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

November 14, 2022 updated by: Zhong Wang

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

"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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

720

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Anhui
      • Anqing, Anhui, China, 230000
        • Recruiting
        • Anqing Municipal Hospital
        • Contact:
    • Beijing
      • Beijing, Beijing, China, 100730
        • Recruiting
        • Beijing Hospital
        • Contact:
      • Beijing, Beijing, China, 100010
        • Recruiting
        • Beijing Hospital of Traditional Chinese Medicine, Capital Medical University
        • Contact:
      • Beijing, Beijing, China, 100078
        • Recruiting
        • Dongfang Hospital of Beijing University of Chinese Medicine
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yang Wu, M.D.
        • Principal Investigator:
          • Yan-Xia Liu, M.D.
    • Heilongjiang
      • Daqing, Heilongjiang, China, 163001
        • Withdrawn
        • Daqing Oilfield General Hospital
    • Henan
      • Luohe, Henan, China, 462000
        • Recruiting
        • Luohe Hospital of Chinese Medicine
        • Contact:
      • Nanyang, Henan, China, 473000
        • Recruiting
        • Nanyang Traditional Chinese Medicine Hospital
        • Contact:
    • Hubei
      • Wuhan, Hubei, China, 430081
        • Recruiting
        • Wuhan Puren Hospital
        • Contact:
    • Jiangsu
      • Taizhou, Jiangsu, China, 225300
        • Recruiting
        • Taizhou Second People's Hospital
        • Contact:
    • Jilin
      • Liaoyuan, Jilin, China, 136200
        • Recruiting
        • Liaoyuan Hospital of Traditional Chinese Medicine
        • Contact:
    • Neimenggu
      • Tongliao, Neimenggu, China, 028007
        • Recruiting
        • Affiliated Hospital of Inner Mongolia University for the Nationalities
        • Contact:
    • Tianjin
      • Tianjin, Tianjin, China, 300193
        • Recruiting
        • First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: XFZY group
2.4g (6 capsules) three times daily for 12 weeks
Drug: Xuefu-Zhuyu Capsule
treatment with 2.4g (6 capsules) of XFZY three times daily for 12 weeks.
Other: conventional therapy
conventional therapy will be given according to the suffering diseases including stable coronary heart disease, chronic insomnia, headache, endometriosis.
PLACEBO_COMPARATOR: Control group
2.4g (6 capsules) three times daily for 12 weeks
Other: conventional therapy
conventional therapy will be given according to the suffering diseases including stable coronary heart disease, chronic insomnia, headache, endometriosis.
Drug: placebo
treatment with 2.4g (6 capsules) of placebo three times daily for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline the Chinese Medicine patient-reported-outcome scale in patients with Qizhi-Xueyu-Zheng (Qizhi-Xueyu-Zheng PRO Scale)
Time Frame: 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
at 12 Week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The single symptom and sign scale of Qizhi Xueyu Zheng
Time Frame: Baseline，4，8，12 Week
According to the degree of symptoms and signs, the score will be assigned as follows: no = 0; mild = 1; moderate = 2; or severe = 3.
Baseline，4，8，12 Week
The pain scale Qizhi Xueyu Zheng
Time Frame: Baseline，4，8，12 Week
The total score includes a visual analogue scale pain index and the score of degree, duration, and frequency of pain. The location of the pain will be recorded independently. The total score ranges from 0 to 19, higher score indicating severer pain.
Baseline，4，8，12 Week
Self-rating anxiety scale (SAS)
Time Frame: Baseline，4，8，12 Week
The SAS scale consists of 20 items each which were scored from 1 to 4. The final score was calculated as the summation of all of the items which was then multiplied by a factor of 1.25. The score ranged from 50-59 indicates mild anxiety；The score from 60-69 indicates moderate anxiety；The score from 60-69 indicates severe anxiety.
Baseline，4，8，12 Week
Self-rating depression scale (SDS)
Time Frame: Baseline，4，8，12 Week
The SDS scale consists of 20 items each which were scored from 1 to 4. The final score was calculated as the summation of all of the items which was then multiplied by a factor of 1.25. The score ranged from 50-59 indicates mild depression；The score from 60-69 indicates moderate depression；The score from 60-69 indicates severe depression.
Baseline，4，8，12 Week
SF-36 Quality of Life Scale
Time Frame: Baseline，4，8，12 Week
SF-36 Quality of Life Scale is used to assess the health-related quality of life of patients, which is a multi-purpose, short-form health survey with 36 items. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary scores and a preference-based health utility index. The SF-36 consists of items: assessing physical functioning (PF-10 items),social functioning (SF-2 items), role limitation due to physical health (RP-4 items),bodily pain (BP-2 items),mental health (MH-5 items),role limitations due to emotional health (RE-3 items),vitality (VT-4 items);general health perceptions (GH-5 items);reported health transition (1 item).
Baseline，4，8，12 Week
Level of the 5-hydroxytryptamine(5-HT)
Time Frame: Baseline，4，8，12 Week
Baseline，4，8，12 Week
Level of the high-sensitivity C-reactive protein
Time Frame: Baseline，4，8，12 Week
Baseline，4，8，12 Week

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
The changes of the expression files on the RNA level via the RNA sequencing in 120 patients
Time Frame: Baseline，4，8，12 Week
Using the nested case-control study，60 patients with effective effect and the paired 60 patients in the control group will be taken with RNA sequencing.
Baseline，4，8，12 Week
The changes of the expression files on the protein level via the quantitative proteomics in 120 patients
Time Frame: Baseline，4，8，12 Week
Using the nested case-control study，60 patients with effective effect and the paired 60 patients in the control group will be taken with quantitative proteomics.
Baseline，4，8，12 Week
The changes of Metabolomics profile in 120 patients
Time Frame: Baseline，4，8，12 Week
Using the nested case-control study，60 patients with effective effect and the paired 60 patients in the control group will be taken with metabolomics.
Baseline，4，8，12 Week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhong Wang

Investigators

  • Study Director: Zhong Wang, M.D., Institute of Basic Chinese Medical Sciences, China Academy of Chinese Medical Sciences
  • Principal Investigator: Qing-Quan Liu, Prof., Beijing Hospital of Traditional Chinese Medicine, Capital Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 31, 2019

Primary Completion (ANTICIPATED)

December 31, 2023

Study Completion (ANTICIPATED)

June 30, 2024

Study Registration Dates

First Submitted

December 29, 2019

First Submitted That Met QC Criteria

January 2, 2020

First Posted (ACTUAL)

January 6, 2020

Study Record Updates

Last Update Posted (ACTUAL)

November 15, 2022

Last Update Submitted That Met QC Criteria

November 14, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XFZY-V3.0

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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