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临床试验/NCT03653793
NCT03653793已完成不适用

LivRelief Varicose Veins Cream in the Treatment of Chronic Venous Insufficiency of the Lower Limbs: A 6-week Single Arm Pilot Study

Delivra, Inc.2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2017年5月23日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
Delivra, Inc.
入组人数
32
试验地点
2
主要终点
Data Collection

研究概览

简要总结

Phase IV interventional design where all participants used the test product as per package instructions for 6-weeks. Baseline observations were compared to those collected after 6-weeks of treatment.

详细描述

The use of the marketed natural product, LivRelief Varicose Veins Cream, was observed in 32 patients with lower limb varicose veins. Participants were recruited from the patient population at The Mayer Institute in Hamilton Ontario, Canada. Patients that agreed to participate in the study and met the eligibility criteria were provided with a 6-week supply of the cream to use at home as directed on the product packaging. The following study measures were performed at the clinic prior to the first use of the cream, then again at the clinic after 6 weeks of use: CEAP (Clinical, Etiological, Anatomical, Pathophysiological) classification and VCSS (Venous Clinical Severity score). These are assessments performed by the doctor or nurse to determine the severity of their varicose veins and CVI (chronic venous insufficiency), measurements taken of the circumference of their legs to measure swelling of the legs, photographs of the varicose veins, a quality of life enjoyment and satisfaction questionnaire (QLES-Q-SF) completed by the subjects to describe their satisfaction with various aspects of their life over the last week and documentation of any reactions to the treatment. The cream was applied to their varicose veins twice a day for 6 weeks.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • At least 19 years of age.
  • Presence of lower limb varicose veins.

排除标准

  • Allergy to witch-hazel or any allergies in the cream.
  • Intent to undergo surgical treatment varicose veins within the next six weeks.
  • Pregnant or breastfeeding or planning to be pregnant.
  • Any Dementia or Major Cognitive dysfunction that would preclude the individual's ability to provide informed consent or complete the Case Report Form.
  • Any unstable medical condition (including but not limited to cardiovascular, cardiac/hypertension disease, moderate to severe kidney disease, and moderate to severe liver disease)
  • Any medical condition that would preclude the participant's or a caregiver's ability to administer the product on a daily basis for the time period required to complete the study.
  • An active ulcer at the site of product application (as evaluated during CEAP screening).

研究组 & 干预措施

LivRelief Varicose Veins Cream

Experimental

Intervention:

All subjects were provided with an adequate supply of the Natural Health Product LivRelief Varicose Veins cream for 6 weeks of at home use.

干预措施: Natural Health Product: LivRelief Varicose Veins Cream (Other)

结局指标

主要结局

Data Collection

时间窗: study duration: ~6 to 12 weeks

Collection of at least 70% of scheduled data

Recruitment feasibility

时间窗: study duration:~4 weeks

Recruitment of at least 70% of all eligible participants

次要结局

未报告次要终点

研究者

发起方
Delivra, Inc.
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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