| CTRI Number |
CTRI/2024/11/077008 [Registered on: 19/11/2024] Trial Registered Prospectively |
| Last Modified On: |
14/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy
Other (Specify) [Therapeutic effectiveness] |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
A clinical study to compare the effectiveness of Homoeopathic drug Arsenicum Sulphuratum Flavum and Customized Homoeopathic Medicines in patients suffering from white spot disease that causes the skin to lose pigment and result in white patches |
|
Scientific Title of Study
|
A Comparative Study on the Effectiveness of ARSENICUM SULPHURATUM FLAVUM and INDIVIDUALIZED
HOMOEOPATHIC MEDICINES in the Treatment of VITILIGO |
| 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 Swiyana B H |
| Designation |
Post Graduate Scholar |
| Affiliation |
Government Homoeopathic Medical College, Thiruvananthapuram |
| Address |
Department of Repertory
Government Homoeopathic Medical College
Iranimuttom
Manacaud P O
Thiruvananthapuram
Kerala
India
Thiruvananthapuram
KERALA
695009
India |
| Phone |
9645293587 |
| Fax |
|
| Email |
carehomoeo2022@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr MAYA B J |
| Designation |
Guide |
| Affiliation |
Government Homoeopathic Medical College, Thiruvananthapuram |
| Address |
Professor and HOD
Department of Repertory
Government Homoeopathic Medical College
Iranimuttom
Manacaud P O
Thiruvananthapuram
Kerala
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 |
Government Homoeopathic Medical College, Thiruvananthapuram |
| Address |
Professor and HOD
Department of Repertory
Government Homoeopathic Medical College
Iranimuttom
Manacaud P O
Thiruvananthapuram
Kerala
India
KERALA
695009
India |
| Phone |
9544306474 |
| Fax |
|
| Email |
drMayaBJ@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Homoeopathic Medical College
Iranimuttom
Manacaud.P.O
Thiruvananthapuram
Kerala
India
695009 |
|
|
Primary Sponsor
|
| Name |
Dr Swiyana B H |
| Address |
Post Graduate Scholar
Department of Repertory
Government Homoeopathic Medical College
Iranimuttom
Manacaud.P.O
Thiruvananthapuram
Kerala
India
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 Swiyana B H |
Government Homoeopathic Medical College |
Dermatology Special OP
Room No.8
Government Homoeopathic Medical College
Iranimuttom
Manacaud.P.O
Thiruvananthapuram
Kerala
India
695009
Thiruvananthapuram
KERALA |
9645293587
carehomoeo2022@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC), Government Homoeopathic Medical College, Iranimuttom, Manacaud P.O, Thiruvananthapuram |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L80||Vitiligo, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Arsenicum Sulphuratum Flavum |
Arsenicum Sulphuratum Flavum in proper dose and potency and reviewed in 1 month interval |
| Comparator Agent |
Individualized Homoeopathic Medicines |
Individualized Homoeopathic Medicines in proper dose and potency and reviewed in 1 month interval. |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients presenting with clinical signs and symptoms of Vitiligo.
2. Those who are willing to give written, informed consent; parental consent for
those under the age of 18. |
|
| ExclusionCriteria |
| Details |
1. Leucoderma
2. Cases with serious systemic illness
3. Patients with malignancies
4. Pregnant and lactating females |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Clinical study:
Assessment of the changes in VASI and VitiQoL scoring indices of patients with Vitiligo before and after administration of
Arsenicum Sulphuratum Flavum as compared to Individualized Homoeopathic Medicines. |
After 1 Year (after completion of the study) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of the relation of Vitiligo with Hypothyroidism, Diabetes Mellitus & Rheumatoid arthritis. |
Required baseline investigations will be done at 0,26 & 52 weeks. |
|
|
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 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
|
Vitiligo is a cosmetically disfiguring and a stigmatizing condition, leading to psychological problems and having a great impact on the quality of life. Since there is no causative treatment available, current conventional treatments are directed toward stopping the progression of the depigmentation and achieving re-pigmentation and the treatment is very costly; whereas homeopathic medicines have shown to be clinically very effective in treating vitiligo and is also affordable for the patients. But the research studies conducted on homeopathic treatment of vitiligo are only a few. The primary objective of the study is to assess the changes in VASI and VitiQoL scoring indices of patients with Vitiligo before and after administration of individualized homoeopathic medicines as compared to Arsenicum Sulphuratum Flavum, which had been specifically used for vitiligo and leucoderma by many homoeopathic practitioners.NULL HYPOTHESIS : There is no significant difference in VASI and VitiQoL scoring indices of patients with Vitiligo before and after treatment with Arsenicum Sulphuratum Flavum as compared to Individualized Homeopathic Medicines. ALTERNATIVE HYPOTHESIS : There is a significant difference in VASI and VitiQoL scoring indices of patients with Vitiligo before and after treatment with Arsenicum Sulphuratum Flavum as compared to Individualized Homeopathic Medicines. |