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

Zhong Wang

Status and phase: Enrolling; Phase 4

Conditions: Stable Coronary Heart Disease; Chronic Insomnia; Endometriosis; Chinese Medicine; Headache

Treatments: Other: conventional therapy; Drug: Xuefu-Zhuyu Capsule; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04218487

XFZY-V3.0

Details and patient eligibility

About

"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.

Enrollment: 720 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Meet the diagnostic criteria of "Qizhi Xueyu Zheng" (Qi Stagnation and Blood Stasis Syndrome).

• Meet the diagnostic criteria of stable coronary heart disease, chronic insomnia, headache (Migraine without Aura and Tension-Type Headache ), or endometriosis, among which:

  • the score of angina pectoris frequency domain in SAQ ≤ 80 points in the patients with 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 3 months before enrollment;
  • In patients with tension-Type headache, within 3 months before enrollment, the number 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 pathological reports(previous diagnosis is also possible).

• Patients were ≥18 and ≤75 years of age.

• Voluntarily provided written informed consent.

Exclusion criteria

• Patients with acute myocardial infarction, rapid atrial fibrillation, atrial flutter, paroxysmal ventricular tachycardia and other severe arrhythmias and severe cardiac and pulmonary insufficiency in the past 3 months
• Patients with acute cerebrovascular disease such as cerebral infarction and cerebral hemorrhage in the past 3 months;
• Those with poorly controlled hypertension (systolic blood pressure ≥160mmHg or diastolic blood pressure ≥100mmHg after treatment);
• Patients with aortic dissection;
• Patients with abnormal liver and kidney function indicators (ALT, AST are 1.5 times greater than the upper limit of normal value, and Scr is greater than the upper limit of 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, who cannot 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 the trial.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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720 participants in 2 patient groups, including a placebo group

XFZY group

Experimental group

Description:

2.4g (6 capsules) three times daily for 12 weeks

Treatment:

Other: conventional therapy

Drug: Xuefu-Zhuyu Capsule

Control group

Placebo Comparator group

Description:

2.4g (6 capsules) three times daily for 12 weeks

Treatment:

Other: conventional therapy

Drug: placebo