Sponsor study identifier
interventional
432
1 country
1
Study Start
July 22, 2020
Actual (reported)Primary Completion
December 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 26, 2020
Actual (reported)May 29, 2020
Actual (reported)July 22, 2020
Actual (reported)December 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Change 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).
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
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
Baseline, at day 14, day 28, day 42 during treatment, and at day 14 after treatment
Subjects will receive orally administered Buqitongluo Granules, combined with guidelines-based standard care.
Subjects will receive orally administered Buqitongluo Granule placeboes, combined with guidelines-based standard care.
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.
Dongzhimen Hospital
Beijing, Beijing Municipality, 100700, China
Liu W, Zhou L, Feng L, Zhang D, Zhang C, Gao Y; behalf of the BOSS Group. BuqiTongluo Granule for Ischemic Stroke, Stable Angina Pectoris, Diabetic Peripheral Neuropathy with Qi Deficiency and Blood Stasis Syndrome: Rationale and Novel Basket Design. Front Pharmacol. 2021 Oct 18;12:764669. doi: 10.3389/fphar.2021.764669. eCollection 2021.
Ying Gao, MD
Dongzhimen Hospital
First Submitted
May 26, 2020
First Posted
May 29, 2020
Study Start
July 22, 2020
Actual (reported)Primary Completion
December 2022
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Continuous changes of Modified Rankin Scale for convalescence of ischemic stroke
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
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
Baseline, at day 42 during treatment, and at 90 days after onset
Guidelines-based standard care for convalescence of ischemic stroke, stable angina pectoris of coronary artery disease or diabetic peripheral neuropathy.
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
April 1, 2021
Record last verified: 2020-05
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Source: ClinicalTrials.gov.
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