A randomized clinical study to evaluate efficacy and safety of Nutrify Genies Capsule v/s commercially available Vitamin B12 in preventing diabetic neuropathy in participants who have type 2 diabetes.

A randomized, open label, clinical trial to investigate efficacy and safety of NG02 in preventing the progression of diabetic neuropathy in type 2 diabetes patients. - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/06/089086

Enrollment

Registered

2025-06-18

Start date

Unknown

Completion date

Unknown

Last updated

2025-06-24

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

Conditions

Health Condition 1: E114- Type 2 diabetes mellitus with neurological complications

Interventions

Intervention1: NG02: Nutrify Genies formula to prevent the progression of diabetic neuropathy in type 2 diabetes patients for 6 months. Control Intervention1: Vitamin B12: Commercially available Vitam

Eligibility

Inclusion criteria

Inclusion criteria: 1. Subject should be diagnosed with Type 2 Diabetes Mellitus for a duration of at least 1 year with HbA1c 6%-12% & a score of more than 50% on DN4 questionnaire. 2. Subject should be diagnosed with Mild to Moderate Diabetic Neuropathy for a duration of at least 6 months. 3. Subject is ready to sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Subject is not ready to sign the informed consent. 2. ect has major systemic diseases such as malignancy, connective tissue disorders, liver, and renal diseases or any other illness which according to investigator forbids him/her from participating in this clinical trial. 3. Subjects having Neuropathic pain from anything other than diabetes. 4. Subjects who have participated in any clinical study in less than a month before the screening visit. 5. Pregnant or breast-feeding female subjects.

Design outcomes

Primary

Measure	Time frame
1. To compare the mean change from baseline scores in the Total Symptom Score (TSS) between the two groups over the treatment period. 2. To compare the mean change from baseline scores in The Douleur Neuropathique 4 (DN4) questionnaire between the two groups over the treatment period. 3. To compare the mean change from baseline levels of Malondialdehyde biomarker between the two groups over the treatment period. 4. To compare the mean change from baseline levels of Nerve Growth Factor between the two groups over the treatment period. Timepoint: Day 1( baseline), Month 2, Month 4 & Month 6.	—

Measure

Time frame

1. To compare the mean change from baseline scores in the Total Symptom Score (TSS) between the two groups over the treatment period. 2. To compare the mean change from baseline scores in The Douleur Neuropathique 4 (DN4) questionnaire between the two groups over the treatment period. 3. To compare the mean change from baseline levels of Malondialdehyde biomarker between the two groups over the treatment period. 4. To compare the mean change from baseline levels of Nerve Growth Factor between the two groups over the treatment period. Timepoint: Day 1( baseline), Month 2, Month 4 & Month 6.

—

Secondary

Measure	Time frame
To compare the improvement of Quality of Life (QoL) from baseline based on Diabetes Quality of Life Questionnaire (DQOL) questionnaire.Timepoint: Day 1( baseline), Month 2, Month 4 & Month 6.	—

Countries

India

Contacts

Public ContactMr Ayan Neogi

Vivforever

ayanneogi@vivforever.in9967968612

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026