CTRI/2021/10/037277已完成4 期
ââ?¬Å?An Open Label, Prospective, Non-comparative, Multicentre, Phase IV Clinical Study to Evaluate the Safety, Tolerability and Efficacy of FDC of Trypsin - Chymotrypsin 50000 AU plus Bromelain 90 mg plus Rutoside Trihydrate 100 mg Tablets in Subjects for the treatment of conditions associated with Inflammation and edema of traumatic origin.ââ?¬?
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 201
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 aged between 18 to 65 (both inclusive) years.
- •2. Patients with conditions associated with Inflammation and edema of traumatic origin such as Ankle sprain or Sport injuries or Tendinitis or Post-surgery of tooth extraction.
- •3. Patients with pain at baseline must be ââ?°Â¥ 30 mm on a 0- 100 mm Visual Analogue Scale.
- •4. Patient with ability to understand and provide written informed consent form, which must have been obtained prior to screening.
- •5. Patients willing to comply with the protocol requirements.
排除标准
- •1. Patients with known history of intolerance, hypersensitivity or any other contraindication to study drug.
- •2. Patients with clinical laboratory evaluations (including clinical chemistry, hematology and complete urinalysis) are not within the reference range for the testing laboratory and the results are deemed clinically significant by the investigator.
- •3. Patients treated with other analgesic (NSAIDS, Opioids and Corticosteroids) medications within 1 week prior to the study.
- •4. Patients with chronic and degenerative conditions of pain.
- •5. Pregnant or lactating women.
- •6. Female patients who are of childbearing potential and who are neither surgically sterilized nor willing to use reliable contraceptive methods (like hormonal, barrier methods or intrauterine device).
- •7. Patients with the history of significant cardiovascular disorders, central nervous system disorders, endocrine disorder, hepatic impairment, renal impairment and other severe condition like asthma, uncontrolled hypertension, collagen disorders, severe infection etc. or any other medical illness that may affect patient safety or difficult to evaluate the efficacy of the product.
- •8. Patients with clinically significant impaired renal or hepatic function (SGOT and SGPT more than 2.5X the UNL).
- •9. Patients with estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73m2.
- •10. Patients with known case of Type 1 Diabetes and Type 2 Diabetes Mellitus whose diabetes has not been stable and uncontrolled for the previous three months and with HbA1c value greater than 8%.
- •11. Patients with a history of actively bleeding peptic ulceration or gastrointestinal bleeding.
研究者
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