| CTRI Number |
CTRI/2025/01/079030 [Registered on: 20/01/2025] Trial Registered Prospectively |
| Last Modified On: |
24/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A study to test the effectiveness of an oral supplement for nerve pain in Diabetes |
|
Scientific Title of Study
|
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 |
| 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 Yohidha Balamurugan |
| Designation |
Postgraduate, General Medicine |
| Affiliation |
Saveetha Medical College and Hospital |
| Address |
Room no.1, Department of General Medicine,Saveetha Medical College and Hospital, Saveetha Nagar, Thandalam, Chennai-602105
Chennai
TAMIL NADU
602105
India |
| Phone |
9894857077 |
| Fax |
|
| Email |
yohidoc1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Ananthakumar P K |
| Designation |
Professor, General Medicine |
| Affiliation |
Saveetha Medical College and Hospital |
| Address |
Room no.1, Department of General Medicine, Saveetha Medical College and Hospital, Saveetha Nagar, Thandalam, Chennai-602105
Chennai
TAMIL NADU
602105
India |
| Phone |
9620916481 |
| Fax |
|
| Email |
ananthakumarpk@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr.Yohidha Balamurugan |
| Designation |
Postgraduate, General Medicine |
| Affiliation |
Saveetha Medical College and Hospital |
| Address |
Room no.1, Department of General Medicine, Saveetha Medical College and Hospital, Saveetha Nagar, Thandalam, Chennai-602105
Chennai
TAMIL NADU
602105
India |
| Phone |
9894857077 |
| Fax |
|
| Email |
yohidoc1997@gmail.com |
|
|
Source of Monetary or Material Support
|
| Saveetha Medical College Hospital, Saveetha Nagar, Thandalam, Chennai-602105 |
|
|
Primary Sponsor
|
| Name |
Saveetha Medical College and Hospital |
| Address |
Saveetha Nagar, Thandalam, Chennai-602105 |
| Type of Sponsor |
Private 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 Yohidha Balamurugan |
Saveetha Medical College and Hospital |
Room no.1, Department of General Medicine, Saveetha Medical College and Hospital, Saveetha Nagar, Thandalam, Chennai-602105
Chennai
TAMIL NADU |
9894857077
yohidoc1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha Medical College and Hospital Instituitional Ethics Committee |
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 |
Acetyl-L carnitine, Palmitoyl Ethanolamide, Vitamin-B12 |
Acetyl-L carnitine 500mg, Palmitoyl Ethanolamide 300mg , vitamin-B12 1500mcg OD po for 3months |
| Intervention |
Placebo |
Gelatin capsules filled with dextrose at a dose of 50mg per capsule, OD for 3 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
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. |
|
| ExclusionCriteria |
| Details |
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 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in neuropathic pain measured by Visual Analogue Score(VAS) and improvement in nerve conduction velocity |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in quality of life and assessing the rate of clinical adverse reactions |
3 months |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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
|
N/A |
|
Date of First Enrollment (India)
|
07/02/2025 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
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 a randomized, double blinded, parallel group, single center trial comparing the efficacy of combined oral formulation of Acetyl-L carnitine(500mg),Palmitoyl Ethanolamide(300mg ) and Vitamin-B12(1500mcg) for 3 months with placebo for 3months in patients with diabetic peripheral neuropathy. A total of 68 patients are to be included in the trial. The primary outcome is reduction in neuropathic pain by assessing Visual Analogue Score(VAS) and improvement in nerve conduction velocity. The secondary outcomes are improvement in quality of life and assessing the rate of clinical adverse reactions at 3 months. |