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EFfect of C.Palmitole(Palmtoylethanolamide,Genistein,Diadzein) in treating Nerves affected by Diabetes

A Comparative Study on Assessing the Efficacy and Safety of Combination of Palmitoylethanolamide, Genistein, Diadzein )(Capsule Palmitole) as an add on therapy with Standard therapy in patients with Diabetic Neuropathy-A Randomised Open Labelled Prospective Study - NIL

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/02/063245
Enrollment
140
Registered
2024-02-28
Start date
Unknown
Completion date
Unknown
Last updated
2024-08-19

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: C.Palmitole,T.Carbamazepine: C.Palmitole 354 mg BD + T.Carbamazepine 200mg OD for 12weeks Control Intervention1: T.Carbamazepine: T.Carbamazepine 200mg-OD for 12 weeks

Sponsors

Government Kilpauk Medical College
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Clinically diagnosed with neuropathy using diagnostic tests (Tip-Therm test, Monofilament test, Biothesiometry) at the Diabetology Clinic in our hospital Participants exhibiting neuropathic pain scoring more than 4 on Neuropathic Pain Diagnostic Questionnaire(DN4) and scoring more than 12 on S-LANSS (Self reported Leeds Assessment of Neuropathic Symptoms and Signs(S-LANSS)

Exclusion criteria

Exclusion criteria: Participants with Type1 diabetes mellitus, not willing to participant,pregnant and lactating mothers, history of hypersensitivity,those who are on longterm steroid, those wtih documented history of other neuropathies

Design outcomes

Primary

MeasureTime frame
Diabetic Neuropathy pain score assesed using BPI-DPN Pain scale with FBS,PPBSTimepoint: at Baseline,4,8,12 weeks

Secondary

MeasureTime frame
Participants will be assessed clinically by Tip-Therm test, Monofilament test, Biothesiometr,CBC, RFT, LFT, Lipid profileTimepoint: At baseline and at 12 weeks

Countries

India

Contacts

Public ContactDr Viswanath S

Tamilnadu Dr MGR Medical university

arunabala511@gmail.com9444276923

Outcome results

None listed

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