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This is a single-blind, cross-over pilot study to observe the safety and efficacy of Ganoderma tea on eczema patients.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A-first intervention | Experimental | Subjects in Arm A receive Ganoderma tea (30g) daily for 8 weeks initially, followed by 8 weeks no intervention. |
|
| B-second intervention | Experimental | Subjects in Arm B receive no intervention for 8 weeks initially, followed by receiving Ganoderma tea (30g) daily for 8 weeks . |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A Master Ganoderma Detox Tea | Dietary Supplement | A Master Ganoderma Detox Tea is consisted of GANODERMA, HERBA HOUTTUYNIAE, GLYCYRRHIZAE RADIX ET RHIZOMA and RUCTUS MOMORDICAE. |
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| Measure | Description | Time Frame |
|---|---|---|
| Patient Oriented Eczema Measure | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Eczema Area and Severity Index | 16 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shi Ping Zhang, PhD | Contact | 85234112466 | 2466 | spzhang@hkbu.edu.hk |
| Carol Leung, BTCM | Contact | 85234688878 | 8878 | 173661@hkbu.edu.hk |
| Name | Affiliation | Role |
|---|---|---|
| Shi Ping Zhang, PhD | Hong Kong Baptist University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School of Chinese Medicine Building | Recruiting | Kowloon Tong | Kowloon | 0000 | Hong Kong |
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| ID | Term |
|---|---|
| D004485 | Eczema |
| ID | Term |
|---|---|
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
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