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临床试验/NCT02533635
NCT02533635Unknown1 期

Product Functional Study of Effect A Master Ganoderma Detox Tea on Eczema Patient

Hong Kong Baptist University2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2015年8月最近更新:
适应症

试验速览

阶段
1 期
入组人数
30
试验地点
2
主要终点
Patient Oriented Eczema Measure

研究概览

简要总结

This is a single-blind, cross-over pilot study to observe the safety and efficacy of Ganoderma tea on eczema patients.

详细描述

Objective This study is to conduct a preliminary observation on the effect of A Master Ganoderma Detox Tea in improving eczema symptoms. Because it is a preliminary study, there will not be a placebo control. However, in order to exclude the impact of spontaneous improvement, we will set up a cross over control group. Thus, we want to find out whether there is any difference in taking the tea and without taking the tea.

Research Design This is a randomized, cross-over-control and assessor-blinded clinical trial. Subjects will be divided into groups A and group B. Group A will receive the intervention for 8 weeks, followed by an 8-week period of no intervention. Group B will be observed without having any intervention for 8 weeks, and then receive the intervention for 8 weeks. Randomization will be carried out using a computer program.

Interventions Subjects in the treatment group (A) will take the A Master Ganoderma Detox Tea for 8 weeks. Initially, the dosage is twice a day, one pack (5g) each time, and then increased to three times a day, two packs each time within two weeks. The control group (B) will not receive any study intervention for 8 weeks, followed by similar intervention for 8 weeks.

In case of allergies or severe adverse reactions occur, the subject should stop taking the tea immediately and be excluded from the trial. During the control or intervention period, if necessary, subject may use short-term steroids or other topical medication to relieve the symptoms of eczema.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • eczema for 1 year, without other systemic illness.

排除标准

  • severe systemic illness,
  • oral steroid in the last month

结局指标

主要结局

Patient Oriented Eczema Measure

时间窗: 16 weeks

次要结局

  • Eczema Area and Severity Index(16 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shi Ping Zhang

Associate Professor

Hong Kong Baptist University

研究点 (2)

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