Ignite Creation Date:
2025-12-17 @ 1:41 PM
Ignite Modification Date:
2025-12-23 @ 10:02 PM
Study NCT ID:
NCT04408261
Status:
UNKNOWN
Last Update Posted:
2021-04-01
First Post:
2020-05-26
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
BuqitongluO Granule for Qi Deficiency and Blood Stasis Syndrome
Sponsor:
Dongzhimen Hospital, Beijing
Organization:
Study Overview
Official Title:
Buqitongluo Granule for Qi Deficiency and Blood Stasis Syndrome: A Multicenter, Randomized, Double-blind, Placebo-Controlled Trial
Status:
UNKNOWN
Status Verified Date:
2020-05
Last Known Status:
RECRUITING
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:
BOSS
Brief Summary:
The main purpose of this trial is to evaluate the efficacy and safety of Buqitongluo Granule in treating qi deficiency and blood stasis syndrome, and explore the effect of the improvement of qi deficiency and blood stasis syndrome on the prognosis of diseases.
Detailed 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 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).
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: