Efficacy and Safety of QiShen YiQi Dripping Pills in Chronic Heart Failure

NCT04983043 | Completed Phase 2

• 1 other identifier: TSL-TCM-QSYQDW-HFrEF-Ⅱ
• Study Type: interventional
• Target: 228
• Locations: 1 country
• Sites: 23

Brief Summary

This study will evaluate the efficacy and safety and the best effective dose of QiShen YiQi Dripping Pills in the treatment of chronic heart failure with decreased ejection fraction of CHD (Qi deficiency and blood stasis syndrome).

Conditions

Chronic Heart Failure With Reduced Ejection Fraction

Outcome Measures

Primary Outcomes (1)

• 6-Minutes-Walking-Test (6MWT) in week 12

  Change from baseline to weeks 12 in exercise capacity as measured by the 6-Minutes-Walking-Test (6MWT) distance.

  Baseline to weeks 12

Secondary Outcomes (8)

• 6-Minutes-Walking-Test (6MWT) in weeks 4 and 8

  Baseline to weeks 4 and 8

• NYHA classification

  Baseline to weeks 4,8 and 12

• Traditional Chinese Medicine Syndrome Score

  Baseline to weeks 4,8 and 12

• Dyspnea, weakness, edema

  Baseline to weeks 4,8 and 12

• Echocardiogram results

  Baseline to weeks 4,8 and 12

Other Outcomes (2)

• Saturation of Peripheral Oxygen

  Week 12

• Grasp strength body mass index test

  Week 12

Study Arms (3)

Low dose group

EXPERIMENTAL

Low dose QiShen YiQi Dripping Pills, 3 bags, take orally after meals, 3 times a day

Drug: Low dose QiShen YiQi Dripping Pills 3 bags

High dose group

EXPERIMENTAL

High dose QiShen YiQi Dripping Pills, 3 bags, take orally after meals, 3 times a day

Drug: High dose QiShen YiQi Dripping Pills 3 bags

Placebo group

PLACEBO COMPARATOR

QiShen YiQi Dripping Pills placebo, 3 bags, take orally after meals, 3 times a day

Drug: QiShen YiQi Dripping Pills placebo 3 bags

Interventions

Low dose QiShen YiQi Dripping Pills 3 bags DRUG

Low dose QiShen YiQi Dripping Pills contain QiShen YiQi Dripping Pills 2 bags(0.52g dripping pills per bag) and QiShen YiQi Dripping Pills placebo 1 bag(0.52g dripping pills placebo per bag),take orally after meals, 3 times a day for 12weeks

Also known as: Low dose group

Low dose group

High dose QiShen YiQi Dripping Pills 3 bags DRUG

High dose QiShen YiQi Dripping Pills contain QiShen YiQi Dripping Pills 3 bags(0.52g dripping pills per bag),take orally after meals, 3 times a day for 12weeks

Also known as: High dose group

High dose group

QiShen YiQi Dripping Pills placebo 3 bags DRUG

QiShen YiQi Dripping Pills placebo contain QiShen YiQi Dripping Pills placebo 3 bags(0.52g dripping pills placebo per bag),take orally after meals, 3 times a day for 12weeks

Also known as: Placebo group

Placebo group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Conformed to the diagnostic criteria of CHD and chronic heart failure
• Conformed to the TCM syndrome differentiation standard of chronic heart failure syndrome of Qi deficiency and blood stasis
• Male or female subjects aged ≥ 40 years and ≤80 years
• LVEF\<45%(modified Simpson method)
• NYHAⅡ-Ⅲ
• Received standardized drug therapy for chronic heart failure at least 2 weeks before randomization, and did not receive intravenous therapy (vasoactive drugs, diuretics) within 2 weeks without adjustment of dose
• Ability to understand the requirements of the study and willingness to provide written informed consent
• Have no pregnancy program and take effective contraceptive measures voluntarily
• Abide by the experimental protocol and cooperate with the data collection according to the researcher's judgment

You may not qualify if:

• Patients with heart failure caused by other heart diseases,such as cor pulmonale, congenital heart disease, primary pulmonary hypertension, secondary severe pulmonary hypertension, severe stenosis or insufficiency of heart valves, cardiomyopathy (including hypertrophic cardiomyopathy, restrictive cardiomyopathy, dilated cardiomyopathy, alcoholic cardiomyopathy), moderate massive pericardial effusion, constrictive pericarditis, infective endocarditis
• Heart failure caused by systemic diseases or other systemic diseases, such as rheumatic immune and secretory diseases;heart failure caused by kidney disease, lung disease, liver disease and serious infection;heart failure caused by chemical or toxicological causes
• Patients who had acute myocardial infarction, underwent coronary revascularization or left ventricular remodeling, underwent cardiac resynchronization with pacemaker implantation, underwent cardiothoracic surgery within 3 months prior to receiving the experimental drug, patients with other acute coronary syndrome, pulmonary embolism or acute cerebrovascular disease
• Severe arrhythmias such as ventricular tachycardia, second degree Ⅱ type or above sinus atrial or atrioventricular block without pacemaker treatment, average QTc \> 500ms, heart rate \< 50 beats/min, etc
• Complicated with other serious diseases, such as pheochromocytoma, hematologic diseases, organ transplantation patients, and any history of malignant tumor
• The presence of uncontrolled hypertension, systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥100mmHg
• Hypotension with a systolic blood pressure \<80mmHg and/or a diastolic blood pressure \<50mmHg
• Patients with hepatic and/or renal dysfunction (ALT≥ 2 times the upper limit of normal, and/or estimated glomerular filtration rate (EGFR) \<30 mL /min/1.73m2
• HbA1c ≥9.0%, or fasting blood glucose ≥13.9mmol/L
• Moderate and severe anemia (Hb \< 90g/L)
• Serum potassium ≥5.5mmol/L
• Patients requiring anticoagulants who did not achieve dose stabilization for 1 month or INR \> 3.0
• In patients who need to take antiplatelet drugs, the dose was stable for less than 1 month, and the platelet value was lower than the lower limit of normal value
• Allergic to the test drug or its related taste or ingredients
• People with complicated mental illness, poor condition control and drug addiction

Sponsors & Collaborators

• Tasly Pharmaceutical Group Co., Ltd: lead

Study Sites (23)

Hefei First People's Hospital

Hefei, Anhui, China

Location

The First Hospital of ANHUI University of Science & Technology

Huainan, Anhui, China

Location

Suzhou Municipal Hospital

Suzhou, Anhui, China

Location

Guang'anmen Hospital, China Academy of Chinese Medical Sciences

Beijing, Beijing Municipality, China

Location

Xiamen Hospital of Traditional Chinese Medicine

Xiamen, Fujian, China

Location

Dongguan TCM Hospital

Dongguan, Guangdong, China

Location

Nanfang Hospital，Southern Medical University

Guangzhou, Guangdong, China

Location

The Affiliated TCM Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Location

The First Affiliated Hospital of Guangzhou University of Chinese Medicine

Guangzhou, Guangdong, China

Location

Zhong Shan Hospital of Chinese Medicine

Zhongshan, Guangdong, China

Location

Ruikang Hospital Affiliated to Guangxi University of Traditional Chinese Medicine

Nanning, Guangxi, China

Location

The First Affiliated Hospital of Heilongjiang University of Chinese Medicine

Harbin, Heilongjiang, China

Location

Luoyang Third People's Hospital

Luoyang, Henan, China

Location

The First Affiliated Hospital of Nanyang Medical College

Nanyang, Henan, China

Location

Pepole's Hospital of Xinzheng

Zhengzhou, Henan, China

Location

Hunan University of Chinese Medicine

Changsha, Hunan, China

Location

The First Affiliated Hospital of University of South China

Hengyang, Hunan, China

Location

Nanjing Hospital of Traditional Chinese Medicine

Nanjing, Jiangsu, China

Location

The Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

Shenyang, Liaoning, China

Location

Xi'an Daxing Hospital

Xi'an, Shaanxi, China

Location

The Affiliated Hospital of Chengdu University of Traditional Chinese Medicine

Chengdu, Sichuan, China

Location

The Second Affiliated Hospital of Tianjin University of traditional Chinese Medicine

Tianjin, Tianjin Municipality, China

Location

Hospital of Traditional Chinese Medicine of Xinjiang Uygur Autonomous Region

Ürümqi, Xinjiang, China

Location

Related Publications (1)

• He X, Jiang Y, Li S, Liu D, Li Z, Han X, Zhang X, Dong X, Liu H, Huang J, Wang X, Long W, Ni S, Yang Z, Ye T. Efficacy and Safety of QiShen YiQi Dripping Pills in the Treatment of Coronary Heart Disease Complicating Chronic Heart Failure (Syndrome of Qi Deficiency with Blood Stasis): Study Protocol for a Randomized, Placebo-Controlled, Double-Blind and Multi-Centre Phase II Clinical Trial. Int J Gen Med. 2023 Dec 28;16:6177-6188. doi: 10.2147/IJGM.S436999. eCollection 2023.

  PMID: 38169574 DERIVED

MeSH Terms

Interventions

Population Groups

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

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: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2021
• First Posted: July 30, 2021
• Study Start: June 10, 2021
• Primary Completion: November 27, 2024
• Study Completion: November 27, 2024
• Last Updated: January 10, 2025

Record last verified: 2024-03

Locations

CN (23)