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.

A Double-Blind, Randomized, Multicentric, Comparative, Phase-IV Clinical Trial to Evaluate Safety, Tolerability and Efficacy of 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 in the treatment of acute painful musculospastic conditions

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/06/025614

Enrollment

200

Registered

2020-06-04

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: M958- Other specified acquired deformities of musculoskeletal system

Interventions

Intervention1: Fixed-dose Combination of Aceclofenac 100 mg, Paracetamol 325 mg and Thiocolchicoside 4 mg: The tablets are taken orally twice a day for a period of 7 days Control Intervention1: Fixed

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
The primary objective of this phase-IV trial is to find out safety & tolerability of the productTimepoint: Day 7	—

Secondary

Measure	Time frame
The secondary objective of this phase-IV trial is to find out efficacy of the product by clinician global assessmentTimepoint: Day 7	—

Countries

India

Contacts

Public ContactMr Sudeep Kumar Patra

CRO PHARMATRENDZ PRIVATE LIMITED

drsai@pharmatrendz.com9861252518

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026