Clinical Trial Scheme of Xinnaoning Capsule

NCT03914131 | Unknown Phase 4

• 1 other identifier: DHZD-XNNJN-001
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a randomized, double-blind, parallel-controlled, multicenter clinical study to evaluate the efficacy and safety of Xinnaoning capsule in the treatment of chronic stable angina pectoris (Qi stagnation and blood stasis syndrome).

Conditions

Chronic Stable Angina Pectoris; Qi Stagnation and Blood Stasis Syndrome

Outcome Measures

Primary Outcomes (1)

• the changes of curative effect of angina pectoris symptoms

  The number of angina attacks, duration, degree of pain, and the dosage of nitroglycerin are used as indicators for scoring. Score ranges 0-15, the higher the score, the more severe the angina.

  Visit1:introduction period,-14±2days; Visit2:treatment period,-4~0day; Visit3:treatment period,4weeks±4days; Visit4:treatment period,8weeks±4days; Visit5:treatment period, 12weeks±4days

Secondary Outcomes (7)

• Therapeutic effect of TCM syndromes

  Visit1:introduction period,-14±2days; Visit2:treatment period,-4~0day; Visit3:treatment period,4weeks±4days; Visit4:treatment period,8weeks±4days; Visit5:treatment period, 12weeks±4days

• Grading changes of severity of angina pectoris

  Visit1:introduction period,-14±2days; Visit2:treatment period,-4~0day; Visit3:treatment period,4weeks±4days; Visit4:treatment period,8weeks±4days; Visit5:treatment period, 12weeks±4days

• Changes in the number of angina attacks per week

  through study completion, an average of 14 weeks

• Nitroglycerin dosage

  through study completion, an average of 14 weeks

• Seattle Angina Questionnaire,SAQ

  Visit1:introduction period,-14±2days; Visit2:treatment period,-4~0day; Visit3:treatment period,4weeks±4days; Visit4:treatment period,8weeks±4days; Visit5:treatment period, 12weeks±4days

Study Arms (2)

study group

EXPERIMENTAL

Introduction period: 2 weeks, time window (±2 days). Dosage regimen: Take Xinnaoning Capsule Simulator 3 tablets per time, 3 times per day, orally, after meals. The treatment period: 12 weeks, time window (±4 days). Dosage regimen:Take Xinnaoning Capsule 3 tablets per time, 3 times per day, orally, after meals. Dosage form:Capsule

Drug: Xinnaoning Capsule; Other: Xinnaoning Capsule Simulator

control group

PLACEBO COMPARATOR

Introduction period: 2 weeks, time window (±2 days). Dosage regimen: Take Xinnaoning Capsule Simulator 3 tablets per time, 3 times per day, orally, after meals. The treatment period: 12 weeks, time window (±4 days). Dosage regimen:Take Xinnaoning Capsule Simulator 3 tablets per time, 3 times per day, orally, after meals. Dosage form:Capsule

Other: Xinnaoning Capsule Simulator

Interventions

Xinnaoning Capsule DRUG

Xinnaoning Capsule used in study group(treatment period) is the true drug that the investigators are to evaluate.

Also known as: Xinnaoning

study group

Xinnaoning Capsule Simulator OTHER

Xinnaoning Capsule Simulator used in control group and introduction period(both groups) is the placebo to reduce the risk of bias.

Also known as: placebo

control group; study group

Eligibility Criteria

• Age: 30 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Refer to the Guidelines for Diagnosis and Treatment of Chronic Stable Angina issued by the Chinese Medical Association in 2007, 2012ACP/ACCF/AHA/AATS/PCNA/STS (Guidelines for Diagnosis and Management of Stable Ischemic Heart Disease: American Heart Foundation/American Heart Association/American Medical Association/American Thoracic Surgery Association/American Association for Cardiovascular Preventive Nursing/American Association for Cardiovascular Angiography and Intervention/American Thoracic Association The Diagnosis of Stable Ischemic Heart Disease: Guidelines for Clinical Practice, Guidelines for the Management of Stable Coronary Artery Diseases in 2013 ESC, which can diagnose coronary heart disease in accordance with any of the following:
• Has a clear history of old myocardial infarction, or PCI history, or bypass history
• Coronary angiography (results indicate at least one coronary artery stenosis with stenosis (\>50%) or coronary CTA suggests stenosis with stenosis (\>50%)
• Those who met the diagnostic criteria of chronic stable angina pectoris: those who had a history of angina pectoris more than 1 month and had no significant changes in the degree, frequency, nature and inducing factors of angina pectoris
• The severity of angina pectoris of the Canadian Cardiovascular Society (CCS) was classified as Grade I to Grade III, and angina pectoris occurred more than twice a week
• The syndrome differentiation of TCM is Qi stagnation and blood stasis syndrome
• Age ranges from 30 to 79 years old
• Sign the informed consent

You may not qualify if:

• Severe cardiopulmonary insufficiency (grade III, IV, severe abnormal pulmonary function);
• Poor control of hypertension (systolic blood pressure (\> 160 mmHg) or diastolic blood pressure (\> 100 mmHg) after treatment;
• Complicated with liver and kidney function damage, ALT, AST (\> 1.5 times of the upper limit of normal value), or Cr (\> the upper limit of normal value), combined with hematopoietic system and other serious primary diseases;
• Acute myocardial infarction within 3 months after interventional therapy;
• Cardiac pacemaker;
• Pregnancy, lactation or pregnancy planners;
• Anaphylactic constitution or allergic to known ingredients of research drugs;
• Chest pain caused by other causes (moderate anemia, hyperthyroidism, etc.)
• Those who participated in other clinical drug trials within one month;
• According to the judgement of the researchers, it is not advisable to participate in clinical researchers.
• Other factors affecting ST-T changes in ECG, such as myocardial hypertrophy, left bundle branch block, etc.

Sponsors & Collaborators

• Beijing Duheng for Drug Evaluation and Research Co., Ltd. (DDER): lead

Study Sites (1)

Xiyuan Hospital, Chinese Academy of Traditional Chinese Medicine

Beijing, Beijing Municipality, 100091, China

RECRUITING

Related Publications (1)

• Zhao JN, Zhang Y, Lan X, Chen Y, Li J, Zhang P, Wu LQ, Jia ST, Liu Y, Xu FQ. Efficacy and safety of Xinnaoning capsule in treating chronic stable angina (qi stagnation and blood stasis syndrome): Study protocol for a multicenter, randomized, double-blind, placebo-controlled trial. Medicine (Baltimore). 2019 Aug;98(31):e16539. doi: 10.1097/MD.0000000000016539.

  PMID: 31374015 DERIVED

Study Officials

• Fengqin Xu, Doctor

  Xiyuan Hospital of China Academy of Chinese Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fengqin Xu, Doctor

CONTACT

010-62835113; 18800021979@163.com

Chunsheng Qiao

CONTACT

010-58462584; qiaocs@drugevaluation.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2019
• First Posted: April 16, 2019
• Study Start: May 15, 2018
• Primary Completion: December 1, 2019
• Study Completion: April 1, 2020
• Last Updated: April 16, 2019

Record last verified: 2019-04

Locations

CN (1)