• Toxicological Research
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• v.17 no.2
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• pp.107-114
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• 2001

This study was designed to evaluate a repeated oral dose toxicity of a new hepatotherapeutic agent GODEX in Sprague-Dawley rats. Male and female rats were orally administered with dosages of 500, 100, 20, and 0 /kg/day of GODEX daily for 4 weeks, respectively. There were no dose-related changes in clinical signs, body weight changes, food and water consumption, opthalmoscopy, organ weights, urine analysis, biochemical examination, and hematological findings of all animals treated with GODEX. Gross and histopathological findings revealed no evidence of specific toxicity related to GODEX. These indicate that GODEX may have no side effects and its oral maximum tolerated dose value may be over 500 mg/kg in rats.

• Biomolecules & Therapeutics
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• v.9 no.2
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• pp.140-142
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• 2001

This study was performed to evaluate an single dose oral toxicity of a new hepatotherapeutic agent GODEX (HEPADIF-S) in Sprague-Dawley rats. Male and female rats were administered dosages of 5, 2.5, 1.25 ,0.625, 0.3125, and 0 g/kg B.W. of GODEX, respectively. After single oral administration of GODEX to rats, we observed them daily for 2 weeks. GODEX slid not induce any toxic signs in the mortalities, clinical signs, body weight changes, and gross necropsy findings of rats. Based on these results, it is concluded that GODEX may have no side effect and its LD$_{50}$ value may be over 5 g/kg B.W, in rats.s.

• Biomolecules & Therapeutics
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• v.10 no.3
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• pp.202-207
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• 2002

The hepato-protective activity of the GODEX (Hepadif-s capsule) has been studied in the rats against $CCl_4$-ethanol induced liver toxicity. The rats were oral1y treated with $CCl_4$ (corn oil/ $CCl_4$ 1:1, 1 mg/kg). And one week passes, $CCl_4$(0.4 mg/kg) administered two times a week for 7 weeks. The drugs have been administered every two days for 4 weeks after $CCl_4$ injection. The experimental groups have consisted of the GODEX (250 mg/kg), Hepadif (200 mg/kg), DDB complex (DDB 50 mg/kg and garlic oil powder 50 mg/kg), DDB (50 mg/kg), and vehicle control respectively. There was a significant decrement on the serum level of aspartate aminotransferase (AST), alanine aminotransferase (ALT) and total bilirubin in all treated groups. Specially, ALT level of GODEX and Hepadif only treated groups was decreased c1early. Also, serum albumin level was significantly enhanced in GODEX treated group compared with control and DDB treated groups. In histological results, hepatocellular vacuolar degeneration, lobular restructure and necrosis of bile duct were severely showed in control. But other treated groups showed centerilobular degeneration and mild hyper-plasia. Hepadif or DDB has a effects of the recovery on serum parameters and structure ill liver injury. When it was compared GODEX to Hepadif alone or DDB complex or DDB, it suggested to have the best activity of the liver recovery.

• The Journal of Internal Korean Medicine
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• v.41 no.2
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• pp.186-193
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• 2020

Objectives: This study aimed to report a case that showed improvements in the symptoms of patients with alcoholic hepatitis without any indication of deterioration of the disease. Methods: Western medicine with Urusa tablets and Godex capsules and Korean medicine therapeutic approaches, including Shihogayonggolmoryo-tang, acupuncture, and moxibustion, were administered to a patient during the period of treatment. Blood tests were used to determine levels of aspartate aminotransferase (AST), alanine aminotransferase (ALT), AST/ALT ratio, alkaline phosphatase (ALP), gamma glutamyltransferase (GGT), total bilirubin, direct bilirubin, and total cholesterol. Fatigue was measured using the numeric rating scale (NRS), and the patient's total sleeping time was checked, daily. Results: After the combined treatment, the AST/ALT ratio and the AST, ALT, ALP, GGT, total cholesterol, and direct bilirubin levels were decreased. Through Oriental medicine for the purpose of improving symptoms, NRS of fatigue decreased from 10 to 5, and the amount of sleeping time increased from 2 to 5 hours. Conclusions: The herbal medicine had no effect on the hepatoprotective drugs such as Urusa tablets and Godex capsules used to treat alcoholic hepatitis, and no adverse reaction from the combined administration was observed. To reduce fatigue and insomnia in patients with alcoholic hepatitis, it might be helpful to combine Western medications with Korean medicine treatments, including acupuncture, moxibustion, and Shihogayonggolmoryo-tang.

• Journal of Korean Medicine Rehabilitation
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• v.26 no.3
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• pp.183-189
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• 2016

A 84 year old male patient with amyotrophic lateral sclerosis (ALS) was treated by Jeungsonbaekchulsan and Gakbyeongyeonsu-tang for ten days. In the course of treatments, this patient was evaluated with Roussel Uclaf Casusality Assessment Method (RUCAM), showing results of drug induced liver injury. Herb medicine was immediately discontinued, followed by therapeutic laser treatments once a day for one week combined with 2 weeks of GODEX$^{(R)}$ administration. Transaminase results were lowered and changes in blood test results were time-effective changes. Therapeutic laser therapy could be considered effective on drug induced liver injury with further studies.