A study comparing Vitamin B2 with a dummy pill

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 - NIL

Status

Recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/03/105920

Enrollment

Registered

2026-03-11

Start date

Unknown

Completion date

Unknown

Last updated

2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: G63- Polyneuropathy in diseases classified elsewhere

Interventions

Intervention1: Riboflavin: Riboflavin 100 mg Once Daily for 3 Months in the Intervention Arm Control Intervention1: Placebo: Placebo Once Daily for 3 Months

Eligibility

Inclusion criteria

Inclusion criteria: Diagnosed treatment naive patients with type two diabetes mellitus and symptoms of diabetic neuropathy

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Improvement in symptom score between placebo and riboflavin after three months Improvement in Nerve Muscle Conduction velocity and amplitudeTimepoint: Eighteen months	—

Secondary

Measure	Time frame
Improvement in Quality of Life Association of diabetic neuropathy with MTHFR C677T gene polymorphism Number of Advers drug reactions Timepoint: Eighteen months	—

Countries

India

Contacts

Public ContactSyed Shariq Naeem

Jawaharlal Nehru Medical College Aligarh Muslim University Aligarh Uttar Pradesh

syedshariq1@gmail.com9634912166

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026