| CTRI Number |
CTRI/2024/11/076955 [Registered on: 18/11/2024] Trial Registered Prospectively |
| Last Modified On: |
14/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Comparing ARSENICUM ALBUM IN LM POTENCY to INDIVIDUALIZED HOMOEOPATHIC MEDICINE for the treatment of ECZEMA/ATOPIC DERMATITIS |
|
Scientific Title of Study
|
Effectiveness of ARSENICUM ALBUM in LM Potency as compared to INDIVIDUALISED HOMOEOPATHIC MEDICINES in the management of ATOPIC DERMATITIS |
| 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 NEETHU V |
| Designation |
Post Graduate Scholar |
| Affiliation |
Government Homoeopathoic Medical College,Thiruvananthapuram |
| Address |
Department of Repertory Government Homoeopathic Medical
College Iranimuttom, thiruvananthapuram
KERALA
695009
India
Thiruvananthapuram
KERALA
695009
India |
| Phone |
7510835620 |
| Fax |
|
| Email |
drneethuvijay@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr MAYA B J |
| Designation |
Guide |
| Affiliation |
Goverment homoeopathic medical college ,thiruvananthapuram |
| Address |
Professor and HOD
Department of Repertory Government Homoeopathic Medical
College Iranimuttom, thiruvananthapuram
KERALA
695009
India
Thiruvananthapuram
KERALA
695009
India |
| Phone |
9544306474 |
| Fax |
|
| Email |
drMayaBJ@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr MAYA B J |
| Designation |
Guide |
| Affiliation |
Goverment homoeopathic medical college ,thiruvananthapuram |
| Address |
Professor and HOD
Department of Repertory Government Homoeopathic Medical
College Iranimuttom, thiruvananthapuram
KERALA
695009
India
KERALA
695009
India |
| Phone |
9544306474 |
| Fax |
|
| Email |
drMayaBJ@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Homoeopathic Medical college, Thiruvananthapuram, Kerala, INDIA
PINCODE :695009 |
|
|
Primary Sponsor
|
| Name |
Dr NEETHU V |
| Address |
Post Graduate Scholar Department of Homoeopathic Repertory and Case taking Government
Homoeopathic Medical Collage, Thiruvananthapuram.
Kerala.
India
pincode:695009 |
| 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 NEETHU V |
Government homoeopathic medical college |
Dermatology special OP
Department OP Room
Number 8
Government
Homoeopathic Medical
College Iranimuttom,ThiruvananthapuramKerala,
India.
Thiruvananthapuram
KERALA |
7510835620
drneethuvijay@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Government Homoeopathic Medical College , Thiruvananthapuram, Kerala. |
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 |
Arsenicum album |
Arsenicum album in LM potency. 1 Dose given at every two week interval for first 8 week from the beginning of treatment ,after that 1 dose at once in every 8 week duration will be given. |
| Comparator Agent |
Individualised homoeopathic medicines. |
Individualised homoeopathic medicines selected according to the constitution of the patient,1 dose at the beginning of the treatment and will be repeated at 2 week interval for the first 8 week and then 1 dose will be given at once in 8 week duration. |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients of both the sexes in the age group 10-50 years
2.Cases diagnosed as atopic dermatitis using Hanifin and Rajka’s diagnostic criteria
3.Patients with elevated Ig E levels |
|
| ExclusionCriteria |
| Details |
1.Patients with known severe systemic illness such as cardiac dysfunction, renal impairment
and hepatic troubles
2.Patients under corticosteroid treatments
3.Pregnant and lactating females
4.Patients with malignancies |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Clinical study
Title: Effectivness of arsenicum album in LM potency as compared to individualized homoeopathic medicines in the management of atopic dermatitis
|
The effectiveness with arsenicum album and individualized homoeopathic medicine in the management of atopic dermatitis will be assessed at every 4 week interval and the results will be compared at 8 week from the onset of study and also at the end of 20 week using symptoms by the patient using SCORAD score, Ig E levels ,Photographic evidences . |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Relation between the rising & reduction of Ig E & AEC levels with treatment |
assessment done at beginning, at every 4 week , at 8 week of from the beginning of the study |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
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)
|
25/11/2024 |
| 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 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
|
Atopic dermatitis is a chronic and recurrently relapsing skin condition that cause continuous discomfort that affects the confidence, self-worth, and social interactions of the patient.Conventional Medical aid is available for the treatment of atopic dermatitis, but relapses frequently occur after treatment. But the homoeopathic method can lower the likelihood of relapses.NULL HYPOTHESIS • There is no significant difference in SCORAD score in the treatment of Atopic dermatitis with Arsenicum album in LM potency compared to individualized homoeopathic medicines. ALTERNATIVE HYPOTHESIS • There is significant difference in SCORAD score in the treatment of Atopic dermatitis with Arsenicum album in LM potency compared to individualized homoeopathic medicines. |