| CTRI Number |
CTRI/2024/11/077493 [Registered on: 29/11/2024] Trial Registered Prospectively |
| Last Modified On: |
18/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy
Other (Specify) [Therapeutic and research] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Homoeopathy in Alopecia Areata |
|
Scientific Title of Study
|
ROLE OF INDIVIDUALIZED HOMOEOPATHIC MEDICINES IN TREATMENT OF ALOPECIA AREATA IN ADULTS USING KENTS REPERTORY A PRE POST INTERVENTIONAL STUDY |
| 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. Anwesha Mondal |
| Designation |
Post Graduate Scholar |
| Affiliation |
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital |
| Address |
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital
Dr. B. N. Chakraborty Sarani, Doomurjala,Howrah-711104,West Bengal
Haora
WEST BENGAL
711104
India |
| Phone |
9748576335 |
| Fax |
|
| Email |
anwesha7297@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof. Dr. Samit Dey |
| Designation |
Professor |
| Affiliation |
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital |
| Address |
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital
Dr. B. N. Chakraborty Sarani, Doomurjala,Howrah-711104,West Bengal
Haora
WEST BENGAL
711104
India |
| Phone |
9875371414 |
| Fax |
|
| Email |
dr.samit77@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Anwesha Mondal |
| Designation |
Post Graduate Scholar |
| Affiliation |
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital |
| Address |
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital
Dr. B. N. Chakraborty Sarani, Doomurjala,Howrah-711104,West Bengal
Haora
WEST BENGAL
711104
India |
| Phone |
9748576335 |
| Fax |
|
| Email |
anwesha7297@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahesh Bhattacharyya Homoeopathic Medical College and Hospital, Dr. B. N. Chakraborty Sarani, Doomurjala, Howrah - 711104, West Bengal, India. |
|
|
Primary Sponsor
|
| Name |
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital |
| Address |
Dr. B. N. Chakraborty Sarani, Doomurjala,Howrah-711104,West Bengal |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Nil |
Not applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anwesha Mondal |
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital |
Room No. 9 (PG OPD), Mahesh Bhattacharyya Homoeopathic Medical College and Hospital,
Dr. B. N. Chakraborty Sarani, Doomurjala, Howrah - 711104, West Bengal, India.
Haora
WEST BENGAL |
9748576335
anwesha7297@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Mahesh Bhattacharyya Homoeopathic Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L639||Alopecia areata, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized Homoeopathic Medicine |
Medicines will be procured from GMP certified company and will be dispensed from the Dispensary of MBHMC&H. All the medicines will be administered orally.
Potency, dose and repetition will be as per the guideline of Organon of Medicine.
Each dose consists of 4 medicated globules no. 20.
Duration of intervention: 6 months for each individual patient. |
| Comparator Agent |
Not applicable |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Diagnosed cases of Alopecia areata (Using Symptoms mainly)
The diagnosis of alopecia areata is usually made on clinical grounds and in most cases, further tests are not needed. Affected individuals report hair loss and the abrupt appearance of a hairless area which is circular having standard skin color. Presence of Exclamation mark hair at the periphery of the lesion is pathognomonic.
2. Adult population Aged between 18years to 65 years of all sexes.
3. Patients using topical agents for Alopecia will be included after a washout period of one month.
4. Patients giving written consent to participate.
|
|
| ExclusionCriteria |
| Details |
1. Alopecia universalis.
2. Alopecia Totalis.
3. Ophiasis and Sisaipho.
4. Individuals diagnosed with unstable psychiatric illness.
5. Any uncontrolled systemic diseases.
6. Substance abuse and/or dependance.
7. Pregnant and Lactating women.
8. Those treated with any kind of local steroidal injection.
9. Undergoing homoeopathic treatment for any chronic diseases within last 1 month.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The Severity of Alopecia Tool (SALT) |
will be assessed at Baseline & after 6 months of treatment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Alopecia Areata Quality of Life Questionnaire (AA-QLI) |
will be assessed at Baseline & after 6 months of treatment. |
| Modified Naranjo Criteria for Homoeopathy(MONARCH) |
will be assessed after 6 months of treatment. |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
08/12/2024 |
| 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)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
Modification(s)
|
Alopecia areata (AA) is a chronic, immune-mediated autoimmune disorder that affects hair follicles, nails, and, rarely, the retinal pigment epithelium. The classic presentation of AA is isolated, smooth, sudden, non-scarring, and patchy hair loss on the scalp or any area with hair growth. AA targets the anagen hair follicles of individuals and leads to hair loss without permanent damage to the follicles. There is a dearth of evidence-based documentation on this particular subject in homoeopathy. A single-arm pre-post interventional study will be conducted with 40 participants having AA. All the participants will be given individualized homoeopathic medicines. Thye medicines will be procured from GMP certified company and will be dispensed from the dispensory of the hospital (MBHMC&H). The medicines will be administered orally. The medicines’ potency, dose, and repetition will be as per the guidelines of Organon of Medicine. The period of enrolment will be 12 months and the duration of follow-up for each patient will be 6 months. |