ISRCTN54360155已完成未知
Herbal medicine combination containing acetyl salicylic acid and asiaticoside plus acemannan in topical gel formulation for chronic venous insufficiency: a 3 month double-blind randomized placebo-controlled trial among Thai patients diagnosed as mild-to-moderate chronic venous insufficiency
ational Research University Project, Office of the Higher Education Commission (WCU-58-034-AS)0 个研究点目标入组 42 人开始时间: 2016年1月14日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 42
研究概览
简要总结
2017 Results article in https://www.tci-thaijo.org/index.php/EAUHJSci/article/view/101887 results 2018 Results article in http://journalcra.com/sites/default/files/issue-pdf/28347.pdf results 2019 Results article in https://doi.org/10.15419/bmrat.v6i2.523 results 2019 Results article in http://dx.doi.org/10.5455/IJMRCR.Chronic-Venous-Disease-Thai-Patients results 2020 Abstract results in https://doi.org/10.1016/j.imr.2020.100558 Presented at KIOM-SAR 2020 International Research Conference (added 04/01/2022)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 15/12/2017:
- •Patients seeking advice at the surgery ambulatory clinics with at least 5 of the following symptoms:
- •1. Heavy leg
- •2. Pain in the leg
- •3. Sensation of leg swelling
- •4. Night cramp
- •5. Itching leg
- •6. Sensation of burning
- •7. Sensation of pins/needle in the leg
- •8. Presence of superficial varicose vein
- •9. Presence of spider veins 10. Presence of blood-clotting.
- •And must have been accurately diagnosed as chronic venous insufficiency by physician as per WHO- ICD10 Criteria and also being graded as appropriate staging of the chronic venous insufficiency stage as per the CEAP Criteria.
- •Previous inclusion criteria:
- •Patients seeking advice at the surgery ambulatory clinics with at least 5 of the following symptoms:
- •1. Heavy leg
- •2. Pain in the leg
- •3. Sensation of leg swelling
- •4. Night cramp
- •5. Itching leg
- •6. Sensation of burning
- •7. Sensation of pins/needle in the leg
- •8. Presence of superficial varicose vein
- •9. Presence of spider veins 10. Presence of blood-clotting.
- •Plus these patients must have at least one risk factor as follows :
- •1. Sibling history with presence of swollen leg, spider & varicose veins and ankle/leg ulcer
- •2. Long hours standing per day (=3 hours)
- •3. Long hours sitting per day (=3 hours)
- •4. No regular exercise
- •6. Taking hormone replacement therapy and/or contraceptive (oral/injectable)
- •And must have been accurately diagnosed as chronic venous insufficiency by physician as per WHO- ICD10 Criteria and also being graded as appropriate staging of the chronic venous insufficiency stage as per the CEAP Criteria.
排除标准
- •Patients with known history of:
- •1. ASA-exacerbated respiratory disease (AERD) and/or asthma
- •2. ASA-sensitivity and Rhinitis/Nasal Polyps
- •3. ASA and NSAIDs induce cutaneous reactions with Urticaria, Angioedema
- •4. ASA-induced anaphylactoid reactions with Hypotension, swelling, laryngeal edema, generalized pruritus, tachypnea
- •5. Patients with known sensitivity or allergic to centenella asiaticosa or asiaticoside.
- •6. Patients with known sensitivity or allergic to acemannan and the aloe vera products
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