Ganoderma Tea on Eczema Patient

Eczema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02533635
• Other study ID #: HongKongBU
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: August 18, 2015
• Last updated: August 24, 2015
• Start date: August 2015
• Est. completion date: December 2016

Study information

• Verified date: August 2015
• Source: Hong Kong Baptist University
• Contact: Shi Ping Zhang, PhD
• Phone: 85234112466
• Email: spzhang[@]hkbu.edu.hk
• Is FDA regulated: No
• Health authority: Ethics Committee of HKBU, Hong Kong:
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• eczema for 1 year, without other systemic illness.

Exclusion Criteria:

• severe systemic illness,

• oral steroid in the last month

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dermatitis
• Eczema

Intervention

Dietary Supplement:
• A Master Ganoderma Detox Tea
A Master Ganoderma Detox Tea is consisted of GANODERMA, HERBA HOUTTUYNIAE, GLYCYRRHIZAE RADIX ET RHIZOMA and RUCTUS MOMORDICAE.

Locations

Country	Name	City	State
Hong Kong	School of Chinese Medicine Building	Kowloon Tong	Kowloon

Sponsors (1)

Lead Sponsor	Collaborator
Hong Kong Baptist University

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Oriented Eczema Measure		16 weeks	No
Secondary	Eczema Area and Severity Index		16 weeks	No