Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: The Efficacy and Safety of the Xu-Fu-Zhu-Yu Capsule in Treating qi Stagnation and Blood Stasis Syndrome: a Multicenter, Double-blind, Randomized and Placebo-controlled Tri
Brief Summary: This is a multicenter, double-blind, randomized and placebo-controled trial. the purpose of this trial is to evaluate the efficacy and safety of the Xu-Fu-Zhu-Yu Capsule in Treatment of Qi Stagnation and Blood Stasis syndrome(QS&BSS).QS&BSS is a group of symptoms and signs of human, 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. it's a maladjustment of our body that almost everyone would fall into this condition several times in the long period of our life. it has some potential connections with several kinds of disease, such as cardiovascular,endometriosis, fracture. Xu-Fu-Zhu-Yu capsule is a patent drug which has been approved by the China Food and Drug Administration. It derives from an ancient Chinese traditional medicine formula, which has been used to treat QS&BSS for almost 200 years. Experimental studies have shown that Xu-Fu-Zhu-Yu capsule can treat many kinds of disease, such as coronary heart disease, insomnia, headache. And, all these patients have QS&BSS. So, our research group plan this randomized controlled trial to evaluate the efficacy and safety of the Xu-Fu-Zhu-Yu Capsule in Treatment of QS&BSS. a total of 120 paticipants will be randomly allocated into either the test group or control group in a 1:1 ratio at 3 sites. All paticipants, with different kinds of disease, will be given the standard medical care according to the guidelines. Participants will undergo a 7-week treatment. the primary outcome is the efficacy of QS&BSS and the improvement of single symptom. the secondary outcome is the change in the total score of the patient reported outcomes of QS&BSS(PRO index). Safety outcomes include physical examination (temperature, respiration, heart rate, blood pressure, height and weight), complete blood cell count, urinalysis, stool examination, fecal occult blood test, liver function (alanine aminotra