Thoicolchicoside Oral Spray in Acute Non Specific Low Back Pain

A clinical study to compare efficacy and safety of test product Thiocolchicoside Oral Spray with Reference Product Myoril 8 mg capsules in patients with Acute Non Specific Low Back Pain

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2012/11/003107

Enrollment

220

Registered

2012-11-14

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 Non Specific Low Back Pain

Interventions

Intervention1: Thiocolchicoside Oral Spray (thiocolchicoside 8 mg per two squirts): Dose and Duration: Two squirts Two times daily for Seven consecutive days. Control Intervention1: Myoril 8 mg cap

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patient with either sex with the age between 16 and 70 years. 2. Non specific low back pain with an acute episode of recent onset ( 3. Ability to understand and comply with protocol requirements. 4. Patients who have signed and dated their written informed consent prior to initial of the study. 5. Low back pain of diagnosis category 1 (low back pain radiating no further than the knee), as defined by the International Paris Task Force on Back Pain.

Exclusion criteria

Exclusion criteria: 1. Acute low back pain due to vertebral collapse or neoplastic, inflammatory (ankylosing spondylitis), or infective origins 2. Patients with psychiatric or mental diseases, or unable to follow the requests of the protocol 3. Positive history of cerebro-vascular accidents 4. Patients treated during two days prior to inclusion with steroidal agents. 5. Known or suspected hypersensitivity to thiocolchicoside. 6. Concomitant treatment with 2-agonists (i.e. clonidine). 7. Pregnant or breast feeding women. 8. Females of child bearing potential, not taking adequate contraception. 9. Patients with history of alcohol, drugs or narcotics abuse.

Design outcomes

Primary

Measure	Time frame
Average pain within the last 24 hours (VAS -I) at Day 1 (before starting treatment), Day 3 & Day 8Timepoint: at Day 1 (before starting treatment), Day 3 & Day 8	—

Secondary

Measure	Time frame
-Pain on movement (VAS - II) at D1, D3 and D8 -Stiffness (Hand-to-floor distance) at D1, D3 and D8 -Disability (Roland Morris questionnaire) at D1, D3 and D8 -Patient perceived change after treatment (Global Perceived Effect, GPE) at D8Timepoint: at Day 1 (before starting treatment), Day 3 & Day 8	—

Countries

India

Contacts

Public ContactMr Hiren Patel

Lincoln Pharmaceuticals Ltd.

hiren.rnd@lincolnpharma.com09825800168

Outcome results

None listed

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