| CTRI Number |
CTRI/2026/03/105920 [Registered on: 11/03/2026] Trial Registered Prospectively |
| Last Modified On: |
21/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A study comparing Vitamin B2 with a dummy pill |
|
Scientific Title of Study
|
A Double Blinded Randomized Placebo Controlled Trial Evaluating the Efficacy of Riboflavin and its Association with MTHFR Gene Polymorphism in Treatment Naive Patients of Diabetic 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 |
Alfiya Tahreen |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Nehru Medical College Aligarh Muslim University Aligarh Uttar Pradesh |
| Address |
Department of Pharmacology
Jawaharlal Nehru Medical College
Aligarh Muslim University
Aligarh
Uttar Pradesh
Aligarh
UTTAR PRADESH
202001
India |
| Phone |
8217707331 |
| Fax |
|
| Email |
sk.tahreen@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Syed Shariq Naeem |
| Designation |
Assistant Professor |
| Affiliation |
Jawaharlal Nehru Medical College Aligarh Muslim University Aligarh Uttar Pradesh |
| Address |
Department of Pharmacology
Jawaharlal Nehru Medical College
Aligarh Muslim University
Aligarh
Uttar Pradesh
Aligarh
UTTAR PRADESH
202001
India |
| Phone |
9634912166 |
| Fax |
|
| Email |
syedshariq1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Syed Shariq Naeem |
| Designation |
Assistant Professor |
| Affiliation |
Jawaharlal Nehru Medical College Aligarh Muslim University Aligarh Uttar Pradesh |
| Address |
Department of Pharmacology
Jawaharlal Nehru Medical College
Aligarh Muslim University
Aligarh
Uttar Pradesh
UTTAR PRADESH
202001
India |
| Phone |
9634912166 |
| Fax |
|
| Email |
syedshariq1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Nehru Medical College
Aligarh Muslim University
|
|
|
Primary Sponsor
|
| Name |
AlfiyaTahreen |
| Address |
Department of Pharmacology
Jawaharlal Nehru Medical College
Aligarh Muslim University
Aligarh 202001
Uttar Pradesh |
| 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 syed shariq naeem |
jawaharlal nehru medical college and hospital aligarh muslim university |
OPD block Rajeev Gandhi Centre for Diabetes and Endocrinology
Aligarh 202001
Uttar Pradesh
Aligarh
UTTAR PRADESH |
9634912166
syedshariq1@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 Aligarh Uttar Pradesh |
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 |
Placebo |
Placebo Once Daily for 3 Months |
| Intervention |
Riboflavin |
Riboflavin 100 mg Once Daily for 3 Months in the Intervention Arm |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed treatment naive patients with type two diabetes mellitus and symptoms of diabetic neuropathy
|
|
| ExclusionCriteria |
| Details |
Other causes of neuropathy
No history of concurrent use of neuropathy medications
Pregnancy or lactation
No history of any chronic and untreated illness or metabolic syndrome
Known allergy or history of allergy to riboflavin
Has a history of alcohol or other drug abuse in past one year or currently under the influence of alcohol or any other drug
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement in symptom score between placebo and riboflavin after three months
Improvement in Nerve Muscle Conduction velocity and amplitude |
Eighteen months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in Quality of Life
Association of diabetic neuropathy with MTHFR C677T gene polymorphism
Number of Advers drug reactions
|
Eighteen months |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
15/04/2026 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| 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
|
This study is a double blinded randomized placebo controlled clinical trial designed to evaluate the efficacy of riboflavin Vitamin B2 in treatment naive patients with painful diabetic neuropathy and to explore the influence of MTHFR C677T gene polymorphism on treatment response. A total of 80 patients will be enrolled and randomized into two groups one receiving 100 mg oral riboflavin daily and the other receiving placebo for a duration of three months. The study will assess changes in neuropathic symptoms using the Michigan Neuropathy Screening Instrument MNSI nerve conduction studies NCV quality of life scores Norfolk QOL DN and monitor adverse effects. Genetic testing for MTHFR polymorphism will be conducted at baseline using PCR based sequencing. Statistical analysis will include intergroup comparisons and multivariate regression to evaluate the association between genetic variants and clinical outcomes. The aim is to determine whether riboflavin can serve as a safe cost effective therapeutic option in diabetic neuropathy and whether genotype influences treatment efficacy |