60 （1028）

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第 11 号（2016 年 11 月）

HAIR RESTORATION EFFICACY OF SUPPLEMENTSCONTAINING BANANA EXTRACT, PARTHENOLIDE DERIVED FROM FEVERFEW,AND SOY ISOFLAVONE IN HEALTHY JAPANESE― A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY ―Masatomo NAJIMA1), Akinobu MIYATA2), Katsuhisa KINOSHITA3)
Asako HORIKAWA3) and Kenji KUNISHIGE3)
1) JACTA (Japan Clinical Trial Association)2) Nihonbashi M s Clinic3) Kitanotatsujin Corporation

Abstract
Objective The objective of this research was to investigate the effectiveness of daily
ingestion of a capsule, which contains banana extract, parthenolide derived from Feverfew,
and soy isoﬂavone on hair growth.
Methods A randomized, placebo-controlled, double-blind study was conducted. To
evaluate, the thickness of the hair, the level of sebum around the pore, 6 indexes to scorethe condition of the scalp (inflammation, rash, amount of dandruff, pore-clogging, sebum
capacity and dryness) and the physician s assessments of the change in scalp coverage were
measured.
Results From all of 83 applicants, 43 were eliminated according to the Hamilton s index ofthinning hair (for males), or according to the modiﬁed Ludwig Type (for females). Among 40
subjects, 4 were withdrawn due to illness or business, and the remaining 36 subjects
completed the study (MO = 16: M ; 8, F ; 8, Placebo = 20: M ; 11, F ; 9). After 12 weeks
ingestion, the study showed significant improvement in the level of sebum around thepore , the condition of the scalp, including amount of dandruﬀ, pore-clogging, and sebum
capacity , and the physician s assessments of scalp coverage . The result of selfassessment also showed the signiﬁcant improvement in many items related to hair loss. No
adverse eﬀects were observed after the ingestion of the test product.
Conclusion We found out that, compared with Placebo, the ingestion of the supplement
containing banana extract (cycloeucalenone), parthenolide derived from Feverfew, and soy
isoflavone for 12 weeks contributed to hair restoration, which is achieved by the
improvement of scalp conditions such as pore-clogging, dandruff, and/or itching, and by
reducing hair loss. In addition, no safety-related matters occurred during the 12-week test
period.
Key words banana, Feverfew, parthenolide, soy isoflavone, hair growth, hair loss, hairfollicles, scalp condition

1. INTRODUCTION
We tend to build up anxiety regarding hair loss withadvancing age. Along with slimming products, a
substantial amount of products for hair are released andbecome outdated every day in the current market.
Although the problem of hair loss or thinning hair is aphysiological phenomenon, still many people areconscious about thin hair or hair loss since the hair eﬀects
his/her outward impression. According to the statistics
conducted by Itami, et al., about 12.6 million men areaware of thinning hair, about 8 million men are concerned
about thinning hair, and about 6.5 million men haveexperiences of coping with the thinning hair problem 1). In
addition, another study recently reported the mechanismof thin hair: that is, with advancing age the hair follicle
stem cells (which play an important role in hair
regeneration) stop their self-replication, and this action
leads to lack of XVII-type collagen which encourages thetransformation of the hair follicle stem cells to corniﬁed
cells. As a result, the corniﬁed cells drop out of skin andthe hair follicles themselves become miniature , andeventually the hair becomes thinner and thinner, andﬁnally falls out 2).
Although everyone run the risk of thinning hair withadvancing age, the degree of which thinning hair occurs,

診療と新薬・第 53 巻

ranges from person to person. The risk of thin hair isthought to increase by several factors such as unbalanced
dietary habit, irregular living, heavy drinking, smoking,eyestrain due to overuse of electric devices, and/or scalp
uncleanliness. For the prevention, some try to change
their life style, and others start to use shampoo dedicatedto the removal of scalp uncleanliness. In addition, there
are some curative medicines against AGA (androgenetic
alopecia) in the market 3). However, since these medicines
are only available via prescription, obtaining them issomewhat a hurdle for general consumers. This fact
accelerates the need to prevent the thinning hair problem
simply by taking supplements. Although many
supplements advocating their function of hair restoration
are sold in Japan, there are few published reports that
discuss its eﬀect and safety for Japanese hair.
Therefore in this study, we examined the eﬀects of hair
restoration by ingesting a supplement containing banana
extract which contains plenty of vitamins, amino acids,and plant sterols4)5), which is thought to have function of
suppressing male hormones, parthenolide derived fromFeverfew which is reported to have functions ofimproving blood flow, suppressing the release ofserotonin that is a sort of excitatory transmitter and antiinﬂammatory6)7), and soy isoﬂavone which is known for
its female hormone-like eﬀect 8). The test method was arandomized, placebo-controlled, double- blind study,
using Japanese as its test target.

2. METHODS
2.1. Trial design
A randomized, placebo-controlled, double-blind study was
conducted with the aid of a fund from Kitanotatujin
Corporation (Sapporo) at two centers, OZ clinic (Tokyo)
and JACTA (Tokyo). The study period was 12 weeks,
from December 18, 2015 to March 11, 2016. This study
was conducted in accordance with the ethical principlesof the declaration of Helsinki. The study protocol was
a p p r o ve d b y t h e I n s t i t u t i o n a l R e v i e w B o a r d o f
Pharmaceutical Law Wisdoms (Tokyo). Written informed
consent was obtained from all subjects.
The allocation of the test product to the subjects was
carried out by the person in charge of allocation. The
allocation list was sealed and strictly controlled in a safe
deposit box of JACTA until the end of the study.
2.2. Subjects
Healthy subjects participated in the present study. Allof the subjects in this study were public volunteers who
had enrolled in the monitor bank of CROee Inc. (Tokyo),recruited from November through December in 2015.
2.2.1. Inclusion criteria(1) Healthy people aged between 30 and 59 years;(2) Male with Hamilton-Norwood Hair Loss Scale II or
III;(3) Female with modiﬁed Ludwig Type 1 or 2.
Hamilton-Norwood Scale 9)10) is a way of measuring the

第 11 号（2016 年 11 月）

Table 161（1029）

Nutritional content of the sample per 100 g

Item

MO

PlaceboProtein23.3 g16.4 g

Lipid
Carbohydrates
EnergySalt equivalent

4.3 g
60.5 g
374 kcal
0.706 g76.0 g
277 kcal
0.114 g2.2 gpattern of baldness in males and is generally accepted.
The typical pattern of hair loss is divided into sevencategories. The higher the number, the more advanced.
Type II indicates minor recessions of the frontal hairline.
Type III shows farther frontal hair loss, and is considered
cosmetically signiﬁcant.
On the other hand, Ludwig Type 11) is the measurementof hair loss for females and is used worldwide. Ludwig
Type has 3 diﬀerent classiﬁcations. In Type I, hair loss is
considered to be mild. Hair loss may occur on the top andfront of the scalp. Such hair loss may be noticeable when
the hair is parted down the center of the scalp. In thisstudy we adopted subjects with this type and subjects
with a little milder than this type.
2.2.2. Exclusion criteria(1) Individuals diagnosed with alopecia;(2) Individuals undergoing treatment of thinning hair;(3) Individuals taking medication, including herbal
medicines;(4) Individuals who are pregnant or lactating;(5) Individuals judged to be unsuitable to participate in
the trial by the principle investigator.
2.3. Randomization
From all of 83 applicants, 43 were eliminated according to
Hamilton-Norwood Hair Loss Scale (for male), or
modified Ludwig Type (for female). The inclusion
criterion was judged by the principle investigator.
All subjects were sequentially allocated to Group A(n = 20) and Group B (n = 20) based on a random number
table. In the process of subject assignment, backgroundfactors such as gender, age, and thickness of the hairwere taken into consideration to avoid biased distribution.
Subjects in Group A ingested placebo and subjects inGroup B ingested the test sample for 12 weeks.
2.4. Description of test foods and blinding
The test product MOSIGN ( MO ) was prepared by
Kitanotatsujin Corporation. The amount of daily intake
was 4 capsules (1 capsule weighed 260 mg, therefore 4
capsules weighed 1,040 mg). The Placebo did not include
banana extract, parthenolide derived from Feverfew, andsoy isoﬂavone. Table 1 shows the nutritional content of
the sample. Both capsules were indistinguishable inshape, color or taste. Capsules were managed by theidentiﬁcation symbol. All involved were blinded.

62 （1030）

診療と新薬・第 53 巻

Table 2

第 11 号（2016 年 11 月）

Schedule for the study

Term
Item
Informed consent
Selection and/or allocation
Thickness of the hair
Level of sebum around the pore
6 indexes to score the condition of the scalp
Physician s assessment of the change in scalp coverage
Subjective reporting
Ingestion of test foods
Log

Screening

Test period

Pretrial
test

4w

8w

12 w

●
●
●
●
●

●
●
●
●

●
●
●
●

●
●
●
●
●

●
●

● : Implementation↔ : Daily practice during the test period

2.5. Experimental procedures
2.5.1. Experimental protocol
Subjects consumed 4 capsules of the supplement with hotor cold water every day for 12weeks. Subjects were
instructed as follows: to take the assigned foods as
indicated; to maintain their usual lifestyles and habits; toavoid excessive amounts of food, drink or alcohol; torecord a daily diary of their life style during the test
period; and to send the diary to the study coordinator.
2.5.2. Outcome
The objective of this study was to verify the eﬀect of hair
growth by ingesting food containing banana extract,parthenolide derived from Feverfew, and soy isoﬂavone.
To evaluate this objective, the thickness of the hair, thelevel of sebum around the pore, 6 indexes to score thecondition of the scalp (inflammation, rash, amount ofdandruff, pore-clogging, sebum capacity, and dryness),
and the physician s assessments of the change in scalp
coverage were measured as the primary outcomes.
The average thickness of the hair was calculated by thefollowing method;- the crown of the head was cleansed.
- 3 single hairs from an area of 3 cm2 were cut.
- the circumference of 1 cm from the bottom of the hair
was measured, using the digital micro meter (Shinwa
Rules Co., Ltd., Niigata) for the computation of theaverage.
The level of the sebum around the pore in the area ofthe thinning hair was assessed with photographs taken bya microscope-camera (UK-02, MIYOSHI CORP., Tokyo)
by the principle investigator. The assessments wererated on a scale of − 4 to + 4. The rating was performed
as follows: 0 = baseline status, 4 = highly improved,
3 = improved, 2 = moderately improved, 1 = mildly
improved − 4 = highly deteriorated, − 3 = deteriorated,− 2 = moderately deteriorated, − 1 = mildly deteriorated.
6 indexes to score the condition of the scalp(inflammation, rash, amount of dandruff, pore-clogging,sebum capacity, and dryness) were evaluated withphotographs of the area of thinning hair. The principle
investigator rated on a scale of 0 to 4, with lower scoresindicating a better result.
The physician s assessment of the change in scalp
coverage was performed with photographs of the area ofthe thinning hair. The rating was performed on a scale of−1 t o 1 , −1 =d e t e r i o r a t e d , 0 =n o c h a n g e ,1 = improved.
Subject s self-assessments of the hair and scalp werealso observed as the primary outcome. The questionnaire
covered: hair fallout during shampooing and in daily life,
tension of the hair, texture of the hair, sebum capacity ofthe scalp and itching of the scalp. They were rated in 9
grades from 1 to 9. Better condition was indicated by ahigher grade and poorer condition by a lower grade.
To evaluate the safety of the test sample, adverse
events were collected by means of a written
questionnaire during the study.
As shown in the test schedule in Table 2, parameters
on eﬃcacy and safety were measured.
2.6. Data analysis
A full analysis set was adopted in the present study andno sample size design was used. Data was expressed asmean ± SD. For the thickness of the hair, differencesfrom the baseline in the same group were assessed using
the paired t-test. Student t-test was used for intergroupcomparisons of changes from the baseline. For the levelof sebum around the pore and subjective reporting of thehair and scalp condition, changes from baseline in thesame group were assessed using Wilcoxon signed-rank
test. Mann-Whitney U test was used for intergroupcomparisons of changes from the baseline. As for the 6indexes to score the condition of the scalp and thephysician s assessment of the change in scalp coverage,
Wilcoxon signed-rank test was conducted for intragroupcomparison, and ANOVA for intergroup comparison.
Student s t-test was used to compare subject backgrounds
between groups.
Multiplicity according to the occasions was not診療と新薬・第 53 巻

第 11 号（2016 年 11 月）

63（1031）

Assessed for eligibility (n ＝ 83)〔M: 46, F: 37〕

Enrollment

Excluded (n ＝ 43)〔M: 24, F: 19〕¨Did not meet inclusion criteria (n ＝ 43)¨Declined to participate (n ＝ 0)
¨Other reasons (n ＝ 0)

Randomized (n ＝ 40)〔M: 22, F: 18〕

Group AGroup B

Allocation
Allocated to Placebo (n ＝ 20)〔M: 11, F: 9〕¨Received allocated intervention (n ＝ 20)

Allocated to MO (n ＝ 20)〔M: 11, F: 9〕¨Received allocated intervention (n ＝ 20)¨Did not receive allocated intervention (n ＝ 0)

¨Did not receive allocated intervention (n ＝ 0)

Follow-Up
Lost to follow-up (n ＝ 0)
Discontinued intervention (n ＝ 4)〔M: 3, F: 1〕

Lost to follow-up (n ＝ 0)
Discontinued intervention (n ＝ 0)

¨Unwell (n ＝ 1)〔M: 0, F: 1〕¨Unexpected business (n ＝ 3)〔M: 3, F: 0〕

AnalysisAnalysed (n ＝ 20)〔M: 11, F: 9〕¨Excluded from analysis (n ＝ 0)

Analysed (n ＝ 16)〔M: 8, F: 8〕¨Excluded from analysis (n ＝ 0)

Fig. 1 Flow diagram of subject disposition

Table 3 Subject demographics
Item

Unit

PlaceboMO

Subjects
Male: female ＊numbers
numbers
years
mm

20
11:9
44.4 ± 9.3
0.0394 ± 0.0128

16
8:8
48.3 ± 7.8
0.0474 ± 0.0118

Age ＊Thickness of the hair ＊mean ± SD＊

No signiﬁcant diﬀerence

adjusted. Any subjects with missing values were
eliminated from the analysis. Statistical analyses were
performed using Statcel 3 (Yanai, 2011). The results
were considered signiﬁcant at a < 5% level in the twosided test.

3. RESULTS
3.1. Participant demographics
The 40 subjects were randomly assigned to intervention
groups and made a start with ingestion. 4 werewithdrawn due to being unwell or unexpected business,and the remaining 36 subjects completed the study. Thus,
data obtained from 36 subjects (MO; 16, Placebo; 20) was

64 （1032）

診療と新薬・第 53 巻

Table 4

第 11 号（2016 年 11 月）

Changes in the thickness of the hair and the level of sebum around the pore

Item

Values/ Scores

Time point（unit）

Thickness ofthe hair（mm）

Level ofsebum aroundthe pore（score）

P‑value 2）MO（n = 16）1）

Placebo（n = 20）1）

Baseline
4‑week⊿ 0‑4 w

0.0394 ± 0.0128
0.0418 ± 0.0111
0.0024 ± 0.0147

0.0474 ± 0.0118
0.0459 ± 0.0078− 0.0015 ± 0.0078

0.316

8‑week⊿ 0‑8 w

0.0720 ± 0.1016
0.0326 ± 0.1033

0.0643 ± 0.0987
0.0169 ± 0.0973

0.642

0.0663 ± 0.0978
0.0189 ± 0.1018

0.716

0.00 ± 0.00
− 0.15 ± 0.49
− 0.15 ± 0.49

0.286

12‑week⊿ 0‑12 w

0.0489 ± 0.0124
0.0095 ± 0.0087

Baseline
4‑week⊿ 0‑4 w

0.00 ± 0.00
0.13 ± 0.50
0.13 ± 0.50＊＊＊

8‑week⊿ 0‑8 w

0.44 ± 0.63
0.44 ± 0.63

12‑week⊿ 0‑12 w

0.56 ± 0.63 ＊0.56 ± 0.63

− 0.30 ± 0.57
− 0.30 ± 0.57＊

− 0.35 ± 0.59 ＊− 0.35 ± 0.59

0.007 ##
＜ 0.001 ##Values and scores are expressed as the mean ± SD.
1） ＊ p ＜ 0.05, ＊＊ p ＜ 0.01 against baseline.
2）## p ＜ 0.01 between-group diﬀerence in change from baseline.

Table 5 6 indexes to score the condition of the scalp
Item

Group

Inﬂammation

p‑value 2）

ScoresBaseline

4‑week 1）

8‑week 1）

12‑week 1）

Time×GroupMO
Placebo0.00 ± 0.00
0.00 ± 0.00

0.00 ± 0.00
0.00 ± 0.00

0.00 ± 0.00
0.00 ± 0.00

0.00 ± 0.00
0.05 ± 0.22

0.499

Rash

MO
Placebo

0.19 ± 0.54
0.20 ± 0.52

0.00 ± 0.00
0.15 ± 0.49

0.06 ± 0.25
0.15 ± 0.37

0.00 ± 0.00
0.00 ± 0.00

0.779

Amount of dandruﬀ

MOPlacebo0.25 ± 0.68
0.05 ± 0.22

0.13 ± 0.34
0.00 ± 0.00

0.00 ± 0.00
0.20 ± 0.41

0.00 ± 0.00
0.05 ± 0.22

0.018 #

Pore-clogging

MO
Placebo1.13 ± 0.72
0.75 ± 0.64

1.00 ± 0.82
0.75 ± 0.55

0.69 ± 0.70 ＊0.75 ± 0.55

0.63 ± 0.72 ＊0.95 ± 0.60

＜ 0.001 ##Sebum capacity

MO
Placebo0.88 ± 0.72
0.75 ± 0.44

0.50 ± 0.63 ＊0.75 ± 0.44

0.38 ± 0.62 ＊0.85 ± 0.49

0.25 ± 0.45 ＊0.90 ± 0.45

＜ 0.001 ##Dryness

MO
Placebo

0.19 ± 0.54
0.05 ± 0.22

0.06 ± 0.25
0.05 ± 0.22

0.00 ± 0.00
0.05 ± 0.22

0.00 ± 0.00
0.05 ± 0.22

0.085 ‡

MO; n = 16, Placebo; n = 20
Scores are expressed as the mean ± SD.
1）＊ p ＜ 0.05 intra-group diﬀerences against baseline.
2）‡ p ＜ 0.1, # p ＜ 0.05, ## p ＜ 0.01 between-group diﬀerence

used for efficacy analysis (Fig. 1). There were no
signiﬁcant diﬀerences in the mean age, gender ratios, orThickness of the hair between groups. (Table 3.)
3.2. Thickness of the hair, Level of sebum aroundthe pore
Table 4 shows the changes in the thickness of the hairand the level of sebum around the pore.

After 12 weeks ingestion, the values of the MO showed asigniﬁcant diﬀerence in the thickness of the hair, whereas
the Placebo showed no differences. As for the level ofsebum around the pore, the values of the MO showed asigniﬁcant diﬀerence of plus at week 8 and 12, whereas
the Placebo group showed that of minus at week 8 and12. Moreover the diﬀerences in change between the two

診療と新薬・第 53 巻

Table 6Group
MO
Placebo

第 11 号（2016 年 11 月）

65（1033）

Scalp coveragep‑value 2）

ScoresBaseline
0.0 ± 0.0
0.0 ± 0.0

4‑week 1）
0.2 ± 0.4
0.1 ± 0.2

8‑week 1）
0.4 ± 0.5
0.1 ± 0.3＊

12‑week 1）
0.3 ± 0.4
0.1 ± 0.3

Time×Group†0.029 #

MO; n = 16, Placebo; n = 20
Scores are expressed as the mean ± SD.
1）† p ＜ 0.1, ＊ p ＜ 0.05 intra-group diﬀerences against baseline.
2）# p ＜ 0.05 between-group diﬀerence

Table 7 Results of questionnaire analyses
ScoresItem

TimepointsMO（n = 16）

Hair fallout during shampooing

Baseline
12‑week⊿ 0‑12 w

5.0 ± 1.6
6.1 ± 1.3 ＊1.1 ± 1.3

5.1 ± 0.9
4.9 ± 1.1
− 0.2 ± 0.6＜ 0.001 ##Baseline
12‑week⊿ 0‑12 w

4.9 ± 1.3
5.9 ± 1.1 ＊1.1 ± 1.5

5.0 ± 0.6
4.8 ± 0.8
− 0.2 ± 0.5

0.001 ##

Baseline
12‑week⊿ 0‑12 w

5.1 ± 1.1
6.1 ± 1.0 ＊＊1.0 ± 1.2

4.8 ± 0.8
4.6 ± 0.8
− 0.2 ± 0.7

0.002 ##

Baseline
12‑week⊿ 0‑12 w

5.1 ± 1.2
6.1 ± 0.9 ＊0.9 ± 1.2

5.0 ± 0.9
4.8 ± 1.2
− 0.2 ± 0.6

0.004 ##

Baseline
12‑week⊿ 0‑12 w

4.9 ± 1.2
5.6 ± 1.4 †0.7 ± 1.4

4.9 ± 0.9
4.9 ± 1.0
0.0 ± 0.6

0.027 #

Baseline
12‑week⊿ 0‑12 w

5.3 ± 1.4
6.0 ± 1.1 ＊0.8 ± 1.2

5.2 ± 1.3
5.0 ± 1.3
− 0.2 ± 0.4

0.0104 #Hai fallout in daily life

Tension of the hair

Texture of the hair

Sebum capacity of the scalp

Itching of the scalp

1）

Placebo（n = 20）1）

P‑value 2）

Scores are expressed as the mean ± SD.
1）† p ＜ 0.1, ＊ p ＜ 0.05, ＊＊ p ＜ 0.01 against baseline.
2）# p ＜ 0.05, ## p ＜ 0.01 between-group diﬀerence in change from baseline.

groups illustrated signiﬁcant diﬀerence at week 8 and 12.
3.3. 6 indexes to score the condition of the scalp
Table 5 shows the results of 6 indexes to score thecondition of the scalp.
The values of the MO showed a signiﬁcant diﬀerence in
the items of pore- clogging at week 8 and 12, and inthat of sebum capacity at week 4,8 and 12, whereas thePlacebo showed no signiﬁcant diﬀerence in all items. In
addition, the intergroup analysis of changes after 12
weeks presented a significant difference in the items
including Amount of dandruff , Pore-clogging , andSebum capacity . Dryness tended to decrease.

3.4. The physician s assessment of the change inscalp coverage.
The physician s assessment of the change in scalp
coverage is shown in Table 6.
Signiﬁcant diﬀerences were observed in the intragroup
analyses of the MO at week 8 and 12. Furthermore, theintergroup comparison of changes after 12 weeks showeda signiﬁcant diﬀerence.
3.5. Subject s self-assessment
The result of subject s self-assessment is shown in Table
7.
Changes from week-0 values in all six items of Hair
fallout during shampooing , Hair fallout in daily life ,Tension of the hair , Texture of the hair , Sebum66 （1034）

診療と新薬・第 53 巻

capacity of the scalp , and Itching of the scalp weresigniﬁcantly greater in the MO than in the Placebo after
12 weeks ingestion.
3.6. Safety
No adverse eﬀects associated with the test product wereobserved in the course of the reporting.

4. DISCUSSION
We conducted a randomized, placebo-controlled, doubleblind study examining the efficacy of a supplement
containing banana extract (cycloeucalenone),parthenolide derived from Feverfew, and soy isoﬂavone,on hair restoration of Japanese men and women.
As the primary outcome, the study showed thesignificant improvement in the level of sebum aroundthe pore , the condition of the scalp of amount ofdandruff, pore-clogging, and sebum capacity , and thephysician s assessments of scalp coverage . The result of
self-assessment also showed significant improvement inmany items related to hair loss. Therefore this suggeststhat there is a trend toward hair restoration whit theingestion of the test product. In addition, as thesecondary outcome, the fact that no adverse event had
occurred during the test period proved that no abnormalchange is triggered by the ingestion of the test product.
Main Findings
This study indicates the possibility of hair restoration by
the ingestion of the test products containing banana
extract (cycloeucalenone), parthenolide derived fromFeverfew, and soy isoﬂavone. After 12-week ingestion of
the test product, it showed significant differences
between groups in level of sebum around the pore , andthe condition of the scalp of amount of dandruff, poreclogging, and sebum capacity . As for thickness of thehair , MO showed the significant differences in the
results after 12-week ingestion compared to those at the
beginning, whereas there was no signiﬁcant diﬀerence inPlacebo. In addition, the ingestion of the test producttended to improve in Dryness of the condition of thescalp. Furthermore, Scalp coverage showed
improvement after 12-week ingestion. The result of theself-assessment also showed significant differences in
items such as Hair fallout during shampooing , Hair
fallout in daily life , Tension of the hair , Texture of
the hair , Sebum capacity of the scalp , and Itching of
the scalp , which supports the self-assessment that thecondition of the hair and scalp had improved and theamount of hair loss had decreased. Based on the above, it
can be said that 12-week ingestion of the test productimproved the scalp condition such as pore-clogging,dandruff, or itching and also improved one s subjective
impressions of their hair/scalp condition and the amountof hair loss; these results indicate the test product likely
has hair restorative properties.
The test product contains banana extract(cycloeucalenone), parthenolide derived from Feverfew,

第 11 号（2016 年 11 月）

and soy isoflavone. Although the reasons for increasing
the amount of hair loss may vary depending on the typeof hair loss among males/females, it is thought that
androgen is one of the key factors for the growth of abeard, chest hair, terminal hair on the four limbs, hair of
the frontal cortex and top of the head 12). Testosterone,
which is as a male hormone, is metabolized to thestronger hormone of dihydrotestosterone by the functionof 5α-reductase. It is said that when thedihydrotestosterone combines with the androgen
receptor and moves to the nucleus of Follicle Dermal
Papilla Cells, the alopecia factor is discharged from thecells, damages the hair root and eventually causes
atrophy (loss of hair) 13). Banana extract is reported tocontain cycloeucalenone, a type of phytosterol 14). It isreported that phytosterol has a function of inhibiting theactivity of 5α-reductase and preventing hair loss 15). In
addition, bananas may possibly be an agent for hair
regeneration since it contains plenty of glutamic acid andarginine which are both constituent amino acids of thehair 16)17). It also contains vitamins and minerals such as
Vitamin B2 which accelerates hair metabolism andVitamin B6 which stimulates the generation ofprotein 18)19) . In addition, parthenolide contained inFeverfew is a plant- derived sesquiterpene lactone andhas a function of anti-inflammatory properties 20) .
Parthenolide also functions as an inhibitor of a protein
complex called nuclear factor- kappa B, which isconverted to testosterone and dihydrotestosterone 21)22); inother words, it prevents the hair loss by the samefunctional mechanism as the cycloeucalenone containedin the banana extract. Soy isoflavone is a type ofpolyphenol which has a structural similarity to the female
hormone (estrogen), and it is reported that since it
functions the same as a female hormone internally, as
appropriate, it suppresses the dihydrotestosterone 23).
Therefore, the prevention of hair loss as a result ofsuppression of the dihydrotestosterone is to be expected.
There are reports that male hormone such as
dihydrotestosterone stimulates sebum secretion of
scalp 24)25). It is considered that the ingestion of test
product suppresses the dihydrotestosterone and sebum
secretion of scalp, eliminates the pore-clogging, leads tothe improvement of scalp condition and eventuallycontributes to maintaining good quality hair. Achieving
this quality of hair may be a result of the provision ofgood nutrition for hair using elements found in bananas.
In addition, since there is a report that isoflavonespromote hair growth by increasing the insulin-like growth
factor (IGF-I) production in hair follicles 26) , it isreasonable to consider that the ingestion of the test
product has promoted the hair growth and affected thequality of hair positively.
Based on the above discussion, it is thought that thefunctions of each ingredient contained in the test product,
and mutual eﬀects among them, both contributed to hair

診療と新薬・第 53 巻

restoration.
Secondary Findings
In this study, adverse events were collected by means ofa written questionnaire during the study, and noabnormal change caused by the test product wasobserved during the ingesting period. During the test
period four test subjects discontinued the test. The
reasons for discontinuance were personal ones such as
illness (catching a cold) or business-related matters, andit had nothing to do with the ingestion of the test product.
These results indicated the safety of the ingestion of thetest product for the 12-week test period.
General Information
Generally, the hair appearance plays quite an importantrole in one s first impression to others, therefore hair
health may signiﬁcantly eﬀects one s quality of life (QOL).
In clinical practice medicine with an active ingredient offinasteride which suppresses 5α- reductase is widelyused, but at the same time, many reports point out thatits usage also triggers several side effects such as ED(erectile dysfunction), liver dysfunction, cancer,
depressive symptoms, and/or sterility 27)-29). In addition,s i n c e f i n a s t e r i d e i s a b s o r b e d i n t o t h e b od y v i apercutaneous absorption, the ingestion of ﬁnasteride by apregnant women can trigger adverse effects on normal
development of the sexual organs of a fetus 30)31).
There were no abnormal changes observed after theingestion of this test product for 12 weeks. Also, theingredients contained in the test product such as banana
and soybeans are foods we eat quite regularly. Feverfew,
on the other hand, is not a common food in Japan, but iswidely consumed as a herb in the place of origin andtherefore the safety is verified. Although the degree ofeffectiveness might be somewhat gradual compared tothat of medicine, ingesting the food products expected tosuppress 5α- reductase, and a lower risk of the abnormalchange which can contribute not only to preventing hairloss but also to improving our QOL.
Limitations
The problem of thinning hair has several types which
diﬀer between men and women, and the process of hairloss varies depending on these types 32)-35). In some types
the hair loss occurs even without any involvement ofmale hormones. Therefore the result of this study should
not apply to every type of hair loss or thinning hairproblem. In addition, although the test product used forthis study contains ingredients which are viewed ashaving several functionalities, we have not yet discovered
the mutual influence among them when ingested
simultaneously, or how the mutual influence between
these ingredients and the other components of the test
product aﬀected the hair restoration. Therefore, it can besaid that the functional mechanism found in this study ismerely a speculation based on knowledge of each
ingredient, and it is necessary to further scrutinize thefunctional mechanism by various methodologies including

第 11 号（2016 年 11 月）

67（1035）

in vivo- / in vitro study.

5. CONCLUSION
In conclusion, we found out that, compared with Placebo,
the ingestion of the supplement containing banana extract(cycloeucalenone), parthenolide derived from Feverfew,
and soy isoflavone for 12 weeks contributed to the hair
restoration, which is achieved by the improvement thescalp condition such as pore-clogging, dandruff and/or
itching, and by reducing hair loss. In addition, no safetyrelated matter occurred during 12-week test period.
CONFLICT OF INTEREST
All parts of this study were funded by Kitanotatsujin Corporation.
Katsuhisa Kinoshita is a principal, Asako Horikawa is a director, and Kenji
Kunishige is an employee of them. All authors state that the study was
conducted in the absence of any other relationships that could beinterpreted as a conﬂict of interest.

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