| CTRI Number |
CTRI/2024/08/072788 [Registered on: 20/08/2024] Trial Registered Prospectively |
| Last Modified On: |
14/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to assess the efficacy of methotrexate with metformin in the treatment of chronic plaque psoriasis with metabolic syndrome |
|
Scientific Title of Study
|
A prospective randomized control study to assess the efficacy of methotrexate monotherapy versus methotrexate with metformin in chronic plaque psoriasis with metabolic syndrome |
| 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 Deepa K |
| Designation |
Post Graduate Student |
| Affiliation |
Government stanley medical college and hospital , chennai |
| Address |
Dept of DVL, Government Stanley Medical College and Hospital no 1 , old jail road george town , Chennai
Chennai
TAMIL NADU
600001
India |
| Phone |
8807407078 |
| Fax |
|
| Email |
deepakrishna26193@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijayabhaskar C |
| Designation |
Professor |
| Affiliation |
Government stanley medical college and hospital , chennai |
| Address |
Dept of DVL, Government Stanley Medical College and Hospital no 1 , old jail road george town , Chennai
Chennai
TAMIL NADU
600001
India |
| Phone |
9940429206 |
| Fax |
|
| Email |
buskibuski@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vijayabhaskar C |
| Designation |
Professor |
| Affiliation |
Government stanley medical college and hospital , chennai |
| Address |
Dept of DVL, Government Stanley Medical College and Hospital no 1 , old jail road george town , Chennai
Chennai
TAMIL NADU
600001
India |
| Phone |
9940429206 |
| Fax |
|
| Email |
buskibuski@gmail.com |
|
|
Source of Monetary or Material Support
|
| Govt stanley medical college and hospital , no 1 , old jail road , george town , chennai - 600001 |
|
|
Primary Sponsor
|
| Name |
Dr.Deepa. K |
| Address |
Dept of DVL , Govt stanley medical college and hospital , chennai - 600001 |
| 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 |
| Dr Deepa K |
Government stanley medical college and hospital |
Dept of DVL , Room No - 81, 1st floor super speciality block , George Town, Chennai ,Tamil Nadu- 600001
Chennai
TAMIL NADU |
8807407078
deepakrishna26193@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government Stanley Medical College and Hospital , Chennai-01,Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L400||Psoriasis vulgaris, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Methotrexate |
Methotrexate 15mg/week oral for 16 weeks |
| Intervention |
Methotrexate with metformin |
Methotrexate 15mg/week oral with metformin 1g/day oral in divided doses for 16 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
moderate to severe chronic plaque psoriasis with PASI more than or equal to 5 with metabolic syndrome, patients of either sex aged 18-65 years, patients who are willing to participate in the study, patients who are willing to take photographs of skin lesions |
|
| ExclusionCriteria |
| Details |
severe types such as erythrodermic , guttate , pustular psoriasis and psoriatic arthritis , liver disease , cardiac disease with history of CCF , renal failure , pregnancy and lactation , patients with active and latent infections - tuberculosis , HIV ,syphilis , hepatitis , known contraindication to methotrexate and metformin |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| For Psoriasis assesed by PASI score . Improvement in skin lesions will be noted using serial photographs taken . For Metabolic Syndrome assessed by parameters like FBS ,PPBS ,BP ,Waist circumference and Fasting lipid profile |
Every 4 weeks till the end of study which is 16 weeks and during follow up period of 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Subjective satisfaction will be assessed by Dermatology Life Quality Index questionnaire at the end of study |
After 16 weeks at the end of the study |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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 3 |
|
Date of First Enrollment (India)
|
10/09/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 prospective randomized control trial to assess the efficacy of methotrexate monotherapy versus methotrexate with metformin in chronic plaque psoriasis with metabolic syndrome patients of chronic plaque psoriasis with metabolic syndrome of both sex aged 18-65 years who are willing to take part in the study and willing to take photographs of skin lesions are split into two groups after conducting thorough systemic and dermatological examination one group is treated with oral methotrexate 15 mg/week for 16 weeks with regular assessment every 4 weeks and another group is treated with oral methotrexate 15mg/week with oral metformin 1g daily in divided doses for 16 weeks with regular assessment every 4 weeks .both groups will be followed up after the study period every 4 weeks for a period of 12 weeks |