| CTRI Number |
CTRI/2024/05/067563 [Registered on: 17/05/2024] Trial Registered Prospectively |
| Last Modified On: |
21/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Arsenicum Sulphuratum Flavum 3X as an adjunct to Individualized Homoeopathic Medicine in the treatment of Vitiligo |
|
Scientific Title of Study
|
To assess the efficacy of Arsenicum Sulphuratum Flavum 3X as an adjunct to Individualized Homoeopathic Medicine in the treatment of Vitiligo:Double blind,double arm randomised controlled trial. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Joshina Bellai |
| Designation |
Junior Resident |
| Affiliation |
Nehru Homoeopathic Medical College and Hospital |
| Address |
Vitiligo Project OPD 4
Nehru Homoeopathic Medical College and Hospital
B Block
Defence Colony
New Delhi
South
DELHI
110024
India |
| Phone |
7896770691 |
| Fax |
|
| Email |
josiebellai14@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrRashmi Chowdhry |
| Designation |
Professor |
| Affiliation |
Nehru Homoeopathic Medical College and Hospital |
| Address |
Department of Organon of Medicine and Homoeopathic philosophy
Nehru Homoeopathic Medical College and Hospital
B Block
Defence Colony
New Delhi
South
DELHI
110024
India |
| Phone |
9818366119 |
| Fax |
|
| Email |
rashmichowdhry62@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrRashmi Chowdhry |
| Designation |
Professor |
| Affiliation |
Nehru Homoeopathic Medical College and Hospital |
| Address |
Nehru Homoeopathic Medical College and Hospital
B Block
Defence Colony
New Delhi
South
DELHI
110024
India |
| Phone |
9818366119 |
| Fax |
|
| Email |
rashmichowdhry62@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indoor Patient and Outdoor Patient Department of Nehru Homoeopathic Medical College |
|
Primary Sponsor
Modification(s)
|
| Name |
Nehru Homoeopathic Medical College and Hospital |
| Address |
Nehru Homoeopathic Medical College and Hospital
B Block Defence Colony
New Delhi 110024
India |
| Type of Sponsor |
Government 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 |
| Joshina Bellai |
Nehru Homoeopathic Medical College and Hospital |
Vitiligo Project OPD 4 Nehru Homoeopathic Medical College and Hospital
B Block Defence Colony
New Delhi
South
DELHI |
7896770691
josiebellai14@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Nehru Homoeopathic Medical College and Hospital |
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 3X with Individualized Homoeopathic Medicine(IHM) |
IHM will be selected through the Kentian concept of symptom totality. And the potency selection, dose, repetition shall be done on the basis of instructions given by Dr.C.F.S Hahnemann in the Organon of Medicine and follow up shall be done for 6 months. ASF 3X will be given 2 tablets , once daily till the appearance of signs of improvement in the span of 6 months. |
| Comparator Agent |
look-alike placebo(diskette) with Individualized Homoeopathic Medicine(IHM) |
IHM will be selected through the Kentian concept of symptom totality. And the potency selection, dose, repetition shall be done on the basis of instructions given by Dr.C.F.S Hahnemann in the Organon of Medicine and follow up shall be done for 6 months. Look alike placebo(diskette) will be given 2 tabs once daily till the appearance of signs of improvement in the span of 6 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. At least 1 vitiligo skin lesion measuring at least 2x2cm in size.
2. Subjects suffering from vitiligo for at least 03 months.
3. Providing written informed consent.
4. Patients using oral/topical agents for Vitiligo will be included after a washout period of two weeks.
5. Patients with known but controlled systemic diseases.
|
|
| ExclusionCriteria |
| Details |
• Vitiligo universalis
• Patients who are too sick for consultation and not willing to cooperate Unwilling to take part and not giving consent to join the study.
• Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled or life-threatening illness affecting quality of life or any organ failure.
• Pregnant and Lactating women
• Uncontrolled Diabetes, Hypertension, Mental illness or depression, kidney or heart disease
• Substance abuse and/or dependence.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Vitiligo Area Scoring Index (VASI) |
At baseline and every month till one year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Vitiligo Quality of Life Index (VitiQoL) questionnaire |
At baseline and every month till one year |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
30/05/2024 |
| 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="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
|
Although vitiligo has no physically
restrictive symptoms but it has a huge negative impact on the psychological well-being and quality of life.The existing conventional
treatment modalities ranging from topical
and systemic immunosuppressants, to
phototherapy and surgical techniques, none curative.Thus, the treatment modality needs to be tailored for each individual patient
taking into consideration the disease characteristics and also its efficacy and
safety. Studies identify a positive role
of Homoeopathy in Vitiligo .Further, a larger number of studies on convincing
evidence-based parameters including validated scales are essential requirements
to document the usefulness of Homoeopathy in vitiligo.Positive findings from the previous
Homoeopathic trials encourage taking up this study on induction
of pigmentation in vitiligo patients. If the efficacy of ASF 6x as add
on to individualized Homoeopathic medicine is established, it can be used in
the effective management of vitiligo.Hence ,the objective of this
explorative study is to assess the efficacy of ASF 3X as an adjunct to IHM in
the treatment of vitiligo.It is a double blind, double arm randomized controlled trial , 80 participants will be enrolled which be randomely divided into 2 groups in the ratio of 1:1. Duration of study is 1 year .Primary outcome of the study will be measure through VASI score .
|