A 24-Week, Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate the Efficacy and Safety of Proso Millet and Wheat Extract(Keranat™) on Hair Health
Phase: NA
Conditions: Hair Damage
Sponsor: Nutracore

Protocol Number NC07-NOVA-2022 
Protocol Ver1.5_01 Dec 2023 
 
A 24-Week, Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate the 
Efficacy and Safety of Proso Millet and Wheat Extract(Keranat™) on Hair Health 
Brief Title 
Evaluate 
the 
Efficacy 
and 
Safety 
of 
Proso 
Millet 
and 
Wheat 
Extract(Keranat™) on Hair Health 
Protocol Number 
NC07-NOVA-2022 
Study Design 
Randomized, Double blind, Parallel Assignment 
Name of product(s) 
Keranat™(proso millet and wheat extract) 300 mg/capsule, and respective 
matched Placebos. 
Indication 
Hair health / Dietary supplement 
Phase 
Interventional- Dietary supplement 
Enrollment: 
100 (50 Experimental, 50 Placebo Comparator) 
How to eat 
Take 1 capsules 2 times daily for 24 weeks 
Sponsor/CRO 
Novarex / Nutracore 
Site 
Korean Skin Research Center(KSRC) 
Seongnam-si, Gyeonggido, South Korea, 11234 
 
1. 
Background 
Millet (Panicum miliaceum) and its main compound, miliacin, arouse a lot of interest in 
dermatological research, especially for its tissue repair and wound healing properties. Miliacin, 
also called Panicol or Prosol, belongs to the class of organic compounds known as triterpenoids. 
Miliacin is a white odorless solid crystal practically fat‐ and water‐insoluble. Cellular studies 
using thymocyte and splenocyte cultures have revealed a protective effect of miliacin from DNA 
fragmentation and apoptosis. Animal and clinical studies with suppurating wounds in different 
physiopathological conditions have confirmed and deepened these first results. Thanks to its 
strong anti‐inflammatory properties, topical application of millet oil promoted rapid cleansing of 
the wounds and significantly activated the reparative processes. More recent studies focusing 
on miliacin have showed that it improved cellular renewal and proliferation and promoted the 
process of hair growth. When normal human keratinocytes derived from the foreskin were 
exposed to miliacin (6 mg/mL), the metabolic capacity of these cells was increased (+162%) 
and their proliferation was also stimulated (215%). Miliacin, the main triterpenoid from millet, is 
known to stimulate keratinocyte metabolism and proliferation. Polar lipids are able to form 
vesicles with active compounds and to improve their bioavailability. 

Protocol Number NC07-NOVA-2022 
Protocol Ver1.5_01 Dec 2023 
 
2. 
Trial objective and endpoint 
2.1. 
Objectives 
The purpose of this randomized, double-blind, placebo-controlled study will be to evaluate 
whether the daily intake of Keranat™ for 24 weeks can promote the gloss and elasticity of hairs, 
improve their density and strength, and reduce hair loss. 
2.1.1. Primary Objective 
⚫ 
To evaluate the change in hair elasticity between the Keranat™ and placebo group 
at baseline and 24 weeks, as measured by Expert 7601Tension Testing System. 
⚫ 
To evaluate the change in hair gloss between the Keranat™ and placebo group at 
baseline and 24 weeks, as measured by Skin-Glossy meter GL200. 
2.1.2. Secondary Objective 
⚫ 
To evaluate the change in hair thickness improvement between the Keranat™ and 
placebo group at baseline and 24 weeks, as measured by microscope and ToupLite 
software. 
⚫ 
To evaluate the change in the ratio of anagen hair between the Keranat™ and 
placebo group at baseline and 24 weeks, as measured by Image-Pro® 10 program. 
⚫ 
To evaluate the change in the number of hair loss between the Keranat™ and 
placebo group at baseline and 24 weeks. Collected and counted the number of lost 
hair. 
⚫ 
To evaluate the change in the number of hairs per unit area between the Keranat™ 
and placebo group at baseline and 24 weeks, as measured by Folliscope PS.  
⚫ 
To evaluate the change in hair distribution score through clinical photography 
between the Keranat™ and placebo group before and after intake. This evaluates 
improvement and deterioration on a 7-point scale, with higher scores meaning 
improvement. By comparing photos before and after intake, if there is no change, 0 
points, improvement is a maximum of 3 points, and worsening is a minimum of -3 
points. 
⚫ 
To evaluate the change in Hair health improvement between the Keranat™ and 
placebo group at baseline and 24 weeks. The evaluation was conducted through 
Patient Report Outcome(PRO) using a standardized survey form. Survey allowing 
for participant-report changes in hair health because of intervention using a 7-point 
scale. 
⚫ 
To evaluate the change in serum levels of cytokines through clinical photography 
between the Keranat™ and placebo group at baseline and 24 weeks.  
 

Protocol Number NC07-NOVA-2022 
Protocol Ver1.5_01 Dec 2023 
 
2.2. Trial Endpoints 
2.2.1. Primary Endpoints 
⚫ 
The change of hair elasticity: Change of the week 24 from baseline 
⚫ 
The change of hair gloss: Change of the week 24 from baseline 
 
2.2.2. Secondary Endpoints 
⚫ 
The change of hair thickness: Change of the week 24 from baseline 
⚫ 
The change of anagen hair ratio(%): Change of the week 24 from baseline 
⚫ 
The change in hair loss amount: Change of the week 24 from baseline 
⚫ 
The change of number of hair per unit area: Change of the week 24 from baseline 
⚫ 
The change of hair distribution score through clinical photography: Change of the 
week 24 from baseline 
⚫ 
Self-reported Hair health assessments: Change of the week 24 from baseline 
⚫ 
The change of serum levels of cytokines (IL-1, TNF-α, PGE2): Change of the week 
24 from baseline 
 
2.3.3. Safety Endpoints 
⚫ 
Incidence and severity of adverse events (clinical, laboratory measurements, 
hormone measurement, hCG) 
Safety will be assessed through routine monitoring of adverse events, evaluation 
of hematological and blood chemistry values, regular measurement of vital signs, 
and physical examination at selected trial visits (according to the trial schedule). 
 
3. 
Selection of Patients 
3.1. 
Inclusion Criteria 
⚫ 
Age 19 and 60 
⚫ 
Hair gloss score of 3 or less and a hair damage score of less than 18 according to 
the visual evaluation classification method. 
⚫ 
Willing to maintain the same hairstyle, hair color, hair length, and hair regimen 
throughout the study period. 
⚫ 
Subject must be able to comprehend and voluntarily sign study procedures and 
consent forms. 
3.2. 
Exclusion Criteria 
⚫ 
Those diagnosed with and receiving treatment for the alopecia within 3 months 
before screening (androgenetic alopecia, alopecia areata, Telogen effluvium, etc.) 
⚫ 
Use of that may affect hair or hair loss symptoms treatment medicine, dietary 

Protocol Number NC07-NOVA-2022 
Protocol Ver1.5_01 Dec 2023 
 
supplements, or treatments containing herbal medicine ingredients within 3 months 
before screening. 
⚫ 
Any active scalp or skin disease that may interfere with the study treatment and 
evaluations. 
⚫ 
Pregnancy or breastfeeding or planning pregnancy. 
⚫ 
Case of abnormal values at creatinine (excess at the upper limit of the reference 
range) 
⚫ 
Case of abnormal values at ALT or AST (2 times excess at the upper limit of the 
reference range) 
4. Randomization 
A random number will be assigned during visit 1 (week 0) in the order in which the subject is enrolled 
according to the inclusion and exclusion criteria. Subjects will be assigned to the study group, based 
on a random list prepared by a third party independent of the study before the study begins. Study 
participants will be allocated to the control group, and the test group (KeranatTM) at a 1:1 ratio using a 
block randomization method. The study will be double-blind and group assignments will not be 
disclosed to investigators or subjects until the end of the study. 
5. Study setting and design 
This randomized controlled study will be conducted at the Korean skin research center(KSRC) 
in South Korea. 
This will be a 24-week, randomized, double-blind, parallel group, placebo-controlled trial with 
two arms, as summarized below: 
⚫ 
Arm 1 (Placebo arm): placebo; 300 mg capsule twice a day 
⚫ 
Arm 2 (Test group 1): KeranatTM; proso millet and wheat extract; 150 mg/capsule 
twice a day 
 
Study subjects who voluntarily consent to the study at visit 1 (week 0) will be judged for eligibility 
according to inclusion and exclusion criteria. Selected subjects will be randomly assigned to 
study groups and tested for functional biomarkers after ingesting the experimental or control 
foods for 24 weeks. 
 
 
 

Protocol Number NC07-NOVA-2022 
Protocol Ver1.5_01 Dec 2023 
 
6. Schedule of Events 
Item 
Screening 
Pre-V1 
V1 
V2 
V3 
V4 
V5 
-21~-D1 
D-3 
D0 
8w±7 
 16w±7 
24w-3 
24w±7 
Medicine takes 
history 
● 
 
● 
● 
● 
● 
● 
Physical 
measurement 
● 
Ⅹ 
Ⅹ 
● 
● 
Ⅹ 
● 
Drinking and 
smoking history 
● 
Ⅹ 
Ⅹ 
● 
● 
Ⅹ 
● 
Hair damage 
assessment 
● 
Ⅹ 
Ⅹ 
Ⅹ 
Ⅹ 
Ⅹ 
Ⅹ 
Clinical 
photography (DSLR) 
Ⅹ 
Ⅹ 
● 
● 
● 
Ⅹ 
● 
Hair elasticity 
Ⅹ 
Ⅹ 
● 
Ⅹ 
Ⅹ 
Ⅹ 
● 
Hair gloss 
● 
Ⅹ 
● 
● 
● 
Ⅹ 
● 
Hair thickness 
Ⅹ 
Ⅹ 
● 
Ⅹ 
Ⅹ 
Ⅹ 
● 
Hair loss amount 
Ⅹ 
Ⅹ 
● 
Ⅹ 
Ⅹ 
Ⅹ 
● 
Self-reported Hair 
health assessments 
Ⅹ 
Ⅹ 
● 
Ⅹ 
Ⅹ 
Ⅹ 
● 
anagen hair ratio(%) 
Ⅹ 
Ⅹ 
● 
Ⅹ 
Ⅹ 
Ⅹ 
● 
IL-1, TNF-α, PGE2 
Ⅹ 
Ⅹ 
● 
Ⅹ 
Ⅹ 
Ⅹ 
● 
Laboratory 
measurements 
● 
◐ 
Ⅹ 
Ⅹ 
Ⅹ 
Ⅹ 
● 
Adverse reaction 
Ⅹ 
Ⅹ 
Ⅹ 
● 
● 
● 
● 
Vital sigh 
● 
Ⅹ 
● 
● 
● 
Ⅹ 
● 
Dietary intake 
Ⅹ 
Ⅹ 
● 
Ⅹ 
Ⅹ 
Ⅹ 
● 
Physical activity 
Ⅹ 
Ⅹ 
● 
Ⅹ 
Ⅹ 
Ⅹ 
● 
Life habits 
Ⅹ 
Ⅹ 
● 
Ⅹ 
Ⅹ 
Ⅹ 
● 
Compliance check 
Ⅹ 
Ⅹ 
Ⅹ 
● 
● 
Ⅹ 
● 
 
7. Treatments 
7.1. Investigational Products 
Investigational products supplied for this will include: 
KeranatTM 300mg capsules or matching placebos in PTP packaging are going to be 
supplied to Subjects. 
 
KeranatTM capsules are containing 150mg of proso millet and wheat extract.  
 
7.2. 
Dosage 
All treatment arms consider the regimens in fixed doses. KeranatTM 300mg and placebo 
are administered in two separate daily doses for 24 weeks.  
 

Protocol Number NC07-NOVA-2022 
Protocol Ver1.5_01 Dec 2023 
 
8. Statistical Analysis Plan 
The Statistical Analysis Plan will be written after the protocol finalization and definitely finalized 
before breaking the blind mode, prior to the first database lock. These specifications will detail 
the implementation of all statistical analyzes planned according to the main features reported in 
the protocol. 
8.1. 
Sample size determination 
This study hypothesizes that the use of KeranatTM will improve hair health. Therefore, 
a primary comparison will be conducted between the placebo arm and the test 
arm(KeranatTM). 
 
To calculate the number of test subjects, based on a 24-week intake study similar to 
this clinical trial, the change in hair count per unit area (Mean ± SD) of the test group 
was assumed to be 16.9 ± 15.6 and the control group was 4.5 ± 14.9. (d=12.4) 
(1) H0 : 𝜇𝑡 = 𝜇𝑐 VS H1 : 𝜇𝑡 ≠ 𝜇𝑐 
(2) At the 5% significance level, the type 2 error is 0.2, maintaining 95% power. (α = 
0.05, β = 0.2, statistical power =95%) 
(3) test group : placebo group = 1:1(k=1) 
(4) Calculation program: G*power 3.1.9.2 
 
As a result of calculating the number of subjects using G*power 3.1.9.2, the number of 
subjects was calculated to be 41 per group and a total of 82. After considering the 
dropout rate of 20%, the number of subjects was calculated to be 50 per group and a 
total of 100. 
 
8.2. 
Definition of trial populations included in the analysis 
- 
The efficacy analyses will be performed on the PPS(Per protocol set), defined as all 
randomized subjects by their assigned treatment arms. 
- 
The PPS(Per protocol set) will be defined as subjects receiving randomized 
treatment, who meets entry criteria, have not permanently discontinued treatment 
administration and had no major protocol deviation 
- 
Additionally, efficacy analyses will be performed on a FAS(Full Analysis Set). 
- 
All safety analyses will be performed on the Safety Set, defined as all patients who 
received at least one dose of the treatment. 
- 
Tests of normality will be performed to evaluate the data distribution. Test group of 
continuous variables will be compared to the placebo group using Independent T-

Protocol Number NC07-NOVA-2022 
Protocol Ver1.5_01 Dec 2023 
 
test, analysis of covariance, and the Wilcoxon rank-sum test. Comparison between 
groups according to changes in time will be analyzed using Paired T-test. 
Categorical data will be analyzed using the chi-square test or Fisher’s exact test. A 
two-sided test will be considered significant when the p value <0.05. 
 
9. Confidentiality 
Records confirming the subject’s identity will be kept confidential. Monitoring staff and officers 
involved in the study may access subject records for the purpose of monitoring, reviewing, or 
managing the progress of the study, but such information will also be kept confidential. All documents 
related to the study, such as case records, will be recorded and distinguished using a subject 
identification code, not subject name. The collected information will be kept in the document storage 
room of the research institute for 3 years after the end of the study and will be discarded after 3 years 
according to the standards and procedures prescribed by the Personal Information Protection Act. 
During or after the study, research data, including medical records, may be reviewed to verify the 
conduct of the study and the reliability of the data, but this access is limited to the extent to which 
confidentiality of each subject’s identity is protected.