| CTRI Number |
CTRI/2024/08/071850 [Registered on: 02/08/2024] Trial Registered Prospectively |
| Last Modified On: |
01/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing the benefits and safety of Metformin and Canthex® for treating dark skin patches in patients of Acanthosis Nigricans |
|
Scientific Title of Study
|
A comparative study on efficacy and safety of metformin versus canthex ® (alpha lipoic acid, biotin, chromium polynicotinate, zinc) in patients with acanthosis nigricans-Randomised controlled 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 |
Rutuja Angad Shinde |
| Designation |
Postgraduate resident |
| Affiliation |
MGM institute of health sciences Aurangabad |
| Address |
Resident doctors quarters room number 404 MGM medical college and hospital campus N6 Cidco Aurangabad 431003
Osmanabad
MAHARASHTRA
413501
India |
| Phone |
7887377176 |
| Fax |
|
| Email |
rutujashinde002@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashish Ramchadrarao Deshmukh |
| Designation |
Professor and Head |
| Affiliation |
MGM institute of health sciences Aurangabad |
| Address |
MGM medical college and hospital campus N6 Cidco Aurangabad
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
9422213292 |
| Fax |
|
| Email |
ashish7557@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashish Ramchadrarao Deshmukh |
| Designation |
Professor and Head |
| Affiliation |
MGM institute of health sciences Aurangabad |
| Address |
MGM medical college and hospital campus N6 Cidco Aurangabad
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
9422213292 |
| Fax |
|
| Email |
ashish7557@gmail.com |
|
|
Source of Monetary or Material Support
|
| MGM medical college and hospital
N6 Cidco Aurangabad 431003 Maharashtra India |
|
|
Primary Sponsor
|
| Name |
Rutuja Angad Shinde |
| Address |
MGM medical college and hospital Aurangabad 431003 |
| Type of Sponsor |
Other [self] |
|
|
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 |
| Rutuja Shinde |
MGM medical college and hospital |
Department of Dermatology Venereology and leprology 256
N6 Cidco Aurangabad 431003
Aurangabad
MAHARASHTRA |
7887377176
rutujashinde002@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MGM Ethics Committee for Research on Human Subjects |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L83||Acanthosis nigricans, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Administration of capsule Canthex in acanthosis nigricans patients |
Dose 1 capsule twice daily
Duration 3 months |
| Intervention |
Administration of tablet metformin in acanthosis nigricans patients |
Dose 500 mg twice daily
Duration 3 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Clinically diagnosed with acanthosis nigricans and HOMAIR greater than 1.8 |
|
| ExclusionCriteria |
| Details |
Female Patients who are pregnant and lactating.
Patients who are already taking some antidiabetic medication
Patients with renal compromise
Patients with hepatic compromise
Drug induced acanthosis nigricans
Malignant acanthosis nigricans
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome measures for effectiveness will be improvement of severity of neck lesions and neck texture which is to be measured by quantitative scale of acanthosis nigricans by Burke et al |
at the end of 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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)
|
12/08/2024 |
| 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="2"
Months="0"
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
|
A comparative study on efficacy and safety of metformin versus cathex alpha lipoic acid biotin chromium polynicotinate zinc in patients with acanthosis nigricans It is a randomized controlled trial objectives are To evaluate the effectiveness of metformin in acanthosis nigricans To evaluate the effectiveness of Canthex in acanthosis nigricans To compare the effectiveness of metformin versus canthex in acanthosis nigricans patients To study the side effect profile of metformin and canthex in patients of acanthosis nigricans To compare the improvement of insulin resistance profile of metformin and canthex in acanthosis nigricans
|