Delving into the Latest Updates on Wuling San with Synapse

Overview

Basic Info

Drug Type

Herbal medicine

Synonyms

Goreisan, Gui Zhi/Fu Ling/Zhu Ling/Ze Xie/Bai Ju, Wu Lin San

+ [8]

Target-

Action-

Mechanism-

Therapeutic Areas

Nervous System DiseasesDigestive System DisordersUrogenital Diseases+ [1]

Active Indication

EdemaAcute gastroenteritisHeadache+ [7]

Inactive Indication-

Originator Organization

Sanwa Shoyaku Co., Ltd.

Active Organization

Sanwa Shoyaku Co., Ltd.Kowa Yakutsu Y.K.

Beijing Tongrentang Co. Ltd. Tongrentang Pharmaceutical Factor

+ [1]

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

Japan (18 Jul 1986),

Gastrointestinal DiseasesNauseaNephrosis

Regulation-

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In this study, a randomized, partially double-blind, controlled, multi-center clinical research method was used. A total of 4 groups were designed, namely, single decoction group, co-decoction group, powder group and simulation group. The four groups of patients all received basic health education, diet control and increased exercise guidance. All the patients in the group have taken western medicine according to their own conditions and followed the doctor's instructions for hypoglycemic, blood pressure, and lipid-lowering treatments. After joining the group, they continue to take the medicine at the original dose, and the patients are advised not to change the medicine during the observation period. Take 12 weeks as a course of treatment, and set the observation period to 12 weeks. Follow up every 4 weeks.

Start Date01 Apr 2021

Sponsor / Collaborator

Jiangsu Famous Medical Technology Co., Ltd

NCT04691700

/ RecruitingPhase 4IIT

GOREISAN for Heart Failure (GOREISAN-HF) Trial

The objective of the GOREISAN-HF trial is to assess the effect of the administration of Goreisan (TJ-17) plus standard therapy compared to standard therapy alone on the improvement rate of cardiac edema and clinical outcomes in worsening congestive heart failure with volume overload.

Start Date19 Jan 2021

Sponsor / Collaborator

Kyoto University

100 Clinical Results associated with Wuling San

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100 Translational Medicine associated with Wuling San

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100 Patents (Medical) associated with Wuling San

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77

Literatures (Medical) associated with Wuling San

01 Mar 2025·Journal of Cardiology

Association between complementary use of Goreisan (a Japanese herbal Kampo medicine) and heart failure readmission: A nationwide propensity score-matched study

Article

Author: Okada, Akira ; Miyawaki, Atsushi ; Michihata, Nobuaki ; Isogai, Toshiaki ; Matsui, Hiroki ; Morita, Kojiro ; Jo, Taisuke ; Yasunaga, Hideo

BACKGROUNDGoreisan, a Japanese herbal medicine, possesses aquaretic properties to regulate body fluid homeostasis and may therefore be effective as a complement to standard therapy in improving outcomes in patients with heart failure (HF).METHODSWe retrospectively identified 431,393 patients (mean age 79.2 ± 12.6 years; male 52.3 %) who were admitted for HF for the first time and were discharged alive with standard HF medications between April 2016 and March 2022, using the Japanese Diagnosis Procedure Combination database. We divided patients into two groups according to the prescription of Goreisan at discharge: patients who received standard HF medications plus Goreisan and those who received standard medications alone. We compared the incidence of HF readmission within 1 year after discharge between the groups using propensity score matching.RESULTSOverall, Goreisan was prescribed in 1957 (0.45 %) patients at discharge. Patients who received Goreisan were older and received diuretics more frequently than those who did not. One-to-four propensity score matching created a cohort of 1957 and 7828 patients treated with and without Goreisan, respectively. No significant difference was found in the incidence of 1-year HF readmission between the groups [22.1 % vs. 21.7 %; hazard ratio (HR) = 1.02, 95 % confidence interval (CI) = 0.92-1.13]. This result was consistent with that from competing risk analysis (subdistribution HR = 1.02, 95 % CI = 0.92-1.13) and across clinically relevant subgroups except for renal disease. Goreisan use was associated with a lower incidence of HF readmission among patients with renal disease (HR = 0.77, 95 % CI = 0.60-0.97), but not among those without (HR = 1.09, 95 % CI = 0.97-1.23; p for interaction = 0.009).CONCLUSIONSThis nationwide propensity score-matched analysis did not demonstrate that complementary Goreisan use at discharge was associated with a lower incidence of 1-year HF readmission in patients with HF receiving standard medications. An ongoing randomized trial is awaited to establish the effectiveness of Goreisan use in patients with HF.

01 Mar 2025·Drugs - Real World Outcomes

Effects of the Japanese Kampo Medicines Rikkunshito, Shakuyakukanzoto and Goreisan on Lenvatinib Plasma Concentrations in Japanese Patients with Thyroid Cancer

Article

Author: Sugino, Kiminori ; Masaki, Chie ; Ito, Koichi ; Fujita, Kazuma ; Miura, Masatomo ; Nagahama, Mitsuji ; Suzuki, Akifumi

BACKGROUNDKampo medicines are often used in Japan as therapy for the side effects induced by oral kinase inhibitors. However, the pharmacokinetic interactions between Kampo medicines and oral kinase inhibitors such as lenvatinib have not been studied.OBJECTIVEWe investigated the effects of Kampo medicines (rikkunshito, shakuyakukanzoto and goreisan) on the steady-state plasma trough concentration (C₀) of lenvatinib in patients with thyroid cancer.METHODSThirty-nine patients receiving lenvatinib therapy at Ito Hospital between May 2015 and December 2019 were enrolled. The mean C₀ of lenvatinib with Kampo medicine, at the same dose as before initiating Kampo medicines, was used.RESULTSAfter the repeated administration of rikkunshito (n = 21), shakuyakukanzoto (n = 10) or goreisan (n = 8), the mean C₀ of lenvatinib and the laboratory test values of patients did not change significantly. In contrast to rikkunshito, which alleviates emesis by enhancing gastric emptying, the C₀ values of lenvatinib with a proton pump inhibitor (PPI) (n = 16) or histamine H₂ receptor antagonist (H2RA) (n = 4) were significantly lower than the C₀ values without a PPI or H2RA (P = 0.007). The mean (range) change rate of the C₀ of lenvatinib with a PPI or H2RA versus without a PPI or H2RA was 88.6% (69.9-115%), and was significantly greater than the change rate for rikkunshito (P = 0.029). There was no significant difference between the C₀ of lenvatinib with a prokinetic agent (n = 7) versus without a prokinetic agent (P = 0.365).CONCLUSIONSAlthough these Kampo medicines are reported to inhibit drug-metabolizing enzymes and drug transporters, the risk of drug interactions for patients receiving lenvatinib therapy is low. Patients should feel confident that they can receive Kampo medicines as supportive care for lenvatinib therapy without a risk of drug interactions that could affect treatment efficacy.

01 Feb 2025·Journal of Pharmacological Sciences

Goreisan suppresses cardiac remodeling and dysfunction in a new mouse model with diabetic cardiomyopathy

Article

Author: Imanishi, Masaki ; Tsuchiya, Koichiro ; Ito, Mai ; Ebi, Fuka ; Ikeda, Yasumasa ; Ohminami, Hirokazu ; Du Ly-Nguyen, Hai ; Yamamoto, Mizuho ; Funamoto, Masafumi ; Hirose, Shunji

BACKGROUNDThe global increase in diabetes, driven by aging populations and lifestyle changes, has led to an increase in the incidence of diabetic cardiomyopathy (DCM). DCM is characterized by metabolic abnormalities, oxidative stress, and inflammation, leading to cardiac remodeling and dysfunction. Goreisan (GRS), a traditional Japanese Kampo medicine, is commonly used to treat fluid control such as edema, due to its diuretic effect. In this study, we examined the effects of GRS on DCM.METHODSWe first established a new mouse model of DCM and then evaluated the effects of GRS on DCM using a recently developed model.RESULTSThe DCM mouse model developed cardiac hypertrophy, fibrosis, and dysfunction by nine weeks, which was ameliorated by GRS administration. GRS suppressed apoptosis and protein degradation by inhibiting Akt dephosphorylation and oxidative stress in DCM mice. In contrast, no differences in inflammatory cytokine levels were observed, regardless of GRS administration.CONCLUSIONGRS has potential efficacy in preventing DCM onset and development.

100 Deals associated with Wuling San

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R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Edema	China	Beijing Tongrentang Co. Ltd. Tongrentang Pharmaceutical Factor	17 Aug 2020
Acute gastroenteritis	Japan	Kracie Pharmaceutical Ltd.	08 Sep 1986
Headache	Japan	Kracie Pharmaceutical Ltd.	08 Sep 1986
Watery diarrhoea	Japan	Kracie Pharmaceutical Ltd.	08 Sep 1986
Diarrhea	Japan	Kowa Yakutsu Y.K.	02 Sep 1986
Gastroenteritis	Japan	Kowa Yakutsu Y.K.	02 Sep 1986
Tumescence	Japan	Kowa Yakutsu Y.K.	02 Sep 1986
Gastrointestinal Diseases	Japan	Sanwa Shoyaku Co., Ltd.	18 Jul 1986
Nausea	Japan	Sanwa Shoyaku Co., Ltd.	18 Jul 1986
Nephrosis	Japan	Sanwa Shoyaku Co., Ltd.	18 Jul 1986

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04144088 (CTgov)	Phase 2	Hyperuricemia	60	Wu Ling San (Wu Ling San)	pvacyrniou(otglapvhpe) = xblljgoitw uxjzeccggi (jsrfzyrvbh, hxayrxsozc - njwlsskofi) View more	-	06 Dec 2019
				Yin-Chen Wu Ling San (Yin-Chen Wu Ling San)	pvacyrniou(otglapvhpe) = haumtzwuck uxjzeccggi (jsrfzyrvbh, oivaerooil - kxpzjrquzf) View more