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"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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| XFZY group | Experimental | 2.4g (6 capsules) three times daily for 12 weeks |
|
| Control group | Placebo Comparator | 2.4g (6 capsules) three times daily for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xuefu-Zhuyu Capsule | Drug | treatment with 2.4g (6 capsules) of XFZY three times daily for 12 weeks. |
|
| 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) | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline,4,8,12 Week |
| The pain scale Qizhi Xueyu Zheng |
| Measure | Description | Time Frame |
|---|---|---|
| The changes of the expression files on the RNA level via the RNA sequencing in 120 patients | 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 |
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:
Patients were ≥18 and ≤75 years of age.
Voluntarily provided written informed consent.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jun Liu, PhD. | Contact | 15010529005 | franlj1104@aliyun.com | |
| Pei-Yan Du | Contact | 18769735071 | 2570620211@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anqing Municipal Hospital | Recruiting | Anqing | Anhui | 230000 | China |
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| placebo | Drug | treatment with 2.4g (6 capsules) of placebo three times daily for 12 weeks. |
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| conventional therapy | Other | conventional therapy will be given according to the suffering diseases including stable coronary heart disease, chronic insomnia, headache, endometriosis. |
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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) | 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) | 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 | 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) | Baseline,4,8,12 Week |
| Level of the high-sensitivity C-reactive protein | 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 | 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 |
| Beijing Hospital of Traditional Chinese Medicine, Capital Medical University | Recruiting | Beijing | Beijing Municipality | 100010 | China |
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| Dongfang Hospital of Beijing University of Chinese Medicine | Recruiting | Beijing | Beijing Municipality | 100078 | China |
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| Beijing Hospital | Recruiting | Beijing | Beijing Municipality | 100730 | China |
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| Daqing Oilfield General Hospital | Withdrawn | Daqing | Heilongjiang | 163001 | China |
| Luohe Hospital of Chinese Medicine | Recruiting | Luohe | Henan | 462000 | China |
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| Nanyang Traditional Chinese Medicine Hospital | Recruiting | Nanyang | Henan | 473000 | China |
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| Wuhan Puren Hospital | Recruiting | Wuhan | Hubei | 430081 | China |
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| Taizhou Second People's Hospital | Recruiting | Taizhou | Jiangsu | 225300 | China |
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| Liaoyuan Hospital of Traditional Chinese Medicine | Recruiting | Liaoyuan | Jilin | 136200 | China |
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| Affiliated Hospital of Inner Mongolia University for the Nationalities | Recruiting | Tongliao | Neimenggu | 028007 | China |
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| First Teaching Hospital of Tianjin University of Traditional Chinese Medicine | Recruiting | Tianjin | Tianjin Municipality | 300193 | China |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| D006261 | Headache |
| D004715 | Endometriosis |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| C513826 | Xue-Fu-Zhu-Yu decoction |
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