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Clinical study for Shishi Yi-Qi Bu-Shen Tong-Luo granule combined with manipulation on the rehabilitation after distal radius fracture

Clinical study for Shishi Yi-Qi Bu-Shen Tong-Luo granule combined with wrist adhesion release operation on the rehabilitation after distal radius fracture

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2000002887
Enrollment
Unknown
Registered
2020-01-01
Start date
2019-10-01
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

Distal Radius Fracture

Interventions

Sponsors

Shanghai Ninth People's Hospital Huangpu Branch
Lead Sponsor

Eligibility

Sex/Gender
All
Age
48 Years to 78 Years

Inclusion criteria

Inclusion criteria: 1. The diagnosis of unilateral distal radius fracture was clear, and the patients who received plaster external fixation, small splint fixation, external fixation and other conservative treatment; 2. Aged 48 to 78 years old; 3. The X-ray showed that the fracture line was indistinct and the callus grew well, and the plaster and brace were removed for external fixation; 4. After 6 weeks of fracture, wrist joint dysfunction, stiffness, swelling and pain can be seen locally, and joint mobility is significantly lower than that of the healthy side; 5. It can accept oral Chinese medicine and manual therapy; 6. Sign the informed consent and ensure the compliance of the test.

Exclusion criteria

Exclusion criteria: (1) Those who are allergic to the test drug or have serious adverse reactions when using the test drug; (2) The stability of fracture site is poor, and it is easy to re shift in rehabilitation treatment; (3) Patients with nerve injury or severe osteoporosis; (4) Tumor and cancer patients; (5) Mania, depression and other mental disorders; (6) People with a history of infectious diseases such as tuberculosis, hepatitis B and HIV carriers and other infectious diseases. (7) Medical diseases with poor control, such as diabetes, hyperlipidemia, respiratory tract infection, etc; (8) Having a history of opioid analgesics, sedative hypnotics and alcohol abuse; (9) Severe liver and kidney diseases or damage of liver and kidney function (ALT or AST is more than 1.5 times higher than the upper limit of normal, and serum creatinine level is more than 1.5 times higher than the upper limit of normal) (10) Poor compliance, unable to cooperate with the manipulation and meet the follow-up requirements; (11) Patients who participated in clinical trials of other drugs in the past 3 months.

Design outcomes

Primary

MeasureTime frame
Cooney Wrist Score;

Secondary

MeasureTime frame
Patient-Rated Wrist Evaluation Score;Numerical rating scale;the MOS item short from health survey,SF-36;

Countries

China

Contacts

Public ContactHaiyang Wu
286948197@qq.com+86 17601284900

Outcome results

None listed

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