CTRI/2017/10/010223招募中4 期
A Multicentric, Randomized, Prospective, Open Label, Comparative,Parallel Group Clinical Trial to Evaluate the Efficacy and Safety of Fixeddose combination of Trypsin - Chymotrypsin Enzyme and Diclofenac OralTablet in comparison with Diclofenac oral Tablet in the management ofacute inflammation due to soft tissue injuries
Torrent Pharamceutical Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
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
- Interventional
入排标准
入选标准
- •1. Male or female patients of age between 18 and 65 years.
- •2. Patients with minor traumatic inflammatory soft tissues injuries like sprains, strains, hematomas (Sub-dermal type only), contusion, abrasions, lacerations, acute sports injuries (excluding suspected fractures), seen within 24 hours of the injury at screening. (Refer appendix 18.1 for terms)
- •3. Patients with moderate to severe pain (Numeric Pain Rating Scale of more than or equal to 4 on scale of 0 to 10) and swelling (Swelling score more than or equal to 2)
- •4. Patients willing to give written informed consent and to comply with study procedures
排除标准
- •1. Any long standing/chronic inflammatory condition like rheumatoid arthritis, osteoarthritis or spondylitis where the patient had been on long term (i.e., past 3 months or more) anti-inflammatory drugs including non-steroidal anti-inflammatory drugs, corticosteroids or analgesics.
- •2. Patients with infected wounds, tissue abscesses and cellulitis.
- •3. Patients who are known case of diabetes mellitus.
- •4. Patients with a known hypersensitivity to any ingredient of study drugs.
- •5. Patients with injuries (such as sprains/strains) requiring immobilization for more than 48 hours, orthopaedic or surgical intervention.
- •6. Patients with multiple soft tissue injuries, fractures, ruptured ligaments or complicated wound requiring surgical intervention.
- •7. Patients with active or history of recurrent peptic ulcer/gastro-intestinal bleeding or perforation.
- •8. Patients known to have established congestive heart failure, ischemic heart disease, peripheral arterial disease, cerebrovascular disease, renal and liver disease or any clinically significant disease as per investigator discretion.
- •9. Patients who are known seropositive cases of HIV, Hepatatis B or Hepatitis C.
- •10. Patients with clinically significant abnormality in ECG at screening.
- •11. Patients with localized skin disease (e.g. eczema, psoriasis etc.) at the site of injury that may interfere in evaluation of the injury.
- •12. Patients who had participated in any clinical trial within one month prior to enrolment.
- •13. Pregnant or breast-feeding women.
- •14. Female patients who are of childbearing potential and who have neither used a medically acceptable contraceptive method (like hormonal agents, barrier methods or intrauterine device or) nor surgically sterilized within 3 weeks prior to screening visit and not willing to use any of the contraceptive methods or abstinence from sex during the study period.
- •15. Patients who have taken prohibited medications (other NSAIDs, opioid analgesics and systemic corticosteroids) in last 7 days.
研究者
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