What is the effect of Xinkeshu tablets added to usual treatment on the function of the circulatory system in patients with coronary artery disease and high blood pressure?
| ISRCTN | ISRCTN22691979 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN22691979 |
| Secondary identifying numbers | 2017154 |
- Submission date
- 03/12/2019
- Registration date
- 05/02/2020
- Last edited
- 28/03/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
Hypertension (high blood pressure) and coronary artery disease (CAD) are increasingly common. Having these conditions means a person is more likely to suffer a heart attack or stroke. In addition, 3 in 10 patients with CAD suffer from depression. Hypertension and CAD are linked to damage to blood vessels and the blood vessels then start to lose the ability to function normally.
Xinkeshu, a traditional Chinese medicine containing herbs, has been proven to reduce blood pressure, improve CAD symptoms and improve depression and anxiety. This study aims to investigate whether Xinkeshu can protect blood vessels in patients with CAD and hypertension, and also whether it can improve symptoms of depression and anxiety.
Who can participate?
Patients aged 18-65 years with CAD and hypertension
What does the study involve?
Participants will be randomly allocated to one of two groups. One group will receive usual treatment for hypertension and CAD (aspirin, atorvastatin and amlodipine). The other group will receive the usual treatment and Xinkeshu tablets. Both groups will take the treatment for 12 weeks. They will have blood samples taken, will have their blood vessels examined using a blood pressure measuring device and ultrasound, and will fill in questionnaires about symptoms of depression and anxiety before they start the treatment and at 4 week s and 12 weeks after the start of treatment.
What are the possible benefits and risks of participating?
Participants will get XKS pills for free to treat their CAD and hypertension. The usual treatment medicines are commonly used and generally safe.
Where is the study run from?
The First Affiliated Hospital, Sun Yat-Sen University (China)
When is the study starting and how long is it expected to run for?
July 2017 to September 2020
Who is funding the study?
Shandong Wohua Pharmaceutical Technology Co Ltd (China)
Who is the main contact?
Jun Tao, taojungz123@163.com
Contact information
Public
Department of Hypertension and Vascular Disease
The First Affiliated Hospital
Sun Yat-sen University
No.58, Zhongshan Road 2
Guangzhou
510000
China
| Phone | 15622122042 |
|---|---|
| sunjp3@mail3.sysu.edu.cn |
Scientific
Department of Hypertension and Vascular Disease
The First Affiliated Hospital
Sun Yat-sen University
58 Zhongshan Road 2
Guangzhou
Guangdong
Guangzhou
510000
China
 ORCID ID |
0000-0002-2226-765X |
|---|---|
| taojungz123@163.com |
Study information
| Study design | Randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available. |
| Scientific title | The protective effect of Xinkeshu tablets on vascular function in patients with coronary artery disease combined with hypertension: a randomized controlled study. |
| Study acronym | X-CHRCS |
| Study objectives | Xinkeshu tablets have a protective effect on vascular endothelium by improving endothelial progenitor cells function and accelerating vascular repair in patients with coronary artery disease combine with hypertension through the CXCR4/JAK2 signaling pathway. |
| Ethics approval(s) | Approved 15/08/2017, Ethics Committee of Clinical Research and Experimental Animals, The First Affiliated Hospital, Sun Yat-Sen University in Guangzhou (58 Zhongshan Road 2, Guangzhou, Guangdong, 510000, China; +86 020-87755766; linf7@mail.sysu.edu.cn), ref: 2017[154] |
| Health condition(s) or problem(s) studied | Coronary heart disease combined with hypertension and vascular dysfunction |
| Intervention | We will recruit 68 patients with hypertension and coronary artery disease who had been admitted to The First Affiliated Hospital, Sun Yat-Sen University. Patients will be randomly divided into XKS group (34) and control group (34). The XKS group will receive routine treatment (aspirin 100 mg qd, atorvastatin 20 mg qd, amlodipine 5 mg qd) combined with Xinkeshu tablets (Shandong Wohua Pharmaceutical Co Ltd), 4 tablets, three times a day for 3 months. The control group will receive routine treatment for 3 months. At the first day, the end of 1st, 2nd and 3rd month, blood samples will be collected, their arterial function will be assessed, and any anxiety and depressive symptoms will be evaluated. The blood sample tests include endothelial microparticles (EMPs), endothelial progenitor cells (EPCs), liver function, kidney function, blood lipid, blood glucose and so on. Arterial function examination includes artery flow-mediated dilation (FMD) and brachial-ankle pulse wave velocity (baPWV). Anxiety and depressive symptoms would be evaluated by using GAD-7 and PHQ-9 score.The patients need to provide their peripheral blood to get their endothelial progenitor cells. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Xinkeshu tablets |
| Primary outcome measure | 1. Brachial arterial flow-mediated dilation measured using ultrasound at baseline, 4 weeks and 12 weeks 2. Brachial-ankle pulse wave velocity measured using a blood pressure measuring device at baseline, 4 weeks and 12 weeks 3. Anxiety assessed using the GAD-7 questionnaire at baseline, 4 weeks and 12 weeks 4. Depression assessed using the PHQ-9 questionnaire at baseline, 4 weeks and 12 weeks |
| Secondary outcome measures | 1. Endothelial microparticles measured using flow cytometry of peripheral blood samples taken at baseline, 4 weeks and 12 weeks 2. Quantity of endothelial progenitor cells measured using flow cytometry of peripheral blood samples taken at baseline, 4 weeks and 12 weeks 3. Blood pressure measured using a tronic sphygmomanometer (HEM-7071, OMRON, China) at baseline, 4 weeks and 12 weeks |
| Overall study start date | 01/07/2017 |
| Completion date | 01/09/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 70 Years |
| Sex | Both |
| Target number of participants | 120 |
| Key inclusion criteria | 1. Aged 18-70 years 2. Diagnosed with hypertension and coronary artery disease and have received regular coronary heart disease secondary prevention drugs and antihypertensive drugs 3. Baseline GAD-7 and PHQ-9 score were both between 5-14 points 4. Have given written informed consent prior to study participation |
| Key exclusion criteria | 1. Severe liver or kidney dysfunction or malignant tumors 2. Allergic to any component of Xinkeshu tablet 3. Cardiovascular or cerebrovascular accident within previous 3 months 4. Pregnant or lactating women |
| Date of first enrolment | 01/12/2019 |
| Date of final enrolment | 30/06/2020 |
Locations
Countries of recruitment
- China
Study participating centre
First Affiliated Hospital, Sun Yat-sen University
No.58, Zhongshan Road 2
Guangzhou
510000
China
Sponsor information
Industry
3517 Liyuan street
Weifang High-tech Industrial Development Zone
Shandong province
Weifang
261021
China
| Phone | +86 15101008647 |
|---|---|
| yanlong@ccpi.net.cn |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 31/12/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | We intend to publish in one of the SCI journals in 2020 after finishing the study. |
| IPD sharing plan | The datasets generated and/or analysed during this study will be included in the subsequent results publication |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 19/07/2021 | 28/03/2023 | Yes | No |
Editorial Notes
28/03/2023: Publication reference added.
21/01/2020: Trial's existence confirmed by Ethics Committee of the First Affiliated Hospital of Sun Yat-sen University.
