Clinical trial NCT04218487: Xuefu-Zhuyu Capsule for the Treatment of "Qizhi Xueyu Zheng" (Qi Stagnation and Blood Stasis Syndrome)
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Chinese Medicine
Stable Coronary Heart Disease
Chronic Insomnia
Headache
Endometriosis
Keywords: Adaptive design
Qizhi Xueyu Zheng
Enrichment design
Lead sponsor: China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2020-01-06
Enrollment: 720
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.

Primary outcomes:
measure: Change from baseline the Chinese Medicine patient-reported-outcome scale in patients with Qizhi-Xueyu-Zheng (Qizhi-Xueyu-Zheng PRO Scale)
timeFrame: at 12 Week
Secondary outcomes:
measure: The single symptom and sign scale of Qizhi Xueyu Zheng
timeFrame: Baseline，4，8，12 Week
measure: The pain scale Qizhi Xueyu Zheng
timeFrame: Baseline，4，8，12 Week
measure: Self-rating anxiety scale (SAS)
timeFrame: Baseline，4，8，12 Week
measure: Self-rating depression scale (SDS)
timeFrame: Baseline，4，8，12 Week
measure: SF-36 Quality of Life Scale
timeFrame: Baseline，4，8，12 Week
measure: Level of the 5-hydroxytryptamine(5-HT)
timeFrame: Baseline，4，8，12 Week
measure: Level of the high-sensitivity C-reactive protein
timeFrame: Baseline，4，8，12 Week
Other outcomes:
measure: The changes of the expression files on the RNA level via the RNA sequencing in 120 patients
timeFrame: Baseline，4，8，12 Week
measure: The changes of the expression files on the protein level via the quantitative proteomics in 120 patients
timeFrame: Baseline，4，8，12 Week
measure: The changes of Metabolomics profile in 120 patients
timeFrame: Baseline，4，8，12 Week
Locations:
city: Anqing
country: China
facility: Anqing Municipal Hospital
state: Anhui
city: Beijing
country: China
facility: Beijing Hospital of Traditional Chinese Medicine, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Dongfang Hospital of Beijing University of Chinese Medicine
state: Beijing
city: Beijing
country: China
facility: Beijing Hospital
state: Beijing
city: Daqing
country: China
facility: Daqing Oilfield General Hospital
state: Heilongjiang
city: Luohe
country: China
facility: Luohe Hospital of Chinese Medicine
state: Henan
city: Nanyang
country: China
facility: Nanyang Traditional Chinese Medicine Hospital
state: Henan
city: Wuhan
country: China
facility: Wuhan Puren Hospital
state: Hubei
city: Taizhou
country: China
facility: Taizhou Second People's Hospital
state: Jiangsu
city: Liaoyuan
country: China
facility: Liaoyuan Hospital of Traditional Chinese Medicine
state: Jilin
city: Tongliao
country: China
facility: Affiliated Hospital of Inner Mongolia University for the Nationalities
state: Neimenggu
city: Tianjin
country: China
facility: First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
state: Tianjin
Study officials:
affiliation: Institute of Basic Chinese Medical Sciences, China Academy of Chinese Medical Sciences
name: Zhong Wang, M.D.
role: STUDY_DIRECTOR
affiliation: Beijing Hospital of Traditional Chinese Medicine
name: Qing-Quan Liu, Prof.
role: PRINCIPAL_INVESTIGATOR
References: