ITMCTR2200005606招募中4 期
A randomized, double-blind, parallel-controlled, multi-center clinical trial of traditional Chinese medicine variety protection with Wuhu Oral Liquid in the treatment of acute soft tissue injury (Qi stagnation and blood stasis syndrome)
onghua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine0 个研究点开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational study
入排标准
- 年龄范围
- 18 至 65（—）
- 性别
- All
入选标准
- •(1) Meet the diagnostic criteria for acute soft tissue injury in Western medicine;
- •(2) Comply with the standard of TCM syndrome differentiation of qi stagnation and blood stasis;
- •(3) The duration of soft tissue injury is less than or equal to 48 hours;
- •(4) VAS score of resting pain score of the affected area is more than 3 points, and activity pain is less than 9 points;
- •(5) Age 18 to 65 years old (including 18 and 65 years old), gender is not limited;
- •(6) Subjects gave informed consent, voluntarily tested and signed the informed consent form.
排除标准
- •(1) Soft tissue injury sites with fractures, bone cracks, open wounds, or complete rupture of soft tissues such as muscles, tendons, and ligaments;
- •(2) =2 soft tissue injury sites;
- •(3) When the affected part is the joint part, other inflammatory and painful diseases, such as rheumatoid arthritis, psoriatic arthritis, gout, tumor, villonodular synovitis, joint trauma, septic arthritis, tuberculosis Arthritis;
- •(4) Use short-acting non-steroidal anti-inflammatory drugs or traditional Chinese medicines with the functions of promoting blood circulation and removing blood stasis, reducing swelling and relieving pain within 12 hours before the first dose; use long-acting or sustained-release non-steroidal anti-inflammatory drugs within 3 days; use corticosteroids within one week Steroids or antibiotics; those who have received acupuncture, physiotherapy, massage and other treatments during the course of the disease;
- •(5) Complicated with severe heart disease, renal failure, hematological disease; abnormal liver and kidney function ALT, AST, TBiL, Cr > upper limit of normal;
- •(6) Pregnant, suspected pregnancy, lactating female patients or patients who refuse to use contraceptives during the study (including male and female);
- •(7) Those who cannot cooperate with physical or mental diseases (such as blindness, deafness, muteness, intellectual disability, mental disorder, etc.), or those with serious diseases (such as tumors, etc.) that affect survival;
- •(8) Suspect or have a history of alcohol or drug abuse;
- •(9) Those who are known to be allergic to test drugs, excipients (alcohol) or emergency drugs specified in the protocol;
- •(10) Engaged in high-altitude, high-risk operations, or driving workers;
- •(11) Patients who have participated in other clinical trials within three months;
- •Other circumstances in which the investigator or assistant investigator determines that it is inappropriate to participate in the study.
研究者
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