[Translation] A randomized, double-blind, placebo-controlled, multicenter clinical trial to evaluate the efficacy and safety of Wendan tablets in the treatment of generalized anxiety disorder (phlegm-heat internal disturbance syndrome)

以安慰剂为对照初步评价温胆片治疗广泛性焦虑(痰热内扰证)的有效性和安全性。

[Translation]

Using placebo as a control, the efficacy and safety of Wen Dan tablets in the treatment of generalized anxiety disorder (phlegm-heat internal disturbance syndrome) were preliminarily evaluated.

Start Date-

Sponsor / Collaborator

The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine

CTR20201189 / CompletedPhase 2IIT

温胆片治疗轻中度广泛性焦虑障碍(痰热内扰证)有效性和安全性的随机双盲安慰剂阳性药平行对照多中心临床试验

[Translation] A randomized, double-blind, placebo-controlled, multicenter clinical trial on the efficacy and safety of Wendan Tablets in the treatment of mild to moderate generalized anxiety disorder (phlegm-heat internal disturbance syndrome)

1、以安慰剂和阳性药为对照初步评价温胆片治疗轻、中度广泛性焦虑障碍(痰热内扰证)的有效性和安全性。 2、探索去甲肾上腺素转运蛋白(NET)基因 T182C 位点多态性。

[Translation]

1. To preliminarily evaluate the efficacy and safety of Wendan Tablets in the treatment of mild to moderate generalized anxiety disorder (phlegm-heat internal disturbance syndrome) using placebo and active drugs as controls. 2. To explore the polymorphism of the T182C site of the norepinephrine transporter (NET) gene.

Start Date13 Oct 2020

Sponsor / Collaborator

The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine

100 Clinical Results associated with Wendan Tablets

100 Translational Medicine associated with Wendan Tablets

100 Patents (Medical) associated with Wendan Tablets

Literatures (Medical) associated with Wendan Tablets

01 Dec 2023·Journal of Ethnopharmacology

Clinical efficacy and metabolomics study of Wendan Decoction in the treatment of phlegm-dampness obstructive sleep apnea-hypopnea syndrome with type 2 diabetes mellitus

Article

Author: Fan, Xinsheng ; Zhu, Jieyun ; Xu, Haishu ; Zhou, Sifeng ; Zhang, Jinming

ETHNOPHARMACOLOGICAL RELEVANCEWendan Decoction (WDD) is one of the classic traditional Chinese prescriptions that has been used in the treatment of type 2 diabetes mellitus (T2DM), metabolic syndrome, obstructive sleep apnea-hypopnea syndrome (OSAHS) and so on. The therapeutic effects and mechanism of WDD remain to be explored, especially from the perspective of metabolomics, oxidative stress and inflammation.AIM OF THE STUDYTo investigate the therapeutic and metabolic regulatory effects and the underlying mechanism of WDD in OSAHS with T2DM patients.MATERIALS AND METHODSAll included patients were from Rudong Hospital of Traditional Chinese Medicine, Nantong, Jiangsu Province, China. Both groups received lifestyle interventions; at the same time, all of them were administered metformin (1500 mg/day) and dapagliflozin (10 mg/day), and the treatment group was administered WDD orally. All patients were treated for two months. Before and after treatment, the changes in clinical symptoms and signs of the two groups of patients were evaluated, and the detection indicators such as body mass index (BMI), apnea-hypopnea index (AHI), lowest arterial oxygen saturation (LSaO₂), Epworth sleepiness scale (ESS), percentage of total sleep time with oxygen saturation <90% (TST90), fasting plasma glucose (FPG), 2-h post-load glucose(2h-PG), fasting insulin (FINS), homeostasis model assessment of insulin resistance (HOMA-IR)，hemoglobin A1c (HbA1c), blood lipid levels, as well as the adverse reactions and compliance of the patients were observed and detection of serum metabolites in patients to screen out specific biomarkers. The serum metabolic profile of WDD in OSAHS with T2DM patients was explored using ultra-high-performance liquid chromatography-quadrupole/electrostatic field orbitrap high-resolution mass spectrometry (UPLC-Q Orbitrap HRMS).RESULTSAfter treatment with WDD for 8 weeks, biochemical indicators, including BMI, FPG, 2h-PG, blood lipid, FINS, HbA1c, AHI, ESS, LSaO₂, TST90, and HOMA-IR, were significantly improved. Serum metabolomic analysis showed that metabolites were differentially expressed before and after WDD-treated patients. Metabolomics results revealed that WDD regulated the biomarkers, such as DL-arginine, guaiacol sulfate, azelaic acid, phloroglucinol, uracil, L-tyrosine, cascarillin, Cortisol and L-alpha-lysophosphatidylcholine. Pathway enrichment analysis showed that the metabolites were associated with oxidative stress and inflammation.CONCLUSIONThe study based on clinical research and metabolomics indicated that WDD can improve OSAHS with T2DM through multiple targets and pathways, and it may be a useful alternative therapy for the treatment of OSAHS with T2DM patients.

01 Jan 2023·Journal of Separation Science

Metabolic profile and potential mechanisms of Wendan decoction on coronary heart disease by ultra‐high‐performance quadrupole time of flight‐mass spectrometry combined with network pharmacology analysis

Article

Author: Qin, Zifei ; Zhang, Yezi ; Wu, Huanlin ; Yao, Zhihong ; Chen, Jiayun ; Wang, Qi ; Xu, Danping ; Lin, Pei ; He, Liangliang

Wendan decoction, a well‐known classical traditional Chinese medicine prescription, has been widely used in the clinical application of coronary heart disease for thousands of years. However, due to a lack of research on the overall metabolism of Wendan decoction, the bioavailable components responsible for the therapeutic effects remain unclear, hindering the revelation of its mechanisms against coronary heart disease. Consequently, an efficient joint research pattern combined with characterization of the metabolic profile and network pharmacology analysis was proposed. As a result, a total of 172 Wendan decoction‐related xenobiotics (57 prototypes and 115 metabolites) were detected based on the exploration of the typical metabolic pathways of representative pure compounds in vivo, describing their multi‐component metabolic characteristics comprehensively. Subsequently, an integrated network of “herbs‐bioavailable compounds‐coronary heart disease targets‐pathways‐therapeutic effects” was constructed, and its seven compounds were finally screened out as the key components acting on five main targets of coronary heart disease. Overall, this work not only provided a crucial biological foundation for interpreting the effective components and action mechanisms of Wendan decoction on coronary heart disease but also showed a reference value for revealing the bioactive components of traditional Chinese medicine prescriptions.

01 May 2020·The Journal of Alternative and Complementary MedicineQ4 · MEDICINE

Efficacy and Safety of Wendan Decoction for Acute Brain Injury: A Randomized Controlled Study

Q4 · MEDICINE

Article

Author: Cheng, Yu-Chen ; Chiang, Pei-Yeh ; Huang, Bor-Ren ; Huang, Chung-Chun

Objectives: Despite the remarkable advances in critical care management of acute brain injury for the past 20 years, the prognoses remain poor. However, numerous reports indicate the efficacy of Traditional Chinese Medicine (TCM) therapy in stroke rehabilitation. This study aimed to determine the efficacy and safety of integrated TCM (Wendan decoction [WDD]) in patients with acute brain injury as a combination therapy in the early stages. Design: Prospective randomized controlled trial. Setting: Single-center study. Subjects: Sixty patients diagnosed with acute brain injury were randomly assigned to intervention and control groups, equally, and 41 patients completed the study. Interventions: All patients were treated by conventional neurologic intensive care. The 23 patients in the intervention group were administered with an integrated WDD in the early stages three times daily; combination treatment was initiated within 14 days and lasted >1 month. Outcome measures: Duration of ventilator use, intensive care unit stays, Glasgow Coma Scale (GCS) scores, motor response, the best muscle power, disability rating scale (DRS) scores, modified Rankin scale (mRS) scores, and the mortality rate for the first month. The other outcome measures were GCS scores, motor response, the best muscle power, DRS, mRS, and Barthel index (BI) scores 6 months later. Results: There was no mortality in the intervention group, but the rate was 39% in the control group for first month. Comparisons between groups showed significant differences (p < 0.05) in GCS, DRS, mRS, and BI scores, indicating improvements in the intervention group after 6 months. Conclusions: In the early stages of acute brain injury, combination treatment with WDD was found to be safe. Furthermore, this treatment may improve neurologic functional outcomes after 6 months.

100 Deals associated with Wendan Tablets

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Indication	Highest Phase	Country/Location	Organization	Date
Generalized anxiety disorder	Phase 2	CN	The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine	13 May 2019

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