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A cohort study on the effect of Shenlingbaizhusan on quadriceps strength in knee osteoarthritis of Pixushizu type

A cohort study on the effect of Shenlingbaizhusan on quadriceps strength in knee osteoarthritis of Pixushizu type

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ITMCTR
Registry ID
ITMCTR2024000784
Enrollment
Unknown
Registered
2024-12-11
Start date
2024-04-01
Completion date
Unknown
Last updated
2025-01-06

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

Conditions

Knee osteoarthritis

Interventions

Non-exposure group :Celecoxib orally
exposure group:Shenlingbaizhusan

Sponsors

GuangDong Second Traditional Chinese Medicine Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1) Meet the Western medical diagnostic criteria for osteoarthritis of the knee (Osteoarthritis Diagnostic and Treatment Guidelines issued by the Orthopaedic Branch Group of the Chinese Medical Association in 2018); 2)Comply with the Chinese medicine evidence diagnostic criteria of Pixushizu (September 2006 Chinese Medicine Association of Chinese Medicine Spleen and Stomach Disease Branch Group's Guidelines for the Diagnosis and Treatment of Digestive Diseases in Chinese Medicine combined with Internal Medicine of Chinese Medicine 6th edition); 3)Age 40-70 years oldgender is not limited; 4)Knee pain Visual Analogue Scale (VAS) score >2; 5)Patients with unilateral KOA with Kellgren & Lawrence classification > grade I; 6)Patients voluntarily participated in this study read and signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1) History of knee surgery or pending surgery (knee replacement or knee arthroscopy); 2) Patients with other types of arthritis (e.g. traumatic arthritis infections autoimmune diseases etc.); 3) Participation in another clinical study within the past three months; or those who received knee joint cavity injection therapy within three months; 4) those with comorbid cardiovascular hepatic renal and other serious life-threatening primary diseases as well as those with psychiatric disorders; and those suffering from other primary or hereditary muscle diseases (spinal muscular atrophy amyotrophic lateral sclerosis etc.); 5)Those who have been taking other Chinese medicines or proprietary Chinese medicines orally for a long period of time within the last six months for treatment of other diseases; 6)Women who are pregnant preparing for pregnancy or breastfeeding.

Design outcomes

Primary

MeasureTime frame
Quadriceps peak torque/body weight ratio;

Secondary

MeasureTime frame
quadriceps muscle tone;Chinese Medicine Symptom Score;VAS;Modulus of elasticity of quadriceps muscle;Western Ontario and McMaster University Osteoarthritis Index;Lower extremity muscle composition;

Countries

China

Contacts

Public ContactWengang Liu

Guangdong Second Traditional Chinese Medicine Hospital

liuwengang2022@gmail.com+86 13924037789

Outcome results

None listed

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