| CTRI Number |
CTRI/2023/11/060024 [Registered on: 20/11/2023] Trial Registered Prospectively |
| Last Modified On: |
19/11/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical study to find out the effectiveness of Homoeopathic Medicine in the management of Pityriasis Versicolor |
|
Scientific Title of Study
|
A clinical Study to determine the effectiveness of Individualized Homoeopathic Medicine in the management of Pityriasis Versicolor |
| 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 Shruthi Gopi |
| Designation |
PG Scholar Department of Practice of Medicine |
| Affiliation |
National Homoeopathy Research Institute in Mental Health |
| Address |
National Homoeopathy Research Institute in Mental Health, P O Sachivothamapuram
Kottayam
KERALA
686532
India |
| Phone |
7736178093 |
| Fax |
|
| Email |
shruthigopi2345@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr P Dastagiri |
| Designation |
Associate Professor Department of Practice of Medicine |
| Affiliation |
National Homoeopathy Research Institute in Mental Health |
| Address |
National Homoeopathy Research Institute in Mental Health, P O Sachivothamapuram
Kottayam
KERALA
686532
India |
| Phone |
9000444409 |
| Fax |
|
| Email |
drdastagirinhrimh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr P Dastagiri |
| Designation |
Associate Professor Department of Practice of Medicine |
| Affiliation |
National Homoeopathy Research Institute in Mental Health |
| Address |
National Homoeopathy Research Institute in Mental Health, P O Sachivothamapuram
KERALA
686532
India |
| Phone |
9000444409 |
| Fax |
|
| Email |
drdastagirinhrimh@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Homoeopathy Research Institute in Mental Health, Sachivothamapuram P O, Kottayam 686532 |
|
|
Primary Sponsor
|
| Name |
Dr Shruthi Gopi |
| Address |
National Homoeopathy Research Institute in Mental Health, Sachivothamapuram P O, Kottayam 686532 |
| 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 Shruthi Gopi |
National Homoeopathy Research Institute in Mental Health |
OPD Department of Practice of Medicine
National Homoeopathy Research Institute in Mental Health Sachivothamapuram P O Kottayam 686532
Kottayam
KERALA |
7736178093
shruthigopi2345@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee- National Homoeopathy Research Institute in Mental Health Kottayam |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B360||Pityriasis versicolor, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized Homoeopathic Medicine |
Administering Individualized Homoeopathic Medicine for the Management of Pityriasis Versicolor for a time period of one year |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients presenting with typical hypopigmented or hyperpigmented macules, scales, pruritis and erythema. 2.Patients confirmed by microscopic KOH test. |
|
| ExclusionCriteria |
| Details |
1.Patients with co-existing dermatological conditions
2.Pregnant and lactating women
3. Patients with advanced systemic illnesses. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in signs and symptoms of Pityriasis versicolor using TSSS |
One year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in Skindex-16 score |
One year |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
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 2 |
|
Date of First Enrollment (India)
|
29/11/2023 |
| 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 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 single arm clinical study to find out the effectiveness of Individualized Homoeopathic Medicine in the management of Pityriasis Versicolor. The primary outcome measures the changes in signs and symptoms of Pityriasis Versicolor using TSSS. The secondary outcome measures the changes in Skindex-16 score. The study duration is 1 year 6 months (6 months for enrollment and 1 year for Intervention and Follow-up)
|