| CTRI Number |
CTRI/2024/04/066054 [Registered on: 22/04/2024] Trial Registered Prospectively |
| Last Modified On: |
15/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Knowledge, Attitude and Practices of Medical Practitioners on Chronic Itch |
|
Scientific Title of Study
|
Knowledge, Attitude and Practices of Medical Practitioners on
Chronic Pruritus and its management |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| DRL-IND-GGI-056-ATAR/2024 (Version: 1.0; March 11, 2024) |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Monil Yogesh Gala |
| Designation |
Medical Advisor |
| Affiliation |
Dr. Reddy’s Laboratories Ltd. |
| Address |
Medical Affairs Department, Global Generics India Division, 8-2-337, Road No. 3, Banjara Hills
Hyderabad
TELANGANA
500034
India |
| Phone |
9004117134 |
| Fax |
|
| Email |
monil.yogesh@drreddys.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sagar Katare |
| Designation |
Medical Advisor |
| Affiliation |
Dr. Reddy’s Laboratories Ltd. |
| Address |
Medical Affairs Department, Global Generics India Division, 8-2-337, Road No. 3, Banjara Hills
Hyderabad
TELANGANA
500034
India |
| Phone |
9223772427 |
| Fax |
|
| Email |
sagarkatare@drreddys.com |
|
Details of Contact Person
Public Query
|
| Name |
Sagar Katare |
| Designation |
Medical Advisor |
| Affiliation |
Dr. Reddy’s Laboratories Ltd. |
| Address |
Medical Affairs Department, Global Generics India Division, 8-2-337, Road No. 3, Banjara Hills
Hyderabad
TELANGANA
500034
India |
| Phone |
9223772427 |
| Fax |
|
| Email |
sagarkatare@drreddys.com |
|
|
Source of Monetary or Material Support
|
| Dr. Reddys Laboratories,
8-2-337, Road No. 3, Banjara Hills,
Hyderabad, Telangana-500034, India. |
|
|
Primary Sponsor
|
| Name |
Dr. Reddys Laboratories Ltd. |
| Address |
8-2-337, Road No. 3, Banjara Hills,
Hyderabad, Telangana-500034, India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Monil Yogesh Gala |
Dr. Reddys Laboratories Ltd. |
Medical Affairs Department, Global Generics India Division, 8-2-337, Road No. 3, Banjara Hills
Hyderabad
TELANGANA |
9004117134
monil.yogesh@drreddys.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Shubhdisha Business Solutions |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Chronic Pruritus |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Dermatologists treating chronic pruritus cases, practicing in any healthcare set-up/ clinics/ Hospitals/ Medical colleges in India and having a minimum of 5 years of clinical experience. |
|
| ExclusionCriteria |
| Details |
Dermatologists unwilling to voluntarily participate in the study and/or provide written consent. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the level of knowledge about chronic pruritus, its causes, and the role of antihistamines in its management among practicing dermatologists. |
10 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To understand the attitude of practicing dermatologists towards antihistamine use for chronic pruritus, including perceived effectiveness, safety concerns, and side effects. |
10 weeks |
| To assess the current practices of antihistamine use for chronic pruritus among practicing dermatologists, including adherence rates, dosage recommendations, and treatment duration. |
10 weeks |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
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)
|
03/05/2024 |
| 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="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 is a cross-sectional, objective as well as subjective question-based study conducted in 500 practicing dermatologists to assess the knowledge, attitude, and practices regarding chronic pruritus, its causes, and management. The primary outcome measures will be to evaluate the level of knowledge of practicing dermatologists about chronic pruritus, understand their attitude towards antihistamine use for chronic pruritus. And the secondary outcome measure will be to assess the current practices of antihistamine use for chronic pruritus management among practicing dermatologists. The duration of the study is up to 6 months. |