Ignite Creation Date:
2024-05-06 @ 1:03 AM
Last Modification Date:
2024-10-26 @ 10:58 AM
Study NCT ID:
NCT01715740
Status:
COMPLETED
Last Update Posted:
2016-11-10
First Post:
2012-10-25
Brief Title:
Study of the Effects of Chinese Herbal Medicine on Chronic Urticaria
Sponsor:
Chang Gung Memorial Hospital
Organization:
Chang Gung Memorial Hospital
Study Overview
Official Title:
Study of the Effects of Antipruritic Chinese Herbal Medicine on Chronic Urticaria a Randomized Double-blind Placebo-controlled Phase III Clinical Trial
Status:
COMPLETED
Status Verified Date:
2016-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Urticaria is a common dermatology disease Urticaria affects nearly 25 of the population at some time in their lives Recurrent skin itch insomnia daily activities limitation greatly affect the quality of life Some patient with chronic urticaria who had poor response to antihistamine may need second line medication In United States up to 54 chronic urticarial patient use oral corticosteroid to control However long-term use of oral steroids still needs to consider the impact of its side effects Therefore patients may seek for alternative medicine as an adjuvant therapy
It is still lack large-scale clinical trials in Traditional Chinese Medicine research of chronic urticarial The aim of this study is to conduct a double-blind randomized clinical trial to analyze the effectiveness of Chinese medicine in chronic urticaria and its possible mechanisms
It is still lack large-scale clinical trials in Traditional Chinese Medicine research of chronic urticarial The aim of this study is to conduct a double-blind randomized clinical trial to analyze the effectiveness of Chinese medicine in chronic urticaria and its possible mechanisms
Detailed Description:
Traditional Chinese medicine has been used widely in Taiwan for several diseases such as allergic rhinitis atopic dermatitis For urticariacertain antipruritic Chinese herbal medicine such and Xiao-feng-san XFS Qing-shang-fang-fen-tang QSFFT have been commonly used in clinical practice yet no clinical trials have been done to prove the effectiveness
In this study a double-blinded randomized placebo control trial is designed and total 100 chronic urticaria patients will be enrolled All subjects will be divided into Chinese herbal medicine CHM and placebo control groups in 11 allocation ratio CHM group will receive capsule of mixture of XFS and QSFFT 4gm four times a day total 16 gm in a single day while control group will receive placebo capsule with similar look smell and taste with same scheme Total 1 month treatment course with 1 month follow-up study course will be done Changes in symptom severity is the primary outcome while improvement in sleep disturbance and serologic marker evolution are the secondary outcome
In this study a double-blinded randomized placebo control trial is designed and total 100 chronic urticaria patients will be enrolled All subjects will be divided into Chinese herbal medicine CHM and placebo control groups in 11 allocation ratio CHM group will receive capsule of mixture of XFS and QSFFT 4gm four times a day total 16 gm in a single day while control group will receive placebo capsule with similar look smell and taste with same scheme Total 1 month treatment course with 1 month follow-up study course will be done Changes in symptom severity is the primary outcome while improvement in sleep disturbance and serologic marker evolution are the secondary outcome
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None