| CTRI Number |
CTRI/2025/07/090485 [Registered on: 08/07/2025] Trial Registered Prospectively |
| Last Modified On: |
03/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to evaluate the efficacy of test regime in lactating females with hair fall. |
|
Scientific Title of Study
|
An open label, single-arm, clinical study to evaluate the efficacy and safety of a test regime in lactating female with hair fall. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| C3B05859; Version: 01, Dated 18 Jun 25 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bhagirath Patel |
| Designation |
Principal Investigator |
| Affiliation |
Cliantha Research |
| Address |
Consumer Research Department, Corporate House 17, Sigma 1 Corporate House,
BH. Rajpath Club, Off. Sindhubhavan Road, Nr. Mann Party Plot Cross Road, Bodakdev, Ahmedabad-380054-India
Ahmadabad
GUJARAT
380054
India |
| Phone |
9825618138 |
| Fax |
|
| Email |
bpatel3@cliantha.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Simran Sethi |
| Designation |
Director-Consumer Research |
| Affiliation |
Cliantha Research |
| Address |
Consumer Research Department, Corporate House 17, Sigma 1 Corporate House,
BH. Rajpath Club, Off. Sindhubhavan Road, Nr. Mann Party Plot Cross Road, Bodakdev, Ahmedabad-380054-India
Ahmadabad
GUJARAT
380054
India |
| Phone |
9825784942 |
| Fax |
|
| Email |
ssethi@cliantha.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Saurav Patnaik |
| Designation |
Director |
| Affiliation |
ANVEYA LIVING PRIVATE LIMITED |
| Address |
Plot 417, Udyog Vihar Phase 3, Sector 20, Gurugram - 122008, Haryana
Gurgaon
HARYANA
122008
India |
| Phone |
9560993594 |
| Fax |
|
| Email |
saurav@anveya.com |
|
|
Source of Monetary or Material Support
|
| ANVEYA LIVING PRIVATE LIMITED, 417, Udyog Vihar Phase - 3, Sector 20, Gurugram - 122009. |
| Cliantha Research, Corporate House 17, Sigma 1 Corporate House, BH. Rajpath Club, Off Sindhubhavan Road, Nr. Mann Party Plot Cross Road, Bodakdev, Ahmedabad-380054, Gujarat, India. |
|
|
Primary Sponsor
|
| Name |
ANVEYA LIVING PRIVATE LIMITED |
| Address |
417, Udyog Vihar Phase - 3, Sector 20, Gurugram - 122009. |
| Type of Sponsor |
Other [Personal care - FMCG] |
|
|
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 Bhagirath Patel |
Cliantha Research |
Consumer Research Department,
Corporate House 17, Sigma 1 Corporate House,
BH. Rajpath Club, Off Sindhubhavan Road,
Nr. Mann Party Plot Cross Road,
Bodakdev, Ahmedabad-380054, Gujarat.
Ahmadabad
GUJARAT |
9825618138
bpatel3@cliantha.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| OM Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy lactating female subjects complaining of hair fall. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Test Regime
(Serum + Women’s Post-Partum Hair Growth Supplement)
|
ThriveCo Hair Serum 2.0: Approx. 0.5 ml (half dropper) hair serum will be applied to scalp area of hair loss. Once daily application at night (before going to bed) for 3 months.
Women’s Post-Partum Hair Growth Supplement: Two capsules with water each night (after meal). Daily consumption for 3 months. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Healthy lactating female subjects with age between 20 and 40 years (both inclusive at the time of consent).
2. Participants complaining about having at least 50 to 100 hair fall per day.
3. Participants with 50 counts of hair fall from hair combing method (60-sec hair count).
4. Participants having good general health as determined by the Investigator on the basis of medical history and vital signs.
5. Participants of childbearing potential must have a negative urine pregnancy test performed at screening visit. |
|
| ExclusionCriteria |
| Details |
1. Participants with clinical diagnosis of hair loss disorder such as alopecia areata or scarring forms of alopecia.
2. Participants with hair loss due to Autoimmune disorder/ Chemotherapy/ immunosuppressive drugs.
3. Participants with history of surgical correction of hair loss on the scalp.
4. Participants with history of any dermatological condition (like psoriasis or infections) of the scalp other than hair loss OR with any active scalp disease which may interfere in the study.
5. Participants with current hair loss or skin disease (e.g., psoriasis, atopic dermatitis, skin cancer, sun damage, seborrheic dermatitis), infections, cuts, and/or abrasions on the scalp or condition (e.g., sunburn, tattoo) on the treatment area, that in the opinion of the investigator, might put the participant at risk or interfere with the study conduct or evaluations.
6. Participants with a history of chronic health conditions (eg, diabetes, hypertension, chronic renal failure, heart and liver disease), endocrine abnormalities including stable thyroid disease, psychiatric illness, bariatric surgery/eating disorders such as bulimia or binge eating, cardiovascular surgery, or history of any other major surgery.
7. Participants with the history of malignancy OR known history of autoimmune thyroid disease, any other thyroid disorder/abnormality or other autoimmune disorders.
8. Participants with known allergy or sensitivity to cosmetic products and/or any ingredients of the test product.
9. Participants who had undergone chemotherapy or radiation within the last 2 years.
10. Participants who have started using hormones for birth control or hormone replacement therapy within the last 6 months.
11. Participants who have undergone hair regrowth treatments (minoxidil, finasteride, PRP, etc.) within 6 months before screening.
12. Participants who using any products/devices aimed to promote scalp hair growth within the 6 months prior to study initiation.
13. Participants who have applied topical treatment for hair loss for at least 4 weeks and any systemic treatment for at least 3 months, prior to their participation in the study.
14. Participants with a history or presence of significant alcoholism or drug abuse and smoking or consumption of tobacco products.
15. Any other condition which could warrant exclusion from the study, as per the investigator’s discretion. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Clinical assessment of hair fall and Instrumental assessment of Hair thickness and Hair growth rate |
Day 00, Day 45 and Day 90 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Clinical assessment of anagen and telogen ratio (A:T ratio), hair strength, hair and scalp related parameters |
Day 00, Day 45 and Day 90 |
| Instrumental assessment of hair density and Vellus & terminal hair count. |
Day 00, Day 45 and Day 90 |
| Laboratory assessments of hormonal and nutritional blood markers |
Day 00 and Day 90 |
| Participant Evaluation Questionnaire |
Day 45 and Day 90 |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
28/07/2025 |
| 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="0"
Months="3"
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 is an open
label, non-randomized, single-arm, clinical study to evaluate the efficacy and
safety of a test regime (Topical Serum +
Women’s Post-partum Hair growth Supplement) in lactating female with hair fall.
The potential participants
will be screened as per the inclusion and exclusion criteria only after
obtaining written informed consent from the participants.
All eligible
participants will undergo instrumental assessments, dermatological assessments,
laboratory assessments (blood tests) and subjective
assessment. Safety will be assessed throughout the study by monitoring adverse
events and changes in vital signs (Body
temperature, Pulse rate and Blood pressure). |