Ganoderma Tea on Eczema Patient

Phase 1

• Conditions: Eczema

• Registration Number: NCT02533635
• Lead Sponsor: Hong Kong Baptist University

Brief Summary

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

Detailed Description

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.

Study Timeline

• Status Verified: 2015-08
• Study Start: 2015-08
• Study First Submitted: 2015-08-18
• Study First Submitted QC: 2015-08-24
• Last Update Submitted: 2015-08-24
• Study First Posted: 2015-08-27
• Last Update Posted: 2015-08-27
• Primary Completion: 2016-03
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• eczema for 1 year, without other systemic illness.

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Patient Oriented Eczema Measure	16 weeks

Secondary Outcome Measures

Name	Time	Method
Eczema Area and Severity Index	16 weeks

Trial Locations

Locations (1)

School of Chinese Medicine Building; 🇭🇰 Kowloon Tong, Kowloon, Hong Kong