Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Angina Pectoris, Stable
  • Coronary (Artery) Disease
  • Diabetic Peripheral Neuropathy
  • Stroke Ischemic
Type
Interventional
Phase
Phase 2
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Treatment

Participation Requirements

Age
Between 35 years and 80 years
Gender
Both males and females

Description

The BOSS study is a multicenter, randomized, double-blind, placebo-controlled clinical trial. The primary hypothesis of this trial is that Buqitongluo Granule will improve the syndrome score of Qi Deficiency and Blood Stasis in convalescence of ischemic stroke, stable angina pectoris of coronary art...

The BOSS study is a multicenter, randomized, double-blind, placebo-controlled clinical trial. The primary hypothesis of this trial is that Buqitongluo Granule will improve the syndrome score of Qi Deficiency and Blood Stasis in convalescence of ischemic stroke, stable angina pectoris of coronary artery disease and diabetic peripheral neuropathy with qi deficiency and blood stasis syndrome. Buqitongluo Granule will be compared to placebo, combined with guidelines-based standard care in patients. During the trial, it is forbidden to use acupuncture, Traditional Chinese Medicine decoction (compound granule), Traditional Chinese Medicine injection, Chinese patent medicine (including external use), external washing of Traditional Chinese Medicine and health product (composition or efficacy similar to the study drug).

Tracking Information

NCT #
NCT04408261
Collaborators
  • The First Affiliated Hospital of Heilongjiang University of Traditional Chinese Medicine
  • The Affiliated Hospital of Shandong University of Chinese Medicine
  • The Affiliated Hospital of Changchun University of Chinese Medicine
  • The Affiliated Hospital of Chengdu University of Chinese Medicine
  • Wuhan Zhizhi Medical Technology Co., Ltd.
  • Jiangbin Hospital of Guangxi Zhuang Autonomous Region
  • Rizhao Hospital of Traditional Chinese Medicine
  • The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
  • The Second Affiliated Hospital of Heilongjiang University of Traditional Chinese Medicine
  • Wuhan Third Hospital
  • Shanghai Youningwei Biotechnology Co., Ltd.
  • The Second Affiliated Hospital of Hunan University of Traditional Chinese Medicine
  • Hunan Academy of Traditional Chinese Medicine Affiliated Hospital
  • The First Clinical Hospital of Jilin Academy of Traditional Chinese Medicine
  • The First Affiliated Hospital of Guangxi University of Traditional Chinese Medicine
  • Shaanxi Buchang Pharmaceuticals Co., Ltd.
  • Beijing Chuanglikechuang Medical Technology Development Co., Ltd.
Investigators
Principal Investigator: Ying Gao, MD Dongzhimen Hospital