CTRI/2021/01/030508进行中（未招募）4 期
A phase IV, randomized, multicentre, prospective, open-label, comparative, post-marketing study to evaluate safety & efficacy of combination of Diclofenac, Paracetamol, Trypsin and Chymotrypsin versus combination of Diclofenac and Paracetamol in patients with soft tissue injury.
Cachet Pharmaceutical Pvt Ltd0 个研究点目标入组 220 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 220
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Male or female patients between 18-65 years of age.
- •2. Patients with soft tissues injuries associated with inflammation & swelling like sprains, strains, hematomas (Sub-dermal type only), contusion, acute sports injuries (excluding suspected fractures), seen within 24 hours of the injury at screening.
- •3. Patients with pain VAS score between 4 - 6
- •4. Patients with ankle injury not requiring interventional treatment
- •5. Patients willing to give written informed consent and willing to comply with trial protocol
排除标准
- •1. Patients previously hypersensitive to diclofenac, paracetamol, trypsin or chymotrypsin
- •2. Patients with significant gastrointestinal complications, such as but not limited to the
- •following conditions:
- •a. Gastrointestinal ulcer
- •b. Gastrointestinal bleeding
- •c. Crohnââ?¬•s disease or ulcerative colitis.
- •3. Any long standing/chronic inflammatory condition like rheumatoid arthritis, osteoarthritis or spondylitis where the patient had been on long term anti-inflammatory drugs including nonsteroidal anti-inflammatory drugs, corticosteroids or analgesics.
- •4. Patients with wounds, tissue abscesses and cellulitis.
- •5. Patients with injuries (such as sprains/strains) requiring immobilization for more than 48 hours, orthopaedic or surgical intervention.
- •6. Patients known to have established congestive heart failure, cerebrovascular disease, renal and liver disease or any clinically significant disease as per investigator discretion.
- •7. Patient with any abnormal renal and hepatic function.
- •8. Patients who are known seropositive cases of HIV, Hepatitis B or Hepatitis C.
- •9. Patients with localized skin disease (e.g. eczema, psoriasis etc.) at the site of injury that may interfere in evaluation of the injury.
- •10. Patients who had participated in any clinical trial within one month prior to enrolment.
- •11. Patients who have taken prohibited medications (other NSAIDs, opioid analgesics and
- •systemic corticosteroids) in last 7 days.
- •12. Pregnant and lactating women or the women of child bearing age who are not practicing
- •effective method of contraception.
研究者
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