The Efficacy and Safety of the Xue-Fu-Zhu-Yu Capsule in Treatment of Qi Stagnation and Blood Stasis Syndrome. (TROTEASOTXZC)
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|ClinicalTrials.gov Identifier: NCT03091634|
Recruitment Status : Completed
First Posted : March 27, 2017
Last Update Posted : November 26, 2019
|Condition or disease||Intervention/treatment||Phase|
|Qi Stagnation and Blood Stasis Syndrome||Drug: xue-fu-zhu-yu capsule Drug: xue-fu-zhu-yu capsule simulated agent||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||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|
|Actual Study Start Date :||May 6, 2017|
|Actual Primary Completion Date :||October 31, 2018|
|Actual Study Completion Date :||December 31, 2018|
Experimental: test group
the patients in this group take 6 xue-fu-zhu-yu capsules once, twice a day, for 7weeks.
Drug: xue-fu-zhu-yu capsule
participants are given to 6 xue-fu-zhu-yu capsule per time, twice a day. The duration is 7 weeks
Other Name: xue fu zhu yu capsule
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: xue-fu-zhu-yu capsule simulated agent
participants are given to 6 xue-fu-zhu-yu capsule simulated agent per time, twice a day. The duration is 7 weeks
Other Name: simulated agent
- The Traditional Chinese Medicine PRO Scale [ Time Frame: baseline, 2nd,4th,6th and 7th week ]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.
- The single symptom and sign scale of QS&BSS [ Time Frame: baseline, 2nd,4th,6th and 7th week ]Patients' single symptom and sign evaluation will use the score of the single symptom and sign scale of QS&BSS. According to the degree of symptom and sign, the score is given as no = 0; mild = 1; moderate = 2; severe = 3
- The pain scale of QS&BSS [ Time Frame: baseline, 2nd,4th,6th and 7th week ]The pain will be assessed by the score of the pain scale of QS&BSS. The total score includes visual analogue scale pain index and the score of degree, duration, and frequency of pain . The position of pain will be counted independently.
- safety outcome [ Time Frame: baseline and 7th week ]physical examination (temperature, respiration, heart rate, blood pressure, height and weight), complete blood cell count, urinalysis, stool examination, fecal occult blood test, liver function (ALT, AST, alkaline phosphatase (ALP), serum total bilirubin (STB), and γ-glutamyl transpeptidase (γ-GT)), renal function (Cr, BUN, and urine N-acetyl-β-glucosaminidase) and electrocardiogram (ECG)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03091634
|Guang'anmen Hospital, China Academy of Chinese Medical Sciences|
|Beijing, China, 100053|
|Huguosi TCM Hospital Affiliated to Beijing University of CM|
|Wangjing Hospital, China Academy of Chinese Medical Sciences|
|Study Chair:||Jie Wang, professor||Guang'anmen Hospital of China Academy of Chinese Medical Sciences|
|Principal Investigator:||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|
|Study Chair:||Yongyan Wang, professor||Institute of Basic Research in Clinical Medicine|
|Study Director:||Jianyuan Tang||China Food and Drug Administration|