A Phase IV, Open Label, Randomized, Multi Centric, Prospective, Parallel, Active-Controlled, Comparative Clinical trial to assess the efficacy and safety of Diclofenac Sodium, Paracetamol and Chlorzoxazone compared to Diclofenac sodium and Paracetamol in treating Acute Musculoskeletal Spasm

A Phase IV Open Label Randomised Multi Centric Prospective Parallel Active Controlled Comparative Clinical trial to assess the Efficacy and Safety of Fixed Dose Combination of Diclofenac Sodium IP 50 mg as enteric coated granules Paracetamol IP 325 mg and Chlorzoxazone USP 250 mg uncoated tablet LOBAK of Geno Pharmaceuticals Private Limited compared to Fixed Dose Combination of Diclofenac sodium IP 50 mg as enteric coated granules and Paracetamol IP 325 mg uncoated tablet DICLOMOL of Win Medicare Private Limited in patients with Acute Musculoskeletal Spasm - NIL

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/10/074848

Enrollment

200

Registered

2024-10-07

Start date

Unknown

Completion date

Unknown

Last updated

2025-02-03

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

Conditions

Health Condition 1: M959- Acquired deformity of musculoskeletal system, unspecified

Interventions

Intervention1: Fixed Dose Combination of Diclofenac Sodium IP 50 mg, Paracetamol IP 325 mg and Chlorzoxazone USP 250 mg uncoated tablet: Fixed Dose Combination of Diclofenac Sodium IP 50 mg, Paracetam

Eligibility

Inclusion criteria

Inclusion criteria: 1. Men and women (age 18-60 years) who are diagnosed with Acute Musculoskeletal Spasms can participate in the study 2. Patients willing to take the medications as directed and willing to come for the follow-ups 3. Patients willing to comply with the protocol requirements 4. Patients willing to give the written informed consent

Exclusion criteria

Exclusion criteria: 1. Subjects who are not able to or not willing to sign an IRB/IEC approved consent form 2. Hypersensitivity to NSAlDs or any other component of the formulation or suffering from asthma or other allergic disorders. 3. Subjects with a history of presence of cardiac disorders, peptic ulceration or gastrointestinal bleeding or severe dyspepsia. 4. Subjects with severe concurrent systemic disease, bleeding or irreversible coagulation disorders, cancer. 5. Subjects with Random Blood Glucose level greater than 200mg per dL. 6. Subjects with hypertension (SBP 140, DBP 90). 7. Patients with muscular diseases, such as myositis, muscular dystrophia, myotonia, and myasthenia; 8. History of spine surgery within the previous 24 weeks or scheduled to undergo surgery during the study period; 9. Pregnant and lactating women 10. History of alcohol or drug abuse 11. Opioid use (including tramadol) within the previous three days 12. Clinically significant impairment of hepatic and renal functions 13. Subjects treated with NSAlDs, glucosamine, corticosteroids or skeletal muscle relaxants for 3 days prior to screening visit

Design outcomes

Primary

Measure	Time frame
1. Pain intensity at rest (Based on NRS) 2. Pain intensity on passive movementTimepoint: Baseline to Day3 and Day5	—

Secondary

Measure	Time frame
1. Change from baseline to the end of treatment in pain intensity based on VAS 2. Change from baseline to the end of treatment in Patient satisfaction with pain control status (Scored on a 5-point scale) 3. Change from baseline to the end of treatment in Physician Assessed their satisfaction with their patient’s pain control status (Scored on a 5-point scale)Timepoint: Baseline to EOT	—

Countries

India

Contacts

Public ContactMr Umakant Ghodke

Synergen Bio Private Limited

neel@synergenbio.com9028000444

Outcome results

None listed

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