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第７号（2015 年７月）

57 （733）

EFFICACY OF FOOD INCLUDING 5,7-DIMETHOXYFLAVONEFOR OBESITY UNDER CONDITIONS
OF A CERTAIN AMOUNT OF EXERCISE
Masatomo NAJIMA,1) Hiromi HASEGAWA2) and Hisako MIURA3)
1) JACTA ( Japan Clinical Trial Association)
2) OZ Clinic3) Mizuhashihojyudo Pharmaceutical Inc

Abstract
Objective: The effects of food including 5,7-Dimethoxyflavone (NMC) for obesity underconditions of a certain amount of exercise were investigated with a placebo-controlled
double-blind trial.
Methods: Healthy, slightly-obese Japanese men and women (30-59 years of age) wererandomly assigned to two groups (n = 25). Each subject ingested 1 capsule of NMC orplacebo and exercised lightly about 7 minuts every day for 12 weeks. Weight, body fat
percentage, BMI, waist circumference, hip circumference and subjective symptoms were
evaluated.
Results: The ingestion of NMC for 12 weeks significantly improved weight, body fat
percentage, BMI, waist circumference and hip circumference relative to that of placebogroup (p < 0.01). An intergroup analysis showed that the weight, body fat percentage, BMI,
waist circumference and hip circumference decreased signiﬁcantly in the NMC group (p <0.05), but not in the placebo group. Subjective evaluations were not signiﬁcantly changed inthis study. No adverse eﬀects attributable to MNC were observed.
Conclusions: These results suggests that the ingestion of MNC under conditions of a certain
amount of exercise for 12 weeks improves obesity prevention and waist and hip
circumferences.
Key words: 5,7-Dimethoxyﬂavone, obesity, black ginger

INTRODUCTION
In contemporary Japan, as the society that often allows
excess intake of calories and irregular lifestyles, many
people have a tendency to be distressed about theirobesity. Obesity is a state of excessive body fat
accumulation than a prescribed level, however, a visceralfat obesity that accumulates excessive fat around internalorgans specially causes high cholesterol and blood sugar
level, and even leads to serious arteriosclerosis at theend.1) Consequently, obesity becomes a major risk factor
of many diseases including so-called lifestyle diseases inreality, prevention and solution of obesity are expectationof many people in common.
Obviously, diet and exercise are essentials toprevention and solution of obesity, however, dietary
supplements have also become one of eﬀective measures
for many people who have the same problem. And those
supplements are made from variety of ingredient inaccordance with its end effect and a role as a nutritioncompensator, an appetite suppressor or a bowel
movement promoter, so on. A black ginger is one of thekind.
A black ginger (Kaempferia parviflora ) that is calledkuro-shouga (or black termeric), or krachaidam in
Thailand as a place of origin, has been known fromancient times as a nourishing Thai herb root to be boiledfor drink when one has an arthralgia. It s been also said
that it contains anthocyanin, methoxyﬂavone, selenium,
amino acid and curcumin, however, above all of those,
5,7-Dimethoxyflavone as a largest portion ofpolymethooxyﬂavone must be the most essential element
for black ginger.2) Originally, 5,7-Dimethoxyflavone hasb e e n r e p o r t e d f o r i t s a n t i - i n f l a m m a t o r y 3) a n dvasorelaxation actions,4) however, black ginger extract
itself that contains abundant 5,7-Dimethoxyﬂavone is said
to be a major functional food element which works for
improvements in bloodstream5) and anti-obesity6) as well.
Therefore, this report aimed to prove the anti-obesity
effect of food that contains black ginger extract(5,7-Dimethoxyﬂavone) as a test material, to a group of
healthy men and women including some light obese
subject, along with a certain level of daily exercise as an
obligation.

MATERIALS AND METHODS
1. Examining Bodies
This study was conducted by JACTA (Japan Clinical Trial
Association, Tokyo) associated with Dr. Mitsuhiko
Munekata. The measurements were carried out in both
JACTA and OZ Clinic (Tokyo).
2. Subjects
The study participants were recruited by JACTA, andselected according to the following criteria.

58 （734）

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Table 1 Components and Nutritional Constituents of the Test Samples
Components of NMC

Components of Placebo

Ingredients

Quantity (mg)

Ingredients

Quantity (mg)Vegetable Fat and Oil
Black Ginger Extract
Dextrin
Cyclodextrin
Ginger Extract PowderBlack Pepper Extract
Grape Seed Extract
Beeswax
Spice Extract
Vitamin E

129.2
13.36
13.32
13.32
36
0.5
0.3
22
1
1

Saﬄower Oil

230 mgNutritional Constituents
EnergyProtein
Fat
Carbohydrate
SodiumNMC

Placebo2.13 kcal
0.1 g
0.16 g0.09 g0.34 mg2.59 kcal
0.1 g
0.23 g0.03 g0.27 mg

Per 1 capsule 230 mg

Inclusion Criteria:① Healthy adults aged 30-59 years
Exclusion Criteria:① Who s BMI score is under 20② Have a prior medical history of food allergy③ Are taking hormonal therapy④ Are in pregnancy or lactation⑤ Are taking drugs that might aﬀect the result⑥ Are taking supplements or functional foods thatmight aﬀect the result⑦ Are judged to be unsuitable test subjects by thedoctor responsible for the present study
The Ethics Committee and Informed Consent:
This study received the approval of the Institutional
Review Board of LLP Pharmaceutical Law Wisdoms inaccordance with the ethical standard established in theHelsinki declaration, and written and spontaneous
informed consent was obtained from the subjects withwritten and oral explanation of the test objective and its
method.
3. Test Materials
Test Food and Placebo:
The test food was Nenshou Meramera Capsule (NMC), a
food supplement containing black ginger extract(5,7-Dimethoxyflavone) (Supplier: Mizuhashihojyudo
Pharmaceutical Inc), along with placebo without the black
ginger extract (5,7-Dimethoxyflavone). Ingredients andnutrient composition of each are indicated in Table 1.
Intake Method:
The test subject were instructed to take 1 capsule, 1 time

per day with water or tepid water, and also recommended
to take it after supper, with proper regards for
restraining carbohydrate intake.
4. Examination Method
Study Design:
Conducted a double-blind, placebo-controlled parallelgroup study.
Allocation of the Subjects:
An allocation manager who was not involved in theexamination assigned the subjects to the test groups(25/25). The allocation status that had been severely kept
during the test period by the allocation manager was
eventually disclosed after ﬁxation of the test results.
Test Schedule:
Table 2 indicates the test schedule. The test period wasset between July and October, 2014; begun withacquisition of baseline data before examination, followedby regular ingestion of test materials for 12 consecutive
weeks. The assay dates were set before ingestion, andafter 4 weeks, 8 weeks and 12 weeks. A biochemical
blood test and an urinalysis were conducted twice, before
ingestion and after 12 weeks. The subjects wereprohibited from engaging in alcohol consumption thenight before, and asked to come to the clinic at the sametime on each examination day after taking regularbreakfast.
During the test period, they were also asked to engage
in light exercise everyday. The exercise was instructedto pull back a belly for 10 sec. and relieve it for another10 sec. during they are walking, and to repeat the motion

診療と新薬・第 52 巻

Table 2Term
Item

BeforeIngestion

Coming to Hospital○

Informed Consent○

第７号（2015 年７月）

Test Schedule

Screening

Selection of Applicants

59 （735）

Test Period (12 w)
After 4 w After 8 w After 12 w
○

○

○

○

Subjective Evaluation

○

○

○

○

Physical Test

○

○

○

○

Blood Test○○

Urinalysis○○

Ingestion of Test Foods
Diary○：Implementation：Daily practice during the test period

20 times (approx. 7 mins per day).They were also
instructed not to take any other new supplements nor
having excessive physical exercises and bulimia for daily
standards. In order to confirm their observance of therules, they were obliged to submit a diary that keeps
daily records of their meals and total count ofpedometers.
5. Examination Items
Evaluation of Eﬀectiveness:① Primary Outcome
The examiner in cooperation with Yamato Biospace
Technology (Yamato Scale Co., Ltd.) conducted physicalmeasurements of weight, body fat percentage, BMI,
waist circumference and hip circumference.
② Secondary Outcome
Subjective evaluations of the participants were conducted
before and after 4, 8, 12 weeks of ingestion, questioning
about their bowel movement, skin condition, physicalcondition in general and sleep, by showing 10-degree
measurement scale from 0 (very bad) to 9 (very good)with 5 as a standard score before ingestion. Fig.1
indicates the questionnaire.
Evaluation of Safety:
Items for safety evaluation were also added to secondary
outcome.
① Biochemical Blood Test
The subjects were taken blood samples after 10 minuterepose from their show ups. It examined in-blood levelsof total bilirubin, total protein, albumen, AST (GOT),
ALT (GPT), ALP, LD (LDH), γ-GT (γGTP), CK (CPK),
total cholesterol, neutral fat (TG), sodium, chloride,potassium, calcium, inorganic phosphorus, urea nitrogen,creatinine, blood sugar (serum).
② Urinalysis
Urinalyses were conducted after the subjects show ups,
examined urine protein, sugar, urobilinogen, keton body,

Questionnaire
Test material
Name

age
Item

Degree of Improvement
0w
1
2
3
4
⑤
6
7
8
9
4w
1
2
3
4
5
6
7
8
9
Bowel
Movement 8 w
1
2
3
4
5
6
7
8
9
12 w 1
2
3
4
5
6
7
8
9
0w
1
2
3
4
⑤
6
7
8
9
4w
1
2
3
4
5
6
7
8
9
Skin
Condition 8 w
1
2
3
4
5
6
7
8
9
12 w 1
2
3
4
5
6
7
8
9
0w
1
2
3
4
⑤
6
7
8
9
1
2
3
4
5
6
7
8
9
Physical 4 w
Condition 8 w
1
2
3
4
5
6
7
8
9
12 w 1
2
3
4
5
6
7
8
9
0w
1
2
3
4
⑤
6
7
8
9
4w
1
2
3
4
5
6
7
8
9
Sleep
8w
1
2
3
4
5
6
7
8
9
12 w 1
2
3
4
5
6
7
8
9
● Your impression after 4 wks? (Name anything you might feel to be
diﬀerent from what it was before.)● Your impression after 8 wks? (Name anything you might feel to be
diﬀerent from what it was before.)● Your impression after 12 wks? (Name anything you might feel tobe diﬀerent from what it was before.)

Fig. 1 Questionnaire for Subjective Evaluation

occult blood, bilirubin (all of above are qualitative) andpH, speciﬁc gravity (both are quantitative).
③ Diary
The subjects life customs and adverse events were
evaluated with examination using diary.
Statistical Processing:
Measured values of each evaluation items were indicatedSD. As for measured values from physicalin Meanevaluation, paired t-test was conducted for intragroupcomparison, and repeated-measures ANOVA was forintergroup comparison. For subjective evaluations,60 （736）

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第７号（2015 年７月）

50 Applicants(F = 26, M = 24)

25 for NMC group(F = 13, M = 12)

25 for Placebo group(F = 13, M = 12)

5 Drop Out(F = 2, M = 3)<Spontaneous>

12 Drop Out(F = 5, M = 7)
<Spontaneous>

Full Analysis Set (FAS)Per Protocol Set (PPS)
20 for NMC group(F = 11, M = 9)

13 for Placebo group(F = 8, M = 5)

Fig. 2 Screening Process of the Subjects

Table 3 Subjects Demographics (PPS)
Item

Unit

NMC

Placebo

Total PPS

Number*Gender (F/M)*
Age
Height
BMI

psn.
psn.
Yr.
cm
kg/㎡

20
11/9
47.8 6.0
163.0 6.4
25.8 3.2

13
8/5
48.2 5.3
163.3 6.9
24.6 3.6

33
19/14
47.9 5.7
163.1 6.5
25.3 3.4*Total number of subjects
Mean SD.
No signiﬁcant diﬀerence

Wilcoxon signed-rank test was for intragroup comparison.
Mann-Whitney U test was for intergroup comparison. For
safety evaluation, paired t-test was for intragroupcomparison. And Student s t-test was for intergroupcomparison. For measurements of deviation in thesubjects background, Student s t-test was conducted. The
signiﬁcant level used was the 95% conﬁdence level (p <0.05). Statcel 3 (Yanai, 2011) as a statistical analysis
application was used for those evaluations.

RESULTS
Fig.2 indicates the process for screening the subjects.
The test commenced after selecting 50 candidates based
upon both inclusion and exclusion criteria, then allocate
25 subjects. (F = 13, M = 12) to the NMC group andanother 25. (F = 13, M = 12) to the placebo group.
Consequently, total of 17 (5 out of the NMC group, 12 outof the placebo group) amongst the 50 subjects were
dropped. Then, 1 amongst the dropouts (the NMC group)
spontaneously quitted due to physical deconditioning, andthe rest of 16 were spontaneously quitted for otherreasons to make the continuation unable, such as work-

related issues. Total of 33 subjects (20 out of the NMC
group and 13 out of the placebo group) completed thewhole 12 wks test (FAS). In both groups, there were no
subject who corresponded to the exclusion standard,
therefore, the per protocol set (PPS) were eventually 33
in total (age 47.9
5.7 yr, height 163.1
6.5 cm, BMI
25.3
3.4 kg/m2). In detail, there were 20 out of the
NMC group (age 47.8
6.0 yr, height 163.0
6.4 cm,BMI 25.8
3.2 kg/m2) and 13 out of the placebo group(age 48.2
5.3 yr, height 163.3
6.9 cm, BMI 24.6
3.6 kg/m2). Table 3 indicates demographic background of
those test subjects. Between those two groups, there
were no significant difference observed in gender, age,height, and BMI.
Table 4 shows changes in anthropometric parameters.
Weight, body fat percentage, BMI, waist circumference
and hip circumference after 12 wks were significantly
diﬀerent between the NMC group and the placebo group
analyzed by repeated-measures ANOVA.
Table 5 indicates transition of the measured values ofsubjective evaluations. It indicates that the scores for bothgroups had no signiﬁcant change in transition from before

診療と新薬・第 52 巻

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Table 4 Transition of Physical Values (NMC; N = 20, Placebo; N = 13)
Item

Unit

12 w1)

0w

Group

Mean

SD

Placebo

69.23
66.03

12.60 65.81
12.26 66.52

12.38

NMC

Mean

SD
12.14**

p -value2)
Time

group

< 0.01 ##Weightkg

Body Fat
Percentage％

NMC
Placebo

32.4
30.9

6.9
7.2

30.6
31.2

6.7**
7.5

< 0.01 ##

BMI

kg/m2

NMC
Placebo

25.8
24.6

3.2
3.6

24.6
24.8

3.1**
3.7

< 0.01 ##Waist
Circumferencecm

NMC
Placebo

88.4
85.2

8.3
12.2

85.6
85.7

8.3**
12.6

< 0.01 ##Hip
Circumferencecm

NMC
Placebo

95.4
96.1

5.3
7.1

93.5
96.2

5.5**
7.2

< 0.01 ##1) **p < 0.01 vs. baseline (0w) (paired t-test)
2) ## p < 0.01 (repeated-measures ANOVA)
Table 5 Transition of Subjective Evaluation (NMC; N = 21, Placebo; N = 19)
Item

Group

12 w1)
MeanSD

p -value2)

Bowel Movement

NMC
Placebo

5.5
5.0

1.1
0.9

p = 0.29

Skin Condition

NMC
Placebo

5.0
5.4

1.0
1.4

p = 0.63

Physical Condition

NMC
Placebo

5.5
5.5

1.3
1.3

p = 0.97

Sleep

NMC
Placebo

5.3
5.7

1.2
1.0*

p = 0.41

Unit：Point
1) *p < 0.05 vs. baseline (0w) (Wilcoxon signed-rank test)2) vs. Placebo group (Mann-Whitney U test)

ingestion to after 12 wks.
Table 6 indicates transition of the measured values ofbiochemical blood test. For both group, there wereseveral significant changes. They were deemed justtemporary, and most of them were remained within
levels of the reference values. Plus, even those values
except γ-GT (γGTP) (for men) and calcium, there wereno significant difference between those two groups.
Regarding changes of γ-GT (γGTP) (for men) andcalcium, the doctor in charge judged as noncritical inclinical term, for its variance within the normal range.
Table 7 indicates transition of the measured values ofurinalysis. For the NMC group, there were significant
change in specific gravity in intragroup, however, it
deemed as temporary and still within a level of reference
value. In the placebo group, those two scores had no
signiﬁcant changes in intragroup and intergroup. As forurine protein, sugar, urobilinogen, keton body, occult

blood and bilirubin items, no speciﬁc critical ﬁnding wasobserved in qualitative evaluation. (Data not shown) The
doctor in charge judged that there should be no problem
from clinical stand point.
As a result of evaluation of the diary, there were no
critical adverse event observed in this test at all.

DISCUSSION
A double-blind, placebo-controlled parallel group study intotal of 12 weeks, testing black ginger extract(5,7-Dimethoxyﬂavone) was conducted to healthy adults
including light obese subjects (PPS: N = 33, age 47.9
5.7, BMI 25.3 3.4 kg/m2), along with an instruction tohave 7 minute exercise pulling back their bellies
everyday. As a result, there were no significant
improvement in subjective evaluation, however, weight,
body fat percentage, BMI, waist circumference, hip
circumference were equally showed improvements after62 （738）

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Table 6 Transition of Biochemical Blood Test (NMC; N = 20, Placebo; N = 13)
Item

Unit

Std.
Value

Gender

Group

Total Bilirubin

mg/dL

0.2 -1.2

M/F

Total Protein

g/dL

6.5 - 8.3

Albumeng/dL

AST (GOT)

12 w1)2)

0w
Mean

SD

Mean

SD

NMC
Placebo

0.80
0.70

0.48
0.31

0.77
0.65

0.49
0.24

M/F

NMC
Placebo

7.3
7.4

0.3
0.4

7.2
7.5

0.3
0.4

3.8 - 5.3

M/F

NMC
Placebo

4.5
4.7

0.3
0.2

4.4
4.6

0.3*
0.2 †

U/L

8 - 38

M/F

NMC
Placebo

21.1
22.7

5.6
8.1

21.5
19.8

5.5
3.6

ALT (GPT)

U/L

4 - 43

M/F

NMC
Placebo

19.5
23.8

11.0
15.0

21.6
21.6

11.3
10.2

ALP

U/L

110 - 354

M/F

NMC
Placebo

201.7
194.3

64.1
47.7

208.2
195.6

59.8
48.5

LD (LDH)U/L

121 - 245

M/F

NMC
Placebo

196.7
204.1

26.7
88.3

186.2
169.6

17.9*
31.4 †

86 and
under

M

NMC
Placebo

49.4
74.6

62.9
46.8

47.4
54.4

55.0 #
32.8*

48 and
under

F

NMC
Placebo

19.0
22.0

10.6
6.9

19.8
24.8

9.4
8.2 †

38 -196

M

NMC
Placebo

164.9
160.0

115.7
103.7

125.6
114.4

42.0
75.7

30 -172

F

NMC
Placebo

153.3
91.5

166.9
33.7

162.6
89.3

259.4
34.1

γ-GT ( γ GTP)CK (CPK)

U/L

U/L

］

Total Cholesterol

mg/dL

130 - 219

M/F

NMC
Placebo

213.6
209.4

38.8
36.3

209.7
198.9

36.3
32.0

Neutral Fat (TG)mg/dL

30 -149

M/F

NMC
Placebo

146.2
245.8

90.4
295.5

121.3
140.4

75.2
81.5

SodiummEq/L

135 -150

M/F

NMC
Placebo

140.1
139.1

2.2
2.3

141.8
142.8

3.3*
3.4**

Chloride

mEq/L

98 -110

M/F

NMC
Placebo

104.1
102.9

2.0
1.7

104.5
103.9

1.6
1.7 †

Potassium

mEq/L

3.5 - 5.3

M/F

NMC
Placebo

6.6
7.0

1.0
1.2

4.4
4.5

0.5**
0.6**

Calcium

mg/dL

8.4 -10.2

M/F

NMC
Placebo

9.5
9.5

0.3
0.3

9.3
9.5

0.3*
0.4

Inorganic Phosphorus

mg/dL

2.5 - 4.5

M/F

NMC
Placebo

3.1
3.3

0.4
0.4

3.1
3.5

0.6
0.5

Urea Nitrogen

mg/dL

8.0 - 22.0

M/F

NMC
Placebo

14.3
12.7

2.7
2.6

12.8
12.3

2.7*
3.0

0.61 -1.04

M

NMC
Placebo

0.80
0.81

0.16
0.17

0.80
0.90

0.15
0.13

0.47 - 0.79

F

NMC
Placebo

0.67
0.63

0.09
0.09

0.68
0.66

0.11
0.08

60 -109

M/F

NMC
Placebo

55.4
60.0

20.6
12.0

71.2
74.3

14.9**
13.0**Creatinine

Blood Sugar (Serum)

mg/dL

mg/dL

1) †p < 0.1, *p < 0.05, **p < 0.01 vs. baseline (0w) (paired t-test)2) #p < 0.05, ##p < 0.01 vs. Placebo group (Student s t-test)##］

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第７号（2015 年７月）

63 （739）

Table 7 Transition of Urinalysis (NMC; N = 20, Placebo; N = 13)
Item

†

Unit

Std.
Value

GenderSpeciﬁc Gravity

mg/dL

1.0102-1.025

M/F

pH

g/dL

4.5 - 8.0

M/F

0w

Group
NMC

Mean

Placebo

1.02271.0362NMC
Placebo

6.1
6.4

12 w
SD

0.0072
0.05
0.7
0.9

Mean
1.01771.01776.1
5.8

SD0.0049**0.00440.8
0.7 †p < 0.1, **p < 0.01 vs. baseline (0w) (paired t-test)

12 wks in the NMC group, against the placebo group.
Looking at the change of the group, all of weight, bodyfat percentage, BMI, waist circumference, hip
circumference showed constant improvements after 12
wks as well.
For working mechanism, black ginger extract(5,7-Dimethoxyflavone) in the test material has beenreported to have various effects on improvement of ananti-inﬂammatory act or bloodstream, however, it s been
also reported to be a pancreatic lipase inhibitor at thesame time. 7) Therefore, ingested fat during the test
period might have been hardly accumulated in subjects
bodies.
In addition, accumulated fats are used as an importantorgan for energy expenditure through thermogenesis byincreasing cAMP that is caused by binding blood
adrenalin to the receptor of the fat cell surface, byactivating hormone-sensitive lipase and by breaking down
into fatty acids and glycerol. 8) Black ginger extract(5,7-Dimethoxyﬂavone) is reported to activate hormonesensitive lipase or suppress the effect of body fat
accumulation by working as inhibitor ofphosphodiesterase (PDE), by breaking down cAMP and
by raising cAMP density.9)
Furthermore, black ginger extract(5,7-Dimethoxyflavone) is reported to increase theexpression levels of the uncoupling protein-1 (UCP1) inmitochondria of brown adipose tissue that is considered
to play an important role in activity of hormone-sensitive
lipase.10) Although it was reported in mice, recently theother study reported that brown adipose tissue are foundon the human adults existing of brown adipose tissue
have been suspected thereby useful food products
promotes activating brown adipose tissue and increasing
UCP1, to reduce obesity.11) Therefore, in this study black
ginger extract (5,7-Dimethoxyﬂavone) was suggested towork as some irritation for brown adipose tissue
hyperactivity in the human body. However, it is only
speculative and therefore is to be hoped that future
research will clarify this point.
Also, black ginger extract (5,7-Dimethoxyﬂavone) suchas above of functionality as well as ginger extract powder
contained in the test products which is reported to raise
metabolism or improve blood flow,12)13) and black pepper

extract which is reported to increase the absorption ofingested together raise metabolism and inﬂuence14)15) arealso considered to lead the test results supplementarily.
However, these interactions are unknown and are an
issue in the future.
And in this study, because the subjects were obliged tohave daily 7 minutes exercise pulling back their bellies
beside ingestion of the food, it might have affected theresult as well.
Under the circumstance, it is suggested that thosesignificant differences between two groups in weight,
body fat percentage, BMI, waist circumference, hip
circumference were aided by the exercise to someextent, however, we would like to work on this issue
further.
And also in this study, there were no significant
difference in subjective evaluation of bowel movement
and skin condition, however, it could be explained asabsence of the problem with their bowel movement andskin condition before the test, therefore, they could
hardly feel the difference. Or simply, the test material
itself could hardly have either positive or negative eﬀects
on those bowel movement and skin condition in any
sense.
In summary, the test food was thought to be safe, since
there were no chance to observe any adverse event
which might caused by the food through the whole 12
week test period.

CONCLUSION
A placebo-controlled parallel group study testing Nensho
Meramera Capsule that contains black ginger extract(5,7-Dimethoxyflavone), under conditions of a certain
amount of exercise, has proven signiﬁcant improvements
in general obesity prevention and partial body structuresuch as waist circumference and hip circumference in
speciﬁc.
CONFLICT OF INTEREST
This research and its thesis authoring have been conducted by request ofMizuhashihojyudo Pharmaceutical Inc with their ﬁnancial aid.

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