ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 12 of 838 for:    eczema

Ganoderma Tea on Eczema Patient

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02533635
Recruitment Status : Unknown
Verified August 2015 by Shi Ping Zhang, Hong Kong Baptist University.
Recruitment status was:  Recruiting
First Posted : August 27, 2015
Last Update Posted : August 27, 2015
Sponsor:
Information provided by (Responsible Party):
Shi Ping Zhang, Hong Kong Baptist University

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

Condition or disease Intervention/treatment Phase
Eczema Dietary Supplement: A Master Ganoderma Detox Tea Phase 1 Phase 2

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  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Product Functional Study of Effect A Master Ganoderma Detox Tea on Eczema Patient
Study Start Date : August 2015
Estimated Primary Completion Date : March 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

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 Name: 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 Name: 老和尚靈芝健康茶(又名老和尚靈芝排毒茶)




Primary Outcome Measures :
  1. Patient Oriented Eczema Measure [ Time Frame: 16 weeks ]

Secondary Outcome Measures :
  1. Eczema Area and Severity Index [ Time Frame: 16 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • eczema for 1 year, without other systemic illness.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02533635


Contacts
Contact: Shi Ping Zhang, PhD 85234112466 ext 2466 spzhang@hkbu.edu.hk
Contact: Carol Leung, BTCM 85234688878 ext 8878 173661@hkbu.edu.hk

Locations
Hong Kong
School of Chinese Medicine Building Recruiting
Kowloon Tong, Kowloon, Hong Kong, 0000
Contact: Carol Leung, Master of TCM    85234688878 ext 8878    173661@hkbu.edu.hk   
Contact: Shi Ping Zhang, PhD    85234112466 ext 2466    spzhang@hkbu.edu.hk   
Sponsors and Collaborators
Hong Kong Baptist University
Investigators
Principal Investigator: Shi Ping Zhang, PhD Hong Kong Baptist University

Responsible Party: Shi Ping Zhang, Associate Professor, Hong Kong Baptist University
ClinicalTrials.gov Identifier: NCT02533635     History of Changes
Other Study ID Numbers: HongKongBU
First Posted: August 27, 2015    Key Record Dates
Last Update Posted: August 27, 2015
Last Verified: August 2015

Additional relevant MeSH terms:
Eczema
Dermatitis
Skin Diseases
Skin Diseases, Eczematous