| CTRI Number |
CTRI/2025/10/095753 [Registered on: 08/10/2025] Trial Registered Prospectively |
| Last Modified On: |
20/04/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Post Marketing Observational Study to Evaluate the Effectiveness of an oral multivitamin and multimineral supplement without any inventions in participants which can prevents hair loss |
|
Scientific Title of Study
|
A prospective multicenter post marketing observational study to evaluate the effectiveness of an oral multivitamin and multimineral supplement also containing amino acids in patients with hair loss telogen effluvium |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SCMB-523-0603 Version 1.0 Dated 05.08.2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shehnaz Arsiwala |
| Designation |
Principal Investigator |
| Affiliation |
Renewderm Skin Hair Laser Aesthetics Centre |
| Address |
Room number 36 370 371 3rd floor Renewderm Skin Hair Laser Aesthetics Centre New Mazgaon Co op Hsg Soc Ltd A Wing 3rd Floor Office No 36(I) 37 370 371 Nesbit Road Next to Mazgaon Court Mazgaon Mumbai 400 010
Mumbai
MAHARASHTRA
400010
India |
| Phone |
9833114856 |
| Fax |
|
| Email |
drshenaz.arsiwala@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kartik Peethambaran |
| Designation |
Director Medical Affairs |
| Affiliation |
Abbott Healthcare Private Limited |
| Address |
Cabin number 17 CA 001 Floor 17-18 Godrej BKC Plot No C 68 BKC Near MCA Club Bandra (E) Mumbai MAHARASHTRA 400051 India
Mumbai
MAHARASHTRA
400051
India |
| Phone |
8454041733 |
| Fax |
|
| Email |
kartik.peethambaran@abbott.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shivani Acharya |
| Designation |
Director Clinical Development and Operations |
| Affiliation |
Abbott Healthcare Private Limited |
| Address |
Cabin number 16 CA 004 Floor 16 Godrej BKC Plot No C 68 BKC Near MCA Club Bandra (E) Mumbai MAHARASHTRA 400051 India
Mumbai
MAHARASHTRA
400051
India |
| Phone |
8657552543 |
| Fax |
|
| Email |
shivani.acharya@abbott.com |
|
|
Source of Monetary or Material Support
|
| Abbott Healthcare Private Limited |
|
|
Primary Sponsor
|
| Name |
Abbott Healthcare Private Limited |
| Address |
Floor 17-18 Godrej BKC Plot No C 68 BKC Near MCA Club, Bandra (E) Mumbai MAHARASHTRA 400051 India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 7 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anil Ganjoo |
Dr Ganjoo Skin and Laser Cosmetology Centre |
Dr Ganjoo Skin and Laser Cosmetology Centre 105 4 LSC Gujranwala Town Near Model Town Metro Station New Delhi Delhi 110009
New Delhi
DELHI |
9811066584
drganjoo1965@yahoo.co.in |
| Dr Bikash Kar |
Dr. Bikash Kar |
Dr. Kars Skin clinic,MIG-A/9, BRIT colony street, BRIT colony, Nilkantha Nagar, Bhubaneswar-751012. Odisha
Khordha
ORISSA |
9937428181
karbikash@gmail.com |
| Dr Turpati Narayana Rao |
Dr. Turpati Narayana Rao |
NR skin & cosmatology center, Krishna Nagar, Maharanipeta, Visakhapatnam-530002, Andra Pradesh, India
Visakhapatnam
ANDHRA PRADESH |
9849129912
tnr_derma@yahoo.com |
| Dr Anjeeta Dhawan |
Maharaja Agrasen Hospital |
West Punjabi Bagh New Delhi- 110026
New Delhi
DELHI |
9810631823
anjeetadr@gmail.com |
| Dr Shehnaz Arsiwala |
Renewderm Skin Hair Laser Aesthetics Centre |
Renewderm Skin Hair Laser Aesthetics Centre New Mazgaon Co op Hsg Soc Ltd A Wing 3rd Floor Office No 36(I) 37 370 371 Nesbit Road Next to Mazgaon Court Mazgaon Mumbai 400 010
Mumbai
MAHARASHTRA |
9833114856
drshenaz.arsiwala@gmail.com |
| Dr Maya Vedamurty |
RSV Skin and Research Center |
9/5 2 nd cross street
Mahalingapuram
Chennai-600034
TamilNadu
Chennai
TAMIL NADU |
9840062115
mayavedamurthy@yahoo.com |
| Dr Indrasish Podder |
Upasana Diagnostic Centre |
Number 3 Island / Circle, AD 71, 1st Ave Rd,near bd bus stand or, AD Block, Sector 1, Bidhannagar,
Kolkata, West Bengal 700064
Kolkata
WEST BENGAL |
9007977161
ipodder88@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 7 |
| Name of Committee |
Approval Status |
| Altezza Institutional Ethics Committee |
Approved |
| CUTM Independent Ethics Committee |
Approved |
| Good Society for Ethical Research |
Approved |
| HP Poddar Memorial Clinic And Nursing Home |
Approved |
| Indus Institutional Ethics Committee |
Approved |
| Maharaja Agrasen Hospital Institutional Ethics Committe |
Approved |
| RIPON Independent Ethics Committee (RIPON IEC) |
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 |
An oral multivitamin and multimineral supplement |
Twice daily Oral |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Male and Female patients aged 18 to 60 years diagnosed with Telogen Effluvium by a dermatologist
Willingness and ability to provide informed consent for participation in the study
Agreement to comply with the prescribed Follihair AM PM and attend scheduled follow up assessments during the study period |
|
| ExclusionCriteria |
| Details |
Pregnancy or lactation, as hormonal changes during these periods can influence hair health Use of contraceptive medications with known hormonal effects that could affect hair growth
Diagnosed with Androgenetic alopecia
Concomitant use of drugs that cause hair loss as per dermatologist’ discretion
Use of hair growth medications or treatments within the last 6 months, which may confound the study results as per treating dermatologist’s discretion
Use of nutritional supplements for hair loss in the last 3 months as per dermatologist’s discretion
Any known history of allergies or adverse reactions to the components of the study products- similar products as per dermatologist’s discretion
Current participation in other clinical trials involving hair health or dermatological treatments
Any other medical conditions that could impact hair health as per dermatologist’s discretion
History of major surgical procedures or significant trauma in the last 6 months |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effectiveness of the treatment with oral nutritional supplements in reducing hair loss at 12 weeks using hair pull test |
Baseline and 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the effectiveness of treatment with oral nutritional
supplements in reducing hair loss at 12 weeks using global assessment score the GAS a 7 point score from minus 3 severe worsening to plus 3 excellent
improvement performed using standardized global photographs.
To evaluate hair strength with hair pluck test at 12 weeks
Satisfaction will be measured through patient satisfaction questionnaire and
Physician satisfaction Questionnaire at 6 weeks and 12 weeks
Assessment of the acceptability of the therapy by using a scale from 1 very accepted to 10 not accepted at 6 weeks and 12 weeks
Assessment of patient compliance through pill counts and adherence to the prescribed regimen at 6 weeks & 12 weeks |
Baseline 6 weeks and 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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 4 |
|
Date of First Enrollment (India)
|
20/10/2025 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 is a prospective multicenter post marketing observational study to evaluate the effectiveness of an oral multivitamin and multimineral supplement also containing amino acids in patients with hair loss telogen effluvium with age group 18 to 60 years This multicenter study will enrol approximately 200 patients with telogen effluvium The patients will be followed up for 3 months after enrolment The enrolment of patients for the study will be based on the approved protocol by the local ethics committee All the patients with a clinical diagnosis of telogen effluvium, meeting all inclusion and none of the exclusion criteria, and ready to give informed consent for study participation, are eligible for participation in this observational study The study is planned to be conducted for approximately 12 months. |