| CTRI Number |
CTRI/2026/01/101593 [Registered on: 19/01/2026] Trial Registered Prospectively |
| Last Modified On: |
19/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Understanding the patient profile for Methylcobalamin, duloxetine and pregabalin combination, in Indian patients with Diabetes related neuropathic pain |
|
Scientific Title of Study
|
A retrospective multicentre observational study to assess the patient profile for the fixed dose combination of Methylcobalamin, duloxetine and pregabalin, in Indian patients with Diabetic Peripheral Neuropathy - (BLUE FEATHER DPN) |
| Trial Acronym |
BLUE FEATHER DPN |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| TPL2504004, Version- 01, Dated- 10/06/2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Lokesh R V |
| Designation |
General Manager, Medical Affairs |
| Affiliation |
Torrent Pharmaceuticals Ltd. |
| Address |
7th floor RD side, Torrent House, Off Ashram Road, Ahmedabad – 380009
Ahmadabad
GUJARAT
380009
India |
| Phone |
917069000601 |
| Fax |
|
| Email |
LokeshRV@torrentpharma.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Lokesh R V |
| Designation |
General Manager, Medical Affairs |
| Affiliation |
Torrent Pharmaceuticals Ltd. |
| Address |
7th floor RD side, Torrent House, Off Ashram Road, Ahmedabad – 380009
GUJARAT
380009
India |
| Phone |
917069000601 |
| Fax |
|
| Email |
LokeshRV@torrentpharma.com |
|
Details of Contact Person
Public Query
|
| Name |
Narendra Chouksey |
| Designation |
Assistant General Manager, Medical Affairs |
| Affiliation |
Torrent Pharmaceuticals Ltd. |
| Address |
7th floor RD side, Torrent House, Off Ashram Road, Ahmedabad – 380009
Ahmadabad
GUJARAT
380009
India |
| Phone |
917069000413 |
| Fax |
|
| Email |
narendrachouksey@torrentpharma.com |
|
|
Source of Monetary or Material Support
|
| Torrent Pharmaceuticals Ltd., Torrent House, Off. Ashram Road, Ahmedabad - 380009, Gujarat, India |
|
|
Primary Sponsor
|
| Name |
Torrent Pharmaceuticals Ltd. |
| Address |
Torrent House, Off. Ashram Road, Ahmedabad - 380009, Gujarat, India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr JOOZER RANGWALA |
Rangwala Clinic |
Near Punjab National Bank, Ahmedabad
Ahmadabad
GUJARAT |
9979099133
drjoozer@gmail.com |
| Dr MANISH KAMALBHAI HATHILA |
Sai Krupa Hospital |
Satellite Road
Ahmadabad
GUJARAT |
9428415979
manishathila@gmail.com |
| Dr NITESH C PATEL |
SAMARPAN HOSPITAL |
AKHBAR NAGAR
Ahmadabad
GUJARAT |
9909990054
samarpanhospital2011@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Sangini Ethics Committee |
Approved |
| Sangini Ethics Committee |
Approved |
| Sangini Ethics Committee |
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 |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients diagnosed with Diabetic Peripheral Neuropathy
2. Patients who were prescribed FDC of Pregabalin, Duloxetine, Methylcobalamin FDCs (any dosage) |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. To understand epidemiological profile of patients of diabetic peripheral neuropathy, naïve or switching over to Pregabalin, Duloxetine & Methylcobalamin FDCs |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Percentage of new patients who were prescribed triple FDC
2. Percentage of patients on monotherapy switched over to triple FDC & switched from which therapy
3. Percentage of patients on dual therapy switched over to triple FDC & switched from which therapy |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="12500"
Sample Size from India="12500"
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
|
N/A |
|
Date of First Enrollment (India)
|
30/01/2026 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Diabetes is a serious chronic disease and a leading cause of death globally, accounting for an estimated four million deaths in 2017. The global prevalence of diabetes was 9.3% (463 million people) in 2019, projected to rise to 10.9 Percent (700 million) by 2045. In India, an estimated 77 million people were living with diabetes in 2019, expected to exceed 134 million by 2045. The growing diabetic population has led to a surge in chronic complications, particularly Diabetic Peripheral Neuropathy (DPN), one of the most common and disabling conditions. No curative therapies currently exist for DPN; treatments focus on symptom control and slowing progression. First-line pharmacological options for painful DPN include pregabalin, duloxetine, and amitriptyline, among others. Vitamin B12 (Methylcobalamin) deficiency has been linked to peripheral neuropathy due to its role in nerve function and myelin sheath maintenance. Despite frequent clinical use, there is a lack of large-scale Indian data on real-world prescribing patterns and patient profiles for these FDCs. This study proposes a retrospective clinic-based analysis of approximately 12,500 patients from 500 outpatient clinics across India to better understand the real-world use of pregabalin, duloxetine, and Methylcobalamin FDCs in the management of DPN. Patients who were prescribed FDC of Pregabalin, Duloxetine, Methylcobalamin FDCs (any dosage) will be included for the study and the following variables will be considered for analysis- - Demographic variables such as: Age, Sex, Weight, Height - Percentage of new patients who were prescribed triple FDC - Percentage of patients on monotherapy switched over to triple FDC and switched from which therapy - Percentage of patients on dual therapy switched over to triple FDC and switched from which therapy |