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

NCT03091634 | Completed Phase 2 DMC

• 1 other identifier: HHe
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 3

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.

Conditions

Qi Stagnation and Blood Stasis Syndrome

Keywords

Xue-Fu-Zhu-Yu Capsule; Qi Stagnation and Blood Stasis syndrome; National Center for Complementary and Integrative Health

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• The single symptom and sign scale of QS&BSS

  baseline, 2nd,4th,6th and 7th week

• The pain scale of QS&BSS

  baseline, 2nd,4th,6th and 7th week

Other Outcomes (1)

• safety outcome

  baseline and 7th week

Study Arms (2)

test group

EXPERIMENTAL

the patients in this group take 6 xue-fu-zhu-yu capsules once, twice a day, for 7weeks.

Drug: xue-fu-zhu-yu capsule

control group

PLACEBO COMPARATOR

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

Interventions

xue-fu-zhu-yu capsule DRUG

participants are given to 6 xue-fu-zhu-yu capsule per time, twice a day. The duration is 7 weeks

Also known as: xue fu zhu yu capsule

test group

xue-fu-zhu-yu capsule simulated agent DRUG

participants are given to 6 xue-fu-zhu-yu capsule simulated agent per time, twice a day. The duration is 7 weeks

Also known as: simulated agent

control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The participants diagnosed as QS\&BSS;
• The age of participants is from 18 to 65;
• Participants who voluntarily signed informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guang'anmen Hospital of China Academy of Chinese Medical Sciences: lead
• China Food and Drug Administration: collaborator
• Chinese Academy of Medical Sciences: collaborator

Study Sites (3)

Guang'anmen Hospital, China Academy of Chinese Medical Sciences

Beijing, 100053, China

Location

Huguosi TCM Hospital Affiliated to Beijing University of CM

Beijing, China

Location

Wangjing Hospital, China Academy of Chinese Medical Sciences

Beijing, China

Location

Related Publications (1)

• 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.

  PMID: 30241562 DERIVED

Study Officials

• Jie Wang, professor

  Guang'anmen Hospital of China Academy of Chinese Medical Sciences

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

• Yongyan Wang, professor

  Institute of Basic Research in Clinical Medicine

  STUDY CHAIR

• Jianyuan Tang

  China Food and Drug Administration

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: master degree candidate

Study Record Dates

• First Submitted: March 17, 2017
• First Posted: March 27, 2017
• Study Start: May 6, 2017
• Primary Completion: October 31, 2018
• Study Completion: December 31, 2018
• Last Updated: November 26, 2019

Record last verified: 2019-11

Locations

CN (3)