| CTRI Number |
CTRI/2023/08/057018 [Registered on: 29/08/2023] Trial Registered Prospectively |
| Last Modified On: |
24/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy
Other (Specify) [THERAPEUTIC] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Homoeopathic Medicine In Female Pattern Hair Loss |
|
Scientific Title of Study
|
Effectiveness Of Individualized Homoeopathic Medicine In The Treatment Of Female Pattern Hair Loss(FPHL): An Open Observational 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 Tanmoy Saha |
| Designation |
Post Graduate Trainee |
| Affiliation |
National Institute Of Homoeopathy |
| Address |
OPD No 14 Department Of Organon Of Medicine
National Institute Of Homoeopathy
Block-GE, Sector-III,
Salt Lake Kolkata-700106
North Twentyfour Parganas
WEST BENGAL
700106
India |
| Phone |
06009197201 |
| Fax |
|
| Email |
tanmoys479@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Subhas Singh |
| Designation |
Director, National Institute Of Homoeopathy |
| Affiliation |
National Institute Of Homoeopathy |
| Address |
Department Of Organon Of Medicine
National Institute Of Homoeopathy
Block- GE, Sector-III,
Salt Lake Kolkata-700106
North Twentyfour Parganas
WEST BENGAL
700106
India |
| Phone |
9830644223 |
| Fax |
|
| Email |
drssubhas@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Subhas Singh |
| Designation |
Director, National Institute Of Homoeopathy |
| Affiliation |
National Institute Of Homoeopathy |
| Address |
Department Of Organon Of Medicine
National Institute Of Homoeopathy
Block-GE, Sector-III,
Salt Lake KOLKATA-700106
North Twentyfour Parganas
WEST BENGAL
700106
India |
| Phone |
9830644223 |
| Fax |
|
| Email |
drssubhas@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute Of Homoeopathy
Block GE Sector III
Salt Lake Kolkata 700106
|
|
|
Primary Sponsor
|
| Name |
National Institute Of Homoeopathy |
| Address |
Block GE Sector III
Salt Lake Kolkata 700106
The West Bengal University Of Health Sciences
Block-DD 36, Sector-1, Salt Lake Kolkata 700064
West Bengal
|
| 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 |
| Dr TANMOY SAHA |
National Institute Of Homoeopathy |
BLOCK-GE, SECTOR-III,
SALT LAKE KOLKATA-700106
Department Of Organon Of Medicine, OPD No. 14
North Twentyfour Parganas
WEST BENGAL |
06009197201
tanmoys479@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| THE INSTITUTIONAL ETHICAL COMMITTEE OF NATIONAL INSTITUTE OF HOMOEOPATHY KOLKATA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L659||Nonscarring hair loss, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized Homoeopathic Medicine |
Medicine will be prescribed in Centesimal or Fifty Millesimal potency, maintaining
the strict Homoeopathic principles regarding dose and repetition.Administering indicated Homoeopathic medicine for a period of 6months.Medicine will be dispensed in 50 millesimal potency. Dispensed as 1 medicated globule, size "10", mixed in 100 ml of distilled water. Rectified spirit will be added for preservation of the medicine and patient will be advised to give 10 strokes before consuming it. In Centesimal potency medicine will be dispensed in sugar of milk or "40" size globules.Total duration of therapy: 6 months for each individual patient. Data will be recorded at baseline, at 3months and at 6 months for each individual patient.
|
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
49.00 Year(s) |
| Gender |
Female |
| Details |
1.Female patient of reproductive age group (15 TO 49 years) suffering from Patients with
FPHL.
2.Patients of all religions and of varied socioeconomic status.
3.Patients giving written consent to participate in the study.
4.Patients with FPHL with or without comorbidity.
5.Must know/understand either Bengali or Hindi or English.
6. Providing written informed consents. |
|
| ExclusionCriteria |
| Details |
1. Female patients below the age of 15years & above the age of 49 years.
1. Cases suffering from uncontrolled systemic illness or life-threatening infections.
2. Unwilling to take part and not giving consent to join the study.
3. Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled or life
threatening illness affecting quality of life or any organ failure.
4. Pregnant women and lactating mothers
5. Substance abuse and/or dependence.
6. Self-reported immune-compromised state, and
7. Undergoing homoeopathic treatment for any chronic disease within last 6 months |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Each enrolled case will be followed up every month, examination will be done at the
baseline, at 3 months & at end of the study to assess decrease in hair fall.
The general well-being & reduction of hair fall of the patient will be recorded on the
basis of score obtained by dermatology life quality index (DLQI)
questionnaires.
|
The outcomes will be assessed at baseline & after 3 months & at 6 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The general well-being & reduction of hair fall of the patient will be recorded on the
basis of score obtained by ludwigs criteria.
|
The outcomes will be assessed at baseline & after 3 months & at 6 months. |
|
|
Target Sample Size
|
Total Sample Size="41"
Sample Size from India="41"
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)
|
04/09/2023 |
| 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
|
Female pattern hair loss (FPHL) has replaced androgenetic alopecia (AGA) in women as the accepted nomenclature due to the lack of clarity surrounding the relationship between androgens and this disorder.A Prospective, open label, non-randomized, non-controlled, single-arm clinical study. The whole study will take approximately around 12 months. Detailed and thorough case taking of each and every Female patient of reproductive age group (15 - 49 years) suffering from Patients with FPHL shall be done in accordance with the direction laid down by Dr. C. F. S. Hahnemann in the Organon of Medicine from §83 to §104. Indicated Homoeopathic medicines in Centesimal or Fifty Millesimal potencies will be given as per the requirement and direction of Hahnemann, from NIH dispensary as selected appropriate to the case or condition according to the symptom totality based on §153 i.e. Striking, Singular, Uncommon and Peculiar (Characteristics) Signs and Symptoms, dose and repetition will be according to the case.The outcomes will be assessed at baseline & after 3 months and at 6 months if possible. Each enrolled case will be followed up every month, examination will be done at the baseline, at 3 months and at end of the study to assess decrease in hair fall. The general well-being and reduction of hair fall of the patient will be recorded on the basis of score obtained by Ludwig’s criteria and dermatology life quality index (DLQI) questionnaires.
|