Abstract | INTRODUCTION: METHODS AND ANALYSIS: In this study, we will conduct a 4-week randomized, controlled feasibility study, with participants recruited from Guang'anmen Hospital, Chinese Academy of Traditional Chinese Medicine. Sixty subjects are to be diagnosed as having phlegm-blood stasis syndrome and randomly divided into a treatment group (GLDS) and placebo group in a 1:1 ratio. Result measurements will include therapeutic indicators (Clinical Symptom Rating Scale, Phlegm-Blood Stasis Syndrome Scale, and Seattle Angina Questionnaire) and safety indicators (blood routine, urine routine, electrocardiogram, liver function, and kidney function). The clinical data management system (http://www.tcmcec.net/) will be used to collect and manage data. Quality control will be implemented according to good clinical practice. DISCUSSION: TRIAL REGISTRATION: This study is approved by the Ethics Committee of Guang'anmen Hospital of the China Academy of Chinese Medical Sciences (no. 2019-187-KY-02) and is registered with chictr.org (registration number ChiCTR2000031780).
|
Authors | Jianbo Guo, Shuang Dai, Yukun Ding, Haoqiang He, Hui Zhang, Wenchao Dan, Kun Qin, Hui Wang, Anqi Li, Peipei Meng, Shangjin Li, Qingyong He |
Journal | Medicine
(Medicine (Baltimore))
Vol. 99
Issue 33
Pg. e21593
(Aug 14 2020)
ISSN: 1536-5964 [Electronic] United States |
PMID | 32872012
(Publication Type: Clinical Trial Protocol, Journal Article)
|
Chemical References |
- dan-shen root extract
- Drugs, Chinese Herbal
|
Topics |
- Adult
- Aged
- Female
- Humans
- Male
- Middle Aged
- Angina, Unstable
(drug therapy, therapy)
- Double-Blind Method
- Drugs, Chinese Herbal
(administration & dosage, adverse effects, therapeutic use)
- Medicine, Chinese Traditional
(methods)
- Salvia miltiorrhiza
- Feasibility Studies
- Randomized Controlled Trials as Topic
|