| CTRI Number |
CTRI/2025/10/095929 [Registered on: 13/10/2025] Trial Registered Prospectively |
| Last Modified On: |
11/10/2025 |
| 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 to compare ability to reduce pain and improve quality of life of pregabalin versus amitriptyline for diabetic neuropathic pain |
|
Scientific Title of Study
|
A study to compare the efficacy,safety and Quality of life in patients with Moderate Diabetic Peripheral Neuropathic Pain on Pregabalin versus Amitriptyline at a tertiary care centre-A Randomised Control Study |
| 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 Chethana Amarnath |
| Designation |
Junior Resident |
| Affiliation |
Banglore Medical College and Research Institute |
| Address |
307 6th main Remco layout Vijaynagar Bangalore
Fort Krishna Rajendra Rd Kalasipalya Bengaluru Karnataka 560002
Bangalore
KARNATAKA
560040
India |
| Phone |
9448727610 |
| Fax |
080-26704342 |
| Email |
chethanaamarnath17@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Geetha Mam - HOD Pharmac Dept @ BMCRI |
| Designation |
Professor |
| Affiliation |
Banglore Medical College and Research Institute |
| Address |
K R Fort road ,kalasipalya Bangalore 560002
Fort Krishna Rajendra Rd Kalasipalya Bengaluru Karnataka 560002
Bangalore
KARNATAKA
560002
India |
| Phone |
9886224085 |
| Fax |
080-26704342 |
| Email |
Geethaanathramaih@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chethana Amarnath |
| Designation |
Junior Resident |
| Affiliation |
Banglore Medical College and Research Institute |
| Address |
307 6th main Remco layout Vijaynagar Bangalore
Fort Krishna Rajendra Rd Kalasipalya Bengaluru Karnataka 560002
Bangalore
KARNATAKA
560040
India |
| Phone |
9448727610 |
| Fax |
080-26704342 |
| Email |
chethanaamarnath17@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Chethana |
| Address |
Fort, Krishna Rajendra Rd, Kalasipalya, Bengaluru, Karnataka 560002 |
| 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 |
| CHETHANA |
Bangalore Medical College & Research Institute |
Department of pharmacology, ROOM 1, Fort, Krishna Rajendra Rd, Kalasipalya, Bengaluru, Karnataka 560002
Bangalore
KARNATAKA |
9448727610
080-26704342
chethanaamarnath17@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Bangalore Medical College and Research Institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: G63||Polyneuropathy in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Tab Amitriptyline 25mg H S |
HALF TABLET O.D AT NIGHT AFTER FOOD |
| Intervention |
Tab Pregabalin 75mg |
tablet taken O.D in the night after food |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with moderate diabetic neuropathic pain |
|
| ExclusionCriteria |
| Details |
pregnancy
lactation
hepatic dysfunction
renal dysfunction
arryhthmias |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in severity of Neuropathic pain assessed by NRS SCALE |
Reduction in severity of Neuropathic pain assessed by NRS SCALE IN 6 WEEKS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement of quality of life index with pain reduction assessed by NEUROQOL SCORE |
6 weeks |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
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 2 |
|
Date of First Enrollment (India)
|
15/11/2025 |
| 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="2"
Months="5"
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
|
Chronic pain in patients with diabetic peripheral neuropathy significantly affects physical functioning emotional well-being and overall quality of life Pregabalin and Amitriptyline are commonly used first-line agents for pain management This study could highlight evident variations in their impact on quality of life with Pregabalin and Amitriptyline conferring more substantial improvements in overall QoL particularly across the domains of energy sleep and emotional well-being |