Efficacy and Safety of Prunella Oral Liquid in the Treatment of Thyroid Nodules: a Multicenter, Prospective, Randomized, Double-blind, Placebo-controlled Study

A multicenter, prospective, randomized, double-blind, placebo-controlled clinical trial was designed to evaluate the efficacy and safety of Prunella oral liquid in patients with benign thyroid nodules, which belongs to the post-marketing reevaluation clinical study.
In this study, 426 subjects will be enrolled by competitive enrollment at several research centers across China. The main inclusion criteria are:
① Thyroid ultrasound examination found thyroid nodules, can be accompanied by goiter, and the nodules meet the following conditions: 1) There were dominant nodules in single or multiple nodules (the largest diameter of the second largest nodules was not more than 50% of the largest nodules), 2) solid nodules, 3) the longest diameter of nodules was ≥1cm and < 3cm, 4) C-TIRADS 3
4A nodules.
② Patients who met the puncture indication were confirmed by fine needle aspiration biopsy (FNAB) as benign nodules (Bethesda II).
③ Levels of TSH, FT3 and FT4 were normal, and the antibody titers of TgAb and TPOAb were normal.
Eligible subjects will be randomly assigned on a 1:1:2:2 scale to: Group A (placebo conventional dose group, 10 mL/times, 2 times/day), group B (placebo 2x dose group, 10ml/times, 2 times/day), group C (conventional dose group of Prunella oral liquid), group D (Prunella oral liquid 2x dose group). All subjects will receive the treatment for 9 months and follow up at 3rd, 6th, 9th and 12th month.
The primary efficacy endpoint of this study was the rate of change in thyroid nodule volume from baseline at 6 months of treatment. The rate of change in thyroid nodule volume from baseline at 3 and 9 months of treatment was a secondary efficacy endpoint. Other secondary efficacy endpoints included maximum thyroid nodule diameter, number of thyroid nodules, proportion of patients with reduced thyroid nodule volume or ≥50% from baseline, thyroid volume, thyroid function (serum TSH, FT3, FT4, thyroid egg levels (Tg), thyroid antibody levels (TgAb, TPOAb), quality of life evaluation (SF-36), etc. Safety endpoints included incidence of AE/ serious adverse events (SAE), causality, and outcomes. Incidence of AE/SAE leading to discontinuation. Changes in safety laboratory test values from baseline.

Start Date30 Jul 2024

Sponsor / Collaborator

Guiyang Xintian Pharmaceutical Co., Ltd.

CTR20240680 / RecruitingPhase 3

复方苦参凝胶治疗细菌性阴道病（湿热下注证）的有效性和安全性的随机、双盲、安慰剂对照、多中心Ⅲ期临床试验

[Translation] A randomized, double-blind, placebo-controlled, multicenter phase III clinical trial on the efficacy and safety of compound Sophora flavescens gel in the treatment of bacterial vaginosis (damp-heat syndrome)

（1）评价复方苦参凝胶治疗细菌性阴道病（湿热下注证）的有效性。（2）评价复方苦参凝胶的安全性。

[Translation]

(1) To evaluate the efficacy of compound Sophora flavescens gel in the treatment of bacterial vaginosis (damp-heat syndrome). (2) To evaluate the safety of compound Sophora flavescens gel.

Start Date17 Apr 2024

Sponsor / Collaborator

Shandong University of Traditional Chinese Medicine

[+1]

NCT06159114 / Not yet recruitingPhase 4

Efficacy and Safety of Ningmitai Capsule Alone or Combined With Celecoxib in the Treatment of Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS): A Prospective, Randomized, Double-blind, Multicenter Clinical Study

Clinical trial title：Efficacy and safety of Ningmitai capsule alone or combined with celecoxib in the treatment of Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS): A prospective, randomized, double-blind, multicenter clinical study
Version number/date：1.1/2023-10-09
Principal investigator：Zhou Huiliang
Main research units：The First Affiliated Hospital of Fujian Medical University
Clinical trial start and end dates：2023/07/01-2025/12/31
Objective: To evaluate whether Ningmitai capsule(NMT) alone or combined with Celecoxib for 6 weeks is more effective than Celecoxib in improving pain symptoms of CP/CPPS patients.
Study type: Interventional study
Total sample size:240
Inclusion criteria:
（1）Age: male patients aged 18-60 years; （2）Long-term and repeated pelvic discomfort or pain (NIH-CPSI pain score ≥ 4 points), lasting more than 3 months, may be accompanied by different degrees of urination symptoms and sexual dysfunction; （3）Negative bacterial in urine before and after prostate massage; （4）Voluntarily participate in the trial. 10、Exclusion criteria:
Utilize any drugs for the treatment of chronic prostatitis in the past 2 weeks;
Patients who have received prostate surgery and treatment;
Urine WBC ≥ 5/HP, urinary system infection within 12 months, and effective antibiotic treatment in the early stage;
Pelvic pain and voiding dysfunction caused by non-prostatitis factors.
Suffering from serious primary cardiovascular disease, liver disease, kidney disease, hematological disease, lung disease or other serious diseases such as tumors or AIDS;
Significant adverse events in clinical or laboratory examination.
Allergic to the components of the test drugs or sulfa;
Previous active peptic ulcer / bleeding;
A birth plan within the past 8 months;
Legally disabled patients or psychiatric patients;
Suspected or confirmed alcohol or drug abuse, or other conditions that reduce the possibility of enrollment；
Participating in other clinical trials;
Considered unsuitable for enrollment by the investigator. 11、Interventions:
（1）Ningmitai group （2）Celecoxib group （3）Combination group

Start Date01 Dec 2023

Sponsor / Collaborator

Guiyang Xintian Pharmaceutical Co., Ltd.

100 Clinical Results associated with Guiyang Xintian Pharmaceutical Co., Ltd.

0 Patents (Medical) associated with Guiyang Xintian Pharmaceutical Co., Ltd.

Literatures (Medical) associated with Guiyang Xintian Pharmaceutical Co., Ltd.

01 Jul 2024·Biochemical and Biophysical Research Communications

Uric acid-lowering effect of harpagoside and its protective effect against hyperuricemia-induced renal injury in mice

Article

Author: Wang, Fang ; Zhu, Qin-Feng ; Liao, Shang-Gao ; Li, Jing ; Yu, Ling-Ling ; He, Xun ; Fu, Qiong ; Xu, Guo-Bo ; Zhang, Jin-Juan ; Ao, Jun-Li ; Liao, Xing-Jiang ; Wei, Mao-Chen

Hyperuricemia (HUA) is caused by increased synthesis and/or insufficient excretion of uric acid (UA). Long-lasting HUA may lead to a number of diseases including gout and kidney injury. Harpagoside (Harp) is a bioactive compound with potent anti-inflammatory activity from the roots of Scrophularia ningpoensis. Nevertheless, its potential effect on HUA was not reported. The anti-HUA and nephroprotective effects of Harp on HUA mice were assessed by biochemical and histological analysis. The proteins responsible for UA production and transportation were investigated to figure out its anti-HUA mechanism, while proteins related to NF-κB/NLRP3 pathway were evaluated to reveal its nephroprotective mechanism. The safety was evaluated by testing its effect on body weight and organ coefficients. The results showed that Harp significantly reduced the SUA level and protected the kidney against HUA-induced injury but had no negative effect on safety. Mechanistically, Harp significantly reduced UA production by acting as inhibitors of xanthine oxidase (XOD) and adenosine deaminase (ADA) and decreased UA excretion by acting as activators of ABCG2, OAT1 and inhibitors of GLUT9 and URAT1. Moreover, Harp markedly reduced infiltration of inflammatory cells and down-regulated expressions of TNF-α, NF-κB, NLRP3 and IL-1β in the kidney. Harp was a promising anti-HUA agent.

01 Jul 2023·Phytomedicine

Amelioration effects of α-viniferin on hyperuricemia and hyperuricemia-induced kidney injury in mice

Article

Author: Zhang, Jian ; Zou, Shu-Han ; He, Xun ; Yang, Ya-Xin ; Zhang, Jin-Juan ; Guo, Xiao-Li ; Liao, Shang-Gao ; Guan, Huan-Yu ; Wei, Mao-Chen ; Zhang, Chun-Lei ; Zhu, Qin-Feng ; Gao, Yan-Yan ; Wang, Ya ; Xu, Guo-Bo

BACKGROUNDα-Viniferin, the major constituent of the roots of Caragana sinica (Buc'hoz) Rehder with a trimeric resveratrol oligostilbenoid skeleton, was demonstrated to possess a strong inhibitory effect on xanthine oxidase in vitro, suggesting it to be a potential anti-hyperuricemia agent. However, the in vivo anti-hyperuricemia effect and its underlying mechanism were still unknown.PURPOSEThe current study aimed to evaluate the anti-hyperuricemia effect of α-viniferin in a mouse model and to assess its safety profile with emphasis on its protective effect on hyperuricemia-induced renal injury.METHODSThe effects were assessed in a potassium oxonate (PO)- and hypoxanthine (HX)-induced hyperuricemia mice model by analyzing the levels of serum uric acid (SUA), urine uric acid (UUA), serum creatinine (SCRE), serum urea nitrogen (SBUN), and histological changes. Western blotting and transcriptomic analysis were used to identify the genes, proteins, and signaling pathways involved.RESULTSα-Viniferin treatment significantly reduced SUA levels and markedly mitigated hyperuricemia-induced kidney injury in the hyperuricemia mice. Besides, α-viniferin did not show any obvious toxicity in mice. Research into the mechanism of action of α-viniferin revealed that it not only inhibited uric acid formation by acting as an XOD inhibitor, but also reduced uric acid absorption by acting as a GLUT9 and URAT1 dual inhibitor as well as promoted uric acid excretion by acting as a ABCG2 and OAT1 dual activator. Then, 54 differentially expressed (log₂ FPKM ≥ 1.5, p ≤ 0.01) genes (DEGs) repressed by the treatment of α-viniferin in the hyperuricemia mice were identified in the kidney. Finally, gene annotation results revealed that downregulation of S100A9 in the IL-17 pathway, of CCR5 and PIK3R5 in the chemokine signaling pathway, and of TLR2, ITGA4, and PIK3R5 in the PI3K-AKT signaling pathway were involved in the protective effect of α-viniferin on the hyperuricemia-induced renal injury.CONCLUSIONSα-Viniferin inhibited the production of uric acid through down-regulation of XOD in hyperuricemia mice. Besides, it also down-regulated the expressions of URAT1 and GLUT9 and up-regulated the expressions of ABCG2 and OAT1 to promote the excretion of uric acid. α-Viniferin could prevent hyperuricemia mice from renal damage by regulating the IL-17, chemokine, and PI3K-AKT signaling pathways. Collectively, α-viniferin was a promising antihyperuricemia agent with desirable safety profile. This is the first report of α-viniferin as an antihyperuricemia agent.

Anhui Nongye Kexue

Extraction and Content Determination of Polysaccharide in Gniyang Commercial Available Radix Pseudostellariae

Author: Luo, Zhong-sheng ; Tan, Rong-gui ; Zhou, Mei ; Huang, Xiu-ping ; Fan, Ju-di

To determine the content of polysaccharide in Guiyang com. available Radix pseudostellariae.The polysaccharides were extracted with hot water-ethanol deposit method.The assay of polysaccharides was measured with UV-Vis method by the anthrone-sulfuric acid using glucose as the standard in the 626 nm wavelength.The content of polysaccharide in Radix pseudostellariae from Fukangtang Chinese and Western Pharmacy was the highest, but the content from Chinese crude drug wholesale department was the lowest.The contents of polysaccharides in Radix pseudostellariae from Fukangtang Chinese and Western Pharmacy, Beijing Tongrentang Guiyang pharmacy, Renhe special local products store, Guiyang l- Huaguoyuan Chinese crude drug wholesale market, Taisheng Wuying Chinese crude drug store, Sheng sheng Pharmacy, Baihe Chinese and Western Pharmacy, Tongjitang linkage Pharmacy, Chinese crude drug wholesale department were 18.43%, 17.48%, 15.15%, 13.65%, 12.52%, 12.13%, 11.60%, 10.23%, 9.74% , resp.The contents of polysaccharide in Guiyang com. available Radix pseudostellariae were different significantly, which may affect its action.

News (Medical) associated with Guiyang Xintian Pharmaceutical Co., Ltd.

13 Oct 2022

·www.prnewswire.com

Guiyang's Wudang district shines in pharma sector

GUIYANG, Oct. 12, 2022 /PRNewswire/ -- A news report from chinadaily.com.cn: Southwest China's Guizhou province – one of the four main regions for traditional Chinese medicine materials production in China – has abundant medicine resources and a long history in ethnic medicine, and these days, its activities in the sector are going from strength to strength. Continue Reading Guiyang Xintian Pharmaceutical Co is experiencing rapid growth after its stock market listing. As one of Guizhou's 12 major agriculture industrial sectors, the traditional Chinese medicine materials industry has given birth to various rapidly-expanding companies that are based there. Under Guizhou's five-year plan for industrial development, the province will give full play to its advantages in ethnic medicine and promote the intensive processing of traditional Chinese medicine materials. It will improve the quality of traditional Chinese medicine and ethnic medicine, as well as expand the industrial scale of health care products and medical instrument production. The province will accelerate the development of business entities in the healthcare industry and make it a new growth point and a pillar industry. By 2025, the total value of Guizhou's pharmaceutical industry is projected to reach 200 billion yuan ($27.94 billion). In the Wudang district of Guizhou's capital city Guiyang, 22 percent of the province's Chinese medicinal herb varieties are to be found. The district has identified 1,058 varieties of wild Chinese medicinal herbs and it cultivates 47 varieties of them. In recent years, the district has moved to expand the scale of its pharma sector, which has become one of its core industries, according to Wang Mingming, secretary of the CPC Wudang district committee. Currently, it has a dozen of pharma manufacturers there – each earning at least 20 million yuan annually – and the total annual output value of Wudang's pharmaceutical industry last year came in at 6.02 billion yuan. Guiyang Yongle Pharmaceutical Co, located in Wudang, was recognized again as a national high-tech company in 2020. Since its establishment, the company has endeavored to make full use of Guizhou's ample supply of Chinese medical herbs and process them with advanced technologies. The company focuses on new products and production skills to commercialize its sci-tech achievements. Currently, it has three invention patents, 18 utility model patents and three design patents. Guiyang Xintian Pharmaceutical Co, established in 1995 in Wudang, was listed on Shenzhen Stock Exchange in 2017. Focusing on R&D, production and marketing of Chinese patent medicines, the company has total assets exceeding 1.5 billion yuan. In the wake of its listing, it has seen a marked improvement in its development potential. In 2021, the company's business revenue reached 970 million yuan, up 29.15 percent year-on-year. The company now sells prescription medicines to more than 12,000 hospitals above the county level across the nation and maintains long-term business relationships with about 1,300 medical institutions. It continues to make inroads into intelligent production, energy conservation and environmental protection. By investing more than 240 million yuan in new production lines, the company is forecast to achieve annual production of 570 million bags of formula granules, 20 million tubes of gels and 33 million tubes of admixtures in the future. SOURCE chinadaily.com.cn

100 Deals associated with Guiyang Xintian Pharmaceutical Co., Ltd.

100 Translational Medicine associated with Guiyang Xintian Pharmaceutical Co., Ltd.

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Kuntai Capsule	Menopausal syndrome More	Approved
NingMiTai	Urinary Tract Infections More	Approved
Kue Jieyin Gelatum	Bacterial Vaginosis More	Pending

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