Chinese MedicinePhase 4NCT04218487
Xuefu-Zhuyu Capsule for the Treatment of "Qizhi Xueyu Zheng" (Qi Stagnation and Blood Stasis Syndrome)
A Phase 4 study testing Xuefu-Zhuyu Capsule and conventional therapy in people with Chinese Medicine and Stable Coronary Heart Disease, run by Zhong Wang at 12 sites in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chinese Medicine, Stable Coronary Heart Disease, Chronic Insomnia
- What is being tested?
- Xuefu-Zhuyu Capsule and conventional therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 720 participants
- Where
- 12 sitesChina
- Study dates
- 31 Dec 2019to 30 Jun 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
China12 sites, 11 recruiting
- Recruiting
Anqing Municipal Hospital
Anqing, Anhui, 230000
Qing Li, Chief Physician, 13966603027, 1224563438@qq.com
- Recruiting
Beijing Hospital of Traditional Chinese Medicine, Capital Medical University
Beijing, Beijing Municipality, 100010
Qing-Quan Liu, Prof., 86-10-52176700, liuqingquan2003@126.com
- Recruiting
Dongfang Hospital of Beijing University of Chinese Medicine
Beijing, Beijing Municipality, 100078
Yang Wu, M.D., 86-10-67689756, drwuyang@sohu.com
Yan-Xia Liu, M.D., 86-10-67689705, lyx7028@sina.com
- Recruiting
Beijing Hospital
Beijing, Beijing Municipality, 100730
Lei Lin, 86-10-85133209, 527356968@qq.com
- Withdrawn
Daqing Oilfield General Hospital
Daqing, Heilongjiang, 163001
- Recruiting
Liaoyuan Hospital of Traditional Chinese Medicine
Liaoyuan, Jilin, 136200
Hong-Wei Dai, 86-437-3333720, JLLYYHY@126.com
- Recruiting
Luohe Hospital of Chinese Medicine
Luohe, Henan, 462000
Bao-Shen Wang, 86-395-2512166, lhszyy63480@163.com
- Recruiting
Nanyang Traditional Chinese Medicine Hospital
Nanyang, Henan, 473000
Xiao-Qing Wang, 86-377-63869708, 13837786060@163.com
- Recruiting
Taizhou Second People's Hospital
Taizhou, Jiangsu, 225300
Li-Dong Ding, 86-523-88112601, jsjydld@163.com
- Recruiting
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Tianjin, Tianjin Municipality, 300193
Xian-Liang Wang, 86-22-27986333, xlwang1981@126.com
- Recruiting
Affiliated Hospital of Inner Mongolia University for the Nationalities
Tongliao, Neimenggu, 028007
Yu Gen, 86-475-8214402, genyu2009@126.com
- Recruiting
Wuhan Puren Hospital
Wuhan, Hubei, 430081
Xiao-Jun Hu, 86-27-86360143, 493505911@qq.com
About this study
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
"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
- Being tested
- Xuefu-Zhuyu Capsule, placebo, conventional therapy
- Keywords
- Adaptive design, Qizhi Xueyu Zheng, Enrichment design
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Headache, Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xuefu-Zhuyu CapsuleDrug
treatment with 2.4g (6 capsules) of XFZY three times daily for 12 weeks.
placeboDrug
treatment with 2.4g (6 capsules) of placebo three times daily for 12 weeks.
conventional therapyOther
conventional therapy will be given according to the suffering diseases including stable coronary heart disease, chronic insomnia, headache, endometriosis.
| Study group | Role | What they receive |
|---|---|---|
| XFZY group | Experimental | 2.4g (6 capsules) three times daily for 12 weeks Receives: Drug: Xuefu-Zhuyu Capsule; Other: conventional therapy |
| Control group | Placebo comparator | 2.4g (6 capsules) three times daily for 12 weeks Receives: Drug: placebo; Other: conventional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at 12 Week
Secondary outcomes (7)
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.
Measured: Baseline，4，8，12 Week
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.
Measured: Baseline，4，8，12 Week
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.
Measured: Baseline，4，8，12 Week
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.
Measured: Baseline，4，8，12 Week
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).
Measured: Baseline，4，8，12 Week
Level of the 5-hydroxytryptamine(5-HT)
Measured: Baseline，4，8，12 Week
Level of the high-sensitivity C-reactive protein
Measured: Baseline，4，8，12 Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2020
- Study start31 Dec 2019
- Primary completion31 Dec 2023 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chinese MedicineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 720 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhong Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhong Wang, China Academy of Chinese Medical Sciences
- Investigators
- Zhong Wang, M.D., Study director, Institute of Basic Chinese Medical Sciences, China Academy of Chinese Medical SciencesQing-Quan Liu, Prof., Principal investigator, Beijing Hospital of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04218487
- Sponsor's protocol ID
- XFZY-V3.0
- Status last verified
- Nov 2022
- First submitted
- 29 Dec 2019
- Last updated
- 15 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04218487
- Acronym / sponsor ID
- XFZY-V3.0
- Conditions
- Chinese Medicine, Stable Coronary Heart Disease, Chronic Insomnia, Headache, Endometriosis
- Keywords
- Adaptive design, Qizhi Xueyu Zheng, Enrichment design
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 720 participants (estimated)
- Lead sponsor
- Zhong WangUniversity, hospital or other
- Study start
- 31 Dec 2019 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 6 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
"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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| XFZY group | Experimental | Drug: Xuefu-Zhuyu Capsule, Other: conventional therapy2.4g (6 capsules) three times daily for 12 weeks |
| Control group | Placebo comparator | Drug: placebo, Other: conventional therapy2.4g (6 capsules) three times daily for 12 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
- Patients were ≥18 and ≤75 years of age.
- Voluntarily provided written informed consent.
Key exclusion criteria (17 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Xuefu-Zhuyu Capsuletreatment with 2.4g (6 capsules) of XFZY three times daily for 12 weeks. | Drug | XFZY group |
| placebotreatment with 2.4g (6 capsules) of placebo three times daily for 12 weeks. | Drug | Control group |
| conventional therapyconventional therapy will be given according to the suffering diseases including stable coronary heart disease, chronic insomnia, headache, endometriosis. | Other | Control group, XFZY group |
Primary outcome
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
7 secondary outcomes
The single symptom and sign scale of Qizhi Xueyu Zheng
Time frame: Baseline，4，8，12 Week
The pain scale Qizhi Xueyu Zheng
Time frame: Baseline，4，8，12 Week
Self-rating anxiety scale (SAS)
Time frame: Baseline，4，8，12 Week
Self-rating depression scale (SDS)
Time frame: Baseline，4，8，12 Week
SF-36 Quality of Life Scale
Time frame: Baseline，4，8，12 Week
Level of the 5-hydroxytryptamine(5-HT)
Time frame: Baseline，4，8，12 Week
Level of the high-sensitivity C-reactive protein
Time frame: Baseline，4，8，12 Week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhong Wang, M.D. study director
Institute of Basic Chinese Medical Sciences, China Academy of Chinese Medical Sciences
Qing-Quan Liu, Prof. principal investigator
Beijing Hospital of Traditional Chinese Medicine
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Xuefu-Zhuyu Capsule and conventional therapy in people with Chinese Medicine and Stable Coronary Heart Disease, run by Zhong Wang at 12 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jun Liu, PhD. (15010529005, franlj1104@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2022.