以南京正大天晴制药有限公司研制的柑橘黄酮片（规格：500 mg[以总黄酮计]）为受试制剂（T），Les Laboratoires Servier持证、Les Laboratoires Servier Industrie生产的柑橘黄酮片（商品名：爱脉朗®，规格：500 mg[以总黄酮计]）为参比制剂（R），研究受试制剂和参比制剂在空腹/餐后状态下单剂量给药时的药代动力学参数，评价两制剂的人体生物等效性，并评估南京正大天晴制药有限公司研制的柑橘黄酮片的安全性。

[Translation]

The citrus flavonoids tablets (specification: 500 mg [based on total flavonoids]) developed by Nanjing Zhengda Tianqing Pharmaceutical Co., Ltd. were used as the test preparation (T), and the citrus flavonoids tablets (trade name: Aimalan®, specification: 500 mg [based on total flavonoids]) certified by Les Laboratoires Servier and produced by Les Laboratoires Servier Industrie were used as the reference preparation (R). The pharmacokinetic parameters of the test preparation and the reference preparation when administered in a single dose under fasting/postprandial conditions were studied, the bioequivalence of the two preparations in humans was evaluated, and the safety of the citrus flavonoids tablets developed by Nanjing Zhengda Tianqing Pharmaceutical Co., Ltd. was assessed.

Start Date-

Sponsor / Collaborator

Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd.

CTR20241677 / Not yet recruitingNot Applicable

柑橘黄酮片在中国健康人群中空腹和餐后状态下单次给药的人体生物等效性临床预试验

[Translation] A pilot clinical study on the bioequivalence of citrus flavonoid tablets in Chinese healthy subjects after single administration under fasting and fed conditions

主要目的：以持证商为Les Laboratoires Servier的柑橘黄酮片（500mg（以总黄酮计），商品名：爱脉朗®）为参比制剂，以湖北民康药业集团有限公司研制的柑橘黄酮片（500mg（以总黄酮计））为受试制剂，通过单中心、随机、开放、单次给药、两制剂、两序列、四周期重复交叉设计的空腹和餐后临床预试验，明确空腹和餐后单次给药后的药代动力学特征，进行体内药代动力学过程分析，对比两者间的生物等效性，为后期正式试验提供参考。次要目的：观察受试制剂和参比制剂在中国健康受试者中的安全性。

[Translation]

Main purpose: Using the Citrus Flavonoid Tablets (500 mg (based on total flavonoids), trade name: Ai Mai Lang®) of Les Laboratoires Servier as the reference preparation and the Citrus Flavonoid Tablets (500 mg (based on total flavonoids)) developed by Hubei Minkang Pharmaceutical Group Co., Ltd. as the test preparation, a single-center, randomized, open, single-dose, two-dose, two-sequence, four-cycle repeated crossover design of fasting and postprandial clinical pilot test was conducted to clarify the pharmacokinetic characteristics after single fasting and postprandial administration, conduct in vivo pharmacokinetic process analysis, compare the bioequivalence between the two, and provide reference for the later formal trials. Secondary purpose: Observe the safety of the test preparation and the reference preparation in healthy Chinese subjects.

Start Date-

Sponsor / Collaborator

Hubei Minkang Pharmaceutical Group Co., Ltd.

100 Clinical Results associated with Orange Extract

100 Translational Medicine associated with Orange Extract

100 Patents (Medical) associated with Orange Extract

138

Literatures (Medical) associated with Orange Extract

01 Dec 2024·Annals of Vascular Surgery

Effect of Micronized Purified Flavonoid Fraction on Venous Hemodynamics Evaluated Using Digital Photoplethysmography in Patients with Chronic Venous Disease

Article

Author: Guven, Hakan

BACKGROUNDMicronized purified flavonoid fraction (MPFF) is the most widely prescribed and well-studied venoactive drug available for the treatment of chronic venous disease (CVD). Photoplethysmography (PPG) is used to quantitatively measure venous hemodynamics and provide information about the overall function of the venous system. The aim of this study was to use digital PPG to evaluate the effects of MPFF on venous hemodynamics in patients with CVD.METHODSPatients diagnosed with CVD at an outpatient clinic in Bursa, Turkey between February 2018 and July 2020 were assessed for inclusion in this retrospective analysis. Patients who complied with the advised treatment strategy (MPFF 1,000 mg tablets taken orally once daily and compression garments) and attended follow-up visits were included in the analysis. Digital PPG was used to measure venous refilling time (VRT) and venous pumping capacity (VPC) at diagnosis and 6 months of follow-up. The Venous Clinical Severity Score (VCSS) was also obtained at these visits, and patients completed the 20-item Chronic Venous Insufficiency Questionnaire (CIVIQ-20).RESULTSIn total, 721 patients (mean age 52 years) with C0-C4 CVD were included in the study. PPG showed that VRT and VPC increased significantly from 19.0 sec to 2.0%, respectively, at diagnosis to 27.4 and 4.9%, respectively, at 6 months (both P < 0.05). Mean VCSS improved significantly from 7.9 at diagnosis to 3.1 at 6 months (P < 0.05). Mean CIVIQ-20 score also improved significantly at the 6-month follow-up (20.1 vs 38.6 at diagnosis; P < 0.01).CONCLUSIONSIn patients with C0-C4 CVD, 6 months of MPFF treatment plus the wearing of compression garments was associated with statistically significant improvements in venous hemodynamic parameters measured by PPG, as well as measures of clinical severity and quality of life.

01 Dec 2024·Techniques in Coloproctology

Effectiveness of preoperative micronized purified flavonoid fraction treatment and sucralfate-based rectal ointment on hemorrhoidal disease: A case-matched analysis

Article

Author: Lori, E ; Dezi, A ; Picciariello, A ; Gallo, G ; Grossi, U ; Goglia, M

AbstractBackgroundHemorrhoidal disease (HD) significantly impacts patients’ quality of life. This study aimed to evaluate the effectiveness of preoperative treatment with the micronized purified flavonoid fraction (MPFF) and a sucralfate-based rectal ointment in managing HD symptoms and reducing interventions.MethodsA prospective quasi-experimental study including consecutive cases and controls matched on the basis of sex was performed in a tertiary referral center. Cases received systemic and local therapy for HD, consisting of a rectal ointment containing 3% sucralfate and herbal extracts plus MPFF, in addition to conservative therapy, while controls received conservative therapy alone. The hemorrhoidal disease symptom score (HDSS), the Short Health Scale for HD (SHS-HD) score, and the Vaizey Incontinence Score were used to evaluate symptoms severity and their impact on quality of life and continence. Intervention requirements were assessed at baseline (T0) and after 60 days of treatment (T1).ResultsBetween January and December 2023, a total of 98 patients were assessed for eligibility. After exclusions, 56 patients were enrolled, with 28 in each group. Significant improvements were observed in HD symptom scores from T0 to T1: the intervention group showed a mean change in HDSS of −9 [95% confidence interval (CI) −10 to −8], and the control group showed no significant change (mean change of 0; 95% CI −1.5 to 0). At T1, a higher proportion of patients in the intervention group underwent less invasive interventions compared with controls (18% versus 11%). Age, treatment group, and baseline symptom severity significantly predicted post-treatment symptom scores.ConclusionsIn our study the preoperative treatment with MPFF and a sucralfate-based rectal ointment demonstrated clinical benefits in managing HD symptoms and reducing interventions. Further prospective trials are warranted to confirm and explore additional therapeutic strategies.

01 Aug 2024·Asian Journal of Surgery

The efficacy of Aescin combined with MPFF for early control of bleeding from acute hemorrhoids, A randomized controlled trial

Article

Author: Vipudhamorn, Witcha ; Sutharat, Pawit ; Supatrakul, Ekkarin ; Sanmee, Suwan

BACKGROUNDHemorrhoidal disease, affecting over 20 % of the population, presents management challenges due to its multifaceted nature. While treatments like Micronized Purified Flavonoid Fraction (MPFF) show promise, Aescin's efficacy remains uncertain. This study assesses the combined effectiveness of Aescin with MPFF against MPFF alone in treating Grades 1 and 2 hemorrhoids, focusing on halting bleeding and reducing mass effect.METHODThis study recruited patients from the Division of Colorectal Surgery, Chiang Mai University. Patients were randomly assigned to receive MPFF alone or MPFF with Aescin. Outcomes included the duration until bleeding cessation and resolution of mass effect.RESULTSOf 120 patients randomized to each group, the combination therapy demonstrated superiority in halting bleeding (two days VS four days) and resolving mass effect (four days VS five days) compared to MPFF alone with statistically significant differences. Treatment failure rates were lower in the combination therapy group, with high patient satisfaction.CONCLUSIONCombining Aescin with MPFF shows promise as a therapeutic approach for Grades 1 and 2 internal hemorrhoids, offering expedited relief from bleeding and mass effect. These findings suggest the need for further research to validate results in larger cohorts and optimize treatment strategies for hemorrhoidal disease.

News (Medical) associated with Orange Extract

18 Jan 2023

·www.prnewswire.com

Worldwide Essential Oils Industry to 2027 - Increase in Demand for Aromatherapy Drives Growth

DUBLIN, Jan. 18, 2023 /PRNewswire/ -- The "Essential Oils Market By Product Type, Application (Food & beverages, Cosmetics & Toiletries, Aromatherapy, Home Care, and Health Care), Source (Fruits & Vegetables, Herbs & Spices, Flowers), Method of Extraction and Region - Global Forecast to 2027" report has been added to ResearchAndMarkets.com's offering. The global essential oils market size is estimated to be valued at USD 8.8 billion in 2022 and is projected to reach USD 15.3 billion by 2027, recording a CAGR of 11.8% in terms of value. By application, the aromatherapy is projected to grow rapidly during the forecast period The rising popularity of aromatherapy and other alternative medicine is increasing in demand, as are the relaxing effects of essential oils when applied through a massage. The health industry has begun to incorporate essential oils in aromatherapy applications to treat Alzheimer's, bronchitis, and various cardiovascular problems. Changing lifestyles and their consequences, such as high stress and depression, along with increasing disposable incomes, results in an increase in demand for aromatherapy. Ginger oil, pine oil, oregano oil, and wintergreen oil are some of the essential oils used on a large scale in alternative therapies. The National Association for Holistic Aromatherapy (NAHA), the Alliance of International Aroma Therapists, and The Canadian Federation of Aroma Therapists have established standards for aromatherapy certification in the US and Canada. This would allow the essential oil industry to use different oils for various aromatherapy products, globally. By type, the orange essential oil is widely used in all the domains due to the presence of the high amount of vitamin C and appealing fragrance Oranges are full of vitamin C and offer several health advantages. The rind of the sweet orange, Citrus sinensis, is used to make orange essential oil. Cold pressing, a technique used to extract the oils from the rind, is used to accomplish this. Brazil is the leading orange producer in the world producing about 30% of the world's output. Orange oil, which is energetic, is one of the most widely used options in aromatherapy. The oil can decrease various kinds of pain such as inflammation, muscle spasms, tissue damage, pain from bone fractures, headache, etc. The Asia Pacific market is being driven by an increase in demand for domestic products brought on by an expanding middle class The Asia Pacific region is mostly segmented into India, China, Japan, New Zealand, Australia, and Rest of Asia pacific. The improving standard of living and high per capita income in the region, along with higher expenditure, are driving up the demand for essential oils, which has been significantly influenced by the growth of the wellness and leisure sectors. The demand for citrus-based essential oils like orange and lemon has also attracted a lot of consumer interest in some of nations. The product is becoming more widely used in the personal care and household products sectors, and the usage of citrus essential oil in tastes, odorants, and pharmaceutical substances has lately increased. With emerging economies, growing industrialization, increasing demand for processed foods, and consumer preference for quality products, ingredient suppliers are becoming increasingly optimistic about the growth of the food & beverage industry. Key Topics Covered: 1 Introduction 2 Research Methodology 3 Executive Summary 4 Premium Insights 4.1 Attractive Opportunities for Players in Essential Oil Market 4.2 Essential Oils Market: Major Regional Submarkets 4.3 Asia-Pacific: Essential Oil Market, by Source & Country 4.4 Asia-Pacific: Essential Oil Market, by Application 4.5 Essential Oil Market, by Methods of Extraction 4.6 Essential Oil Market, by Application & Region 5 Market Overview 5.1 Introduction 5.2 Macroeconomic Indicators 5.2.1 Rise in Depression and Anxiety Disorders 5.2.2 Increasing Demand for Organic Food 5.3 Market Dynamics 5.3.1 Drivers 5.3.1.1 Increase in Demand for Aromatherapy 5.3.1.2 Increasing Demand for Natural Ingredients and Clean Label Products 5.3.1.3 Increased Use of Essential Oils in Homecare Products 5.3.1.4 Use of Essential Oils as an Additive in Feed 5.3.1.5 Demand for Essential Oils in Cosmetic & Fragrance Industry 5.3.2 Restraints 5.3.2.1 Depletion of Natural Resources 5.3.2.2 Side Effects Associated with Specific Essential Oils 5.3.3 Opportunities 5.3.3.1 Powdered Essential Oil to Create New Opportunities 5.3.4 Challenges 5.3.4.1 Prevalence of Synthetic/Adulterated Products 6 Industry Trends 6.1 Introduction 6.2 Value Chain 6.2.1 Research and Product Development 6.2.2 Raw Material Sourcing 6.2.3 Production 6.2.4 Packaging, Storage, and Distribution 6.2.5 End-Users 6.3 Supply Chain Analysis 6.4 Market Map and Ecosystem of Essential Oils Market 6.4.1 Demand Side 6.4.2 Supply Side 6.4.3 Ecosystem Map 6.5 Trends/Disruptions Impacting Customers' Businesses 6.5.1 Revenue Shift and New Revenue Pockets in Essential Oil Market 6.6 Technology Analysis 6.6.1 Ultrasonic Hydro Distillation 6.6.2 Pressurized Hot Water Extraction 6.6.3 Drying Technology 6.6.4 Encapsulation 6.7 Pricing Analysis 6.7.1 Selling Prices Charged by Key Players in Terms of Application 6.8 Essential Oils Market: Patent Analysis 6.8.1 List of Major Patents 6.9 Trade Analysis: Essential Oil Market 6.9.1 Export Scenario: Essential Oils for Citrus Fruits 6.9.2 Import Scenario: Citrus Fruit Essential Oils 6.9.3 Export Scenario: Essential Oils 6.9.4 Import Scenario: Essential Oils 6.10 Case Studies: Essential Oil Market 6.10.1 Rocky Mountain Oils: Sustainable Packaging 6.10.2 Doterra: Increase Operations Efficiency 6.11 Key Conferences and Events, 2022-2023 6.12 Tariff and Regulatory Landscape 6.12.1 Regulatory Bodies, Government Agencies, and Other Organizations 6.13 Porter's Five Forces Analysis 6.14 Key Stakeholders and Buying Criteria 7 Essential Oils Market, by Type 7.1 Introduction 7.2 Orange Oil 7.2.1 Increased Use in Aromatherapy 7.3 Peppermint Oil 7.3.1 Europe and Asia-Pacific to Have Significant Impact on Market 7.4 Lemon Oil 7.4.1 Rise in Demand for Nutraceuticals with Natural Flavor 7.5 Lavender Oil 7.5.1 Improves Skin Health 7.6 Lime Oil 7.6.1 Effective for Skin Infection Treatments 7.7 Rosemary Oil 7.7.1 Increased Usage in Healthcare Products due to Antioxidant Properties 7.8 Cornmint Oil 7.8.1 Powerful Antibacterial and Antiseptic Oil 7.9 Spearmint Oil 7.9.1 Extensively Used in Food & Beverage Industry as Flavoring Ingredient 7.10 Geranium Oil 7.10.1 Primary Floral Component in Fragrance and Cosmetics 7.11 Clove Leaf Oil 7.11.1 Used for Oral Health due to Germicidal Properties 7.12 Rose Oil 7.12.1 Widely Used in Aromatherapy 7.13 Coriander Oil 7.13.1 Use in Seasonings due to Flavoring Properties 7.14 Tea Tree Oil 7.14.1 Therapeutic Benefits to Increase Demand in Skincare and Cosmetics Industry 7.15 Citronella Oil 7.15.1 Large-Scale Use in Aromatherapy to Treat Migraine and Headaches 7.16 Eucalyptus Oil 7.16.1 High Demand in Dental Care due to Germicidal Properties 7.17 Jasmine Oil 7.17.1 Extensively Used for Health Benefits 7.18 Other Types 8 Essential Oils Market, by Method of Extraction 8.1 Introduction 8.2 Distillation 8.2.1 Steam Distillation Method Used Extensively to Obtain Essential Oils Economically 8.3 Cold Press Extraction 8.3.1 Citrus Fruits Extracted Via Cold Press 8.4 Carbon Dioxide Extraction 8.4.1 Aroma and Bioactive Components of Essential Oils Effectively Retained 8.5 Other Extractions 9 Essential Oils Market, by Source 9.1 Introduction 9.2 Fruits & Vegetables 9.2.1 Cold Press Method Preferred for Essential Oil Extraction from Fruits and Vegetable 9.3 Flowers 9.3.1 Essential Oils Represent an Upstream Business Opportunity for Floriculture Market 9.4 Herbs & Spices 9.4.1 Herb-Derived Essential Oils as Natural Replacers of Compounds of Synthetic Origin 10 Essential Oils Market, by Application 10.1 Introduction 10.2 Food & Beverages 10.2.1 Extensive Use of Citrus Essential Oils in Food & Beverage Industry 10.3 Cosmetics & Toiletries 10.3.1 Extensive Use of Essential Oils due to Fragrance and Functional Properties 10.4 Aromatherapy 10.4.1 Therapeutic Potential of Essential Oils 10.5 Homecare 10.5.1 Demand for Natural Ingredients to Boost Demand 10.6 Healthcare 10.6.1 Mental Well-Being to Drive Healthcare Industry 10.7 Other Applications 11 Essential Oils Market, by Region 12 Competitive Landscape 12.1 Overview 12.2 Market Share Analysis, 2021 12.3 Segmental Revenue Analysis of Key Players 12.4 Key Player Strategies 12.5 Company Evaluation Quadrant (Key Players) 12.5.1 Stars 12.5.2 Emerging Leaders 12.5.3 Pervasive Players 12.5.4 Participants 12.5.5 Product Footprint 12.6 Essential Oils Market, Evaluation Quadrant for Start-Ups/Smes, 2021 12.6.1 Progressive Companies 12.6.2 Starting Blocks 12.6.3 Responsive Companies 12.6.4 Dynamic Companies 12.6.5 Competitive Benchmarking of Key Start-Ups/Smes 12.7 Competitive Scenario 12.7.1 New Product Launches 12.7.2 Deals 12.7.3 Others 13 Company Profiles 13.1 Introduction 13.2 Key Player 13.2.1 Dsm 13.2.2 Givaudan 13.2.3 International Flavors & Fragrances Inc. (Iff) 13.2.4 Sensient Technologies Corporation 13.2.5 Cargill, Incorporated 13.2.6 Symrise 13.2.7 Robertet, Sa 13.2.8 Mane 13.2.9 Doterra 13.2.10 Now Foods 13.2.11 Synthite Industries Ltd. 13.2.12 Lebermuth, Inc. 13.2.13 Biolandes 13.2.14 Norex Flavours Private Limited 13.2.15 India Essential Oils 13.3 Other Players (Smes/Start-Ups) 13.3.1 Falcon 13.3.2 Farotti S.R.L. 13.3.3 Vidya Herbs 13.3.4 Young Living Essential Oils, Lc. 13.3.5 Essential Oils of New Zealand Ltd. 13.3.6 Veda Oils 13.3.7 Hcp Wellness 13.3.8 Vital Herbs 13.3.9 Cv Rasayana Wangi 13.3.10 Alchemy Chemicals 14 Adjacent & Related Markets 15 Appendix For more information about this report visit Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 Logo: SOURCE Research and Markets

14 Nov 2022

·www.sciencedaily.com

Uterine fibroid growth activated by phthalates, chemicals found in everyday products

Scientists have demonstrated a causal link between environmental phthalates (toxic chemicals found in everyday consumer products) and the increased growth of uterine fibroids, the most common tumors among women. Manufacturers use environmental phthalates in numerous industrial and consumer products, and they've also been detected in medical supplies and food. Although they are known to be toxic, they are currently not banned in the U.S. For the first time, scientists at Northwestern Medicine have demonstrated a causal link between environmental phthalates (toxic chemicals found in everyday consumer products) and the increased growth of uterine fibroids, the most common tumors among women. Manufacturers use environmental phthalates in numerous industrial and consumer products, and they've also been detected in medical supplies and food. Although they are known to be toxic, they are currently unbanned in the U.S. "These toxic pollutants are everywhere, including food packaging, hair and makeup products, and more, and their usage is not banned," said corresponding study author Dr. Serdar Bulun, chair of the department of obstetrics and gynecology at Northwestern University Feinberg School of Medicine and a Northwestern Medicine physician. "These are more than simply environmental pollutants. They can cause specific harm to human tissues." Up to 80% of all women may develop a fibroid tumor during their lifetime, Bulun said. One-quarter of these women become symptomatic with excessive and uncontrolled uterine bleeding, anemia, miscarriages, infertility and large abdominal tumors necessitating technically difficult surgeries. The new study found women with a high exposure to certain phthalates such as DEHP (used as a plasticizer to increase the durability of products such as shower curtains, car upholstery, lunchboxes, shoes and more) and its metabolites have a high risk for having a symptomatic fibroid. The study will be published Nov. 14 in the Proceedings of the National Academy of Sciences (PNAS). Prior epidemiological studies have consistently indicated an association between phthalate exposure and uterine fibroid growth, but this study explains the mechanisms behind that link. The scientists discovered exposure to DEHP may activate a hormonal pathway that activates an environmentally responsive receptor (AHR) to bind to DNA and cause increased growth of fibroid tumors. "Interestingly, AHR was cloned in the early '90s as the receptor for dioxin, the key toxin in the agent orange," Bulun said. "The use of agent orange during the Vietnam war caused significant reproductive abnormalities in the exposed populations; and dioxin and AHR were thought to be responsible for this." This new study, Bulun said, provides further evidence to support these theories. More about DEHP: DEHP has been the most widely used phthalate. Although there has been increased concern in the public and some regulatory restrictions in European Union countries, it is still widely used for the packaging of food and health products in the U.S. and across the world. DEHP can be gradually released from consumer products into indoor environments such as homes, schools, daycare centers, offices and cars. It settles on floors and other surfaces and can accumulate in dust and air. During pregnancy, DEHP can pass from mother to baby.

100 Deals associated with Orange Extract

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Indication	Country/Location	Organization	Date
Hemorrhoids	CN	Servier Tianjin Pharmaceutical Co. Ltd.	20 May 2019

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