Clinical Trial: Ganoderma Tea on Eczema Patient

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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

Detailed Summary:

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.

Sponsor: Hong Kong Baptist University

Current Primary Outcome: Patient Oriented Eczema Measure [ Time Frame: 16 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Eczema Area and Severity Index [ Time Frame: 16 weeks ]

Original Secondary Outcome: Same as current

Information By: Hong Kong Baptist University

Dates:
Date Received: August 18, 2015
Date Started: August 2015
Date Completion: December 2016
Last Updated: August 24, 2015
Last Verified: August 2015