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Last update 08 May 2025

primary varicose veins

Last update 08 May 2025

Basic Info

Synonyms

primary varicose veins, primary varicose veins (diagnosis)

Introduction-

Drugs associated with primary varicose veins

Polidocanol

Target

mAChRs

Mechanism

mAChRs agonists

Active Org.

Chemische Fabrik Kreussler & Co. GmbH [+3]

Originator Org.

Chemische Fabrik Kreussler & Co. GmbH

Active Indication

primary varicose veins [+2]

Inactive Indication

Venous Insufficiency

Drug Highest PhaseApproved

First Approval Ctry. / Loc.

Japan

First Approval Date28 Jun 1991

Clinical Trials associated with primary varicose veins

CTR20241473

/ CompletedNot Applicable

健康受试者空腹及餐后状态下口服羟苯磺酸钙片后人体生物等效性试验

[Translation] Human bioequivalence study after oral administration of calcium dobesilate tablets in healthy subjects in fasting and postprandial states

主要试验目的：在中国健康受试者中评价单次空腹和单次餐后服用宁夏康亚药业股份有限公司生产的羟苯磺酸钙片0.25 g（规格：0.25 g/片；受试制剂）和OM pharma S.A.生产的羟苯磺酸钙片250 mg（商品名：Doxium；规格：250 mg/片；参比制剂）的生物等效性；次要试验目的：观察受试制剂和参比制剂在健康受试者中的安全性。

[Translation]

Primary study objective: To evaluate the bioequivalence of single fasting and single postprandial administration of calcium dobesilate tablets 0.25 g (specification: 0.25 g/tablet; test preparation) produced by Ningxia Kangya Pharmaceutical Co., Ltd. and calcium dobesilate tablets 250 mg (trade name: Doxium; specification: 250 mg/tablet; reference preparation) produced by OM pharma S.A. in healthy Chinese subjects; Secondary study objective: To observe the safety of the test preparation and the reference preparation in healthy subjects.

Start Date27 May 2024

Sponsor / Collaborator

Beijing Kangerfu Pharmaceutical Co., Ltd.

CTR20230534

/ CompletedNot Applicable

一项单中心、随机、开放、单剂量、两制剂、双周期、交叉研究评价羟苯磺酸钙分散片在健康人群中的生物等效性

[Translation] A single-center, randomized, open-label, single-dose, two-formulation, two-period, crossover study to evaluate the bioequivalence of calcium dobesilate dispersible tablets in healthy subjects

以海南林恒制药股份有限公司生产的羟苯磺酸钙分散片作为受试制剂，OM pharma S.A.生产的羟苯磺酸钙片（商品名：Doxium ，规格：250mg/片）为参比制剂，评估两种制剂空腹和餐后给药的生物等效性。

[Translation]

Calcium dobesilate dispersible tablets produced by Hainan Linheng Pharmaceutical Co., Ltd. were used as the test preparation, and calcium dobesilate tablets (trade name: Doxium, specification: 250 mg/tablet) produced by OM pharma S.A. were used as the reference preparation to evaluate the bioequivalence of the two preparations when administered on an empty stomach or after a meal.

Start Date20 Mar 2023

Sponsor / Collaborator

Hainan Linheng Pharmaceutical Co., Ltd.

NCT05342779

/ Unknown statusNot ApplicableIIT

Radio Frequency Ablation Versus Stripping of Great Saphenous Vein in Management of Primary Varicose Veins , Comparative Study

Varicose veins are one of the most common diseases worldwide it constitutes a progressive disease which during its course it produces complications that usually prompt the patient to seek medical care.
Epidemiological studies of the incidence and prevalence of varicose veins found that the majority of adults would develop it over the course of their lifetime; women were found to be four times likely as men to develop it, the incidence of varicose vein occurrence increases with age.
Varicose veins are defined as tortuous dilated veins after or associated with incompetent valves.

Start Date01 Jun 2022

Sponsor / Collaborator

Sohag University

100 Clinical Results associated with primary varicose veins

100 Translational Medicine associated with primary varicose veins

0 Patents (Medical) associated with primary varicose veins

523

Literatures (Medical) associated with primary varicose veins

01 Apr 2025·Journal of Vascular Surgery: Venous and Lymphatic Disorders

Long-Term Outcomes of Electrocoagulation vs. Radiofrequency Thermoablation for Varicose Veins

Article

Author: Tannus, Miguel Monteiro ; Rossi, Fábio Henrique ; Beteli, Camila Baumann

OBJECTIVEThermoablation is increasingly being used as an alternative to traditional surgery for treating primary varicose veins. Electrocoagulation ablation (EA) of the Great Saphenous Vein (GSV) has demonstrated effectiveness and safety comparable to that of radiofrequency ablation (RFA); however, its long-term outcomes have not been previously investigated.METHODSThis study involves a long-term follow-up of patients who participated in a double-blind, randomized clinical trial. Individuals with lower limb varicose veins and incompetence of GSV were randomly assigned to two treatment groups: EA and RFA. Follow-up assessments were scheduled at 1 week, 3 months, 6 months, and annually thereafter. The primary outcome measured was GSV occlusion, evaluated through postoperative duplex ultrasound. Secondary outcomes included the complication rate and improvements in quality of life, assessed using the Aberdeen Varicose Vein Questionnaire (AVVQ) score.RESULTSA total of fifty-seven patients were included, which involved a cumulative 85 treated GSVs; 42 veins were treated with EA and 43 with RFA. At the 1-week, 3-month, and 6-month follow-ups, there were no statistically significant differences between the two groups regarding GSV occlusion rates (P=0.430; 0.157; 0.157, respectively), complication rates (P=0.717; 0.317; 0.320, respectively), or improvements in quality-of-life scores (P=0.540; 0.786; 0.401, respectively). After a median follow-up duration of 4.8 years (95% CI: 4.5-5.1 years), data for 59 procedures (69.4%) were available, showing occlusion rates of 89.7% for the EA group (N=29) and 66.7% for the RFA group (N=30) (P=0.001). There were no procedure-related complications (P=0.127), and no significant differences in the AVVQ scores (P=0.345) between the two groups analyzed.CONCLUSIONSEA has demonstrated effectiveness and safety for the ablation of the GSV, achieving a higher rate of venous occlusion compared to radiofrequency ablation (RFA) in the long-term follow-up. Additionally, the occurrence of complications and the impact on symptoms and quality of life were comparable between the two methods during long-term follow-up.

01 Feb 2025·Phlebology: The Journal of Venous Disease

Comparison of staged versus one shot varicose veins treatment: Depending on tributaries diameter

Article

Author: Pavlychenko, Viktor ; Chernukha, Larisa ; Voloshyn, Olexandr ; Suzdalenko, Olexandr ; Gubka, Viktor ; Machuskui, Serhii

Background One of the most debatable phlebology community’s issue is the choice of the optimal tactics for endovenous varicose tributaries correction after truncal ablation. Which tactic will be most effective? There is practically no data concerning treatment tactics’ choice for varicose tributary depending on its diameter. Therefore, the comparison of staged versus one-stage treatment of varicose veins is relevant problem in modern phlebology. Research on this topic will make possible determination of advantages and potential disadvantages of the proposed tactics. Methods The study included a prospective analysis of the combined treatment of 295 patients with primary varicose veins who underwent outpatient treatment. Results Simultaneous EVLA of saphenous trunks and ligation (gentle phlebectomy) of visible large-diameter tributaries (6 mm or more) with staged sclerotherapy after a month, has significant potential benefits. Conclusion The use of staged varicose veins treatment minimizes the traumatic intervention and discomfort for the patient, while achieving satisfactory treatment results without affecting the quality of life.

01 Feb 2025·Phlebology: The Journal of Venous Disease

Mid-term results of cyanoacrylate closure for the treatment of incompetent great and small saphenous veins: Findings from a Japanese prospective consecutive multi-center registry: Mid-term results of cyanoacrylate closure

Article

Author: Furubayashi, Keichi ; Imai, Takahiro ; Hyodo, Eiichi ; Kurihara, Nobuhisa ; Kusagawa, Hitoshi ; Shirasugi, Nozomu ; Shokoku, Shintaro ; Sugiyama, Satoru ; Mo, Makoto ; Ogawa, Tomohiro ; Yamamoto, Takashi ; Hoshino, Yuji ; Hirokawa, Masayuki

Objectives We evaluated the efficacy and safety of cyanoacrylate closure (CAC) for endovascular treatment of varicose veins with cyanoacrylate adhesive (VenaSeal® closure system) in Japan. Methods A multicenter prospective consecutive registry study was conducted at 12 centers in Japan on 125 patients with primary varicose veins who underwent CAC. The patients were evaluated on target vein occlusion, postoperative complications, Visual Analogue Scale (VAS) for pain, revised Venous Clinical Severity Score (rVCSS), Aberdeen Varicose Vein Questionnaire (AVVQ), and EuroQol 5 dimensions 5-level (EQ-5D-5L) for 1-year after the surgery. Results The closure rate was 92.6% at 1 year postoperatively, and 95.0% and 90.2% for GSV and SSV respectively with little difference ( p = .491). The mean VAS in the immediate postoperative period was 18.9 ± 23.4. Postoperative complications were observed in 20 patients (16%). Hypersensitivity-type phlebitis occurred in 7 patients (5.6%). Infection of the treated vein resulted in resection of GSV. The rVCSS and AVVQ improved significantly after 90 days and 1 year postoperatively ( p < .001), while the EQ-5D-5L have not changed. Conclusion Cyanoacrylate Closure was considered generally a safe and minimally invasive treatment with good mid-term outcomes including SSV. However further study is required for some CAC specific complications.

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