The Efficacy and Safety of Xuefu Zhuyu Capsule in Treating "Qizhi Xueyu Zheng" (Qi Stagnation and Blood Stasis Syndrome): a Randomized, Double-blind, Placebo-controlled, Adaptive Enrichment, Multicenter Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 720
- 试验地点
- 12
- 主要终点
- Change from baseline the Chinese Medicine patient-reported-outcome scale in patients with Qizhi-Xueyu-Zheng (Qizhi-Xueyu-Zheng PRO Scale)
研究概览
简要总结
"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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
XFZY group
2.4g (6 capsules) three times daily for 12 weeks
干预措施: conventional therapy (Other)
Control group
2.4g (6 capsules) three times daily for 12 weeks
干预措施: placebo (Drug)
Control group
2.4g (6 capsules) three times daily for 12 weeks
干预措施: conventional therapy (Other)
XFZY group
2.4g (6 capsules) three times daily for 12 weeks
干预措施: Xuefu-Zhuyu Capsule (Drug)
结局指标
主要结局
Change from baseline the Chinese Medicine patient-reported-outcome scale in patients with Qizhi-Xueyu-Zheng (Qizhi-Xueyu-Zheng PRO Scale)
时间窗: at 12 Week
The Qizhi-Xueyu-Zheng PRO Scale is uesd to access the quality of life on the physical and mental health for the patients with Qizhi Xueyu Zheng. The higher score of this PRO scale indicates higher quality of life. Compared with the baseline, if the improvement of the PRO sacle is more than 30% after treatment, it indicates the effectiveness of the drug. s
次要结局
- Level of the 5-hydroxytryptamine(5-HT)(Baseline，4，8，12 Week)
- The pain scale Qizhi Xueyu Zheng(Baseline，4，8，12 Week)
- Self-rating depression scale (SDS)(Baseline，4，8，12 Week)
- SF-36 Quality of Life Scale(Baseline，4，8，12 Week)
- Self-rating anxiety scale (SAS)(Baseline，4，8，12 Week)
- Level of the high-sensitivity C-reactive protein(Baseline，4，8，12 Week)
- The single symptom and sign scale of Qizhi Xueyu Zheng(Baseline，4，8，12 Week)
研究者
Zhong Wang
Professor
China Academy of Chinese Medical Sciences