A Double-blind, Randomized, Multicentric, Comparative, Phase IV clinical trial to evaluate efficacy, safety & Tolerability of oral tablets of fixed dose combination of Aceclofenac 100 mg + Paracetamol 325 mg + Serratiopeptidase 15 mg in comparison with Aceclofenac 100 mg + Paracetamol 325 mg tablets in the treatment of acute painful musculospastic conditions.
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 250
- 试验地点
- 4
- 主要终点
- 1.Pain reduction on day 7 of treatment by assessing pain intensity using the PI NRS scale, compared to baseline PI NRS scale.
研究概览
简要总结
Aceclofenac + Paracetamol + Serratiopeptidase is a combination of three medicines: Aceclofenac, Paracetamol and Serratiopeptidase. Aceclofenac is a non-steroidal anti-inflammatory drug (NSAID), and Paracetamol is an antipyretic (fever reducer). They work by blocking the release of inflammatory mediator prostaglandin that cause pain and fever. Serratiopeptidase is an enzyme which works by reduces capillary permeability induced by histamine, bradykinin, and serotonin; breaks down abnormal exudates and proteins; facilitates the absorption of decomposed products through blood and lymphatics at the site of inflammation and promotes healing. The rationale of study is to evaluate efficacy and safety & Tolerability of oral tablets of fixed dose combination of Aceclofenac (100 mg) + Paracetamol (325 mg) + Serratiopeptidase (15 mg) in comparison with Fixed dose combination of Aceclofenac (100 mg) + Paracetamol (325 mg) in the treatment of acute painful musculospastic conditions.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or female aged more than 18 years and less than 60 years (both inclusive)
- •Willing to give written informed consent
- •Subjects suffering from acute painful conditions with spasm such as prolapsed intervertebral disc, sprains and dislocations, spondylosis (Lumbar, Cervical, ankylosing spondylosis), spinal stenosis, periarthritis, frozen shoulder, prepatellar bursitis, spondylolisthesis, low backpain, tendonitis, tenosynovitis, bursitis.
排除标准
- •1.Subjects with known hypersensitivity to any of the study drugs.
- •2.History of autoimmune disease.
- •3.Concurrent use of corticosteroids.
- •4.Any medication or indication that might point to an increased risk.
- •Associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the study personnel.
- •Make the subject inappropriate for the inclusion.
- •5.Participation in another clinical trial in the last three months and during study participation 6.Subjects with history of epilepsy, or those at-risk seizures or taking seizure drugs in pregnant, lactating women or women of childbearing age who are not using an acceptable method of birth control 7.Subjects with Galactose or fructose intolerance.
- •8.Subjects with severe renal impairment, including those receiving dialysis 9.Subjects with active liver disease, including those with primary biliary cirrhosis and unexplained persistent liver function abnormalities.
- •10.Subjects with pre-existing gallbladder disease.
- •11.Active peptic ulcer disease.
结局指标
主要结局
1.Pain reduction on day 7 of treatment by assessing pain intensity using the PI NRS scale, compared to baseline PI NRS scale.
时间窗: Day 1, Day 3, Day 7
2.Change or Improvement in the CGI scale from baseline to the end of the treatment.
时间窗: Day 1, Day 3, Day 7
次要结局
- 1.Incidence of adverse events (AEs) and serious adverse events (SAEs).(2.Pain relief with study medication on days 1, 3 and day 7 by using PI NRS scale.)
研究者
Dr Ashwini Kumar
CliniExperts Research Services Pvt Ltd