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N o v e m b e r 0 5 - 0 6 , 2 0 1 8 | P h i l a d e l p h i a , U S A
3rd INTERNATIONAL OBESITY SUMMIT AND EXPO
&
&
DIABETES, NUTRITION, METABOLISM & MEDICARE
2nd International Conference on
Joint Event on
OF EXCELLENCE
IN INTERNATIONAL
MEETINGS
YEARS
LASER, OPTICS AND PHOTONICS
World Conference on
Obesity Summit 2018 & Diabetes Conference 2018 & Laser Photonics Conference 2018 Biomedical Research | ISSN: 0976-1683| Volume 29
Buyanjargal Darkhijav et al., Biomed Res 2018, Volume 29 | DOI: 10.4066/biomedicalresearch-C7-019
THE RESULT OF CLINICAL TRIAL
FOR THE NEW LONAL DRUG FOR
HEPATOPROTECTIVE EFFECT IN PATIENT
WITH DRUG INDUCED STEATOSIS: A
RANDOMIZED PLACEBO-CONTROLLED
DOUBLE BLIND CLINICAL TRAIL
Buyanjargal Darkhijav1, Ariunaa Z2, Sarnai Ts3, Badamjaw S3 and
Erdenetsogt D3
1Bayangol Districts Health Center, Mongolia
2Research and Production Company of The Mong-Em, Mongolia
3School of Medical Science, Mongolian National University of Medical Sciences,
Mongolia
Introduction: Following researchers determined the chronic hepatitis C virus
infection which was 8,2% (Davaalkham.J et al, 2003), 9,6%(Takahashi.M et al,
2004), 9,8% (Tsatsralt-Od.B et al, 2006), 11,8% et al 2005) in
Mongolia. As researchers noted that hepatitis C genotype 1 and 3 enable to
be triglyceride accumulation for liver because it often occurs simultaneously
fatty liver disease. Although many types of traditional medicine have been
used for for hundreds years, their effectiveness of the therapy is relatively
small with inadequate use of poorly understood in practice. These types of
medicine’s storage, form, flavor are to improve which are prepared based on
scientific studying, is to make the clinical trial of drug acts as easily use,
emerged as one of the need for market. Therefore, our research team has
made the clinical trial based on the chemical and pharmacological study of
hepatoprotective effect for lonicera altaica pall fruit, an established clinical
studies and producing new drugs.
Aim: The aim of the clinical trial was to determine hepatoprotective effect of
the new lonal drug in patient with fatty liver disease with chronic hepatitis C.
Material and Method: The research was considered such as clinical trial
guideline for new drug issued by the WHO’s “Good Clinical Practice”. Based
on permission given by biomedical ethical community of the health ministry
of Mongolia approved diagnosis patient with fatty liver disease associated
with chronic hepatitis C. Research design is randomized placebo-controlled,
double blind clinical trial. We studied 3 groups of participants that was given
the following treatment for 21 days: (I) Treatment group: Lonal drug 1.4 gr ×3
times, (II) Control group: Silymarin drug 67.5 mg ×3 times, (III) Placebo group:
Placebo drug 1.4 gr ×3 times. We used on histo-morphometric analysis of
liver biopsy DISKUS ver 4.80, Olympus BX microscopy.
Results: Lonal drug decreases activation of syndrome hepatic cell cytolysis
ALT (p=0.023), AST (p=0.037). Also decreases criteria of cholestasic syn-
drome such as indirect bilirubin (p=0.611), ALP (p=0.04), GGT (p=0.445).
Buyanjargal Darkhijav is currently working at Bayangol
Districts Health Center, Ulaanbaatar city, Mongolia.
BIOGRAPHY
The Lonal medicine was taken during 21 days
and comparing the results of lipid metabolism
exchange before and after treatment, reduces
TG (p=0,402), increases HDL (p=0.047). The par-
ticipants have taken the Fibroscan analysis and
liver biopsy. That was compared to determine
before and after treatment such as steatosis and
fibrosis degree. Before treatment degree of ste-
atosis was S2: 278.4±75.3 dB/m and after treat-
ment it was dropped from S1: 238.6±70.4 dB/m
(p <0.05). And before treatment, such as fibrosis
degree F2-3: 8.84 ± 2.2 kPa, after treatment it
was decreased in F1-2: 7.18 ± 3.87 (p<0.01). In
liver histology, comparing before and after treat-
ment the results of liver cell inflammation-fibro-
sis area was reduced by 1,75 times and decreas-
es hepatic steatosis degree (strong fatty change
was improved mild fatty change).
Conclusion: New lonal medicine is reducing
activation syndrome hepatic cell cytolysis,
cholestatic and some criteria of the metabolic
syndrome in patient with fatty liver disease as-
sociated with chronic hepatitis C. Also new lonal
medicine reduces the degree of liver steatosis
and fibrosis by the analysis of fibroscan and liv-
er biopsy.
Key Words: Fibroscan, liver biopsy, Lonicera Al-
taica Pall, Lonal.