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To study the effects of tolperisone and thiocolchicoside in combination with aceclofenac in females with low back pain

To evaluate the clinical outcome of tolperisone and thiocolchicoside in combination with aceclofenac in females with low back pain - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/04/065501
Enrollment
70
Registered
2024-04-10
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-01

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: Aceclofenac and Tolperisone: Aceclofenac 100mg BD orally and Tolperisone 150mg TDS orally for 7 days or 14 days (wherever applicable) with standard care of treatment Control Interventio

Sponsors

VMMC and Safdarjung Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Female patients with non-specific low back pain of age group 18 years to 45 years with BMI 18.5 to 30 having symptoms for less than 12 weeks

Exclusion criteria

Exclusion criteria: 1. Received skeletal muscle relaxant and NSAIDs during past 1 week 2. Patient with rheumatological disorder 3. Recent history of spinal injections in the past 3 months 4. Gynaecological and obstetric symptoms 5. History of vertebral fracture 6. Contraindication of Aceclofenac, Tolperisone and Thiocolchicoside

Design outcomes

Primary

MeasureTime frame
To assess the clinical outcomes of Tolperisone and Thiocolchicoside used in combination with Aceclofenac on female patients with low back pain using 1. Visual Analogue Scale 2. Finger to Floor Distance 3. Oswestry Disability IndexTimepoint: Day 0, Day 7, Day 21, Day 42—

Secondary

MeasureTime frame
To estimate the frequency of relapse and side effect in the study population in 6 weeks of follow upTimepoint: Day 42—

Countries

India

Contacts

Public ContactDaphika Dkhar

VMMC and Safdarjung Hospital

dragupta2013@gmail.com9810692375

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026