The Efficacy and Safety of Shen Guo Lao Nian Granule for Common Cold of Qi-Deficiency Syndrome: Study Protocol for a Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase II Clinical Trial
Joint Authors
Zhang, Rui-Ming
Mao, Bing
Lan, Ying
Liu, Wei
Jiang, Hong-li
Liu, Xuemei
Fu, Juanjuan
Fan, Tao
Ding, Hong
Yang, Haimiao
Hu, Siyuan
Li, Guanhong
She, Bin
Yuhong, Huang
Source
Evidence-Based Complementary and Alternative Medicine
Issue
Vol. 2017, Issue 2017 (31 Dec. 2017), pp.1-11, 11 p.
Publisher
Hindawi Publishing Corporation
Publication Date
2017-09-24
Country of Publication
Egypt
No. of Pages
11
Main Subjects
Abstract EN
Background.
Common cold is one of the most frequently occurring illnesses in primary healthcare services and represents considerable disease burden.
Common cold of Qi-deficiency syndrome (CCQDS) is an important but less addressed traditional Chinese medicine (TCM) pattern.
We designed a protocol to explore the efficacy, safety, and optimal dose of Shen Guo Lao Nian Granule (SGLNG) for treating CCQDS.
Methods/Design.
This is a multicenter, randomized, double-blind, placebo-controlled, phase II clinical trial.
A total of 240 eligible patients will be recruited from five centers.
Patients are randomly assigned to high-dose group, middle-dose group, low-dose group, or control group in a 1 : 1 : 1 : 1 ratio.
All drugs are required to be taken 3 times daily for 5 days with a 5-day follow-up period.
Primary outcomes are duration of all symptoms, total score reduction on Jackson’s scale, and TCM symptoms scale.
Secondary outcomes include every single TCM symptom duration and score reduction, TCM main symptoms disappearance rate, curative effects, and comparison between Jackson’s scale and TCM symptom scale.
Ethics and Trial Registration.
This study protocol was approved by the Ethics Committee of Clinical Trials and Biomedicine of West China Hospital of Sichuan University (number IRB-2014-12) and registered with the Chinese Clinical Trial Registry (ChiCTR-IPR-15006349).
American Psychological Association (APA)
Liu, Xuemei& Fu, Juanjuan& Fan, Tao& Liu, Wei& Jiang, Hong-li& Zhang, Rui-Ming…[et al.]. 2017. The Efficacy and Safety of Shen Guo Lao Nian Granule for Common Cold of Qi-Deficiency Syndrome: Study Protocol for a Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase II Clinical Trial. Evidence-Based Complementary and Alternative Medicine،Vol. 2017, no. 2017, pp.1-11.
https://search.emarefa.net/detail/BIM-1153122
Modern Language Association (MLA)
Liu, Xuemei…[et al.]. The Efficacy and Safety of Shen Guo Lao Nian Granule for Common Cold of Qi-Deficiency Syndrome: Study Protocol for a Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase II Clinical Trial. Evidence-Based Complementary and Alternative Medicine No. 2017 (2017), pp.1-11.
https://search.emarefa.net/detail/BIM-1153122
American Medical Association (AMA)
Liu, Xuemei& Fu, Juanjuan& Fan, Tao& Liu, Wei& Jiang, Hong-li& Zhang, Rui-Ming…[et al.]. The Efficacy and Safety of Shen Guo Lao Nian Granule for Common Cold of Qi-Deficiency Syndrome: Study Protocol for a Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase II Clinical Trial. Evidence-Based Complementary and Alternative Medicine. 2017. Vol. 2017, no. 2017, pp.1-11.
https://search.emarefa.net/detail/BIM-1153122
Data Type
Journal Articles
Language
English
Notes
Includes bibliographical references
Record ID
BIM-1153122