Trial for evaluating the safety and efficacy of a FDC combination in treatment of painful musculospastic conditio
- Conditions
- Health Condition 1: M150- Primary generalized (osteo)arthritis
- Registration Number
- CTRI/2024/05/067356
- Lead Sponsor
- Albert David Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. Male or female aged more than 18 years and less than 60 years (both inclusive)
2. Willing to give written informed consent
3. 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.
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
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Pain reduction on day 7 of treatment by assessing pain intensity using the PI NRS scale, compared to baseline PI NRS scale. <br/ ><br>2.Change or Improvement in the CGI scale from baseline to the end of the treatment.Timepoint: Day 1, Day 3, Day 7
- Secondary Outcome Measures
Name Time Method 1.Incidence of adverse events (AEs) and serious adverse events (SAEs). <br/ ><br>2.Pain relief with study medication on days 1, 3 and day 7 by using PI NRS scale. <br/ ><br>Timepoint: Day 1, Day 3, Day 7