“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.â€
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 10
- 主要终点
- Proportion of patients reporting incidences of AE and/or SAE during the study and their assessment in respect to intensity, duration, pattern and causal relationship to the study medication.
研究概览
简要总结
Thistrial is an open label, prospective,non-comparative, multicentre, phase IV clinical study to evaluate the safety, tolerabilityand efficacy of FDC of Trypsin - Chymotrypsin 50000 AU + Bromelain 90 mg +Rutoside Trihydrate 100 mg Tablets in subjects for the treatment of conditionsassociated with inflammation and edema of traumatic origin.
Subjectswho are willing and able to participate in the study will sign and date the informedconsent form on the day of screening / baseline visit (Visit 1). During thisscreening period, subjects who are willing to give consent will be evaluatedfor all the eligibility criteria. Eligible subjects with conditions associatedwith inflammation and edema of traumatic origin such as ankle sprain or sportinjuries or tendinitis or post-surgery of tooth extraction and who are aged 18to 65 years of age (both inclusive) will be considered for the study.
After confirming the inclusion/exclusion criteria thesubject will be enrolled and provided with study medication at enrollmentvisit. Subjects will be provided with patient diary at enrollment visit, whichneed to be brought along with in each subsequent visit till the last visit.Follow up visits will be done on day 3 and day 7±1 (Final Visit) of treatmentto assess safety, tolerability and efficacy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or female patients aged between 18 to 65 (both inclusive) years.
- •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.
- •Patients with pain at baseline must be ≥ 30 mm on a 0- 100 mm Visual Analogue Scale.
- •Patient with ability to understand and provide written informed consent form, which must have been obtained prior to screening.
- •Patients willing to comply with the protocol requirements.
排除标准
- •Patients with known history of intolerance, hypersensitivity or any other contraindication to study drug.
- •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.
- •Patients treated with other analgesic (NSAIDS, Opioids and Corticosteroids) medications within 1 week prior to the study.
- •Patients with chronic and degenerative conditions of pain.
- •Pregnant or lactating women.
- •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).
- •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.
- •Patients with clinically significant impaired renal or hepatic function (SGOT and SGPT more than 2.5X the UNL).
- •Patients with estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73m
- •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%.
- •Patients with a history of actively bleeding peptic ulceration or gastrointestinal bleeding.
结局指标
主要结局
Proportion of patients reporting incidences of AE and/or SAE during the study and their assessment in respect to intensity, duration, pattern and causal relationship to the study medication.
时间窗: Throughout the Study
次要结局
- Improvement in Visual Analog Scale (VAS) from baseline to end of the study.(At Baseline, Day 3 and Day 7)
- Improvement in Subjects Global Assessment (SGA) and Physicians Global Assessment (PGA) at the end of the study.(At Day 7)
- Changes in Laboratory Safety Parameters (Hematology, Serum Biochemistry and Urine analysis) from baseline to end of the study.(At Baseline and Day 7)
- Changes in Vital Signs from baseline to end of the study.(At Baseline, Day 3 and Day 7)