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The Efficacy and Safety of the Xue-Fu-Zhu-Yu Capsule in Treatment of Qi Stagnation and Blood Stasis Syndrome. (TROTEASOTXZC)

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ClinicalTrials.gov Identifier: NCT03091634
Recruitment Status : Recruiting
First Posted : March 27, 2017
Last Update Posted : August 14, 2018
Sponsor:
Collaborators:
China Food and Drug Administration
Chinese Academy of Medical Sciences
Information provided by (Responsible Party):
Hao-qiang He, Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Qi Stagnation and Blood Stasis Syndrome Drug: xue-fu-zhu-yu capsule Drug: xue-fu-zhu-yu capsule simulated agent Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : May 6, 2017
Estimated Primary Completion Date : November 1, 2018
Estimated Study Completion Date : December 1, 2018

Arm Intervention/treatment
Experimental: test group
the patients in this group take 6 xue-fu-zhu-yu capsules once, twice a day, for 7weeks.
Drug: xue-fu-zhu-yu capsule
participants are given to 6 xue-fu-zhu-yu capsule per time, twice a day. The duration is 7 weeks
Other Name: xue fu zhu yu capsule

Placebo Comparator: control group
the patients in this group take 6 xue-fu-zhu-yu capsule simulated agents once, twice a day, for 7weeks..
Drug: xue-fu-zhu-yu capsule simulated agent
participants are given to 6 xue-fu-zhu-yu capsule simulated agent per time, twice a day. The duration is 7 weeks
Other Name: simulated agent




Primary Outcome Measures :
  1. The Traditional Chinese Medicine PRO Scale [ Time Frame: baseline, 2nd,4th,6th and 7th week ]
    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.


Secondary Outcome Measures :
  1. The single symptom and sign scale of QS&BSS [ Time Frame: baseline, 2nd,4th,6th and 7th week ]
    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

  2. The pain scale of QS&BSS [ Time Frame: baseline, 2nd,4th,6th and 7th week ]
    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.


Other Outcome Measures:
  1. safety outcome [ Time Frame: baseline and 7th week ]
    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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03091634


Contacts
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Contact: Jie Wang, professor 8610-88001817 wangjie0103@126.com
Contact: Haoqiang He, master 8610-88001817 MyStrong@bucm.edu.cn

Locations
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China
Guang'anmen Hospital, China Academy of Chinese Medical Sciences Recruiting
Beijing, China, 100053
Contact: Jie Wang, professor    8610-88001817    wangjie0103@126.com   
Contact: Haoqiang He, master    8610-88001817    MyStrong@bucm.edu.cn   
Sub-Investigator: Jie Wang, professor         
Sub-Investigator: Haoqiang He, master         
Sub-Investigator: Guang Chen, doctor         
Sub-Investigator: Jialiang Gao, doctor         
Sub-Investigator: Qingyong He, professor         
Huguosi TCM Hospital Affiliated to Beijing University of CM Recruiting
Beijing, China
Contact: Yu Liu, master    0086-13810113116      
Principal Investigator: Yu Liu, master         
Wangjing Hospital, China Academy of Chinese Medical Sciences Recruiting
Beijing, China
Contact: Chenhao Zhang, professor    0086-13671393316      
Principal Investigator: Chenhao Zhang, professor         
Sponsors and Collaborators
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
China Food and Drug Administration
Chinese Academy of Medical Sciences
Investigators
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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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hao-qiang He, master degree candidate, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier: NCT03091634     History of Changes
Other Study ID Numbers: HHe
First Posted: March 27, 2017    Key Record Dates
Last Update Posted: August 14, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hao-qiang He, Guang'anmen Hospital of China Academy of Chinese Medical Sciences:
Xue-Fu-Zhu-Yu Capsule
Qi Stagnation and Blood Stasis syndrome
National Center for Complementary and Integrative Health

Additional relevant MeSH terms:
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Syndrome
Blind Loop Syndrome
Disease
Pathologic Processes
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases