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

NCT04218487 | Unknown Phase 4 DMC

• 1 other identifier: XFZY-V3.0
• Study Type: interventional
• Target: 720
• Locations: 1 country
• Sites: 12

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.

Conditions

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

Keywords

Adaptive design; Qizhi Xueyu Zheng; Enrichment design

Outcome Measures

Primary Outcomes (1)

• Change from baseline the Chinese Medicine patient-reported-outcome scale in patients with Qizhi-Xueyu-Zheng (Qizhi-Xueyu-Zheng PRO Scale)

  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

  at 12 Week

Secondary Outcomes (7)

• The single symptom and sign scale of Qizhi Xueyu Zheng

  Baseline，4，8，12 Week

• The pain scale Qizhi Xueyu Zheng

  Baseline，4，8，12 Week

• Self-rating anxiety scale (SAS)

  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

Other Outcomes (3)

• The changes of the expression files on the RNA level via the RNA sequencing in 120 patients

  Baseline，4，8，12 Week

• The changes of the expression files on the protein level via the quantitative proteomics in 120 patients

  Baseline，4，8，12 Week

• The changes of Metabolomics profile in 120 patients

  Baseline，4，8，12 Week

Study Arms (2)

XFZY group

EXPERIMENTAL

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

Drug: Xuefu-Zhuyu Capsule; Other: conventional therapy

Control group

PLACEBO COMPARATOR

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

Drug: placebo; Other: conventional therapy

Interventions

Xuefu-Zhuyu Capsule DRUG

treatment with 2.4g (6 capsules) of XFZY three times daily for 12 weeks.

XFZY group

placebo DRUG

treatment with 2.4g (6 capsules) of placebo three times daily for 12 weeks.

Control group

conventional therapy OTHER

conventional therapy will be given according to the suffering diseases including stable coronary heart disease, chronic insomnia, headache, endometriosis.

Control group; XFZY group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Zhong Wang: lead

Study Sites (12)

Anqing Municipal Hospital

Anqing, Anhui, 230000, China

RECRUITING

Beijing Hospital of Traditional Chinese Medicine, Capital Medical University

Beijing, Beijing Municipality, 100010, China

RECRUITING

Dongfang Hospital of Beijing University of Chinese Medicine

Beijing, Beijing Municipality, 100078, China

RECRUITING

Beijing Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

Daqing Oilfield General Hospital

Daqing, Heilongjiang, 163001, China

WITHDRAWN

Luohe Hospital of Chinese Medicine

Luohe, Henan, 462000, China

RECRUITING

Nanyang Traditional Chinese Medicine Hospital

Nanyang, Henan, 473000, China

RECRUITING

Wuhan Puren Hospital

Wuhan, Hubei, 430081, China

RECRUITING

Taizhou Second People's Hospital

Taizhou, Jiangsu, 225300, China

RECRUITING

Liaoyuan Hospital of Traditional Chinese Medicine

Liaoyuan, Jilin, 136200, China

RECRUITING

Affiliated Hospital of Inner Mongolia University for the Nationalities

Tongliao, Neimenggu, 028007, China

RECRUITING

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

Tianjin, Tianjin Municipality, 300193, China

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Headache; Endometriosis

Interventions

Xue-Fu-Zhu-Yu decoction

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Zhong Wang, M.D.

  Institute of Basic Chinese Medical Sciences, China Academy of Chinese Medical Sciences

  STUDY DIRECTOR

• Qing-Quan Liu, Prof.

  Beijing Hospital of Traditional Chinese Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jun Liu, PhD.

CONTACT

15010529005; franlj1104@aliyun.com

Pei-Yan Du

CONTACT

18769735071; 2570620211@qq.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 29, 2019
• First Posted: January 6, 2020
• Study Start: December 31, 2019
• Primary Completion: December 31, 2023
• Study Completion: June 30, 2024
• Last Updated: November 15, 2022

Record last verified: 2022-11

Locations

CN (12)