Effect of two drug Eperisone and Tolperisone on patients of Acute Low Back pain

EFFICACY AND SAFETY OF TOLPERISONE HYDROCHLORIDE AND EPERISONE HYDROCHLORIDE IN MANAGEMENT OF ACUTE LOW BACK PAIN: A COMPARATIVE RANDOMIZED DOUBLE BLIND DOUBLE DUMMY CLINICAL TRIAL

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2016/12/007548

Enrollment

Registered

2016-12-07

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- Acute Low Back Pain

Interventions

Intervention1: Eperisone: Eperisone: Eperisone hydrochloride is a centrally acting muscle relaxant acting through poly and mono-synaptic reflexes in the spinal cord, exhibits vasodilator effect, incre

Eligibility

Inclusion criteria

Inclusion criteria: I. Age: age limit between 18 to 55 years. II. Duration of pain: less than 4 weeks. III. Radiological: spondylosis deformanace, prolapsed intervertebral disc. IV. Muscular spasm: acute muscular spasm in lower back muscles. V. Pain exacerbated by hyperextension and alleviated by flexion. VI. Patient who gives written informed consent

Exclusion criteria

Exclusion criteria: I. Patients with a history of sensitivity to any of the drugs. II. Patients with fracture or injury to spine III. Patients with pain more than 4weeks. IV. Patient with history of spondylitis/severe arthritis/T.B. spine / cancer / osteoporosis. V. Patients with history of taking centrally acting muscle relaxant within 7 days. VI. Muscular diseases: myositis, poliomyositis, muscular dystrophia and myotonia. VII. Congenital spinal deformity. VIII. Pregnant or lactating women. IX. Patients with tuberculosis, diabetes, acute renal disease, or liver disease. X. Patients who were unable to continue for the proposed length of treatment or return for follow-up visits. XI. Do not give consent. XII. Patients with lumbar pathologies diagnosed by radiology such as lumbar herniated disc disease, spondylolisthesis, narrow spinal canal, scoliosis or other spinal deformities, fracture, mass lesions XIII. Patients with a history of previous lumbar surgery. XIV. Patients with polyneuropathy or mononeuropathy. XV. Patients with a neoplastic disease. XVI. Patients with a psychiatric disease. XVII. Patients have a sciatica, radiculopathy, neurological deficits. XVIII. Patients with an epileptic or severe neurological disease XIX. Calcium metabolism disease, Vitamin D deficiency, Osteoporosis

Design outcomes

Primary

Measure	Time frame
To find effectiveness of Tolperisone and Eperisone in acute low back painTimepoint: For 7 days	—

Secondary

Measure	Time frame
2) To find effectiveness of central muscle relaxant in acute low back pain. 3) To find how much improvement in patients of acute low back pain after treatment Timepoint: for 7 days	—

Countries

India

Contacts

Public ContactDr C B Tripathi

Govt Medical College, Bhavnagar

cbrtripathi@yahoo.co.in919825951678

Outcome results

None listed

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