The Efficacy and Safety of the Xue-Fu-Zhu-Yu Capsule in Treatment of Qi Stagnation and Blood Stasis Syndrome.
Ключови думи
Резюме
Дати
Последна проверка: | 10/31/2019 |
Първо изпратено: | 03/16/2017 |
Очаквано записване подадено: | 03/23/2017 |
Първо публикувано: | 03/26/2017 |
Изпратена последна актуализация: | 11/22/2019 |
Последна актуализация публикувана: | 11/25/2019 |
Действителна начална дата на проучването: | 05/05/2017 |
Приблизителна дата на първично завършване: | 10/30/2018 |
Очаквана дата на завършване на проучването: | 12/30/2018 |
Състояние или заболяване
Интервенция / лечение
Drug: test group
Drug: control group
Фаза
Групи за ръце
Arm | Интервенция / лечение |
---|---|
Experimental: test group the patients in this group take 6 xue-fu-zhu-yu capsules once, twice a day, for 7weeks. | Drug: test group participants are given to 6 xue-fu-zhu-yu capsule per time, twice a day. The duration is 7 weeks |
Placebo Comparator: control group the patients in this group take 6 xue-fu-zhu-yu capsule simulated agents once, twice a day, for 7weeks.. | Drug: control group participants are given to 6 xue-fu-zhu-yu capsule simulated agent per time, twice a day. The duration is 7 weeks |
Критерии за допустимост
Възрасти, отговарящи на условията за проучване | 18 Years Да се 18 Years |
Полове, допустими за проучване | All |
Приема здрави доброволци | Да |
Критерии | 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. |
Резултат
Първични изходни мерки
1. The Traditional Chinese Medicine PRO Scale [baseline, 2nd,4th,6th and 7th week]
Вторични изходни мерки
1. The single symptom and sign scale of QS&BSS [baseline, 2nd,4th,6th and 7th week]
2. The pain scale of QS&BSS [baseline, 2nd,4th,6th and 7th week]
Други изходни мерки
1. safety outcome [baseline and 7th week]