Qi Stagnation and Blood Stasis SyndromePhase 2TROTEASOTXZCNCT03091634
The Efficacy and Safety of the Xue-Fu-Zhu-Yu Capsule in Treatment of Qi Stagnation and Blood Stasis Syndrome.
A Phase 2 study testing xue-fu-zhu-yu capsule and xue-fu-zhu-yu capsule simulated agent in people with Qi Stagnation and Blood Stasis Syndrome, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 3 sites in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Qi Stagnation and Blood Stasis Syndrome
- What is being tested?
- xue-fu-zhu-yu capsule and xue-fu-zhu-yu capsule simulated agent
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 3 sitesChina
- Study dates
- 6 May 2017to 31 Dec 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The participants diagnosed as QS\&BSS;
- The age of participants is from 18 to 65;
- Participants who voluntarily signed informed consent.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
3 sites in 1 country.
China3 sites
Guang'anmen Hospital, China Academy of Chinese Medical Sciences
Beijing, 100053
Huguosi TCM Hospital Affiliated to Beijing University of CM
Beijing
Wangjing Hospital, China Academy of Chinese Medical Sciences
Beijing
About this study
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
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.
- Conditions
- Qi Stagnation and Blood Stasis Syndrome
- Being tested
- xue-fu-zhu-yu capsule, xue-fu-zhu-yu capsule simulated agent
- Keywords
- Xue-Fu-Zhu-Yu Capsule, Qi Stagnation and Blood Stasis syndrome, National Center for Complementary and Integrative Health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
xue-fu-zhu-yu capsuleDrug
Also called 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
xue-fu-zhu-yu capsule simulated agentDrug
Also called simulated agent
participants are given to 6 xue-fu-zhu-yu capsule simulated agent per time, twice a day. The duration is 7 weeks
| Study group | Role | What they receive |
|---|---|---|
| test group | Experimental | the patients in this group take 6 xue-fu-zhu-yu capsules once, twice a day, for 7weeks. Receives: Drug: xue-fu-zhu-yu capsule |
| control group | Placebo comparator | the patients in this group take 6 xue-fu-zhu-yu capsule simulated agents once, twice a day, for 7weeks.. Receives: Drug: xue-fu-zhu-yu capsule simulated agent |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Traditional Chinese Medicine PRO Scale
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.
Measured: baseline, 2nd,4th,6th and 7th week
Secondary outcomes (2)
The single symptom and sign scale of QS&BSS
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
Measured: baseline, 2nd,4th,6th and 7th week
The pain scale of QS&BSS
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.
Measured: baseline, 2nd,4th,6th and 7th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2017
- Study start6 May 2017
- Primary completion31 Oct 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Qi Stagnation and Blood Stasis SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- China Food and Drug Administration, Chinese Academy of Medical Sciences
- Responsible party
- Principal investigator, Hao-qiang He, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Investigators
- Jie Wang, professor, Study chair, Guang'anmen Hospital of China Academy of Chinese Medical SciencesYu Liu, master, Principal investigator, Huguosi TCM Hospital Affiliated to Beijing University of CMChenhao Zhang, professor, Principal investigator, Wangjing Hospital, China Academy of Chinese Medical SciencesYongyan Wang, professor, Study chair, Institute of Basic Research in Clinical MedicineJianyuan Tang, Study director, China Food and Drug Administration
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03091634
- Sponsor's protocol ID
- HHe
- Acronym
- TROTEASOTXZC
- Status last verified
- Nov 2019
- First submitted
- 17 Mar 2017
- Last updated
- 26 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
He H, Chen G, Gao J, Liu Y, Zhang C, Liu C, Li H, He Q, Li J, Wang J. Xue-Fu-Zhu-Yu capsule in the treatment of qi stagnation and blood stasis syndrome: a study protocol for a randomised controlled pilot and feasibility trial. Trials. 2018 Sep 21;19(1):515. doi: 10.1186/s13063-018-2908-9.
PubMed 30241562
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03091634
- Acronym / sponsor ID
- TROTEASOTXZC / HHe
- Conditions
- Qi Stagnation and Blood Stasis Syndrome
- Keywords
- Xue-Fu-Zhu-Yu Capsule, Qi Stagnation and Blood Stasis syndrome, National Center for Complementary and Integrative Health
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- Collaborators
- China Food and Drug Administration, Chinese Academy of Medical Sciences
- Study start
- 6 May 2017 (actual)
- Primary completion
- 31 Oct 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 27 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| test group | Experimental | Drug: xue-fu-zhu-yu capsulethe patients in this group take 6 xue-fu-zhu-yu capsules once, twice a day, for 7weeks. |
| control group | Placebo comparator | Drug: xue-fu-zhu-yu capsule simulated agentthe patients in this group take 6 xue-fu-zhu-yu capsule simulated agents once, twice a day, for 7weeks.. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The participants diagnosed as QS\&BSS;
- The age of participants is from 18 to 65;
- Participants who voluntarily signed informed consent.
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| xue-fu-zhu-yu capsuleAlso: xue fu zhu yu capsuleparticipants are given to 6 xue-fu-zhu-yu capsule per time, twice a day. The duration is 7 weeks | Drug | test group |
| xue-fu-zhu-yu capsule simulated agentAlso: simulated agentparticipants are given to 6 xue-fu-zhu-yu capsule simulated agent per time, twice a day. The duration is 7 weeks | Drug | control group |
Primary outcome
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.
2 secondary outcomes
The single symptom and sign scale of QS&BSS
Time frame: baseline, 2nd,4th,6th and 7th week
The pain scale of QS&BSS
Time frame: baseline, 2nd,4th,6th and 7th week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2019.
- Derived from this study: PubMed 30241562He H, Chen G, Gao J, Liu Y, Zhang C, Liu C, Li H, He Q, Li J, Wang J. Xue-Fu-Zhu-Yu capsule in the treatment of qi stagnation and blood stasis syndrome: a study protocol for a randomised controlled pilot and feasibility trial. Trials. 2018 Sep 21;19(1):515. doi: 10.1186/s13063-018-2908-9.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jie Wang, professor study chair
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Yu Liu, master principal investigator
Huguosi TCM Hospital Affiliated to Beijing University of CM
Chenhao Zhang, professor principal investigator
Wangjing Hospital, China Academy of Chinese Medical Sciences
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing xue-fu-zhu-yu capsule and xue-fu-zhu-yu capsule simulated agent in people with Qi Stagnation and Blood Stasis Syndrome, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Traditional Chinese Medicine PRO Scale (time frame: baseline, 2nd,4th,6th and 7th week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03091634, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2019.