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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 : Completed
First Posted : March 27, 2017
Last Update Posted : November 26, 2019
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

Tracking Information
First Submitted Date  ICMJE March 17, 2017
First Posted Date  ICMJE March 27, 2017
Last Update Posted Date November 26, 2019
Actual Study Start Date  ICMJE May 6, 2017
Actual Primary Completion Date October 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 24, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 24, 2017)
  • the efficacy of QS&BSS [ Time Frame: 1st, 2nd,4th,6th and 7th week ]
    if QS&BSS is still existing after the 7-week treatment, we count 1 point;if QS&BSS vanish, we count 0 point. we evaluate the efficacy according to the total score of each group.
  • the improvement of single symptom [ Time Frame: 1st, 2nd,4th,6th and 7th week ]
    the improvement of these major symptom,such as pain in a fixed position, lumps in body, irritability or depression, dim complexion, unsmooth or string-like pulse, purplish tongue or petechia in the tongue
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 24, 2017)
  • 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
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 24, 2017)
  • the patient reported outcomes of QS&BSS(PRO of QS&BSS) [ Time Frame: 1st and 7th week ]
    PRO of QS&BSS include 4 aspects of physiology, psychology, independence and social field, and 37 entries totally.
  • visual analogue scale (VAS) pain index [ Time Frame: 1st, 2nd,4th,6th and 7th week ]
    participants give a score (0-10 points) of the degree of the pain
Current Other Pre-specified Outcome Measures
 (submitted: July 24, 2017)
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)
Original Other Pre-specified Outcome Measures
 (submitted: March 24, 2017)
safety outcome [ Time Frame: 1st 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)
 
Descriptive Information
Brief Title  ICMJE The Efficacy and Safety of the Xue-Fu-Zhu-Yu Capsule in Treatment of Qi Stagnation and Blood Stasis Syndrome.
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Qi Stagnation and Blood Stasis Syndrome
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: test group
    the patients in this group take 6 xue-fu-zhu-yu capsules once, twice a day, for 7weeks.
    Intervention: Drug: 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..
    Intervention: Drug: xue-fu-zhu-yu capsule simulated agent
Publications * He H, Chen G, Gao J, Liu Y, Zhang C, Liu C, Li H, He Q, Li J, Wang J. Xue-Fu-Zhu-Yu capsule in the treatment of qi stagnation and blood stasis syndrome: a study protocol for a randomised controlled pilot and feasibility trial. Trials. 2018 Sep 21;19(1):515. doi: 10.1186/s13063-018-2908-9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 24, 2017)
120
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 31, 2018
Actual Primary Completion Date October 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03091634
Other Study ID Numbers  ICMJE HHe
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Hao-qiang He, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Study Sponsor  ICMJE Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Collaborators  ICMJE
  • China Food and Drug Administration
  • Chinese Academy of Medical Sciences
Investigators  ICMJE
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
PRS Account Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP