Ganoderma Tea on Eczema Patient

August 24, 2015 updated by: Shi Ping Zhang, Hong Kong Baptist University

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Hong Kong
    • Kowloon
      • Kowloon Tong, Kowloon, Hong Kong, 0000
        • Recruiting
        • School of Chinese Medicine Building
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • eczema for 1 year, without other systemic illness.

Exclusion Criteria:

  • severe systemic illness,
  • oral steroid in the last month

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A-first intervention
Subjects in Arm A receive Ganoderma tea (30g) daily for 8 weeks initially, followed by 8 weeks no 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.
Other Names:
  • 老和尚靈芝健康茶（又名老和尚靈芝排毒茶）
Experimental: B-second intervention
Subjects in Arm B receive no intervention for 8 weeks initially, followed by receiving Ganoderma tea (30g) daily for 8 weeks .
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.
Other Names:
  • 老和尚靈芝健康茶（又名老和尚靈芝排毒茶）

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Patient Oriented Eczema Measure
Time Frame: 16 weeks
16 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Eczema Area and Severity Index
Time Frame: 16 weeks
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hong Kong Baptist University

Investigators

  • Principal Investigator: Shi Ping Zhang, PhD, Hong Kong Baptist University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Anticipated)

March 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

August 18, 2015

First Submitted That Met QC Criteria

August 24, 2015

First Posted (Estimate)

August 27, 2015

Study Record Updates

Last Update Posted (Estimate)

August 27, 2015

Last Update Submitted That Met QC Criteria

August 24, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HongKongBU

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Eczema

Clinical Trials on A Master Ganoderma Detox Tea

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Croatia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe