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

Endometriosis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04218487
• Other study ID #: XFZY-V3.0
• Status: Recruiting
• Phase: Phase 4
• Start date: December 31, 2019
• Est. completion date: June 30, 2024

Study information

• Verified date: November 2022
• Source: China Academy of Chinese Medical Sciences
• Contact: Jun Liu, PhD.
• Phone: 15010529005
• Email: franlj1104[@]aliyun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 720
• Est. completion date: June 30, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Blind Loop Syndrome
• Chinese Medicine
• Chronic Insomnia
• Coronary Artery Disease
• Coronary Disease
• Endometriosis
• Headache
• Heart Diseases
• Myocardial Ischemia
• Sleep Initiation and Maintenance Disorders
• Stable Coronary Heart Disease

Intervention

Drug:
• Xuefu-Zhuyu Capsule
treatment with 2.4g (6 capsules) of XFZY three times daily for 12 weeks.
• placebo
treatment with 2.4g (6 capsules) of placebo 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.

Locations

Country	Name	City	State
China	Anqing Municipal Hospital	Anqing	Anhui
China	Beijing Hospital	Beijing	Beijing
China	Beijing Hospital of Traditional Chinese Medicine, Capital Medical University	Beijing	Beijing
China	Dongfang Hospital of Beijing University of Chinese Medicine	Beijing	Beijing
China	Daqing Oilfield General Hospital	Daqing	Heilongjiang
China	Liaoyuan Hospital of Traditional Chinese Medicine	Liaoyuan	Jilin
China	Luohe Hospital of Chinese Medicine	Luohe	Henan
China	Nanyang Traditional Chinese Medicine Hospital	Nanyang	Henan
China	Taizhou Second People's Hospital	Taizhou	Jiangsu
China	First Teaching Hospital of Tianjin University of Traditional Chinese Medicine	Tianjin	Tianjin
China	Affiliated Hospital of Inner Mongolia University for the Nationalities	Tongliao	Neimenggu
China	Wuhan Puren Hospital	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Zhong Wang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	The changes of the expression files on the protein level via the quantitative proteomics 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 quantitative proteomics.	Baseline,4,8,12 Week
Other	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
Primary	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
Secondary	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
Secondary	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.	Baseline,4,8,12 Week
Secondary	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
Secondary	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
Secondary	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
Secondary	Level of the 5-hydroxytryptamine(5-HT)		Baseline,4,8,12 Week
Secondary	Level of the high-sensitivity C-reactive protein		Baseline,4,8,12 Week