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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02533635
Other study ID # HongKongBU
Secondary ID
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


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
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