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

Phase 3
Completed
Conditions
Health Condition 1: M791- Myalgia
Registration Number
CTRI/2019/06/019845
Lead Sponsor
SRM Institute of Science and Technology
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
0
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

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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
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 Outcome Measures
NameTimeMethod
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
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