Back to resultsGanoderma Tea on Eczema Patient
Primary Purpose
Eczema
Status
Unknown status
Phase
Phase 1
Locations
Hong Kong
Study Type
Interventional
Intervention
A Master Ganoderma Detox Tea
Sponsored by
About this trial
This is an interventional treatment trial for Eczema
Eligibility Criteria
Inclusion Criteria:
- eczema for 1 year, without other systemic illness.
Exclusion Criteria:
- severe systemic illness,
- oral steroid in the last month
Sites / Locations
- School of Chinese Medicine BuildingRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
A-first intervention
B-second intervention
Arm Description
Subjects in Arm A receive Ganoderma tea (30g) daily for 8 weeks initially, followed by 8 weeks no intervention.
Subjects in Arm B receive no intervention for 8 weeks initially, followed by receiving Ganoderma tea (30g) daily for 8 weeks .
Outcomes
Primary Outcome Measures
Patient Oriented Eczema Measure
Secondary Outcome Measures
Eczema Area and Severity Index
Full Information
NCT ID
NCT02533635
First Posted
August 18, 2015
Last Updated
August 24, 2015
Sponsor
Hong Kong Baptist University
1. Study Identification
Unique Protocol Identification Number
NCT02533635
Brief Title
Ganoderma Tea on Eczema Patient
Official Title
Product Functional Study of Effect A Master Ganoderma Detox Tea on Eczema Patient
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Unknown status
Study Start Date
August 2015 (undefined)
Primary Completion Date
March 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hong Kong Baptist University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eczema
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A-first intervention
Arm Type
Experimental
Arm Description
Subjects in Arm A receive Ganoderma tea (30g) daily for 8 weeks initially, followed by 8 weeks no intervention.
Arm Title
B-second intervention
Arm Type
Experimental
Arm Description
Subjects in Arm B receive no intervention for 8 weeks initially, followed by receiving Ganoderma tea (30g) daily for 8 weeks .
Intervention Type
Dietary Supplement
Intervention Name(s)
A Master Ganoderma Detox Tea
Other Intervention Name(s)
老和尚靈芝健康茶（又名老和尚靈芝排毒茶）
Intervention Description
A Master Ganoderma Detox Tea is consisted of GANODERMA, HERBA HOUTTUYNIAE, GLYCYRRHIZAE RADIX ET RHIZOMA and RUCTUS MOMORDICAE.
Primary Outcome Measure Information:
Title
Patient Oriented Eczema Measure
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Eczema Area and Severity Index
Time Frame
16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
eczema for 1 year, without other systemic illness.
Exclusion Criteria:
severe systemic illness,
oral steroid in the last month
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shi Ping Zhang, PhD
Phone
85234112466
Ext
2466
Email
spzhang@hkbu.edu.hk
First Name & Middle Initial & Last Name or Official Title & Degree
Carol Leung, BTCM
Phone
85234688878
Ext
8878
Email
173661@hkbu.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shi Ping Zhang, PhD
Organizational Affiliation
Hong Kong Baptist University
Official's Role
Principal Investigator
Facility Information:
Facility Name
School of Chinese Medicine Building
City
Kowloon Tong
State/Province
Kowloon
ZIP/Postal Code
0000
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carol Leung, Master of TCM
Phone
85234688878
Ext
8878
Email
173661@hkbu.edu.hk
First Name & Middle Initial & Last Name & Degree
Shi Ping Zhang, PhD
Phone
85234112466
Ext
2466
Email
spzhang@hkbu.edu.hk
12. IPD Sharing Statement
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Ganoderma Tea on Eczema Patient
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