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Single-center, randomized, controlled, double-blind clinical study of Huatan Huoxue Decoction for topical treatment of knee osteoarthritis with phlegm and blood stasis

Single-center, randomized, controlled, double-blind clinical study of Huatan Huoxue Decoction for topical treatment of knee osteoarthritis with phlegm and blood stasis

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2000004088
Enrollment
Unknown
Registered
2020-11-27
Start date
2020-11-30
Completion date
Unknown
Last updated
2023-02-20

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

Conditions

knee osteoarthritis

Interventions

Sponsors

Heping Lane Community Health Service Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Western medicine diagnosis: recurrent knee pain in the past month;X-rays (standing or weight-bearing) show narrowing of joint Spaces, subchondral osteosclerosis and/or cystic changes, and joint marginal osteophyte formation;Age >=50 years old; Morning stiffness for 30 min or less; 2. TCM syndrome diagnosis: joint pain, swelling hypertropia, with joint hypertropia, limited activity, tongue reddish, thin or greasy tongue coating, pulse slip or string; 3. Knee pain such as thorn, VAS pain scale score > 30mm; 4. Aged 50 to 70 years old; 5. Informed consent has been signed before the test. In addition, if the patient has osteoarthritis of both knees, choose the more severe side.If both knees had the same pain score, one side of the knee was selected for intervention according to study needs.

Exclusion criteria

Exclusion criteria: (1) Those who do not meet the inclusion criteria; (2) A history of knee trauma or surgery within 6 months; (3) Arthroscopy, arthroscopic surgery, cartilage repair surgery, force line correction surgery and other restorative therapy, intra-articular injection of drugs or knee arthroplasty were performed within 3 months; (4) Who Is participating or is participating in other clinical trials within 3 months; (5) other knee joint diseases, such as patella softening, rheumatoid arthritis or rheumatoid factor (RF) positive (RF>40 U/ml), gout arthritis involving the knee, etc; (6) Kellgren and Lawrence classification level >=III; (7) Not suitable for intermediate frequency treatment, such as acute suppurative inflammation of the knee, bleeding tendency, malignant tumor, active tuberculosis, pacemaker placement, thrombophlebitis, treatment site with metal foreign body, tetanus, etc.; (8) Patients with mental disorders or serious diseases, such as severe diabetes, severe liver and kidney disease, malignant tumors, infectious diseases or complications affecting the joints; (9) Severe hypersensitivity and hypersensitivity to the ingredients of Huatan Huoxue decoction , placebo liquid, and cloth; (10) skin infection, collapse or other skin diseases; (11) Be pregnant or breast-feeding.

Design outcomes

Primary

MeasureTime frame
The Western Ontario and McMaster Universities Osteo- arthritis Index (WOMAC);

Secondary

MeasureTime frame
the TCM syndrome quantitative score;the point at which the pain begins to relieve;Visual Analogue Scale (VAS);

Countries

China

Contacts

Public ContactYuan Zhou

Heping Lane Community Health Service Center

15801578649@163.com+86 13717671985

Outcome results

None listed

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