- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03091634
The Efficacy and Safety of the Xue-Fu-Zhu-Yu Capsule in Treatment of Qi Stagnation and Blood Stasis Syndrome. (TROTEASOTXZC)
November 23, 2019 updated by: Hao-qiang He, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
The Efficacy and Safety of the Xue-Fu-Zhu-Yu Capsule in Treating qi Stagnation and Blood Stasis Syndrome: a Multicenter, Double-blind, Randomized and Placebo-controlled Trial
This is a multicenter, double-blind, randomized and placebo-controlled trial.
The study aims to evaluate the effectiveness and safety of Xue-Fu-Zhu-Yu Capsule (XFZYC) for Qi Stagnation and Blood Stasis syndrome (QS&BSS).
QS&BSS is one of the common Zhengs in Traditional Chinese Medicine, which manifests as various symptoms and signs, such as distending pain or tingling sensation in a fixed position, irritability or depression, dim complexion, lumps in body, blood spot under the skin, unsmooth or string-like pulse, purplish tongue or petechia in the tongue, etc.
In fact, Qi stagnation and blood stasis are common pathological conditions that would occur on human body for several times in the long period of human's life.
Besides, QS&BSS is associated with over 50 kinds of diseases including Coronary Heart Disease, hypertension, cerebral infarction, gastritis, arthritis, dysmenorrhea, chronic pelvic infection, skin disease, and cancer.
Xue-Fu-Zhu-Yu Capsule, one of Chinese herbal medicine drugs, could perform the function of promoting Qi and activating blood to relieve the symptoms of QS&BSS, which was approved by the China Food and Drug Administration in 2002.
It has been applied for QS&BSS since it was recorded in the book Correction on Errors in Medical Classics 200 years ago.
In recent years, a number of clinical trials have focused on the effectiveness and safety of XFZYC on patients with QS&BSS subtype of coronary heart disease, hyperlipidemia, ischemic cerebrovascular disease, gastritis, dysmenorrhea, and arthritis in terms of the outcomes of relevant diseases.
Our research group plan this randomized controlled trial to evaluate the effectiveness and safety of Xue-Fu-Zhu-Yu Capsule (XFZYC).
A total of 120 patients will be enrolled at the following three hospitals: (1)Guang'anmen Hospital, China Academy of Chinese Medical Sciences, (2)Huguosi TCM Hospital Affiliated to Beijing University of Chinese Medicine, (3)Wangjing Hospital, China Academy of Chinese Medical Sciences, Beijing, China.
All participants, with different kinds of disease, will receive the standard medical care according to the guidelines.
Participants will undergo a 7-week treatment.
The primary outcome is the total score of the Traditional Chinese Medicine Patient Reported Outcome (PRO) Scale in Patients of QS&BSS; the secondary outcome is the score of the single symptom and sign scale of QS&BSS and the score of the pain scale of QS&BSS on the day of enrollment, and at 2nd, 4th, 6th, 7th weeks.
Safety outcomes include physical examination (temperature, respiration, heart rate, blood pressure, height and weight); electrocardiogram (ECG); complete blood cell count; coagulation function (prothrombin time (PT), activated partial thromboplastin time (APTT), thrombin time (TT), fibrinogen (FIB), D-Dimer, INR); urinalysis; fecal occult blood test; Liver function (ALT, aspartate aminotransferase (AST), alkaline phosphatase (ALP), serum total bilirubin (STB), and γ-glutamyl transpeptidase (γ-GT)); renal function (Creatinine (Cr), blood urea nitrogen (BUN), and urine N-acetyl-β glucosaminidase) on the day of enrollment, and at 7th weeks.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
120
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Beijing, China, 100053
- Guang'anmen Hospital, China Academy of Chinese Medical Sciences
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Beijing, China
- Huguosi TCM Hospital Affiliated to Beijing University of CM
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Beijing, China
- Wangjing Hospital, China Academy of Chinese Medical Sciences
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- The participants diagnosed as QS&BSS;
- The age of participants is from 18 to 65;
- Participants who voluntarily signed informed consent.
Exclusion Criteria:
- Participants with other obvious Chinese medicine syndrome
- Participants diagnosed as acute myocardiac infarction, acute phase of cerebral infarction, aortic dissection and other critically illness;
- Participants with poor control of hypertension (systolic pressure >160 millimeters of mercury (mmHg) or diastolic blood pressure >100mmHg), severe heart failure and severe arrhythmia (atrial fibrillation, atrial flutter, ventricular tachycardia, paroxysmal II type II atrioventricular block and complete bundle branch block);
- Participants with severe primary diseases of heart, brain, liver, kidney and hematopoietic system, or liver function ALT or AST value >1.5 times of the upper limit of the normal value, or abnormal renal function;
- Depression or anxiety disorders participants;
- Pregnant or lactating women;
- Participants with nerve or mental illness, or unwilling to cooperate participants;
- Participants have performed a surgery in the past 4 weeks;
- Participants with the tendency of bleeding or abnormal value of disseminated intravascular coagulation (DIC) or International standard ratio (INR) or thrombocytopenia patients;
- Participants have joined in other trial in the past 1 month;
- Participants allergic to the test drug, or people with allergic constitution;
- Participants with aphasia which affects data collection.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: test group
the patients in this group take 6 xue-fu-zhu-yu capsules once, twice a day, for 7weeks.
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participants are given to 6 xue-fu-zhu-yu capsule per time, twice a day.
The duration is 7 weeks
Other Names:
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Placebo Comparator: control group
the patients in this group take 6 xue-fu-zhu-yu capsule simulated agents once, twice a day, for 7weeks..
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participants are given to 6 xue-fu-zhu-yu capsule simulated agent per time, twice a day.
The duration is 7 weeks
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Traditional Chinese Medicine PRO Scale
Time Frame: baseline, 2nd,4th,6th and 7th week
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The Traditional Chinese Medicine PRO scale includes physiological domain,psychological domain,independence and social domain.
And the change of the total score of the Traditional Chinese Medicine PRO Scale in Patients of QS&BSS will be assessed.
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baseline, 2nd,4th,6th and 7th week
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The single symptom and sign scale of QS&BSS
Time Frame: baseline, 2nd,4th,6th and 7th week
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Patients' single symptom and sign evaluation will use the score of the single symptom and sign scale of QS&BSS.
According to the degree of symptom and sign, the score is given as no = 0; mild = 1; moderate = 2; severe = 3
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baseline, 2nd,4th,6th and 7th week
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The pain scale of QS&BSS
Time Frame: baseline, 2nd,4th,6th and 7th week
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The pain will be assessed by the score of the pain scale of QS&BSS.
The total score includes visual analogue scale pain index and the score of degree, duration, and frequency of pain .
The position of pain will be counted independently.
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baseline, 2nd,4th,6th and 7th week
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
safety outcome
Time Frame: baseline and 7th week
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physical examination (temperature, respiration, heart rate, blood pressure, height and weight), complete blood cell count, urinalysis, stool examination, fecal occult blood test, liver function (ALT, AST, alkaline phosphatase (ALP), serum total bilirubin (STB), and γ-glutamyl transpeptidase (γ-GT)), renal function (Cr, BUN, and urine N-acetyl-β-glucosaminidase) and electrocardiogram (ECG)
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baseline and 7th week
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Chair: Jie Wang, professor, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Principal Investigator: Yu Liu, master, Huguosi TCM Hospital Affiliated to Beijing University of CM
- Principal Investigator: Chenhao Zhang, professor, Wangjing Hospital, China Academy of Chinese Medical Sciences
- Study Chair: Yongyan Wang, professor, Institute of Basic Research in Clinical Medicine
- Study Director: Jianyuan Tang, China Food and Drug Administration
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 6, 2017
Primary Completion (Actual)
October 31, 2018
Study Completion (Actual)
December 31, 2018
Study Registration Dates
First Submitted
March 17, 2017
First Submitted That Met QC Criteria
March 24, 2017
First Posted (Actual)
March 27, 2017
Study Record Updates
Last Update Posted (Actual)
November 26, 2019
Last Update Submitted That Met QC Criteria
November 23, 2019
Last Verified
November 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HHe
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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