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CTRI Number  CTRI/2024/02/063245 [Registered on: 28/02/2024] Trial Registered Prospectively
Last Modified On: 15/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Nutraceutical 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   EFfect of C.Palmitole(Palmtoylethanolamide,Genistein,Diadzein) in treating Nerves affected by Diabetes 
Scientific Title of Study   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 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Viswanath S 
Designation  PG student 
Affiliation  Tamilnadu Dr MGR Medical university 
Address  Department of Pharmacology,Second floor,Government Kilpauk medical college,Poonamalle high road,Kilpauk, Chennai
Tamilnadu Dr MGR Medical university,Anna Salai road, Guindy, Chennai-32
Chennai
TAMIL NADU
600010
India 
Phone  9150301578  
Fax    
Email  sviswanath7298@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr T Aruna 
Designation  Professor & Head of Department-Pharmacology 
Affiliation  Tamilnadu Dr MGR Medical university 
Address  Department of Pharmacology,Second floor, Government Kilpauk medical college,Poonamalle high road,Kilpauk, Chennai
Tamilnadu Dr MGR Medical university,Anna Salai road, Guindy, Chennai-32
Chennai
TAMIL NADU
600010
India 
Phone  9444276923  
Fax    
Email  arunabala511@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Viswanath S 
Designation  PG student 
Affiliation  Tamilnadu Dr MGR Medical university 
Address  Department of Pharmacology,Second floor,Government Kilpauk medical college,Poonamalle high road,Kilpauk, Chennai
Tamilnadu Dr MGR Medical university,Anna Salai road, Guindy, Chennai-32
Chennai
TAMIL NADU
600010
India 
Phone  9150301578  
Fax    
Email  sviswanath7298@gmail.com  
 
Source of Monetary or Material Support  
Frimline(A Subsidiary of La Renon),Iscon Elegance, Near Circle P, Prahlad nagar Cross Road, Ahmedabad, Gujarat-380051 
 
Primary Sponsor  
Name  Government Kilpauk Medical College 
Address  Government Kilpauk Medical college, Kilpauk, Chennai-10 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Viswanath S  Government Kilpauk Medical College and Hospital  Room number 20,Institute of Diabetology,OP block
Chennai
TAMIL NADU 
9150301578

sviswanath7298@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Government Kilpauk Medical College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E114||Type 2 diabetes mellitus with neurological complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  C.Palmitole,T.Carbamazepine  C.Palmitole 354 mg BD + T.Carbamazepine 200mg OD for 12weeks 
Comparator Agent  T.Carbamazepine  T.Carbamazepine 200mg-OD for 12 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  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)
 
 
ExclusionCriteria 
Details  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 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Diabetic Neuropathy pain score assesed using BPI-DPN Pain scale with FBS,PPBS   at Baseline,4,8,12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Participants will be assessed clinically by Tip-Therm test, Monofilament test, Biothesiometr,CBC, RFT, LFT, Lipid profile   At baseline and at 12 weeks 
 
Target Sample Size   Total Sample Size="140"
Sample Size from India="140" 
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 4 
Date of First Enrollment (India)   29/03/2024 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details
Modification(s)  
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 aimed to assess the safety and efficacy of Palmitoylethanolamide, Genistein, Daidzein in treatment of diabetic neuropathy as an add on therapy to standard therapy in comparison with standard therapy alone. This can pave the way for a new promising drug in treating neuropathic pain without CNS depressive effect. Patients with Diabetes neuropathy and fulfilling the inclusion criteria will be included in the study.On enrolling for the study, all the participants will be assessed clinically by Tip-Therm test, Monofilament test, Biothesiometry and using Self reported Leeds Assessment of Neuropathic Symptoms and Signs(S-LANSS); Neuropathic pain Diagnostic Questionnaire(DN4).Clinically diagnosed participants with pain score more than 12 on S-LANSS and more than 4 on DN4 will be included for the study. Baseline investigations including CBC,RFT,LFT,FBS,PPBS, Lipid profile before the start of the study. Participants will be randomized  into two groups;Participants in the control group will take standard therapy for diabetic neuropathy whereas the participants in study group  will receive C.Palmitole354mg BD for 12weeks as an add on therapy along with Standard therapy for 12weeks.Participants will be followed up at 4weeks,8 weeks and 12 weeks-pain will be assessed using BPI-DPN Pain scale along with FBS,PPBS at each visit. Participants will be assessed clinically by Tip-Therm test, Monofilament test, Biothesiometry at 12weeks. CBC, RFT, LFT, Lipid profile will be done at 12 weeks of study.All ADRs will be noted, analyzed and reported to the Regional Pharmacovigilance centre using the CDSCO ADR Reporting form.

 
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