A Comparative, Randomized Parallel group, Multicentric Prospective Phase III Clinical trial to evaluate Efficacy and Safety of a Fixed Dose Combination of Thiocolchicoside 16mg SR + Aceclofenac 200mg SR Capsule OD compared with FDC of Thiocolchicoside 8mg + Aceclofenac 100mg Tablet BID for 7 Days in Patients Suffering From Acute Non Specific Low Back Pain associated with muscular spasm.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2011/091/000009

Enrollment

200

Registered

2011-01-07

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: null- Patients Suffering From Acute Non Specific Low Back Pain associated with muscular spasm.

Interventions

Intervention1: Thiocolchicoside 16mg SR + Aceclofenac 200mg SR: Once a day for 7 Days Control Intervention1: Thiocolchicoside 8mg + Aceclofenac 100mg: Twice a day for 7 days

Eligibility

Inclusion criteria

Inclusion criteria: Age Eligible for study: 20 years to 75 years Gender Eligible for study: both Accepts Healthy Volunteers: No Non specific low Back pain with an acute episode of recent onset ( Low Back pain of diagnosis category 1 (low Back pain radiating no farther than the intergluteal fold) or 2 (low Back pain radiating no farther than the knee), as defined by the International Paris Task Force on Back Pain. Willing to give written informed consent.

Exclusion criteria

Exclusion criteria: Backache due to vertebral collapse or of no mechanical origin (suspected by history taking and physical examination), such as neoplasm, infection or inflammatory disorders. Backache of diagnosis category 3 (low back pain radiating beyond the knee, with no neurologic signs) or 4 (low back pain radiating to a precise and entire leg dermatome, with or without neurologic signs), as defined by the International Paris Task Force on Back Pain. History of inflammatory arthritis of large joints. History of seizure disorders. History of malignant tumor. Treatment with steroidal agents (including aspirin) during the two days prior to prospective inclusion, prolonged used of corticosteroids. Treatment with NSAIDs or muscle relaxant or opioid analgesics within 3 days of admission. Psychiatric or mental diseases. Immune Compromised HIV. Inclusion in another study in the past six months or previous inclusion in this study. History of alcohol, drugs or narcotics abuse. Recent history of violent trauma. Constant progressive, non mechanical pain (no relief with bed rest). Thoracic pain. Patient systemically unwell. Unexplained weight loss. Widespread neurological symptoms (including Cauda equine syndrome). Structural deformity. Fever. Clinical significant renal dysfunction defined by Creatinine more than 1.5 mg/dl. Clinically significant hepatic dysfunction defined by: Total Bilirubin more than 2 mg/dl. SGOT (AST) more than 1.5 IU/L. SGPT (ALT) more than 1.5 IU/L. Patients who have received other therapy (physiotherapy, physical manipulations, invasive intervention, acupuncture therapy.) within the last 48 hours. Pregnancy, breast feeding or women of childbearing potential not using efficient contraception.

Design outcomes

Primary

Measure	Time frame
Comparison percent of reduction in pain within the last 24 hours assessed using VAS at Day 4 in both treatment groups.Timepoint: Baseline and completion of treatment	—

Secondary

Measure	Time frame
Average reduction pain within the last 24 hours assessed using VAS by Investigator and Subject at day 7 i.e. completion of protocol treatment in both treatment groups.Timepoint: Baseline and completion of treatment	—

Countries

India

Contacts

Public ContactGautam Saranath

NEXUS CLINICAL RESEARCH (INDIA) LTD.

dramit.bhatt@gmail.com022-27714204

Outcome results

None listed

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