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

Qi Stagnation and Blood Stasis Syndrome Clinical Trial

— TROTEASOTXZC  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03091634
• Other study ID #: HHe
• Status: Completed
• Phase: Phase 2
• Start date: May 6, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: November 2019
• Source: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 31, 2018
• Est. primary completion date: October 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Blind Loop Syndrome
• Qi Stagnation and Blood Stasis Syndrome
• Syndrome

Intervention

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
• 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

Locations

Country	Name	City	State
China	Guang'anmen Hospital, China Academy of Chinese Medical Sciences	Beijing
China	Huguosi TCM Hospital Affiliated to Beijing University of CM	Beijing
China	Wangjing Hospital, China Academy of Chinese Medical Sciences	Beijing

Sponsors (3)

Lead Sponsor	Collaborator
Guang'anmen Hospital of China Academy of Chinese Medical Sciences	China Food and Drug Administration, Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	safety outcome	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 ?-glutamyl transpeptidase (?-GT)), renal function (Cr, BUN, and urine N-acetyl-ß-glucosaminidase) and electrocardiogram (ECG)	baseline and 7th week
Primary	The Traditional Chinese Medicine PRO Scale	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.	baseline, 2nd,4th,6th and 7th week
Secondary	The single symptom and sign scale of QS&BSS	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	baseline, 2nd,4th,6th and 7th week
Secondary	The pain scale of QS&BSS	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.	baseline, 2nd,4th,6th and 7th week