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

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.