| CTRI Number |
CTRI/2024/10/075321 [Registered on: 15/10/2024] Trial Registered Prospectively |
| Last Modified On: |
09/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Treatment of Atopic Dermatitis with Homoeopathic Medicine |
|
Scientific Title of Study
|
PROSPECTIVE STUDY ON EFFECTIVENESS OF HOMOEOPATHIC MEDICINE IN THE TREATMENT OF ATOPIC DERMATITIS IN ADULTS USING 50 MILLESIMAL POTENCY |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
KIRTHANA L |
| Designation |
PG Scholar |
| Affiliation |
White memorial homoeo medical college hospital |
| Address |
Department of Materia Medica White memorial homoeo medical college and hospital
Attoor
Veeyanoor
Kanyakumari District
Ramanathapuram TAMIL NADU 629177 India |
| Phone |
9940535497 |
| Fax |
|
| Email |
kirthuteddy17@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Prasobh M P |
| Designation |
Associate Professor |
| Affiliation |
White memorial homoeo medical college hospital |
| Address |
Department of Materia Medica White memorial homoeo medical college and hospital
Attoor
Veeyanoor
Kanyakumari District
Kanniyakumari TAMIL NADU 629177 India |
| Phone |
9447746688 |
| Fax |
|
| Email |
drprasobhmp@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
KIRTHANAL |
| Designation |
PG Scholar |
| Affiliation |
White memorial homoeo medical college hospital |
| Address |
Department of Materia Medica White memorial homoeo medical college and hospital
Attoor
Veeyanoor
Kanyakumari District
Kanniyakumari TAMIL NADU 629177 India |
| Phone |
9940535497 |
| Fax |
|
| Email |
kirthuteddy@gmail.com |
|
|
Source of Monetary or Material Support
|
| White memorial homoeopathic medical college Attoor veyanoor kanniyakumari
distric 629177 |
|
|
Primary Sponsor
|
| Name |
White memorial homoeopathic medical college |
| Address |
Attoor veyanoor kanniyakumari
distric 629177 |
| Type of Sponsor |
Private 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 KIRTHANA L |
White memorial homoeo medical college hospital |
Materia Medica department OPD IPD and periphery centers of WMHMCH kanniyakumari Kanniyakumari TAMIL NADU |
9940535497
kirthuteddy17@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee White memorial homoeo medical college hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L209||Atopic dermatitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized Homoepathic medicine in 50 millesimal potency |
A single homoeopathic medicine in 50 millesimal potency is
prescribed as per the law of homeopathy.Medicine will be started in 0/1 potency and will be given in increasing dose and will be repeated according to the neeed of case
|
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Patients who are diagnosed with Atopic dermatitis as per Hanifin and Rajka criteria
Subjects of both sexes
Age group of 18-40 years |
|
| ExclusionCriteria |
| Details |
Cases of psychiatric illness
Pregnant and lactating women
Already under treatment (medicinal/surgical/both) for any other chronic disease within last 6 months
Immunocompromised patients with HIV and cancerous
manifestation |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To measure the improvement in Atopic dermatitis in adults
using PO-SCORAD scale |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the effectiveness of Homoeopathic medicines for Atopic dermatitis in 50 millesimal potency |
1 year |
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
20/10/2024 |
| 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
|
A PROSPECTIVE STUDY ON
EFFECTIVENESS OF
HOMOEOPATHIC MEDICINE IN THE
TREATMENT OF ATOPIC
DERMATITIS IN ADULTS USING 50
MILLESIMAL POTENCY Atopic Dermatitis (AD) is a common, chronic, relapsing,
inflammatory skin disease that primarily affects young children but also an
important adult dermatological disease, affecting approximately 2-3% of
adults. Atopic dermatitis (AD) is frequently linked with concurrent atopic
disorders, such as food allergies, asthma, and allergic rhinoconjunctivitis.
Moreover, there is an association with eosinophilic conditions, including
eosinophilic esophagitis and eosinophilic gastroenteritis. It has been proposed
that AD is the first step in an “atopic marchâ€.Atopic dermatitis remains a
serious health concern, and in many countries, particularly in the developing
world, the disease is still very much on the rise. Girls are slightly more likely to develop AD. It has variable rates of
remission, with many patients continuing or recurring with symptoms into
adulthood. AD is under ICD-11-EA-80.The 50 millesimal potency is a powerful and mildest way of
administration of medicine in the least material form but at the same time
increased in power by each dynamization 50,000 times. |