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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
432
Buqitongluo Granules were dissolved with boiled water, administered orally, each bag of 10 grams, one bag each time, three times a day for 42 days.
Buqitongluo Granule placeboes were dissolved with boiled water, administered orally, each bag of 10 grams, one bag each time, three times a day for 42 days.
Guidelines-based standard care for convalescence of ischemic stroke, stable angina pectoris of coronary artery disease or diabetic peripheral neuropathy.
Dongzhimen Hospital
Beijing, Beijing Municipality, China
RECRUITINGChange in the syndrome score of Qi Deficiency and Blood Stasis
The dynamic evaluation will be defined by Evaluation Scale of Qi Deficiency and Blood Stasis Syndrome. The Evaluation Scale of Qi Deficiency and Blood Stasis Syndrome score ranges from 0 (best score) to 51 (worst score).
Time frame: Baseline, at day 14, day 28, day 42 during treatment, and at day 14 after treatment
Neurological impairment will be evaluated by National Institute of Health Stroke Scale (NIHSS) for convalescence of ischemic stroke
The NIHSS score ranges from 0 (best score) to 42 (worst score).
Time frame: Baseline, at day 14, day 28, day 42 during treatment
Self-rating symptoms will be evaluated by Visual Analog Scale (VAS) for convalescence of ischemic stroke
Including limb numbness, swelling of hands or feet, spontaneous sweating (hemilateral sweating). Participants rated their symptoms on the 100 millimeter (mm) Visual Analog Scale (VAS) ranging from 0 mm (no symptom) to 100 mm (worst symptom).
Time frame: Baseline, at day 14, day 28, day 42 during treatment, and at day 14 after treatment
Continuous changes of Modified Rankin Scale for convalescence of ischemic stroke
The Modified Rankin Scale score ranges from 0 (best score) to 6 (worst score).
Time frame: Baseline, at day 42 during treatment, and at 90 days after onset
Activities of daily living will be measured by Barthel Index (BI) score for convalescence of ischemic stroke
The Barthel Index score ranges from 0 (worst score) to 100 (best score).
Time frame: Baseline, at day 42 during treatment, and at 90 days after onset
Quality of life will be measured by Short Form 36 (SF-36) Quality of Life Scale for convalescence of ischemic stroke
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The SF-36 quality of life scale is used to monitor change in subject reported functionality, well-being, and overall health status. The score of each part ranges from 0 (worst score) to 100 (best score).
Time frame: Baseline, at day 42 during treatment, and at 90 days after onset
Change of the Seattle Angina Questionnaire (SAQ) Score for stable angina pectoris of coronary artery disease
The maximum score is 100, and the higher the score, the better the quality of life and the state of body function of patient.
Time frame: Baseline, at day 28 during treatment, at day 14 after treatment, and at 90 days after recruitment
Self-rating symptoms will be evaluated by Visual Analog Scale (VAS) for stable angina pectoris of coronary artery disease
Including chest tightness, chest pain, palpitation, fatigue, spontaneous sweating. Participants rated their symptoms on the 100 millimeter (mm) Visual Analog Scale (VAS) ranging from 0 mm (no symptom) to 100 mm (worst symptom).
Time frame: Baseline, at day 14, day 28, day 42 during treatment, and at day 14 after treatment
Change of the Clinical Scoring System of Toronto (TCSS) for diabetic peripheral neuropathy
TCSS includes a score of neural symptoms, nerve reflex scores and sensory examination. The TCSS score ranges from 0 (best score) to 19 (worst score).
Time frame: Baseline, at day 14, day 28, day 42 during treatment, at day 14 after treatment, and at 90 days after recruitment
Self-rating symptoms will be evaluated by Visual Analog Scale (VAS) for diabetic peripheral neuropathy
Including local pain, limb numbness, paresthesia (e.g. burning sensation, formication, electrical sensation). Participants rated their symptoms on the 100 millimeter (mm) Visual Analog Scale (VAS) ranging from 0 mm (no symptom) to 100 mm (worst symptom).
Time frame: Baseline, at day 14, day 28, day 42 during treatment, and at day 14 after treatment
Quality of life will be measured by Short Form 36 (SF-36) Quality of Life Scale for stable angina pectoris of coronary artery disease and diabetic peripheral neuropathy
The SF-36 quality of life scale is used to monitor change in subject reported functionality, well-being, and overall health status. The score of each part ranges from 0 (worst score) to 100 (best score).
Time frame: Baseline, at day 42 during treatment, and at 90 days after recruitment