

Efficacy and safety of Qingpeng ointment for acute gouty arthritis: a multi-center, randomized, double-blind, placebo-controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN34355813
Enrollment
206
Registered
2021-01-25
Start date
2021-03-01
Completion date
Unknown
Last updated
2024-01-22

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

Conditions

Acute gouty arthritis Musculoskeletal Diseases Idiopathic gout

Interventions

Patients who meet the inclusion and exclusion criteria will be randomly divided into the treatment group and control group, with 103 patients in each group. The random sequence is generated using SAS

Sponsors

Beijing University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients who meet the ACR (American College of Rheumatology)/EULAR (European League Against Rheumatism) gout classification criteria 2. Patients with joint pain intensity score (VAS, 0-10 points) =3 points 3. Patients with an acute flare of gout, the time from the onset to the visit to hospital should not exceed 1 week 4. Patients aged between 18 to 65 years old 5. Patients who are volunteer to participate in the study and sign the informed consent

Exclusion criteria

Exclusion criteria: 1. Patients who also suffer from other types of arthritis 2. Patients who are allergic to the study drugs (Qingpeng Ointment, DSSRT) 3. Patients suffering from severe cardiovascular, cerebrovascular, liver, and kidney diseases 4. Patients suffering from mental diseases and senile dementia 5. Women during pregnancy and lactation 6. Patients with skin ulceration at the affected joint(s) 7. Patients who have newly added uric acid-lowering drugs for any reason in the past week 8. Patients who participate in other clinical trials at the same time

Design outcomes

Secondary

MeasureTime frame
1. Joint mobility measured using a 0-4 point scale (0=the mobility is normal, and is not restricted; 1=the mobility is slightly restricted, but normal activities can still be performed; 2=the mobility is moderately restricted, patient is unable to perform general activities, and is able to take care of self daily life; 3=the mobility is severely restricted, pain is unbearable when the joint moves, patient is unable to take care of self daily life; 4=the joint is unable to move), at baseline, every day during treatment, and after treatment 2. Joint redness measured using a 0-3 point scale (0=the skin color is normal; 1=the skin is slightly red; 2=the skin is obviously red; 3=the skin is dark red), at baseline, every day during treatment, and after treatment 3. C-reactive protein measured from a blood sample taken at baseline and after 7 days of treatment 4. Serum uric acid measured from a blood sample taken at baseline and after 7 days of treatment 5. Remaining amount of rescue medicine recorded after 7 days of treatment

Primary

MeasureTime frame
1. Joint pain measured using a visual analogue scale (VAS, 0-10 points) at baseline, every day during treatment, and after treatment 2. Joint swelling: 2.1. The width and thickness of each affected joint are measured using vernier calipers (brand: Ruineng, model: NR0139) at baseline, every day during treatment, and after treatment 2.2. Joint swelling measured using a visual analogue scale (VAS, 0-10 points) at baseline, every day during treatment, and after treatment

Countries

China

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 12, 2026