A Randomized, Partially Double-blind, Controlled, Multi-center Clinical Study of Wulingsan Single Decoction Granules Combined With Conventional Therapy in the Treatment of Metabolic Syndrome of Spleen Deficiency, Dampness and Sleepiness

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

NCT03195231 / Unknown statusPhase 4IIT

Wuling Powder for the Treatment and Underlying Mechanism of Depressive Symptoms in Patients With Parkinson's Disease: a Randomised, Double-blind, Placebo-controlled Trial.

Depression is one of the most important nonmotor features of idiopathic PD（Parkinson's disease ）which may not just interfere with the motor symptoms of PD but can also cause immense personal suffering as well as decreased quality of life with increased disability and caregiver burden. However,there is little hard evidence to guide clinical treatment. Although some newer dopamine agonists also have antidepressive effect, the use of tricyclic or nontricyclic antidepressants is frequently required.However, the side-effects of these agents may also worsen some preexisting nonmotor problems in PD. Wuling powder is a Chinese medicine which is made by cultivating Xylariasp mycelium using submerged fermentation technology. Xylariasp is the fungus sclerotia which grow in termite nests. Wuling powder is mainly used to soothe nerves and anti-insomnia in clinical. The antidepressant effect of Wuling powder has been confirmed in clinical, but not in the patients of Parkinson's disease. Therefore, the investigators design a randomized, double-blind, placebo-controlled study to evaluate the antidepressant effect of Wuling powder in PD patients and its underlying mechanism.

Start Date25 Jun 2017

Sponsor / Collaborator

Beijing Hospital of the Ministry of Health

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100 Clinical Results associated with Wuling San

100 Translational Medicine associated with Wuling San

100 Patents (Medical) associated with Wuling San

Literatures (Medical) associated with Wuling San

01 Dec 2024·Heart and Vessels

Short-term impact of kampo goreisan in patients with congestive heart failure refractory to tolvaptan-incorporated medical therapy

Article

Author: Onoda, Hiroshi ; Kinugawa, Koichiro ; Kakeshita, Kota ; Hida, Yuki ; Imamura, Teruhiko

We often encounter patients with congestive heart failure refractory to conventional diuretics therapy. Kampo goreisan (Tsumura &Co. Tokyo, Japan) is receiving great concern in mediating body water balance, particularly for such a cohort. However, its detailed biological mechanism remains uncertain. Patients who received goreisan to treat congestive heart failure refractory to tolvaptan-incorporated medical therapy were prospectively included and observed for one week during the therapeutic period. The change in urine biomarkers during the first 24 h was assessed as a primary concern. Baseline factors associated with an increase in urine volume during the first 24 h were investigated as a secondary concern. A total of 18 patients were included. Median age was 81 (77, 86) and 12 (67%) were men. During the first 24 h after the initiation of goreisan, urine cyclic AMP tended to decrease, urine aquaporin-2 decreased significantly, urine osmolality decreased significantly, and urine volume tended to increase. Baseline higher common logarithm of plasma B-type natriuretic peptide was associated with any increases in urine volume during the first 24 h with an odds ratio of 73.2 (95% confidence interval 1.04-5149, p = 0.048). Baseline plasma B-type natriuretic peptide level had a positive correlation with a change in urine volume between baseline and day 1 (r = 0.533, p = 0.026). Goreisan may increase urine volume even in patients with congestive heart failure refractory to tolvaptan-incorporated medical therapy by modulating aquaporin-2 systems in the collecting duct, particularly in individuals with advanced heart failure accompanying significant congestion. Goreisan may have a regulatory effect on body fluid, rather than just forcing aquaresis.

01 Oct 2024·Brain and Behavior

Effects of Goreisan in the Perioperative Period of Subthalamic Deep Brain Stimulation in Parkinson's Disease

Article

Author: Ishikawa, Hidehiro ; Shindo, Akihiro ; Araki, Tomohiro ; Ii, Yuichiro ; Nishiguchi, Yamato ; Ichikawa, Naoki ; Tabei, Ken‐ichi ; Matsuura, Keita ; Matsuda, Kana ; Kajikawa, Hiroyuki ; Nakamura, Naoko ; Kagawa, Ken

ABSTRACTIntroductionPatients with Parkinson's disease (PD) may benefit from deep brain stimulation (DBS). Perifocal brain edema sometimes occurs after DBS surgery, but it is transient and does not affect the final prognosis. Transient deterioration of cognitive function has been reported in patients with frontal edema in the first postoperative week. This study aimed to investigate the effect of Goreisan in preventing edematous changes after DBS and determine the influence of edema on cognition.MethodsWe included 29 patients with PD who underwent bilateral subthalamic nucleus (STN) DBS and who were divided into 2 groups: those using (11 patients) and those not using Goreisan (18 patients). At 1 week postoperatively, all patients underwent magnetic resonance imaging. We measured the volume of edema either in the frontal white matter or STN on fluid‐attenuated inversion recovery (FLAIR) images. Finally, brain edema, motor function, and cognitive function were compared between the groups with and without Goreisan.ResultsIn the FLAIR image 1 week postoperatively, the average postoperative frontal subcortical edema (FE) volume of the group with Goreisan was significantly lower than that without Goreisan (2249 ± 2186 mm3, 6261 ± 7213 mm3, respectively, p = 0.023). Multivariate analysis with age, preoperative Mini‐Mental State Examination (MMSE) score, FE, and peri‐STN edema (SE) as factors, and MMSE at 1 week postoperatively as the dependent variable showed that preoperative MMSE score and SE were significant as associated factors.ConclusionsFE after DBS surgery may be alleviated using Goreisan. SE and preoperative MMSE scores were associated with MMSE scores 1 week postoperatively.Trial RegistrationNot applicable

01 Sep 2024·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 ; Jo, Taisuke ; Morita, Kojiro ; 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.

100 Deals associated with Wuling San

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

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NCT04144088 (CTgov)	Phase 2	Hyperuricemia	60	Wu Ling San (Wu Ling San)	sqtffprykv(axtfrioaex) = jrrceiajfs dxhzzzhnmh (yhyaawebxz, ocnsjokwby - bgmvnlvxlr) View more	-	06 Dec 2019
				Yin-Chen Wu Ling San (Yin-Chen Wu Ling San)	sqtffprykv(axtfrioaex) = clpmxrgsqe dxhzzzhnmh (yhyaawebxz, bquzsvevjn - wwfjgxqwgo) View more

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