A Comparative Phase-IV Clinical Trial for the treatment of acute painful musculospastic conditions using Oral Tablets of Fixed-dose Combination of Aceclofenac 100/100 mg, Paracetamol 325/325 mg and Thiocolchicoside 4/8 mg in comparison with Aceclofenac 100/100 mg and Thiocolchicoside 4/8 mg.
- Conditions
- Health Condition 1: M958- Other specified acquired deformities of musculoskeletal system
- Registration Number
- CTRI/2020/06/025614
- Lead Sponsor
- Akums Drugs and Pharmaceuticals Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1.Subjects of either sex of age 18 to 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 bursistis, spondylilistheisis, Low-back pain, Tendonitis, Tenosynovitis, Bursitis.
1)Patients known, or thought to be hypersensitivity to study drugs
2)History of auto-immune 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, would make the subject inappropriate for inclusion
5)Participation in other clinical trials the last three months and during study participation
6)Patients with history of epilepsy, or those at risk for seizures or taking seizure drugs
7)Pregnant, lactating women or women of childbearing age who are not using an acceptable method of birth control
8)Patients with galactose or fructose intolerance
9)Patients with severe renal impairment, including those receiving dialysis.
10)Patients with active liver disease, including those with primary biliary cirrhosis and unexplained persistent liver function abnormalities.
11)Patients with preexisting gallbladder disease
12)Active peptic ulcer disease
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective of this phase-IV trial is to find out safety & tolerability of the productTimepoint: Day 7
- Secondary Outcome Measures
Name Time Method The secondary objective of this phase-IV trial is to find out efficacy of the product by clinician global assessmentTimepoint: Day 7