| CTRI Number |
CTRI/2026/02/104284 [Registered on: 19/02/2026] Trial Registered Prospectively |
| Last Modified On: |
19/02/2026 |
| 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 study to understand the effects of Pregabalin plus Nortriptyline versus Pregabalin plus Duloxetine in patients of chronic low back pain. |
|
Scientific Title of Study
|
Comparing effectiveness and safety of Pregabalin plus Nortriptyline versus Pregabalin plus Duloxetine in patients of chronic low back pain A Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anna Javed |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute Of Medical Sciences vijaypur jammu 184120 |
| Address |
Department of Pharmacology
All India Institute Of Medical Sciences vijaypur Jammu
Jammu
JAMMU & KASHMIR
184120
India |
| Phone |
9622000255 |
| Fax |
|
| Email |
Mithi902@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anna Javed |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute Of Medical Sciences vijaypur jammu 184120 |
| Address |
Department of Pharmacology
All India Institute Of Medical Sciences vijaypur Jammu
Jammu
JAMMU & KASHMIR
184120
India |
| Phone |
9622000255 |
| Fax |
|
| Email |
Mithi902@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vignesh Kumar |
| Designation |
Junior Resident |
| Affiliation |
All India Institute Of Medical Sciences vijaypur jammu 184120 |
| Address |
Department of Pharmacology
All India Institute Of Medical Sciences vijaypur Jammu
Jammu
JAMMU & KASHMIR
184120
India |
| Phone |
9791266056 |
| Fax |
|
| Email |
vigneshk558@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Vignesh Kumar |
| Address |
Department of Pharmacology AIIMS Jammu
Vijaypur Jammu
Jammu and Kashmir
184120
India
|
| Type of Sponsor |
Other [self] |
|
|
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 Vignesh Kumar |
All India Institute of Medical Sciences vijaypur Jammu |
Orthopaedics OPD
Room no 432
OPD building
Jammu
JAMMU & KASHMIR |
9791266056
vigneshk558@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE AIIMS JAMMU |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M545||Low back pain, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Pregabalin plus Duloxetine |
Pregabalin 75 mg plus Duloxetine 20 mg HS for 12 weeks |
| Intervention |
Pregablin plus Nortriptyline |
Pregabalin 75 mg plus Nortriptyline 10 mg HS for 12 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Adults aged 18–60 years
Patients clinically diagnosed with chronic low back pain persisting for greator than or equal to 3 months
VAS score greator than or equal to 5 out of 10 at baseline
No specific structural cause of low back pain on imaging examples like no fracture or infection or malignancy
Willingness to participate and provide written informed consent
Patient refractory to NSAIDS and opioids for more than 3 months and pregabalin alone |
|
| ExclusionCriteria |
| Details |
Specific pathological causes of back pain such as infection or malignancy or fracture or rheumatoid arthritis or seronegative arthritis or spinal tumors or vascular malformations
History of spinal surgery or severe neurological deficit or cauda equina syndrome
Pregnancy or lactation
Uncontrolled comorbidities such as cardiac disorders advanced diabetes mellitus hypertension chronic kidney disease chronic liver disease
History of depression or psychiatric illness requiring antidepressant treatment in the past 6 months |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Responder Rate greator than or equal to 30 percent reduction in pain intensity using VAS |
At baseline 4 weeks and 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Compare functional improvement measured by the Oswestry Disability Index ODI and Roland-Morris Disability Questionnaire RMDQ
|
From baseline to 12 weeks
|
| To assess safety based on adverse effects associated with above mentioned drugs |
From baseline to 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="76"
Sample Size from India="76"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
02/03/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study will be a prospective single centered randomized open label parallel-group control trial comparing effectiveness and safety of Pregabalin plus Nortriptyline versus Pregabalin plus Duloxetine in patients of chronic low back pain.Primary Outcome is Responder Rate greator than or equal to 30 percent reduction in pain intensity using VAS at baseline 4 weeks and 12 weeks.The Secondary Outcome is to Compare functional improvement measured by the Oswestry Disability Index (ODI) and Roland-Morris Disability Questionnaire RMDQ from baseline to 12 weeks and To assess safety based on adverse effects associated with above mentioned drugs. |