"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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
720
treatment with 2.4g (6 capsules) of XFZY three times daily for 12 weeks.
treatment with 2.4g (6 capsules) of placebo three times daily for 12 weeks.
conventional therapy will be given according to the suffering diseases including stable coronary heart disease, chronic insomnia, headache, endometriosis.
Anqing Municipal Hospital
Anqing, Anhui, China
RECRUITINGBeijing Hospital of Traditional Chinese Medicine, Capital Medical University
Beijing, Beijing Municipality, China
RECRUITINGDongfang Hospital of Beijing University of Chinese Medicine
Beijing, Beijing Municipality, China
RECRUITINGBeijing Hospital
Beijing, Beijing Municipality, China
RECRUITINGDaqing Oilfield General Hospital
Daqing, Heilongjiang, China
WITHDRAWNLuohe Hospital of Chinese Medicine
Luohe, Henan, China
RECRUITINGNanyang Traditional Chinese Medicine Hospital
Nanyang, Henan, China
RECRUITINGWuhan Puren Hospital
Wuhan, Hubei, China
RECRUITINGTaizhou Second People's Hospital
Taizhou, Jiangsu, China
RECRUITINGLiaoyuan Hospital of Traditional Chinese Medicine
Liaoyuan, Jilin, China
RECRUITING...and 2 more locations
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
Time frame: at 12 Week
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
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
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