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A clinical trial to study the effects of two drugs, Fixed Dose Combination of Etoricoxib and Thiocolchicoside and Thiocolchicoside Alone in Patients with Painful Muscle Spasm such as torticollis, lumbago, backache.

A Comparative Study of the Efficacy and Tolerability of Fixed Dose Combination of Etoricoxib and Thiocolchicoside and Thiocolchicoside Alone in Patients with Painful Muscle Spasm

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/11/016371
Enrollment
100
Registered
2018-11-16
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: - Health Condition 2: M00-M99- Diseases of the musculoskeletal system and connective tissue

Interventions

Intervention1: AIMS AND OBJECTIVES OF THE STUDY: 1. To compare the efficacy of the fixed dose combination of Etoricoxib (60mg)and Thiocolchicoside(4mg) versus Thiocolchicoside(4mg) alone 2. To compar

Sponsors

PRIYANKA S
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Subjects between 18-65yrs of age of either gender with painful muscle spasms attending Orthopaedic OPD. 2. Willingness to give written informed consent and available for regular follow up and examination.

Exclusion criteria

Exclusion criteria: 1. Patients with history of liver and kidney damage, cardiovascular disease, acid peptic diseases 2. Pregnant and lactating mothers 3. Patients allergic to NSAIDS and skeletal muscle relaxants or prior history of asthma or hypersensitivity potentially requiring concomitant treatment 4. Patients treated with NSAIDS or skeletal muscle relaxants 1 week prior to study 5. Patients with severe concurrent systemic diseases including bleeding diathesis, on anticoagulant therapy. 6. Patients with malignancy, osteoporosis or previous history of lumbar spine surgery

Design outcomes

Primary

MeasureTime frame
â?¢ The primary efficacy end point of the drug therapy for the intended purpose of treatment will be evaluated through pain assessment scale using VASTimepoint: VAS will be assessed at baseline, 3rd day and 7th day visit to the OPD

Secondary

MeasureTime frame
secondary efficacy end point by patients global assessment in response to treatment (PGART)Timepoint: â?¢ Patients Global assessment in response to treatment-PGART, is measured at the end of the study on a scale of 0 to 4. 0-Poor, 1-Fair, 2-Good, 3-Very Good, 4- Excellent.

Countries

India

Contacts

Public ContactPRIYANKA S

KIMS, Bangalore

drpriyanka110@gmail.com9844093100

Outcome results

None listed

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