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

Phase 3

Completed

• Conditions: Myalgia,

• Registration Number: CTRI/2019/06/019845
• Lead Sponsor: SRM Institute of Science and Technology

Brief Summary

***PRIMARY PURPOSE OF THE PROTOCOL:***

**Aim of the study:** To determine the efficacy and safety of Rupatadine and Aceclofenac CR in comparison with Aceclofenac CR alone in treatment of Chronic low back pain

**Objectives of the study:**



1. To evaluate whether Rupatadine and Aceclofenac CR provide better pain relief in comparison with Aceclofenac CR alone in Chronic low back pain assessed by using Visual Analog Pain score



2.To evaluate whether Rupatadine and Aceclofenac CR decreases disability in comparison with Aceclofenac CR alone in Chronic low back pain assessed by using Oswestry disability index questionnaire



3.To evaluate whether Rupatadine and Aceclofenac CR improves the quality of life in Chronic low back pain in comparison with Aceclofenac CR alone assessed by using WHOQOL BREF questionnaire



**Hypothesis :**

Rupatadine and Aceclofenac CR may be more efficacious when compared to Aceclofenac CR alone in the treatment of Chronic low back pain

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-07
• Last Update Posted: 2020-11-17

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• 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

• 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

Name	Time	Method
Pain relief to be assessed	at the baseline, at second week, at the end of each month for two months using Visual Analog Pain Score

Secondary Outcome Measures

Name	Time	Method
Disability and Quality of Life to be assessed by Oswestry Disability Index questionnaire,WHOQOLBREF questionnaire respectively	at the baseline and at the end of the each month for two months

Trial Locations

Locations (1)

SRM Hospital; 🇮🇳 Kancheepuram, TAMIL NADU, India

SRM Hospital

🇮🇳Kancheepuram, TAMIL NADU, India

Dr Heena Goldin B

Principal investigator

9176468465

heenagoldin8@gmail.com