| CTRI Number |
CTRI/2025/08/092162 [Registered on: 01/08/2025] Trial Registered Prospectively |
| Last Modified On: |
31/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A Study to Assess the Therapeutic Efficacy of Rosmarinus Officinalis 30 in the Management of Telogen Effluvium in Females |
|
Scientific Title of Study
|
A Randomized Single Blind Placebo Controlled Study to Assess the Therapeutic Efficacy of Rosmarinus Officinalis 30 in the Management of Telogen Effluvium in Females |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kirti Rinwa |
| Designation |
Post Graduate Resident |
| Affiliation |
Swasthya Kalyan Homoeopathic Medical College and Research Centre |
| Address |
Swasthya Kalyan Homoeopathic Medical College and Research Centre 10-A Institutional Area, Tonk Road,Sitapura Jaipur
Jaipur
RAJASTHAN
302022
India |
| Phone |
7088124356 |
| Fax |
|
| Email |
Kirti.rinwa27@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Yogeshwari Gupta |
| Designation |
Principal and HOD of Materia Medica |
| Affiliation |
Swasthya Kalyan Homoeopathic Medical College and Research Centre |
| Address |
S62 Mahaveer Nagar,Tonk Road behind Jaipur Hospital Jaipur
Swasthya Kalyan Homoeopathic Medical College and Research Centre 10-A Institutional Area,Tonk Road,Sitapura Jaipur
Jaipur
RAJASTHAN
302018
India |
| Phone |
9414229555 |
| Fax |
|
| Email |
homeopathy@swasthyakalyan.org |
|
Details of Contact Person
Public Query
|
| Name |
DR Yogeshwari Gupta |
| Designation |
Principal and HOD of Materia Medica |
| Affiliation |
Swasthya Kalyan Homoeopathic Medical College and Research Centre |
| Address |
S62 Mahaveer Nagar,Tonk Road behind Jaipur Hospital Jaipur
Swasthya Kalyan Homoeopathic Medical College and Research Centre 10-A Institutional Area,Tonk Road,Sitapura Jaipur
Jaipur
RAJASTHAN
302018
India |
| Phone |
9414229555 |
| Fax |
|
| Email |
homeopathy@swasthyakalyan.org |
|
|
Source of Monetary or Material Support
|
| Swasthya Kalyan Homoeopathic Medical College and Research Centre 10A Sitapura Institutional area Tonk Road,Goner Road Sitapura Industrial Area Jaipur Rajasthan 302022 |
|
|
Primary Sponsor
|
| Name |
Swasthya Kalyan Homoeopathic Medical College and Research Centre |
| Address |
Swasthya Kalyan Homoeopathic Medical College and Research Centre 10A Institutional Area
Tonk Road Sitapura Jaipur 302022 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Kirti Rinwa |
Swasthya Kalyan Homoeopathic Medical College and Research Centre |
Department of General Medicine Opd number 29 and 30
10-A, Sitapura Institutional Area,Tonk Road, Goner Road,Sitapura Industrial Area,Sitapura,Jaipur,Rajasthan
Jaipur
RAJASTHAN |
7088124356
Kirti.rinwa27@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Swasthya Kalyan Homoeopathic Medical College Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: L650||Telogen effluvium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homoeopathic medicine Rosmarinus officinalis |
30 in centesimal scale 4 pills 1 dose once in a day empty stomach in the morning dissolved in one fourth tea cup of water for 3 months
Route of administration oral
Globule number 30 |
| Comparator Agent |
Placebo |
4 pills 1 dose once in a day empty stomach in the morning dissolved in one fourth tea cup of water for 3 months Route of administration oral Globule number 30 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
1 New and Pre Diagnosed cases of Telogen Effluvium
2 Females between age group 18 to 60 years
3 Patients with history of hair fall after Physiological stress like Febrile Illness ,Surgeries ,Infection ,Childbirth but medicine will be given only when she has completely stopped breast feeding
4 Patients who are not taking any medication or those who are taking other modes or allopathic treatment and ready to stop their treatment are included.
5 Patients who are ready to give written consent. |
|
| ExclusionCriteria |
| Details |
1 Pregnant women and lactating mothers will not be included in the study
2 Patients suffering from any systemic illness for example Cancer, Autoimmune diseases, Hyperthyroidism, Hypothyroidism ,Renal disease ,Liver disease or any advance pathology
3 Individuals with scalp-specific dermatological conditions such as psoriasis or seborrheic dermatitis |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment done on pre and post score by using Alopecia Scoring Scale and regular follow up |
12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| This study will identify the most common etiological factors responsible for Telogen Effluvium and evaluate the action of Rosmarinus officinalis against those factors |
12 months |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
18/08/2025 |
| 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
|
This study is a sincere attempt to study the role of Rosmarinus officinalis in the management of Telogen Effluvium in Females. The results may provide valuable insights into an effective non invasive approach to hair loss management and potentially broaden treatment options in homeopathy. This study will assess whether Rosmarinus officinalis significantly reduces hair shedding in females with Telogen Effluvium using Alopecia Scoring Scale and study will also identify the most common etiological factors responsible for Telogen Effluvium using Hair Loss Questionnaire and evaluate the action of Rosmarinus officinalis against those factors. The study will be done for 1 year on total 90 patients of Telogen Effluvium. |