| CTRI Number |
CTRI/2026/04/107308 [Registered on: 01/04/2026] Trial Registered Prospectively |
| Last Modified On: |
01/04/2026 |
| 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 study comparing duloxetine alone and in combination with another medicine for nerve pain in diabetic patients. |
|
Scientific Title of Study
|
A Comparative study to evaluate the efficacy of Duloxetine alone and in
combination with Alpha Lipoic Acid in patients of painful diabetic peripheral neuropathy |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kazi Moonfared Ahamed |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Department of Anaesthesiology
Aliigarh Muslim University , Aligarh, UP.
Aligarh
UTTAR PRADESH
202001
India |
| Phone |
8777296123 |
| Fax |
|
| Email |
dewstar.star@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Kazi Moonfared Ahamed |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Nehru Medical College, Aligarh |
| Address |
Department of Anaesthesiology
Aligarh Muslim University
Aligarh
UTTAR PRADESH
202001
India |
| Phone |
8777296123 |
| Fax |
|
| Email |
dewstar.star@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kazi Moonfared Ahamed |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Department of Anaesthesiology
Aligarh Muslim University
Aligarh
UTTAR PRADESH
202001
India |
| Phone |
8777296123 |
| Fax |
|
| Email |
dewstar.star@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Jawaharlal Nehru Medical College and Hospital , Aligarh Muslim University |
| Address |
Medical Rd, AMU Campus, Aligarh, Uttar Pradesh 202001
Aligarh |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Professor Hammad Usmani |
Jawaharlal Nehru Medical College, Aligarh Muslim University |
Pain Clinic, Department of Anaesthesiology
Aligarh
UTTAR PRADESH |
9897114190
Hammadusmani2002@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Jawaharlal Nehru Medical College & Hospital, Faculty of Medicine, Aligarh Muslim University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E114||Type 2 diabetes mellitus with neurological complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Duloxetine |
Participants will receive tablet Duloxetine 30 mg twice daily for a duration of 6 weeks. |
| Intervention |
Duloxetine + Alpha Lipoic Acid |
Participants will receive tablet Duloxetine 30 mg twice daily along with tablet Alpha lipoic acid 600 mg once daily for a duration of 6 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Age more than or equal to 18 years
2. Diagnosed cases of painful diabetic peripheral neuropathy involving lower limbs
3. Either sex
4. HbA1c less than or equal to 8.5%
5. Willingness to participate and provide written informed consent |
|
| ExclusionCriteria |
| Details |
1. Peripheral neuropathy due to causes other than diabetes
2. Presence of motor weakness/dysfunction in affected limb
3. Recent use of injectable corticosteroids
4. Hepatic or renal dysfunction
5. Known cervical or lumbar radiculopathy
6. History of recent trauma
7. Mental or behavioral disorders affecting participation/compliance
8. History of cerebrovascular accident (stroke) with residual deficits
9. Active infection
10. Prior treatment for diabetic neuropathy without completion of minimum 1-week washout period |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change in Neuropathic Pain Symptom Inventory (NPSI) pain score
Details:
Change in NPSI total score from baseline to 6 weeks of treatment. |
Baseline,week 1,2,4,6
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nerve Conduction Study Parameters of Sural nerve and Posterior tibial nerve |
Baseline, week 6 |
| Quality of Life using SF12 score |
Baseline, 6 weeks |
| Change in serum IL6 and TNF alpha levels |
Baseline, 6 weeks |
| Incidence of adverse drug effects |
Throughout the study duration |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 4 |
|
Date of First Enrollment (India)
|
13/04/2026 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Painful diabetic peripheral neuropathy (PDPN) is a common complication of diabetes that significantly impairs quality of life. Duloxetine, a serotonin–norepinephrine re uptake inhibitor, is an established treatment for PDPN, while alpha lipoic acid (ALA), an antioxidant, has shown beneficial effects in reducing neuropathic symptoms.
This study aims to compare the efficacy and safety of duloxetine alone versus duloxetine in combination with alpha lipoic acid in patients with painful diabetic peripheral neuropathy involving the lower limbs.
In this prospective, randomised, single-blind, parallel-group, active-controlled clinical trial, 60 patients will be allocated into two groups: one group will receive duloxetine alone, and the other will receive duloxetine with alpha lipoic acid for a duration of 6 weeks.
The primary outcome measure will be change in Neuropathic Pain Symptom Inventory (NPSI) score. Secondary outcomes include nerve conduction study parameters, quality of life using SF-12 score, inflammatory biomarkers (IL-6 and TNF-alpha) , and incidence of adverse effects.
The study is expected to provide evidence regarding the additional benefit of alpha lipoic acid when combined with duloxetine in the management of painful diabetic neuropathy.
|