| CTRI Number |
CTRI/2019/06/019845 [Registered on: 25/06/2019] Trial Registered Prospectively |
| Last Modified On: |
17/11/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the beneficial effects of the drug Rupatadine in Low Back Pain |
|
Scientific Title of Study
|
Efficacy and safety of add-on Rupatadine treatment for Chronic low back pain- An assessor blind randomized controlled clinical study-A pilot study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR V Sathyanarayanan |
| Designation |
Professor of Pharmacology |
| Affiliation |
SRM Medical College SRM IST |
| Address |
SRM Medical College Hospital and Research Centre SRM IST SRM Nagar Potheri Kattankulathur post Kanchipuram district
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
919384633405 |
| Fax |
|
| Email |
satya672000@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Heena Goldin B |
| Designation |
Post Graduate |
| Affiliation |
SRM Medical College SRM IST |
| Address |
SRM Medical College Hospital and Research Centre SRM IST SRM Nagar Potheri Kattankulathur post Kanchipuram district
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9176468465 |
| Fax |
|
| Email |
heenagoldin8@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Heena Goldin B |
| Designation |
Post Graduate |
| Affiliation |
SRM Medical College SRM IST |
| Address |
SRM Medical College Hospital and Research Centre SRM IST SRM Nagar Potheri Kattankulathur post Kanchipuram district
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9176468465 |
| Fax |
|
| Email |
heenagoldin8@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRM Medical College Hospital and Research Centre SRM IST
Potheri Kattankulathur post
Kancheepuram district
Tamilnadu
Pincode 603203 |
|
|
Primary Sponsor
|
| Name |
SRM Institute of Science and Technology |
| Address |
SRM Nagar Potheri Kattankulathur Post Kancheepuram district Tamilnadu 603203 India |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Heena Goldin B |
SRM Hospital |
Outpatient Department
Department of Orthopaedics
SRM Nagar Potheri Kattankulathur Post Kancheepuram district Tamilnadu 603203 India
Kancheepuram
TAMIL NADU |
9176468465
heenagoldin8@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M791||Myalgia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Aceclofenac CR |
Aceclofenac CR 200 mg once daily for two months |
| Intervention |
Rupatadine and Aceclofenac CR |
Rupatadine 10 mg once daily and Aceclofenac CR 200 mg once daily for two months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
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
|
|
| ExclusionCriteria |
| Details |
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
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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
|
| Outcome |
TimePoints |
| 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 |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/07/2019 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
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
Rupatadine and Aceclofenac CR may be more efficacious when compared to Aceclofenac CR alone in the treatment of Chronic low back pain |