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The efficacy of Zhang's No. 2 Formula fumigation combined with blood flow restriction training in patients with early knee osteoarthritis of liver and kidney deficiency type in middle-aged and elderly people: A randomized controlled trial research protocol

Based on the theory of "bone, tendon and muscle", this study explores the efficacy of Zhang's No. 2 Formula fumigation combined with blood flow restriction training on middle-aged and elderly patients with early-stage knee osteoarthritis of liver and kidney deficiency type.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026000301
Enrollment
Unknown
Registered
2026-02-09
Start date
2026-01-01
Completion date
Unknown
Last updated
2026-03-02

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

Conditions

knee osteoarthritis

Interventions

control group:The "Knee Osteoarthritis Health Education Manual" was distributed. A 30-minute standard health education session was received (including disease knowledge, life management, self-massage,
Fumigation group:The composition of Zhang's Formula No. 2 (Chinese knotweed 15g, Huai knotweed 15g, safflower 10g, dog spine 15g, whole angelica 15g, roasted eucommia 15g, processed 10g, immortal vine
Training group:Blood flow restriction training was conducted 10 minutes after the fumigation process. An inflatable BFR training device was used, applying pressure to the proximal part of the thigh, w

Sponsors

Fuyang Traditional Chinese Medicine Orthopedic Hospital of Hangzhou City
Lead Sponsor

Eligibility

Sex/Gender
All
Age
45 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) Age 45–75 years; 2) Meeting both the Western medicine diagnostic criteria for knee osteoarthritis and the traditional Chinese medicine diagnostic criteria for "liver-kidney deficiency syndrome"; 3) Knee X-ray examination showing Kellgren–Lawrence (K–L) grade I or II; 4) No relevant treatments that may affect the study results within 1 month prior to enrollment, including oral or topical non-steroidal anti-inflammatory drugs (NSAIDs), joint cavity aspiration, intra-articular corticosteroid or hyaluronic acid injections, etc.; 5) Voluntary participation in this study, written informed consent provided, and capable of completing the 8-week intervention and follow-up.

Exclusion criteria

Exclusion criteria: 1) Acute injuries such as meniscus or ligament damage, local fractures of the knee joint, or a history of trauma or concurrent diseases that affect the structure and function of the knee joint (such as tuberculosis, gout, tumors, rheumatoid arthritis, etc.); 2) Complicated with severe cardiovascular and cerebrovascular diseases, mental disorders, malignant tumors, liver and kidney dysfunction, or bleeding-prone diseases such as hemophilia; 3) Complicated with knee joint infection, skin wounds at the surgical site, or other skin problems that may affect the treatment; 4) Pregnant or lactating women; 5) Those with positive floating patella test; 6) Those with unstable blood sugar control; 7) Those allergic to the drugs in this study or having drug contraindications such as obstruction of lower extremity venous and lymphatic return.

Design outcomes

Primary

MeasureTime frame
WOMAC Score (Western Ontario and McMaster Universities Osteoarthritis Index);

Secondary

MeasureTime frame
Visual Analog Scale (VAS);TCM Syndrome Score;Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) Score;Knee Extension Strength Measurement;Clinical Efficacy Evaluation Criteria;

Countries

China

Contacts

Public ContactLuping Zhang

Fuyang Traditional Chinese Medicine Orthopedic Hospital of Hangzhou City

qq719529@126.com18768108201

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Mar 14, 2026