The Efficacy and Safety of the Xue-Fu-Zhu-Yu Capsule in Treatment of Qi Stagnation and Blood Stasis Syndrome.
Condition: Qi Stagnation and Blood Stasis Syndrome
MeSH terms: Blind Loop Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

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.
    


Intervention name(s): xue-fu-zhu-yu capsule; xue-fu-zhu-yu capsule simulated agent
Intervention type(s): Drug; Drug
Intervention description(s): participants are given to 6 xue-fu-zhu-yu capsule per time, twice a day. The duration is 7 weeks; participants are given to 6 xue-fu-zhu-yu capsule simulated agent per time, twice a day. The duration is 7 weeks
Other intervention name(s): xue fu zhu yu capsule; simulated agent
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Xue-Fu-Zhu-Yu Capsule; Qi Stagnation and Blood Stasis syndrome; National Center for Complementary and Integrative Health