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Research on the Clinical Effect of Effective Prescription in Treating Unstable Angina.

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ClinicalTrials.gov Identifier: NCT03171597
Recruitment Status : Not yet recruiting
First Posted : May 31, 2017
Last Update Posted : May 31, 2017
Sponsor:
Information provided by (Responsible Party):
Jun Li, Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Brief Summary:
This study evaluates the clinical efficacy of the famous prescription in the treatment of unstable angina pectoris. All of the patients will be divided into 4 arms according to their syndrome type. One of the arms will be treated by conventional western medicine, the other three will be treated by different Chinese herbal medicine prescription at the base of conventional western medicine.

Condition or disease Intervention/treatment Phase
Unstable Angina Drug: Anti-Platelet Drugs Drug: Lipid Regulating Drugs Drug: Coronary Vasodilator Drug: Xuefu Zhuyu Decoction Drug: Gualou Xiebai Banxia Decoction & Danshen Decoction Drug: Shuanghe Decoction Phase 4

Detailed Description:

Xuefu Zhuyu Decoction has the function of activating qi and promoting blood circulation, which will be used to treat patients with qi stagnation and blood stasis syndrome.

GualouXiebaiBanxia Decoction compounded with Danshen Decoction has the effect of promoting blood circulation and resolving phlegm, so it will be used for patients taht belong to phlegm and blood stasis type.

Shuanghe Decoction has the function of supplementing Qi and activating blood circulation, which will be used to treat patients with Qi deficiency and blood stasis syndrome.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Research on the Clinical Effect of Effective Prescription in Treating Unstable Angina.
Estimated Study Start Date : August 2017
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angina

Arm Intervention/treatment
conventional western medicine
Patients in this group will be treated by conventional western medicine, including anti-platelet drugss,lipid regulating drugs, coronary vasodilator, etc.
Drug: Anti-Platelet Drugs
Including aspirin and clopidogrel, etc.

Drug: Lipid Regulating Drugs
Mainly including statins

Drug: Coronary Vasodilator
Mainly including nitrates

Experimental: Qi deficiency and blood stasis
Patients in this group will be treated by Shuanghe Decoction at the base of conventional western medicine.
Drug: Anti-Platelet Drugs
Including aspirin and clopidogrel, etc.

Drug: Lipid Regulating Drugs
Mainly including statins

Drug: Coronary Vasodilator
Mainly including nitrates

Drug: Shuanghe Decoction
Mainly including Ginseng, Poria, Calamus, Cyperus, Salvia miltiorrhiza, Radix Polygalae etc.

Experimental: Qi stagnation and blood stasis
Patients in this group will be treated by Xuefu Zhuyu Decoction at the base of conventional western medicine.
Drug: Anti-Platelet Drugs
Including aspirin and clopidogrel, etc.

Drug: Lipid Regulating Drugs
Mainly including statins

Drug: Coronary Vasodilator
Mainly including nitrates

Drug: Xuefu Zhuyu Decoction
Mainly including Peach Kernel, Safflower, Angelica, Bupleurum etc.

Experimental: Phlegm and blood stasis
Patients in this group will be treated by Gualou Xiebai Banxia Decoction & Danshen Decoction at the base of conventional western medicine.
Drug: Anti-Platelet Drugs
Including aspirin and clopidogrel, etc.

Drug: Lipid Regulating Drugs
Mainly including statins

Drug: Coronary Vasodilator
Mainly including nitrates

Drug: Gualou Xiebai Banxia Decoction & Danshen Decoction
Mainly including Fructus Trichosanthis, Rhizoma Pinelliae, Allium, Salvia Miltiorrhiza etc.




Primary Outcome Measures :
  1. Mortality [ Time Frame: Six months after drug intervention ]
    Death caused by cardiovascular disease


Secondary Outcome Measures :
  1. Myocardial enzymes [ Time Frame: At baseline and 4 weeks after drug intervention ]
    The unit is mmol/L

  2. Blood lipid [ Time Frame: At baseline and 4 weeks after drug intervention ]
    The unit is mmol/L.

  3. Treadmill exercise test [ Time Frame: At baseline and 4 weeks after drug intervention ]
    The result will be positive or negative

  4. The incidence of myocardial infarction or heart failure [ Time Frame: Six months after drug intervention ]


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Ages Eligible for Study:   35 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants diagnosed with coronary heart disease through coronary angiography or coronary CTA;

Patients have at least one of these symptoms:

  1. The stability of the nature of angina pectoris changes, that is, frequent attacks of angina pectoris, serious degree and prolonged duration;
  2. Angina pectoris during rest;
  3. The recent occurrence of angina pectoris caused by mild physical activity in the last month.

Exclusion Criteria:

  • Patients dignosed with stable angina; Patients with acute myocardial infarction; Chest pain caused by congenital heart disease, valvular heart disease, severe neurosis or arrhythmia; The heart function grade is III or IV; Patients with acute cerebral infarction; Patients complicated with other serious primary diseases; Patients with acute infection in recent 2 weeks; Uncontrolled hypertension (the resting blood pressure >160/95mmHg within one week); Diabetics emerged with serious diabetic complications; Patients can't finish the questionnaire due to abnormal mental and nervous or mental disorders; Pregnant or lactating women.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03171597


Contacts
Contact: Panpan Tian +86 15652388175 15652388175@163.com

Sponsors and Collaborators
Jun Li
Investigators
Study Director: Jun Li, MD Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Publications of Results:
Other Publications:
Responsible Party: Jun Li, Chief Physician, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier: NCT03171597     History of Changes
Other Study ID Numbers: YXFJ-2017
First Posted: May 31, 2017    Key Record Dates
Last Update Posted: May 31, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jun Li, Guang'anmen Hospital of China Academy of Chinese Medical Sciences:
Unstable Angina
Traditional Chinese Medicine

Additional relevant MeSH terms:
Platelet Aggregation Inhibitors
Angina Pectoris
Angina, Unstable
Chest Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Signs and Symptoms
Vasodilator Agents
Lipid Regulating Agents