BuqitongluO Granule for Qi Deficiency and Blood Stasis Syndrome

NCT04408261 | Unknown Phase 2 DMC

• 1 other identifier: 2017L04609
• Study Type: interventional
• Target: 432
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke, Ischemic; Coronary Artery Disease; Angina Pectoris, Stable; Diabetic Peripheral Neuropathy

Keywords

Qi Deficiency and Blood Stasis Syndrome; Buqitongluo Granule; Traditional Chinese Medicine; Double-Blind; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (10)

• 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

• 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

Study Arms (2)

Buqitongluo Granule

EXPERIMENTAL

Subjects will receive orally administered Buqitongluo Granules, combined with guidelines-based standard care.

Drug: Buqitongluo Granule; Other: Standard care

Placebo

PLACEBO COMPARATOR

Subjects will receive orally administered Buqitongluo Granule placeboes, combined with guidelines-based standard care.

Drug: Buqitongluo Granule Placebo; Other: Standard care

Interventions

Buqitongluo Granule DRUG

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

Buqitongluo Granule Placebo DRUG

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.

Placebo

Standard care OTHER

Guidelines-based standard care for convalescence of ischemic stroke, stable angina pectoris of coronary artery disease or diabetic peripheral neuropathy.

Buqitongluo Granule; Placebo

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of qi deficiency and blood stasis syndrome
• Diagnosis of ischemic stroke
• Age ≥ 35 and ≤ 80 years
• The interval from the onset to recruitment was 14-30 days
• NIHSS score ≥ 4 and ≤ 22
• Patient or legally authorized representative has signed informed consent.

You may not qualify if:

• Confirmed secondary stroke caused by tumor, brain trauma, or hematological diseases by clinical examination;
• Other conditions that lead to motor dysfunction (e.g. lameness, osteoarthrosis, rheumatoid arthritis, gouty arthritis), which render the neurological function examination unlikely to be assessed;
• Uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg), or renal or hepatic insufficiency (hepatic insufficiency is defined as an alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value that is 1.5 times the upper limit of normal, renal insufficiency is defined as a serum creatinine concentration value that is over the upper limit of normal);
• Other conditions or mental disorders which according to the judgement of researchers that restrict evaluation of mental function or render outcomes or follow-up unlikely to be assessed;
• Woman with pregnancy, lactation, or woman who wants to be pregnant in recent;
• Patient who is allergic to the study drug or has severe allergic constitution;
• Patient with yellow thick slimy tongue coating;
• Patient who has been participated in other drug or device clinical trials in recent 3 months.
• Stable angina pectoris of coronary artery disease
• Diagnosis of qi deficiency and blood stasis syndrome
• Diagnosis of stable angina pectoris of coronary artery disease
• Age ≥ 35 and ≤ 80 years
• Canadian Cardiovascular Society (CCS) Classification of Angina Pectoris classⅠ-Ⅲ
• Patient or legally authorized representative has signed informed consent.
• Acute coronary syndrome or unstable angina pectoris in the prior 3 months, or other heart diseases (e.g. cardiomyopathy, pericardial disease);

Sponsors & Collaborators

• Dongzhimen Hospital, Beijing: lead
• The Affiliated Hospital of Changchun University of Chinese Medicine: collaborator
• The Affiliated Hospital of Shandong University of Chinese Medicine: collaborator
• Chengdu University of Traditional Chinese Medicine: collaborator
• The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine: collaborator
• First Affiliated Hospital of Heilongjiang Chinese Medicine University: collaborator
• Second Affiliated Hospital of Heilongjiang University of Chinese Medicine: collaborator
• The Second Affiliated Hospital of Hunan University of Traditional Chinese Medicine: collaborator
• Hunan Academy of Traditional Chinese Medicine Affiliated Hospital: collaborator
• The First Clinical Hospital of Jilin Academy of Traditional Chinese Medicine: collaborator
• Shaanxi Buchang Pharmaceuticals Co., Ltd.: collaborator
• Beijing Chuanglikechuang Medical Technology Development Co., Ltd.: collaborator
• Shanghai Youningwei Biotechnology Co., Ltd.: collaborator
• Wuhan Zhizhi Medical Technology Co., Ltd.: collaborator
• Wuhan Third Hospital: collaborator
• Rizhao Hospital of Traditional Chinese Medicine: collaborator
• The First Affiliated Hospital of Guangxi University of Traditional Chinese Medicine: collaborator
• Jiangbin Hospital of Guangxi Zhuang Autonomous Region: collaborator

Study Sites (1)

Dongzhimen Hospital

Beijing, Beijing Municipality, 100700, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 34733163 DERIVED

MeSH Terms

Conditions

Ischemic Stroke; Coronary Artery Disease; Angina, Stable

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Coronary Disease; Myocardial Ischemia; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Angina Pectoris; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Ying Gao, MD

  Dongzhimen Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ying Gao, MD

CONTACT

0086-010-84013209; gaoying973@126.com

Weidi Liu

CONTACT

0086-15301025939; L305613099@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President of the Institute for Brain Disorders, Beijing University of Chinese Medicine

Study Record Dates

• First Submitted: May 26, 2020
• First Posted: May 29, 2020
• Study Start: July 22, 2020
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: April 1, 2021

Record last verified: 2020-05

Locations

CN (1)