| CTRI Number |
CTRI/2024/12/078069 [Registered on: 13/12/2024] Trial Registered Prospectively |
| Last Modified On: |
12/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
TO STUDY EFFECT OF MIRTAZAPINE IN DIABETIC PATIENTS HAVING ITCHING |
|
Scientific Title of Study
|
Efficacy & Safety of Mirtazapine in Diabetic Patient with Pruritus: A Randomized Controlled 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 Sneha Ambwani |
| Designation |
PROFESSOR & HEAD DEPARTMENT OF PHARMACOLOGY |
| Affiliation |
AIIMS Jodhpur |
| Address |
Gate no. 4, Second floor Department of Pharmacology, Aiims jodhpur, Basni phase 2
Gate no. 4, Second floor Department of Pharmacology, Aiims jodhpur, Basni phase 2
Jodhpur
RAJASTHAN
342001
India |
| Phone |
09414912698 |
| Fax |
|
| Email |
sr_ambwani@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mohit Dadhich |
| Designation |
Junior resident |
| Affiliation |
aiims jodhpur |
| Address |
Gate no.4, room no.250, second floor, Department of Pharmacology Basni phase 2 AIIMS jodhpur
Gate no.4, room no.250, second floor Department of Pharmacology Basni phase 2 AIIMS jodhpur
Jodhpur
RAJASTHAN
342001
India |
| Phone |
09460912576 |
| Fax |
|
| Email |
mohit9460dadhich@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrMohit dadhich |
| Designation |
Junior resident |
| Affiliation |
aiims jodhpur |
| Address |
Gate no.4, room no.250, second floor, Department of Pharmacology Basni phase 2 AIIMS jodhpur
Gate no.4, room no.250, second floor, Department of Pharmacology Basni phase 2 AIIMS jodhpur
Jodhpur
RAJASTHAN
342001
India |
| Phone |
09460912576 |
| Fax |
|
| Email |
mohit9460dadhich@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences Jodhpur |
| Address |
342001, Basni phase 2, AIIMS jodhpur, Rajasthan |
| 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 Mohit Dadhich |
AIIMS, JODHPUR |
Department of Pharmacology ,Department of Endocrinology & metabolism, Department of Dermatology, Venerology and Leprology
Jodhpur
RAJASTHAN |
9460912576
mohit9460dadhich@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee All India Institute Of Medical Sciences, Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E116||Type 2 diabetes mellitus with other specified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mirtazapine |
Mirtazapine 7.5 mg before bed till 12 weeks |
| Comparator Agent |
Standard of Care |
Standard of Care include Moisturizers Cream and lotions |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. patient of either sex and age more than 18 years.
2.persistant pruritus for 6 weeks or more.
3.patient diagnosed with diabetic pruritus and having HbA1cmore than 7.5. |
|
| ExclusionCriteria |
| Details |
1. Patients with AST and ALT three times above the normal level.
2. Creatinine clearance (CrCl) less than 30 ml/min/1.73m2
.
3. Patients with pruritus of known dermatological causes such as liver disease, Psoriasis, Lichen
planus, Scabies, etc.
4. Pregnant and lactating women.
5. Patients taking opioids for therapeutic purpose.
6. History of allergy / hypersensitivity to Mirtazapine.
7.Patient already receiving pregabalin, gabapentin or other therapy.
8.Use of Monoamine oxidase inhibitors (MAO inhibitors). |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to compare the efficacy of mirtazapine in pruritus among diabetic patients to standard care group measured by 50 % reduction in visual analogue scale for pruritus after 12 weeks of therapy from baseline. |
4,8,12 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1.to evaluate the efficacy of mirtazapine in pruritus among diabetic patients using 5D pruritus scale from baseline |
4,8,12 week |
| 2.to evaluate change in dermatology life quality index from baseline. |
4,8,12 week |
| 3.to evaluate change in quality of sleep using epworth sleepiness scale from baseline |
4,8,12 week |
| 4.to evaluate change in anxiety score using hamilton anxiety rating scale from baseline. |
4,8,12 week |
| 5.to evaluate safety (hba1c & FBS) and any adverse effect of mirtazapine |
4,8,12 week |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
24/12/2024 |
| 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)
|
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
|
mirtazapine, an antidepressant with both noradrenergic and serotonergic properties have shown promise in alleviating itch severity. as a blocker of H1,5HT2,5HT3 receptors it may serve as an alternative treatment for pruritus that does not respond to first line therapy. mirtazapine is thought to reduce itch centrally by antagonizing alfa 2 adrenergic receptors. |