[Translation] A single-center, randomized, double-blind, placebo-controlled phase Ib clinical trial of multiple-dose Olantiweikang tablets in healthy adults

观察多次给予健康成人受试者胃康片的安全性和耐受性，评估胃康片的安全剂量范围，确定人体最大耐受量，为制定III期临床试验给药方案提供依据。

[Translation]

To observe the safety and tolerability of multiple administrations of Weikang Tablets to healthy adult subjects, evaluate the safe dosage range of Weikang Tablets, determine the maximum tolerated dose in humans, and provide a basis for formulating the dosing regimen for Phase III clinical trials.

Start Date20 Dec 2017

Sponsor / Collaborator

Jiangxi Qingfeng Pharmaceutical Co. Ltd.

CTR20132371 / CompletedPhase 3

奥兰替胃康片治疗功能性消化不良的安全性及有效性的多中心、随机双盲、阳性药对照III期临床试验

[Translation] A multicenter, randomized, double-blind, active-controlled phase III clinical trial on the safety and efficacy of Olantiweikang tablets in the treatment of functional dyspepsia

以多潘立酮片为对照，评价奥兰替胃康片3片/次，每日3次，治疗功能性消化不良的有效性和安全性

[Translation]

To evaluate the efficacy and safety of Olantiweikang tablets, 3 tablets/time, 3 times a day, in the treatment of functional dyspepsia, using domperidone tablets as a control

Start Date24 Apr 2013

Sponsor / Collaborator

Jiangxi Qingfeng Pharmaceutical Co. Ltd.

CTR20132482 / CompletedPhase 3

奥兰替胃康片治疗功能性消化不良的安全性及有效性的多中心、随机双盲、安慰剂对照Ⅲ期临床试验

[Translation] A multicenter, randomized, double-blind, placebo-controlled phase III clinical trial on the safety and efficacy of Olantiweikang tablets in the treatment of functional dyspepsia

以安慰剂为对照，评价奥兰替胃康片3片/次，每日3次，治疗功能性消化不良的有效性和安全性，为上市提供确证性试验数据支持。

[Translation]

Using placebo as a control, the efficacy and safety of Olantiweikang Tablets, 3 tablets/time, 3 times a day, in the treatment of functional dyspepsia was evaluated to provide confirmatory trial data support for marketing.

Start Date18 Mar 2013

Sponsor / Collaborator

Jiangxi Qingfeng Pharmaceutical Co. Ltd.

100 Clinical Results associated with Citrus aurantium total flavonoid tablets

100 Translational Medicine associated with Citrus aurantium total flavonoid tablets

100 Patents (Medical) associated with Citrus aurantium total flavonoid tablets

Literatures (Medical) associated with Citrus aurantium total flavonoid tablets

01 Jan 2024·International journal of community based nursing and midwifery

The Effect of Citrus Aurantium Vaginal Cream on Vaginal Atrophy in Postmenopausal Women: A Quasi-experimental Study.

Article

Author: Rahmani, Roghayeh ; Rahmati, Zahra ; Asgharpoor, Homeira ; Rakhshandeh, Hassan ; Hadizadeh-Talasaz, Fatemeh

BackgroundVulvovaginal atrophy (VVA) is a common condition and a silent epidemic affecting many postmenopausal women who suffer from it in silence. This study aimed to evaluate the effect of Citrus aurantium vaginal cream on vaginal atrophy in postmenopausal women.MethodsThis single-group pretest-posttest quasi-experimental study was conducted on 30 postmenopausal women who were referred to the Gynecology Clinic of Imam Khomeini Hospital in the city of Noor, Iran, from June to November 2020. Citrus aurantium vaginal cream was administered to women diagnosed with vaginal atrophy (based on subjective symptoms of atrophy, descriptive evaluation of the vagina, vaginal pH measurement, and degree of vaginal maturation determined by vaginal smear) every night in the first two weeks and every other night for the second two weeks. Data were collected using the scale of subjective symptoms of vaginal atrophy; descriptive evaluation checklist of vaginal mucosa; laboratory results registration form (vaginal maturation index, vaginal maturation value, and vaginal pH) before the intervention and two and four weeks after the intervention. Data were analyzed using SPSS software (version 24) through the analysis of variance with repeated measurements, and LSD post-hoc test. A P value less than 0.05 (P<0.05) was considered statistically significant.ResultsCitrus aurantium vaginal cream improved subjective symptoms of vaginal atrophy (P<0.001), reduced the score of descriptive evaluation of vaginal mucosa (P<0.001), decreased vaginal pH (P<0.001), and increased vaginal maturity (P<0.001).ConclusionsThe results showed that citrus aurantium vaginal cream could improve the symptoms of vaginal atrophy without causing serious complications. However, further studies with a control group are suggested to confirm the findings of this study.Trial Registration Number: IRCT20200215046494N.

01 Jan 2023·BioMed Research International

The Effect of Citrus aurantium on Non‐Small‐Cell Lung Cancer: A Research Based on Network and Experimental Pharmacology

Article

Author: Zhang, Xuan ; Wan, Chunpeng Craig ; Huang, Chaoming ; Cai, Yi ; Yao, Liangliang

Purpose. To screen the main active components of Citrus aurantium through a network pharmacology approach, construct a component‐disease target network, explore its molecular mechanism for the treatment of non‐small‐cell lung cancer (NSCLC), and validate it experimentally. Methods. The active ingredients in Citrus aurantium and the targets of Citrus aurantium and NSCLC were collected through the Traditional Chinese Medicine Systematic Pharmacology Database and Analysis Platform (TCMSP), GeneCards, and OMIM databases. The protein interaction network was constructed using the STRING database, and the component‐disease relationship network graph was analyzed using Cytoscape 3.9.1. The Metascape database can be used for GO and KEGG enrichment analyses. The Kaplan‐Meier plotter was applied for overall survival analysis of key targets of Citrus aurantium in the treatment of NSCLC. Real‐time PCR (RT‐PCR) and Western blotting were used to determine the mRNA and protein levels of key targets of Citrus aurantium for the treatment of NSCLC. Results. Five active ingredients of Citrus aurantium were screened, and 54 potential targets for the treatment of NSCLC were found, of which the key ingredient was nobiletin and the key targets are TP53, CXCL8, ESR1, PPAR‐α, and MMP9. GO and KEGG enrichment analyses indicated that the mechanism of nobiletin in treating NSCLC may be related to the regulation of cancer signaling pathway, phosphatidylinositol‐3 kinase (PI3K)/protein kinase B (Akt) signaling pathway, lipid and atherosclerosis signaling pathway, and neurodegenerative signaling pathway. The experimental results showed that nobiletin could inhibit the proliferation of NSCLC cells and upregulate the levels of P53 and PPAR‐α and suppress the expression of MMP9 (P < 0.05). Conclusion. Citrus aurantium can participate in the treatment of NSCLC through multiple targets and pathways.

01 Apr 2022·International journal of community based nursing and midwifery

The Effect of Citrus Aurantium Aroma on the Sleep Quality in Postmenopausal Women: A Randomized Controlled Trial.

Article

Author: Mohaghegh, Zeynab ; Abbaspoor, Zahra ; Siahposh, Amir ; Faal Siahkal, Shahla ; Sharifipour, Foruzan ; Javadifar, Nahid

BackgroundOne of the most common problems in menopausal women is sleep disturbance. Citrus aurantium has sedative, hypnotic, and anti-anxiety effects. The aim of this study was to investigate the effect of Citrus aurantium aroma on the sleep quality of postmenopausal women.MethodsThis was a double-blind randomized controlled trial that was conducted from Feb to Dec 2019 on 80 postmenopausal women who suffered from sleep disturbances. The participants were assigned into two groups randomly. Women in the intervention group were requested to use 2 drops of essential oil of Citrus aurantium, twice a day, for 4 consecutive days in a week, for 4 weeks as inhalation. The control group received almond oil in the same way. The quality of sleep was evaluated using the Pittsburgh Sleep Quality Index (PSQI) before the intervention and 4 weeks after the intervention started. The data were analyzed using the SPSS statistical software, version 21, and P<0.05 was considered statistically significant.ResultsAfter 4-weeks of intervention, the mean score of sleep quality was significantly lower in the Citrus aurantium group compared to the control group (5.75±1.33 vs 13±1.59, P<0.001). In the intervention group, all dimensions of PSQI were improved significantly (P<0.001).ConclusionThe results of this study showed that the aroma of Citrus aurantium essence could significantly improve the sleep quality of postmenopausal women. Therefore, it is recommended that health care providers should inform the postmenopausal women and advise them to use this intervention for reduction of sleep disorders.Trial Registration NumberIRCT20160427027633N7.

100 Deals associated with Citrus aurantium total flavonoid tablets

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Indication	Country/Location	Organization	Date
Dyspepsia	CN	Jiangxi Qingfeng Pharmaceutical Co. Ltd.	19 Oct 2023

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