Control- Labeled, Prospective, Randomized, Parallel group, Multicentric, Phase III Clinical Trial to Evaluate Efficacy and Safety of Eperisone HCl SR 150mg OD Capsule compared with Eperisone HCl 50mg Tablet T.I.D in patients suffering from Acute Musculoskeletal Spasm associated with Low Back Pain.

A Control- Labeled, Prospective, Randomized, Parallel group, Multicentric, Phase III Clinical Trial to Evaluate Efficacy and Safety of Eperisone HCl SR Capsule compared with Eperisone HCl Tablet in patients suffering from Acute Musculoskeletal Spasm associated with Low Back Pain.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/001138

Enrollment

200

Registered

2010-08-09

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- Patient Suffering form Acute Musculoskeletal Spasm associated with Low Back Pain

Interventions

Intervention1: Eperisone HCL SR: 150mg OD for 7 days Control Intervention1: Eperisone: 50 mg three time a day for 7 days

Eligibility

Inclusion criteria

Inclusion criteria: Patients of either sex between 18 to 70 years of age. Patients with confirmed diagnosis of Acute Musculoskeletal spasm with Low Back Pain due to: Spondylosis deformans. Prolapsed Intervertebral Disc (PID). Muscle sprains with spasms. Patients who are willing to take the medications as directed and willing to come for follow-ups. Patients who are willing to comply with the protocol requirements. Patients who are willing to give the written informed consent.

Exclusion criteria

Exclusion criteria: Patients with other associated spasm conditions like traumatic pain with spasms, cervical spondylitis and pain and spasm associated with fractured bone. Patients who had taken any form of skeletal muscle relaxant in the previous seven days Patients with hypersensitivity to any of the ingredients of the study drug formulations. Women of child bearing potential not following adequate contraceptive measures Patients unwilling or unable to comply with the study procedures Patients having a history of severe acute infection, major surgery, trauma, severe metabolic, endocrine or electrolyte disturbances and seizures in preceding eight weeks Patients having severe hepatic insufficiency defined by an SGOT or SGPT value equal or higher than the three fold normal values of the respective laboratory reference value Patients having any of the following disorders: Renal failure, Bulimia, Hypo and Hyperthyroidism, Nephrotic syndrome, Anorexia nervosa, biliary obstruction and severe cardiac dysfunction. Patients having uncontrolled diabetes mellitus, or any other metabolic or endocrine disorder Patients that have received treatment with any investigational drug in the preceding four weeks

Design outcomes

Primary

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

Secondary

Measure	Time frame
Average reduction in mean pain score within last 24 hours assessed using VAS by Investigator and Subject at Day7 i.e. completion of protocol treatment in both treatment groups.Timepoint: Day 7	—

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