| CTRI Number |
CTRI/2024/04/065613 [Registered on: 12/04/2024] Trial Registered Prospectively |
| Last Modified On: |
10/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Homoeopathy in Alopecia Areata |
|
Scientific Title of Study
|
Miasmatic Interpretation Of Alopecia Areata & Its Homoeopathic Management |
| Trial Acronym |
HOM-ALOPECIA AREATA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mital N Kacha |
| Designation |
PhD Scholar |
| Affiliation |
Rajkot Homoeopathic Medical College |
| Address |
Department of organon of medicine & homoeopathic philosophy, Rajkot Homoeopathic
medical College, behind jainath complex, makkam chowk, Rajkot
Rajkot
GUJARAT
360002
India |
| Phone |
9099144019 |
| Fax |
|
| Email |
dr.mitalkacha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Heena Rawal |
| Designation |
Professor |
| Affiliation |
Parul University |
| Address |
Department of organon of medicine & homoeopathic philosophy, Ahmedabad Homoeopathic
medical College,bopal ghuma road,opp.kabeer complex
Ahmadabad
GUJARAT
380058
India |
| Phone |
9427401176 |
| Fax |
|
| Email |
heenarawal28@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mital N Kacha |
| Designation |
PhD Scholar |
| Affiliation |
Rajkot Homoeopathic Medical College |
| Address |
Department of organon of medicine & homoeopathic philosophy, Rajkot Homoeopathic
medical College, behind jainath complex, makkam chowk, Rajkot
Rajkot
GUJARAT
360002
India |
| Phone |
9099144019 |
| Fax |
|
| Email |
dr.mitalkacha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajkot Homoeopathic Medical College, RAjkot, GuJarat, India |
|
|
Primary Sponsor
|
| Name |
Rajkot Homoeopathic Medical College |
| Address |
Rajkot Homoeopathic medical College, behind jainath complex,
makkam chowk, Rajkot |
| 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 Mital N Kacha |
Sainath homoepathic medical college |
Room no,101 department of medicine, rajkot homoeopathic medical college, b/h jaynath petrol pump,near makkam chowk, rajkot
Rajkot
GUJARAT |
9099144019
dr.mitalkacha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee for human research-rajkot homoeopathic medical college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L00-L99||Diseases of the skin and subcutaneous tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homoeopathic medicines selected with the help of homoeopathic principle |
Individualised,selection of medicine and dosage,instructions will be strictly following the homoeopathic principle. |
| Comparator Agent |
nill |
nill |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
all patients are inclusion age of 20yrs to 40 yrs of ages and both gender. |
|
| ExclusionCriteria |
| Details |
Cases without proper follow-up (at least 3 irregular follow-up) will be excluded from the study.
Complication of hypertension, diabetes mellitus, metabolic disorder chronic liver disease.
Immuinocompromised patient, malignancy, drug addiction.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| salt score before and after treatment |
beginning and end of the treatment- monthly follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
SALT before and after
treatment |
Beginning and end of treatment, 18 months |
|
|
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 2 |
|
Date of First Enrollment (India)
|
22/04/2024 |
| 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="6"
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
|
Alopecia areata is an
autoimmune disorder characterized by transient, non-scarring hair loss and
preservation of the hair follicle. Hair loss can take many forms ranging from
loss in well-defined patches to diffuse or total hair loss, which can affect all
hair bearing sites.
Patchy alopecia
affecting the scalp is the most common type. Alopecia areata affects nearly 2%
of the general population at some point during their lifetime.
Alopecia areata is
difficult to manage medically, but recent advances in understanding the
molecular mechanisms have revealed new treatments and the possibility of
remission in the near future.
In homoeopathy where
homoeopathy act marvellously manage on treatment of alopecia areata. |