Ganoderma Tea on Eczema Patient

NCT ID: NCT02533635

Last Updated: 2015-08-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2016-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Eczema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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A-first intervention

Subjects in Arm A receive Ganoderma tea (30g) daily for 8 weeks initially, followed by 8 weeks no intervention.

Group Type EXPERIMENTAL

A Master Ganoderma Detox Tea

Intervention Type DIETARY_SUPPLEMENT

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

B-second intervention

Subjects in Arm B receive no intervention for 8 weeks initially, followed by receiving Ganoderma tea (30g) daily for 8 weeks .

Group Type EXPERIMENTAL

A Master Ganoderma Detox Tea

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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A Master Ganoderma Detox Tea

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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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老和尚靈芝健康茶(又名老和尚靈芝排毒茶)

Eligibility Criteria

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Inclusion Criteria

* eczema for 1 year, without other systemic illness.

Exclusion Criteria

* severe systemic illness,
* oral steroid in the last month
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hong Kong Baptist University

OTHER

Sponsor Role lead

Responsible Party

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Shi Ping Zhang

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shi Ping Zhang, PhD

Role: PRINCIPAL_INVESTIGATOR

Hong Kong Baptist University

Locations

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School of Chinese Medicine Building

Kowloon Tong, Kowloon, Hong Kong

Site Status RECRUITING

Countries

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Hong Kong

Central Contacts

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Shi Ping Zhang, PhD

Role: CONTACT

85234112466 ext. 2466

Carol Leung, BTCM

Role: CONTACT

85234688878 ext. 8878

Facility Contacts

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Carol Leung, Master of TCM

Role: primary

85234688878 ext. 8878

Shi Ping Zhang, PhD

Role: backup

85234112466 ext. 2466

Other Identifiers

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HongKongBU

Identifier Type: -

Identifier Source: org_study_id

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