Xuefu-Zhuyu Capsule for the Treatment of "Qizhi Xueyu Zheng" (Qi Stagnation and Blood Stasis Syndrome)

Last updated: November 14, 2022
Sponsor: Zhong Wang
Overall Status: Active - Recruiting

Phase

4

Condition

Myocardial Ischemia

Endometriosis

Pain (Pediatric)

Treatment

N/A

Clinical Study ID

NCT04218487
XFZY-V3.0
  • Ages 18-75
  • All Genders

Study Summary

"Xuefu-Zhuyu capsule" (XFZY) is made from a classic Fangji "Xuefu-Zhuyu Decoction" in an ancient Chinese medical book "Yi Lin Gai Cuo" by Chinese physician Wang Qingren, which is the most representative formula for the treatment of "Qizhi-Xueyu Zheng" (Qi Stagnation and Blood Stasis Syndrome). XFZY concludes 11 kinds of Chinese herbs: Danggui(Angelica sinensis), Honghua(Safflower Flower), Chishao(Paeoniae Radix Rubra), Shengdihuang(Radix Rehmanniae), Taoren(Peach Seed), Zhike(Fructus Aurantii), Jugeng(Platycodon grandiflorum), Chuanxiong(Rhizome of Chuanxiong), Chaihu(Radix Bupleuri), Chuanniuxi(Cyathula Officinalis),Gancao(liquorice).It is mainly used to treat "Qizhi-Xueyu Zheng", which includes the symptoms such as different types of pain, irritability or depression, insomnia, chest tightness, dark skin, lumps or masses in vitro or in vivo, petechiae on the tongue, and dark purple tongue. The purpose of the trial is to evaluate the efficacy and safety of XFZY in treating "Qizhi-Xueyu Zheng", and investigate the most suitable diseases of XFZY.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Meet the diagnostic criteria of "Qizhi Xueyu Zheng" (Qi Stagnation and Blood StasisSyndrome).
  • Meet the diagnostic criteria of stable coronary heart disease, chronic insomnia,headache (Migraine without Aura and Tension-Type Headache ), or endometriosis, amongwhich:
  • the score of angina pectoris frequency domain in SAQ ≤ 80 points in the patientswith stable coronary heart disease;
  • Pittsburgh sleep quality index> 10 points in patients with chronic insomnia;
  • Patients with migraine without aura have 3 or more attacks per month within 3months before enrollment;
  • In patients with tension-Type headache, within 3 months before enrollment, thenumber of attack days per month is ≥ 2 days;
  • The VAS score of the pain ≥ 40 points in patients with endometriosis;
  • Patients with endometriosis diagnosed with any type of confirmed pathologicalreports(previous diagnosis is also possible).
  • Patients were ≥18 and ≤75 years of age.
  • Voluntarily provided written informed consent.

Exclusion

Exclusion Criteria:

  • Patients with acute myocardial infarction, rapid atrial fibrillation, atrial flutter,paroxysmal ventricular tachycardia and other severe arrhythmias and severe cardiac andpulmonary insufficiency in the past 3 months
  • Patients with acute cerebrovascular disease such as cerebral infarction and cerebralhemorrhage in the past 3 months;
  • Those with poorly controlled hypertension (systolic blood pressure ≥160mmHg ordiastolic blood pressure ≥100mmHg after treatment);
  • Patients with aortic dissection;
  • Patients with abnormal liver and kidney function indicators (ALT, AST are 1.5 timesgreater than the upper limit of normal value, and Scr is greater than the upper limitof normal value);
  • SAS≥70 points;
  • SDS≥73 points;
  • VAS≥80 points;
  • Patients with severe primary heart, brain, liver, kidney, and hematopoietic diseases;
  • Women during pregnancy and lactation;
  • Those with cognitive impairment, consciousness impairment or mental illness, whocannot communicate normally;
  • People with allergies, or those who are known to be allergic to the trial drug (including its components);
  • Surgery(including intervention, radio frequency, etc.) during the past 4 weeks;
  • Those with bleeding tendency;
  • Those who suspect or have a history of alcohol or drug abuse;
  • Participation in another trial in the past 1 month;
  • Other circumstances judged by the researcher to be unsuitable for participation in thetrial.

Study Design

Total Participants: 720
Study Start date:
December 31, 2019
Estimated Completion Date:
June 30, 2024

Connect with a study center

  • Anqing Municipal Hospital

    Anqing, Anhui 230000
    China

    Active - Recruiting

  • Beijing Hospital

    Beijing, Beijing 100730
    China

    Active - Recruiting

  • Beijing Hospital of Traditional Chinese Medicine, Capital Medical University

    Beijing, Beijing 100010
    China

    Active - Recruiting

  • Dongfang Hospital of Beijing University of Chinese Medicine

    Beijing, Beijing 100078
    China

    Active - Recruiting

  • Daqing Oilfield General Hospital

    Daqing, Heilongjiang 163001
    China

    Site Not Available

  • Luohe Hospital of Chinese Medicine

    Luohe, Henan 462000
    China

    Active - Recruiting

  • Nanyang Traditional Chinese Medicine Hospital

    Nanyang, Henan 473000
    China

    Active - Recruiting

  • Wuhan Puren Hospital

    Wuhan, Hubei 430081
    China

    Active - Recruiting

  • Taizhou Second People's Hospital

    Taizhou, Jiangsu 225300
    China

    Active - Recruiting

  • Liaoyuan Hospital of Traditional Chinese Medicine

    Liaoyuan, Jilin 136200
    China

    Active - Recruiting

  • Affiliated Hospital of Inner Mongolia University for the Nationalities

    Tongliao, Neimenggu 028007
    China

    Active - Recruiting

  • Taizhou Second People's Hospital

    Jiangbei, Taizhou 225300
    China

    Site Not Available

  • First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

    Tianjin, Tianjin 300193
    China

    Active - Recruiting

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