| CTRI Number |
CTRI/2025/09/094907 [Registered on: 16/09/2025] Trial Registered Prospectively |
| Last Modified On: |
02/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A study to evaluate the efficacy and safety of Plant Keratin on hair fall. |
|
Scientific Title of Study
|
A randomized, double blind, placebo-controlled, parallel group study to evaluate the efficacy and safety
of Plant Keratin in androgenic alopecia subjects. |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 21PR0201-008 (V-1.0), 11 June 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sunil Kumar S |
| Designation |
Consultant Dermatologist |
| Affiliation |
Vagus Super Specialty Hospital |
| Address |
Room no.8,Ground Floor,Department of Dermatology,No 6,7,8, 18th Cross, 4th main, Malleshwaram
Bangalore
KARNATAKA
560055
India |
| Phone |
81519 94080 |
| Fax |
|
| Email |
sunilkims@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhargav Bhongiri |
| Designation |
Head Medical Writer |
| Affiliation |
Syncorp Health Pvt. Ltd. |
| Address |
No.6,3rd Floor,
second Main Road,
sarvobhaogam Nagar,
Arekere.
Bangalore
KARNATAKA
560076
India |
| Phone |
9000518175 |
| Fax |
|
| Email |
bhargav.b@syncorphealth.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhargav Bhongiri |
| Designation |
Head Medical Writer |
| Affiliation |
Syncorp Health Pvt. Ltd. |
| Address |
No.6,3rd Floor,
second Main Road,
sarvobhaogam Nagar,
Arekere.
Bangalore
KARNATAKA
560076
India |
| Phone |
9000518175 |
| Fax |
|
| Email |
bhargav.b@syncorphealth.com |
|
|
Source of Monetary or Material Support
|
| Vagus Super Specialty Hospital, Department of Dermatology,No 6,7,8 18th Cross,4th main,Malleshwaram, Bangalore, Karnataka, India, 560055
|
|
|
Primary Sponsor
|
| Name |
Vidya Herbs Pvt Ltd. |
| Address |
14A,KIADB Industrial Area,
Jigani 1st Phase,Bangalore,Karnataka,India,560105 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Sunil Kumar S |
Vagus Super Specialty Hospital |
Room no.8,Ground Floor,Department of Dermatology,No 6,7,8, 18th Cross, 4th main, Malleswaram,560055-India
Bangalore
KARNATAKA |
81519 94080
sunilkims@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vagus Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L649||Androgenic alopecia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo |
Dose: One capsule (400mg) containing 0 mg of plant keratin,
Dosage form: Capsule,
Frequency: Once daily with dinner for 12 weeks,
Route of administration: Oral |
| Intervention |
Plant Keratin |
Dose: One capsule (400mg) containing 250 mg of plant
keratin,
Dosage form: Capsule,
Frequency: Once daily with dinner for 12 weeks,
Route of administration: Oral
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects in general good health.
2. Subjects aged 20-50 years (both the ages inclusive).
3. Selection of AGA subjects based on Norwood Hamilton scale (male) and Ludwig scale (female).
4. Subjects willing to give written informed consent and willing to abide by and comply with the study protocol.
5. Hair density of greater than 100 and less than 200 hair follicles per square cm as per Trichoscan measurement.
6. The subjects who agree to refrain from using hair dye/hair color during the study period.
|
|
| ExclusionCriteria |
| Details |
1. Subjects who have undergone hair growth treatment within 3 months before screening into the study.
2. Subjects having any active scalp disease which may interfere with the study dermatologists judgment.
3. Subjects who have taken chemotherapy for cancer in the 6 months before the start of the study or have a plan to do treatments during the study.
4. Subjects who have a history of alcoholism, smoking, crash dieting, and/ or psychiatric disorders including trichotillomania.
5. Subjects who have had hair transplants, who have taken pharmaceutical products which cause hirsutism (ex. phenytoin) and finasteride for androgenic alopecia, under medical treatment for hair problems.
6. A known history or present condition of allergic response/hypersensitivity to any cosmetic ingredients and pharmaceutical products.
7. Subjects on oral medications, undergoing any chemical
hair salon treatment-straightening / perming/colour/
henna which will compromise the study.
8. Subjects with chronic illness which may influence the cutaneous state.
9. Subjects who are pregnant or lactating or nursing as established with medical history.
10. Menopausal female subjects as determined by medical history.
11. Subjects participating in other similar cosmetic or therapeutic trials within the last three months.
12. Subjects with any history of underlying uncontrolled medical illness including diabetes mellitus, hypertension, HIV, hepatitis, severe anemia, serious disorders of heart and respiratory apparatus, or any other serious medical illness
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in hair shedding in Comb test and Hair pull test |
Baseline, Week 4, Week 8, Week 12 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Hair density
|
Baseline, Week 12 |
| Thickness |
Baseline, Week 12 |
| A/T ratio- (Trichoscan analysis) |
Baseline, Week 12 |
Hair assessment for smoothness, shine
|
Baseline, Week 12 |
| Scalp & hair health assessment |
Baseline, Week 12 |
| Digital Photography |
Baseline, Week 12 |
| Perceived self-assessment questionnaire (Hair growth index scale) |
Baseline, Week 12 |
| Norwood Hamilton scale |
Baseline, Week 12 |
| Ludwig scale |
Baseline, Week 12 |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
06/10/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Androgens play a crucial role in regulating the scalp and body hair growth.The androgens
can significantly contribute to the specific pattern hair loss called androgenetic alopecia
(AGA). AGA, commonly known as the male pattern baldness is a predominant form of
hair loss affecting both male and female genders worldwide. Although the specific
mechanism of AGA is not completely understood, it is reported that androgen mediated
androgen receptor (AR) activation leads to the hair miniaturization resulting in hair loss. Plant keratin is a protein blend from different plant sources to simulate the amino acid
composition of animal keratin. The first-of-its-kind proprietary formulation of plant proteins
is a blend of extracts from Trigonella foenum-graecum seeds and Pisum sativum seeds. The
plant keratin is in powder form with characteristic odour and taste and a standardized protein
content of 58-60%. The findings from the present study suggest that plant keratin possess the anti-androgenic
property that can contribute as a DHT-blocker in conditions like AGA. Further, the plant
keratin supplementation may stimulate follicular melanogenesis in the anagen phase to trigger
hair regrowth |