| 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
|
|
|
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
|
|
|
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. |