Xuefu-Zhuyu Capsule for the Treatment of "Qizhi Xueyu Zheng" (Qi Stagnation and Blood Stasis Syndrome)
Primary Purpose
Chinese Medicine, Stable Coronary Heart Disease, Chronic Insomnia
Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Xuefu-Zhuyu Capsule
placebo
conventional therapy
Sponsored by
About this trial
This is an interventional treatment trial for Chinese Medicine focused on measuring Adaptive design, Qizhi Xueyu Zheng, Enrichment design
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.
Sites / Locations
- Anqing Municipal HospitalRecruiting
- Beijing Hospital of Traditional Chinese Medicine, Capital Medical UniversityRecruiting
- Dongfang Hospital of Beijing University of Chinese MedicineRecruiting
- Beijing HospitalRecruiting
- Daqing Oilfield General Hospital
- Luohe Hospital of Chinese MedicineRecruiting
- Nanyang Traditional Chinese Medicine HospitalRecruiting
- Wuhan Puren HospitalRecruiting
- Taizhou Second People's HospitalRecruiting
- Liaoyuan Hospital of Traditional Chinese MedicineRecruiting
- Affiliated Hospital of Inner Mongolia University for the NationalitiesRecruiting
- First Teaching Hospital of Tianjin University of Traditional Chinese MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
XFZY group
Control group
Arm Description
2.4g (6 capsules) three times daily for 12 weeks
2.4g (6 capsules) three times daily for 12 weeks
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
The single symptom and sign scale of Qizhi Xueyu Zheng
According to the degree of symptoms and signs, the score will be assigned as follows: no = 0; mild = 1; moderate = 2; or severe = 3.
The pain scale Qizhi Xueyu Zheng
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.
Self-rating anxiety scale (SAS)
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.
Self-rating depression scale (SDS)
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.
SF-36 Quality of Life Scale
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).
Level of the 5-hydroxytryptamine(5-HT)
Level of the high-sensitivity C-reactive protein
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04218487
Brief Title
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
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 31, 2019 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Zhong Wang
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chinese Medicine, Stable Coronary Heart Disease, Chronic Insomnia, Headache, Endometriosis
Keywords
Adaptive design, Qizhi Xueyu Zheng, Enrichment design
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
720 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
XFZY group
Arm Type
Experimental
Arm Description
2.4g (6 capsules) three times daily for 12 weeks
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
2.4g (6 capsules) three times daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Xuefu-Zhuyu Capsule
Intervention Description
treatment with 2.4g (6 capsules) of XFZY three times daily for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
treatment with 2.4g (6 capsules) of placebo three times daily for 12 weeks.
Intervention Type
Other
Intervention Name(s)
conventional therapy
Intervention Description
conventional therapy will be given according to the suffering diseases including stable coronary heart disease, chronic insomnia, headache, endometriosis.
Primary Outcome Measure Information:
Title
Change from baseline the Chinese Medicine patient-reported-outcome scale in patients with Qizhi-Xueyu-Zheng (Qizhi-Xueyu-Zheng PRO Scale)
Description
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
Time Frame
at 12 Week
Secondary Outcome Measure Information:
Title
The single symptom and sign scale of Qizhi Xueyu Zheng
Description
According to the degree of symptoms and signs, the score will be assigned as follows: no = 0; mild = 1; moderate = 2; or severe = 3.
Time Frame
Baseline,4,8,12 Week
Title
The pain scale Qizhi Xueyu Zheng
Description
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.
Time Frame
Baseline,4,8,12 Week
Title
Self-rating anxiety scale (SAS)
Description
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.
Time Frame
Baseline,4,8,12 Week
Title
Self-rating depression scale (SDS)
Description
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.
Time Frame
Baseline,4,8,12 Week
Title
SF-36 Quality of Life Scale
Description
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).
Time Frame
Baseline,4,8,12 Week
Title
Level of the 5-hydroxytryptamine(5-HT)
Time Frame
Baseline,4,8,12 Week
Title
Level of the high-sensitivity C-reactive protein
Time Frame
Baseline,4,8,12 Week
Other Pre-specified Outcome Measures:
Title
The changes of the expression files on the RNA level via the RNA sequencing in 120 patients
Description
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.
Time Frame
Baseline,4,8,12 Week
Title
The changes of the expression files on the protein level via the quantitative proteomics in 120 patients
Description
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.
Time Frame
Baseline,4,8,12 Week
Title
The changes of Metabolomics profile in 120 patients
Description
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.
Time Frame
Baseline,4,8,12 Week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jun Liu, PhD.
Phone
15010529005
Email
franlj1104@aliyun.com
First Name & Middle Initial & Last Name or Official Title & Degree
Pei-Yan Du
Phone
18769735071
Email
2570620211@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhong Wang, M.D.
Organizational Affiliation
Institute of Basic Chinese Medical Sciences, China Academy of Chinese Medical Sciences
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Qing-Quan Liu, Prof.
Organizational Affiliation
Beijing Hospital of Traditional Chinese Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Anqing Municipal Hospital
City
Anqing
State/Province
Anhui
ZIP/Postal Code
230000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qing Li, Chief Physician
Phone
13966603027
Email
1224563438@qq.com
Facility Name
Beijing Hospital of Traditional Chinese Medicine, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100010
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qing-Quan Liu, Prof.
Phone
86-10-52176700
Email
liuqingquan2003@126.com
Facility Name
Dongfang Hospital of Beijing University of Chinese Medicine
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100078
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yang Wu, M.D.
Phone
86-10-67689756
Email
drwuyang@sohu.com
First Name & Middle Initial & Last Name & Degree
Yan-Xia Liu, M.D.
Phone
86-10-67689705
Email
lyx7028@sina.com
First Name & Middle Initial & Last Name & Degree
Yang Wu, M.D.
First Name & Middle Initial & Last Name & Degree
Yan-Xia Liu, M.D.
Facility Name
Beijing Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lei Lin
Phone
86-10-85133209
Email
527356968@qq.com
Facility Name
Daqing Oilfield General Hospital
City
Daqing
State/Province
Heilongjiang
ZIP/Postal Code
163001
Country
China
Individual Site Status
Withdrawn
Facility Name
Luohe Hospital of Chinese Medicine
City
Luohe
State/Province
Henan
ZIP/Postal Code
462000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bao-Shen Wang
Phone
86-395-2512166
Email
lhszyy63480@163.com
Facility Name
Nanyang Traditional Chinese Medicine Hospital
City
Nanyang
State/Province
Henan
ZIP/Postal Code
473000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiao-Qing Wang
Phone
86-377-63869708
Email
13837786060@163.com
Facility Name
Wuhan Puren Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430081
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiao-Jun Hu
Phone
86-27-86360143
Email
493505911@qq.com
Facility Name
Taizhou Second People's Hospital
City
Taizhou
State/Province
Jiangsu
ZIP/Postal Code
225300
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li-Dong Ding
Phone
86-523-88112601
Email
jsjydld@163.com
Facility Name
Liaoyuan Hospital of Traditional Chinese Medicine
City
Liaoyuan
State/Province
Jilin
ZIP/Postal Code
136200
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hong-Wei Dai
Phone
86-437-3333720
Email
JLLYYHY@126.com
Facility Name
Affiliated Hospital of Inner Mongolia University for the Nationalities
City
Tongliao
State/Province
Neimenggu
ZIP/Postal Code
028007
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yu Gen
Phone
86-475-8214402
Email
genyu2009@126.com
Facility Name
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300193
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xian-Liang Wang
Phone
86-22-27986333
Email
xlwang1981@126.com
12. IPD Sharing Statement
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Xuefu-Zhuyu Capsule for the Treatment of "Qizhi Xueyu Zheng" (Qi Stagnation and Blood Stasis Syndrome)
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