NCT02533635

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Aug 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

August 18, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 27, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

August 27, 2015

Status Verified

August 1, 2015

Enrollment Period

7 months

First QC Date

August 18, 2015

Last Update Submit

August 24, 2015

Conditions

Eczema

Outcome Measures

Primary Outcomes (1)

  • Patient Oriented Eczema Measure

    16 weeks

Secondary Outcomes (1)

  • Eczema Area and Severity Index

    16 weeks

Study Arms (2)

A-first intervention

EXPERIMENTAL

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

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 .

Dietary Supplement: A Master Ganoderma Detox Tea

Interventions

A Master Ganoderma Detox TeaDIETARY_SUPPLEMENT

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

Also known as: 老和尚靈芝健康茶（又名老和尚靈芝排毒茶）
A-first interventionB-second intervention

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • eczema for 1 year, without other systemic illness.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Chinese Medicine Building

Kowloon Tong, Kowloon, 0000, Hong Kong

RECRUITING

MeSH Terms

Conditions

Eczema

Condition Hierarchy (Ancestors)

DermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, Eczematous

Study Officials

  • Shi Ping Zhang, PhD

    Hong Kong Baptist University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shi Ping Zhang, PhD

CONTACT

85234112466spzhang@hkbu.edu.hk

Carol Leung, BTCM

CONTACT

85234688878173661@hkbu.edu.hk

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 18, 2015

First Posted

August 27, 2015

Study Start

August 1, 2015

Primary Completion

March 1, 2016

Study Completion

December 1, 2016

Last Updated

August 27, 2015

Record last verified: 2015-08

Locations

HK(1)