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A study to test the effectiveness of an oral supplement for nerve pain in Diabetes

The efficacy of combined oral formulation of acetyl-L carnitine, palmitoyl ethanolamide and vitamin B12 in alleviating pain in diabetic neuropathy- A randomised control trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/01/079030
Enrollment
68
Registered
2025-01-20
Start date
Unknown
Completion date
Unknown
Last updated
2025-02-03

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: Acetyl-L carnitine, Palmitoyl Ethanolamide, Vitamin-B12: Acetyl-L carnitine 500mg OD po for 3months, Palmitoyl Ethanolamide 300mg OD for 3months, vitamin-B12 1500mcg OD po for 3months I

Sponsors

Saveetha Medical College and Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patient diagnosed with Type-2 diabetes mellitus for more than a year 2.HbA1c of more than 5.9% 3.Patients experiencing moderate to severe neuropathic pain assessed by Visual Analogue Score(VAS) for pain 4.Abnormal nerve conduction velocity and amplitude in at least one of the nerve extremities.

Exclusion criteria

Exclusion criteria: 1.Patients with neuropathy due to other causes other than diabetes mellitus 2.History of alcohol or use of any other illicit drugs 3.Pregnant and lactating women 4.Participation in another clinical trial that might interfere with this study’s result

Design outcomes

Primary

MeasureTime frame
Reduction in neuropathic pain measured by Visual Analogue Score(VAS) and improvement in nerve conduction velocityTimepoint: 3 months

Secondary

MeasureTime frame
Improvement in quality of life and assessing the rate of clinical adverse reactionsTimepoint: 3 months

Countries

India

Contacts

Public ContactDr.Yohidha Balamurugan

Saveetha Medical College and Hospital

ananthakumarpk@gmail.com9620916481

Outcome results

None listed

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