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A clinical trial to study the beneficial effects of the drug Rupatadine in Low Back Pain

Efficacy and safety of add-on Rupatadine treatment for Chronic low back pain- An assessor blind randomized controlled clinical study-A pilot study

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/06/019845
Enrollment
80
Registered
2019-06-25
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: M791- Myalgia

Interventions

Intervention1: Rupatadine and Aceclofenac CR: Rupatadine 10 mg once daily and Aceclofenac CR 200 mg once daily for two months Control Intervention1: Aceclofenac CR: Aceclofenac CR 200 mg once daily fo

Sponsors

SRM Institute of Science and Technology
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age group 18-60 years 2. Subjects with Chronic Low Back Pain more than three months, Visual analog scale more than 40 mm 3. Both genders 4. Patients willing to give consent

Exclusion criteria

Exclusion criteria: 1. History of acute fracture 2. History of malignancy or neurological deficit or severe leg pain mandating surgery 3. History of lumbar disc herniation or spinal stenosis 4. History of fibromyalgia or spinal surgery 5. History of recent trauma or injury 6. History of alcohol or narcotic abuse 7. History of Peptic ulcer disease or hepatic and renal dysfunction 8. History of heart surgery 9. History of Allergy to Aceclofenac CR or H1 antagonists 10. Pregnant,lactating women 11. Psychiatric disorders

Design outcomes

Primary

MeasureTime frame
Pain relief to be assessedTimepoint: at the baseline, at second week, at the end of each month for two months using Visual Analog Pain Score

Secondary

MeasureTime frame
Disability and Quality of Life to be assessed by Oswestry Disability Index questionnaire,WHOQOLBREF questionnaire respectivelyTimepoint: at the baseline and at the end of the each month for two months

Countries

India

Contacts

Public ContactDr Heena Goldin B

SRM Medical College SRM IST

heenagoldin8@gmail.com9176468465

Outcome results

None listed

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