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

Phase 2

Recruiting

• Conditions: Distal Radius Fracture

• Registration Number: ITMCTR2000002887
• Lead Sponsor: Shanghai Ninth People's Hospital Huangpu Branch

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

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

(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.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cooney Wrist Score;

Secondary Outcome Measures

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