A clinical study to compare two medicines used for treating sudden lower back pain with muscle spasms

A phase IV, multicenter, randomized, open label, parallel arm, clinical study to evaluate the efficacy and safety of FDC of Diclofenac sodium IP 50 mg + Paracetamol IP 325 mg + Chlorzoxazone USP 250 mg uncoated Tablet of Windlas Biotech Ltd., as 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 Pvt. Ltd., in patients with acute lower back pain associated with spasms. - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/06/112552

Enrollment

200

Registered

2026-06-11

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-22

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

Conditions

Health Condition 1: M545- Low back pain

Interventions

Intervention1: FDC of Diclofenac sodium IP 50 mg + Paracetamol IP 325 mg + Chlorzoxazone USP 250 mg: Patient will receive one tablet of IMP (FDC of Diclofenac sodium IP 50 mg + Paracetamol IP 325 mg +

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients of either sex (both males and females) of greater than or equal to 18 and less than or equal to 65 years of age (both inclusive). 2.Patients presenting with acute lower back pain associated with spasms of less than or equal to 7 days. 3.Patients with moderate to severe pain on visual analogue scale (VAS greater than or equal to 70 mm). 4.Willing to provide written informed consent. 5.Able to adhere to study visit schedule and other protocol requirements.

Exclusion criteria

Exclusion criteria: 1.History of hypersensitivity to the study medications. 2.Contraindication to use of NSAIDs and skeletal muscle relaxants. 3.Active or suspected gastrointestinal ulcer, gastrointestinal obstruction, severe dyspepsia, or gastrointestinal bleeding, crohn s disease or ulcerative colitis. 4.Patients with back pain due to malignancy, infection, osteoarthritis of hip or any other disease, back pain referred from other organs. 5.Patients suffering from asthma or other allergic disorders. 6.Severe heart failure 7.Patients treated with NSAIDs or skeletal muscle relaxants for 3 days prior to study. 8.Patients with severe concurrent systemic disease including bleedings diathesis and on anticoagulation therapy. 9.Patients suffering from hepatic or renal impairment. 10.Patients with any clinically significant disease with in last 7 days. 11.Pregnant or lactating women. 12.Patients with previous or current cardiovascular disorders, uncontrolled diabetes mellitus or any other metabolic disorder. 13.Patients with moderate to severe hepatic failure, renal failure, bulimia, hypo and hyperthyroidism, nephrotic syndrome, anorexia nervosa, and biliary obstruction. 14.Patients with active or recent history of inflammatory diseases of the gastrointestinal tract, and those with allergic manifestations due to salicylic acid or NSAIDs.

Design outcomes

Primary

Measure	Time frame
1. Change in Visual Analogue Scale (VAS) score 2. Change in Summed Pain Intensity Difference (SPID)Timepoint: From baseline to Day 3	—

Secondary

Measure	Time frame
1. Change in Visual Analogue Scale (VAS) score 2. Change in Summed Pain Intensity Difference (SPID) 3. Change in Total Pain Relief (TOTPAR), Finger-to-Floor Distance (FFD), muscle tension/tone, night discomfort, and effect of pain on daily functions. Timepoint: from baseline to Day 5	—

Countries

India

Contacts

Public ContactDr Neel Lahoti

Synergen Bio Pvt. Ltd

neel@synergenbio.com9028000444

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 29, 2026