Study Results
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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UNKNOWN
PHASE2
66 participants
INTERVENTIONAL
2012-09-30
2014-09-30
Brief Summary
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Detailed Description
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Participants fulfilling eligibility criteria will be selected. Enrolled participants will be randomly allocated to two parallel groups: the KM110329 and placebo arms.
Each participant will be examined for signs and symptoms of Atopic dermatitis before and after taking functional food.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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KM110329
Participants will receive KM110329 for eight weeks. Participants will take 2 tablets by mouth with water two times a day after meals.
KM110329
KM110329, a functional food consist of four herbs which are shown to be beneficial for skin health
Control
Participants will receive placebo drug for eight weeks. Participants will take 2 tablets by mouth with water two times a day after meals.
Placebo
Placebo
Interventions
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KM110329
KM110329, a functional food consist of four herbs which are shown to be beneficial for skin health
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
* Individuals who diagnosed Atopic dermatitis according to the criteria of Hanifin and Rajka
* Individuals who mild to moderate atopic dermatitis (objective SCORAD≤40)
* Written informed consent for participation in the trial
Exclusion Criteria
* Secondary infection with bacteria, fungi, and virus
* Uncontrolled hypertension (SBP \> 145 mmHg or DBP \> 95 mmHg)
* Severe liver disability (2.5-fold the normal high range value for ALT, AST)
* Severe renal disability (sCr \> 2.0mg/dl)
* Women who are pregnant, lactating, planning a pregnancy or women of child-bearing age who do not agree to proper contraception
* Use of oral steroids, oral antibiotic or other immunosuppressants within the past 4 weeks
* Treated by systemic photochemotherapy within past 4 weeks
* History of drug abuse
* Hypersensitivity to Rubi Fructus, Houttuyniae Herba, Rehmanniae Radix, Betulae Platyphyllae Cortex
* Use of other investigational products within the past two months
18 Years
65 Years
ALL
No
Sponsors
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St Mary's Hospital, London
OTHER
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
OTHER
Kyung Hee University Hospital at Gangdong
OTHER
Kyunghee University Medical Center
OTHER
Responsible Party
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Seong-Gyu Ko
Professor
Principal Investigators
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SEONG GYU KO, M.D.(DKM)
Role: STUDY_DIRECTOR
Kyunghee University
Locations
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Kyung Hee University
Seoul, , South Korea
Countries
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Facility Contacts
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CHUNHOO CHEON, M.D.(DKM)
Role: primary
References
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Cheon C, Park S, Park JS, Oh SM, Jang S, Go HY, Jang BH, Shin YC, Ko SG. KM110329 in adult patients with atopic dermatitis: a randomised, double-blind, placebo-controlled, multicentre trial--study protocol. BMC Complement Altern Med. 2013 Nov 27;13:335. doi: 10.1186/1472-6882-13-335.
Other Identifiers
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CCRG_KM110329
Identifier Type: -
Identifier Source: org_study_id