ITMCTR1900002854尚未招募2 期
A multicenter phase II randomized, double-blind, placebo-controlled trial for efficacy and safety of injuries ointment in the treatment of ankle joint sprain (qi and blood stasis zhen)
Beijing hospital of traditional Chinese medicine affiliated to capital medical university0 个研究点开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional 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 ankle sprain;
- •2. Syndrome differentiation of qi stagnation and blood stasis;
- •3. Pain VAS score 4 to 7;
- •4. Only one injured site can be evaluated;
- •5. The injure occurred within 48 hours;
- •6. Aged between 18 and 65 years;
- •7. Informed consent and signed informed consent voluntarily.
排除标准
- •1. The target site is accompanied by severe sprain or strain, resulting in rupture of muscles, tendons and other soft tissues, open trauma, or joint dislocation, fracture, nerve injury and viscera injury;
- •2. The same target has been damaged within 3 months;
- •3. Non-steroidal anti-inflammatory drugs and other drugs with anti-inflammatory and analgesic effects or traditional Chinese medicine therapy with the effect of activating blood circulation and removing stasis and swelling and relieving pain were used within 12 hours before enrollment;
- •4. Those who had used non-drug therapy (such as massage, physiotherapy, acupuncture, etc.) other than rest and cold compress before joining the group;
- •5. Have used steroid drugs within 30 days;
- •6. For patients with severe primary diseases and mental disorders, such as cardiovascular, cerebrovascular, liver, kidney and hematopoietic system, liver function (ALT and AST) was 1.5 times higher than the upper limit of normal value, and SCr was higher than the upper limit of normal value;
- •7. Allergic constitution (allergic to two or more substances) or matrix components such as experimental drug ingredients and alcohol;
- •8. Participants in other clinical trials within the past 1 month;
- •9. Women who are nursing or pregnant, or who are planning to become pregnant;
- •10. Other patients judged inappropriate to participate in this study by the researcher.
- •Note: external force caused the rupture of muscles, tendons and other soft tissues, clinical manifestations of local pain, emptiness or depression, tenderness, loss or loss of muscle or tendon function. Ultrasound is helpful in diagnosis.
研究者
相似试验
进行中（未招募）
不适用
A multi-center phase 2 randomized, double-blind, placebo-controlled dose-ranging study to determine the efficacy, safety, tolerability and pharmacokinetics of RO4389620 in patients with type 2 diabetes mellitusMedDRA version: 7Level: lowClassification code 10012613Type 2 Diabetes MellitusEUCTR2005-002907-18-HUF. Hoffmann-La Roche Ltd250
招募中
2 期
A clinical trial to study the effects of Ifetroban in patients with with diffuse cutaneous systemic sclerosis or systemic sclerosis-associated pulmonary arterial hypertension.CTRI/2019/04/018679Cumberland Pharma Inc
已完成
不适用
A multi-center, randomized, double-blind, phase III clinical trial to evaluate the efficacy and safety of Nebivolol/Rosuvastatin combination treatment in patients with concomitant Hypertension and HyperlipidemiaDiseases of the circulatory systemKCT0002148Elyson Pharmaceutical276
进行中（未招募）
1 期
A multi-center, randomized, double-blind, phase II trial with intraindividual comparison to assess superiority of Soventol HydroCortisonACETAT 1 % Cremogel versus vehicle on lesional skin in patients with mild atopic eczema, seborrheic eczema or stasis dermatitis and to assess safety of Soventol HydroCortisonACETAT 1 % CremogelEUCTR2017-000984-34-DEMedice Arzneimittel Pütter GmbH & Co KG50
进行中（未招募）
不适用
Comparison of defined skin parameters in two comparable lesional skin areas after topical treatment with Soventol HydroCort 1% cream or vehiclemanifest atopic dermatitis diagnosed according to Hanifin and Rajka, or seborrheic eczema or stasis dermatitisMedDRA version: 14.1Level: PTClassification code 10041955Term: Stasis dermatitisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersMedDRA version: 14.1Level: LLTClassification code 10062813Term: Seborrheic eczemaSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersMedDRA version: 14.1Level: LLTClassification code 10003641Term: Atopic eczemaSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersEUCTR2013-000715-25-DEMEDICE Arzneimittel Pütter GmbH & Co.KG