Traditional Chinese MedicineNCT05847959
The Relationship Between XinKang-I and Chronic Heart Failure
A study testing Traditional Chinese medicine prescription：XinKang-I in people with Traditional Chinese Medicine, run by Dongguan Hospital of Traditional Chinese Medicine.
Trial summary
Background: Heart failure is the severe and terminal stage of various heart diseases, which is characterized by high morbidity, mortality and readmission. There are few studies on the relationship between XinKang-I(XK-I) and chronic heart failure. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Traditional Chinese Medicine
- What is being tested?
- Traditional Chinese medicine prescription：XinKang-I
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2023to 31 Dec 2025
- Phase
- Interventional
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of CHF or clinical findings of CHF for more than 3 months. CHF was diagnosed in accordance with the European Society of Cardiology's 2021 Guidelines for the Diagnosis and Treatment of Acute and Chronic Heart Failure.
- Patients ranged in age from 18 to 85.
- Cardiac function was graded at grade II-IV (New York Heart Association functional class).
- Patients who had not used traditional Chinese medicine for treating heart failure within 1 week before enrollment;
- Written informed consent will be obtained.
Who cannot join
- acute cardiac insufficiency, acute myocarditis, severe valvular heart disease, malignant arrhythmia, obstructive cardiomyopathy, pericardial tamponade, constrictive pericarditis or acute coronary syndrome
- severe lung, liver or kidney dysfunction
- nervous and hematopoietic system
- malignant tumors
- hemodynamic nstability
- pulmonary embolism
Show all 9Show fewer
- severe infection
- pregnant or lactating
- refusal to provide written informed consent for this study
About this study
Official title: The Relationship Between XinKang-I and Chronic Heart Failure: Protocol for a Randomized Controlled Study.
Background: Heart failure is the severe and terminal stage of various heart diseases, which is characterized by high morbidity, mortality and readmission. There are few studies on the relationship between XinKang-I(XK-I) and chronic heart failure.
Objective: To explore the relationship between XK-I and chronic heart failure. Methods/design: The trial is a single-center, single-blind, randomized study (1:1). It will recruit 110 patients with chronic heart failure who syndrome of qi deficiency yang deficiency and blood stasis. The intervention group will receive not only Western medicine, but also XK-I. The primary end points will be the changes in oxygen consumption volume of anaerobic threshold (VO2AT), maximum oxygen volume uptake (VO2max), and 6-minute walking distance after 8 weeks of treatment. Both groups will receive 8 weeks of treatment.
Ethics and dissemination: Ethical approval was granted by Ethics Committee of Dongguan TCM Hospital. Results will be disseminated via peer-reviewed publications and presentations at international conferences.
- Conditions
- Traditional Chinese Medicine
- Being tested
- Traditional Chinese medicine prescription：XinKang-I
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional Chinese medicine prescription：XinKang-IDrug
XK-I will be used in intervention group (20 grams of radix astragalus, 20 grams of radix codonopsis, 10 grams of stir-fried semen lepidii, 8 grams of sweet apricot kernel, 10 grams of cassia twig, 15 grams of poria cocos, 10 grams of atractylodes, 5 grams of honey-roasted licorice, 15 grams of radix et rhizoma salviae miltiorrhizae, 10 grams of chuanxiong rhizoma, 5 grams of tangerine peel).Patients will take XK-I once a day, divided into morning and evening administration. The treatment lasted for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Active comparator | The intervention group will receive not only Western medicine, but also XK-I. The therapeutic drugs used in the control group will be according to the European Society of Cardiology's 2021 guidelines for the diagnosis and treatment of acute and chronic heart failure. Receives: Drug: Traditional Chinese medicine prescription：XinKang-I |
| The control group | No intervention | The control group will receive Western medicine.The therapeutic drugs used in the control group will be according to the European Society of Cardiology's 2021 guidelines for the diagnosis and treatment of acute and chronic heart failure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The changes in 6-minute walking distance(distance, meter).
Cardiac function
Measured: 8 weeks
oxygen consumption volume of anaerobic threshold (VO2AT, ml)
Cardiac function
Measured: 8 weeks
maximum oxygen volume uptake (VO2max, ml/min) in cardiopulmonary function test
Cardiac function
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2023
- Study start1 May 2023 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traditional Chinese MedicineStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dongguan Hospital of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianfeng Ye, Dongguan Hospital of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05847959
- Sponsor's protocol ID
- DongguanHTCM
- Status last verified
- Apr 2023
- First submitted
- 13 Apr 2023
- Last updated
- 8 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between XinKang-I and Chronic Heart Failure: Protocol for a Randomized Controlled Study.
- ClinicalTrials.gov ID
- NCT05847959
- Acronym / sponsor ID
- DongguanHTCM
- Conditions
- Traditional Chinese Medicine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Dongguan Hospital of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 1 May 2023 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 8 May 2023 (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.
Background: Heart failure is the severe and terminal stage of various heart diseases, which is characterized by high morbidity, mortality and readmission. There are few studies on the relationship between XinKang-I(XK-I) and chronic heart failure.
Objective: To explore the relationship between XK-I and chronic heart failure. Methods/design: The trial is a single-center, single-blind, randomized study (1:1). It will recruit 110 patients with chronic heart failure who syndrome of qi deficiency yang deficiency and blood stasis. The intervention group will receive not only Western medicine, but also XK-I. The primary end points will be the changes in oxygen consumption volume of anaerobic threshold (VO2AT), maximum oxygen volume uptake (VO2max), and 6-minute walking distance after 8 weeks of treatment. Both groups will receive 8 weeks of treatment.
Ethics and dissemination: Ethical approval was granted by Ethics Committee of Dongguan TCM Hospital. Results will be disseminated via peer-reviewed publications and presentations at international conferences.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Active comparator | Drug: Traditional Chinese medicine prescription：XinKang-IThe intervention group will receive not only Western medicine, but also XK-I. The therapeutic drugs used in the control group will be according to the European Society of Cardiology's 2021 guidelines for the diagnosis and treatment of acute and chronic heart failure. |
| The control group | No intervention | –The control group will receive Western medicine.The therapeutic drugs used in the control group will be according to the European Society of Cardiology's 2021 guidelines for the diagnosis and treatment of acute and chronic heart failure. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- History of CHF or clinical findings of CHF for more than 3 months. CHF was diagnosed in accordance with the European Society of Cardiology's 2021 Guidelines for the Diagnosis and Treatment of Acute and Chronic Heart Failure.
- Patients ranged in age from 18 to 85.
- Cardiac function was graded at grade II-IV (New York Heart Association functional class).
- Patients who had not used traditional Chinese medicine for treating heart failure within 1 week before enrollment;
- Written informed consent will be obtained.
Key exclusion criteria (9 listed)
- acute cardiac insufficiency, acute myocarditis, severe valvular heart disease, malignant arrhythmia, obstructive cardiomyopathy, pericardial tamponade, constrictive pericarditis or acute coronary syndrome
- severe lung, liver or kidney dysfunction
- nervous and hematopoietic system
- malignant tumors
- hemodynamic nstability
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 |
|---|---|---|
| Traditional Chinese medicine prescription：XinKang-IXK-I will be used in intervention group (20 grams of radix astragalus, 20 grams of radix codonopsis, 10 grams of stir-fried semen lepidii, 8 grams of sweet apricot kernel, 10 grams of cassia twig, 15 grams of poria cocos, 10 grams of atractylodes, 5 grams of honey-roasted licorice, 15 grams of radix et rhizoma salviae miltiorrhizae, 10 grams of chuanxiong rhizoma, 5 grams of tangerine peel).Patients will take XK-I once a day, divided into morning and evening administration. The treatment lasted for 8 weeks. | Drug | intervention group |
Primary outcome
The changes in 6-minute walking distance(distance, meter).
Time frame: 8 weeks
Cardiac function
oxygen consumption volume of anaerobic threshold (VO2AT, ml)
Time frame: 8 weeks
Cardiac function
maximum oxygen volume uptake (VO2max, ml/min) in cardiopulmonary function test
Time frame: 8 weeks
Cardiac function
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional Chinese medicine prescription：XinKang-I in people with Traditional Chinese Medicine, run by Dongguan Hospital of Traditional Chinese Medicine.
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 5 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 8 May 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
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 changes in 6-minute walking distance(distance, meter). (time frame: 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 May 2023.