Qishen Yiqi Dripping Pills improve cardiopulmonary function in post-percutaneous coronary intervention patients
| ISRCTN | ISRCTN83433606 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN83433606 |
| Secondary identifying numbers | CCA-TCM-002 |
- Submission date
- 26/09/2024
- Registration date
- 30/09/2024
- Last edited
- 30/09/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
The study will aim to investigate the effects of Qi Shenyi Qi Drops/Pills on cardiopulmonary function, traditional Chinese medicine symptom scores, and quality of life in patients with coronary heart disease (CHD) who have undergone percutaneous coronary intervention (PCI). It will seek to introduce new perspectives for integrating traditional Chinese and Western medicine.
Who can participate?
Patients aged 25-80 years old with CHD who have undergone PCI
What does the study involve?
Participants will be randomly assigned to receive either Qi Shenyi Qi Drops/Pills or a placebo. The study will use double-blind, placebo-controlled methods to ensure unbiased results. Cardiopulmonary exercise testing (CPET) will be used to evaluate the impact of the treatment on cardiopulmonary function and traditional Chinese medicine symptoms.
What are the possible benefits and risks of participating?
Participants may benefit from improved cardiopulmonary function and symptom relief. However, as with any clinical study, there may be risks, including potential side effects from the medication.
Where is the study run from?
Yijishan Hospital Affiliated with Wannan Medical College
When is the study starting and how long is it expected to run for?
April 2023 to June 2025
Who is funding the study?
China Traditional Chinese Medicine Research and Innovation Fund
Who is the main contact?
Prof Deguo Wang, wangdeguo@wnmc.edu.cn
Contact information
Public, Scientific, Principal Investigator
The First Affiliated Hospital of Wannan Medical College, Yijishan Hospital, Zheshan Western Road No. 2
Wuhu City, Anhui Province
241001
China
 ORCID ID |
0000-0002-9489-7300 |
|---|---|
| Phone | +8618226726360 |
| wangdeguo@wnmc.edu.cn |
Study information
| Study design | Randomized double-blind placebo-controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Quality of life, Treatment, Efficacy |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Evaluation of the effect of Qishen Yiqi Dripping Pills on cardiopulmonary exercise tests in patients with coronary heart disease after percutaneous coronary intervention |
| Study objectives | The improvement of Qishen Yiqi Dripping Pills in traditional Chinese medicine (TCM) syndrome and cardiovascular protection observed in patients with coronary heart disease (CHD) after undergoing interventional surgery, which incorporates TCM, is attributed to its positive effects on enhancing the patient's cardiopulmonary function. Cardiopulmonary exercise testing (CPET) can serve as a pivotal, objective metric for the clinical assessment of the efficacy of TCM treatments. |
| Ethics approval(s) |
Approved 18/09/2023, Scientific Research and New Technology of Wannan Medical College Yijishan Hospital IRB (Zheshan Western Road No 2, Wuhu City, Anhui Province, 241001, China; +86 553 573 9209; wupei@yjsyy.com), ref: (2023) Ethics Approval No. (106) |
| Health condition(s) or problem(s) studied | Cardiovascular protection observed in post-PCI patients with coronary heart disease (CHD) |
| Intervention | This is a randomized, double-blind, placebo-controlled study of the effects of Qishen Yiqi Dripping Pills on cardiopulmonary function, Chinese medicine symptom scale, and quality of life in patients with coronary heart disease (CHD) after PCI. Control group: Patients in post-PCI receive “QishenYiqi dripping pill Placebo”(0.5 PO. TID) plus general drug treatment including lipid-lowering drugs (aspirin 100 mg qd, Tigrelor 90 mg bid), antiplatelet drugs (Atorvastatin 20 mg QN/Ezemeb 10 mg QD). Intervention group: Patients in post-PCI receive “QishenYiqi dripping pill”(0.5 PO. TID) plus general drug treatment including lipid-lowering drugs(aspirin 100 mg qd, Tigrelor 90 mg bid), antiplatelet drugs (Atorvastatin 20 mg QN/Ezemeb 10 mg QD). Drug name: QishenYiqi dripping pill Dosage and method: 0.5g/PO. Frequency of administration: three times a day. Total duration of treatment: three months Follow-up for all treatment arms: three months Randomisation process(double-blind): Random number table |
| Intervention type | Drug |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Qishen Yiqi Dripping Pills |
| Primary outcome measure | Cardiopulmonary function is measured using Cardiopulmonary Exercise Testing at 3 months after PCI |
| Secondary outcome measures | 1. Quality of life is measured using the 36-Item Short Form Survey Instrument (SF-36) at baseline, 1, 2 and 3 months after PCI 2. Cardiac function is measured using echocardiography at baseline and 3 months after PCI 3. Serum inflammatory markers (CRP, IL-6, TNFa, etc.) are measured using chemiluminescence at 3 months after PCI 4. Qi deficiency and blood stasis syndrome scores are measured by a Traditional Chinese medicine doctor using Traditional Chinese four ways of diagnosis including looking, listening, questioning and feeling the pulse 3 months after PCI. |
| Overall study start date | 10/04/2023 |
| Completion date | 30/06/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 25 Years |
| Upper age limit | 80 Years |
| Sex | Both |
| Target number of participants | 100 |
| Key inclusion criteria | 1. Aged 25-80 years old 2. Patients with acute coronary syndrome after coronary interventional treatment 3. Traditional Chinese medicine Qi deficiency and blood stasis certificate (both certificates include: phlegm certificate, Yin deficiency, Yang deficiency certificate) 4. Co Cardiopulmonary exercise testing (CPET) contraindications |
| Key exclusion criteria | 1. Serious heart complications such as ventricular septal perforation 2. Cardiogenic shock and cardiac arrest 3. Vascular interventional treatment success but with vascular lesions with greater than 70% occlusion 4. Severe liver and kidney dysfunction, mental abnormalities, hematopoietic dysfunction, co-infection or severe immune system diseases 5. Pregnant or lactating women |
| Date of first enrolment | 01/01/2024 |
| Date of final enrolment | 30/04/2025 |
Locations
Countries of recruitment
- China
Study participating centre
Wuhu City, Anhui Province
241001
China
Sponsor information
Research organisation
No. 36 Shuifang Road, Suzhou Industrial Park
Hanzhou
241001
China
| Phone | +8613667685212 |
|---|---|
| l.li@ccahouse.org |
Funders
Funder type
Research organisation
No information available
Results and Publications
| Intention to publish date | 30/06/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Prof Deguo Wang, wangdeguo@wnmc.edu.cn |
Editorial Notes
30/09/2024: Study's existence confirmed by the Scientific Research and New Technology of Wannan Medical College Yijishan Hospital IRB, China.
