Hypertensive Heart DiseaseNCT04505228
The Personalized Chinese Herb Formulas Over Hypertensive Bradyarrhythmia
A study testing Safflower (Carthamus Tinctorius) IgG4 | Serum | Allergy and Atropine Sulfate in people with Hypertensive Heart Disease, run by Jun Xiao at 1 site in China.
Trial summary
72 patients who have been diagnosed with hypertensive bradyarrhythmia were selected and randomly divided into research group and control group. The research group received regular medication against hypertension and the personalized formulas based on syndrome differentiation, meanwhile the control group only received… Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Hypertensive Heart Disease
- What is being tested?
- Safflower (Carthamus Tinctorius) IgG4 | Serum | Allergy and Atropine Sulfate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- 20 Jan 2020to 20 Jun 2020
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of hypertensive bradyarhhythmia
Who cannot join
- With other elementary diseases
- With pregnant
- With receiving other treatment within past half year from the beginning of trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Personalized Chinese Herb Formulas Are Evaluated for Their Effectiveness to Relieve Symptoms in Hypertensive Bradyarrhythmia
72 patients who have been diagnosed with hypertensive bradyarrhythmia were selected and randomly divided into research group and control group. The research group received regular medication against hypertension and the personalized formulas based on syndrome differentiation, meanwhile the control group only received the regular medication. The five symptoms (palpitation, short of breath, angina, dizzy and lumbar debility) were graded and used for evaluation of treatment.
Read the detailed description
To test the effect of Chinese herb against the hypertensive heart disease, we designed this randomized controlled clinical trial. 72 patients who have been diagnosed with hypertensive bradyarrhythmia were selected and randomly divided into research group and control group. The five symptoms (palpitation, short of breath, angina, dizzy and lumbar debility) were graded. The research group received regular medication against hypertension and the personalized formulas based on syndrome differentiation, meanwhile the control group only received the regular medication. 2 weeks after treatment, all the symptoms were graded again.
- Conditions
- Hypertensive Heart Disease
- Being tested
- Safflower (Carthamus Tinctorius) IgG4 | Serum | Allergy, Atropine Sulfate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Safflower (Carthamus Tinctorius) IgG4 | Serum | AllergyDrug
Also called Xuefuzhuyu
The designed Chinese herb formulas
Atropine SulfateDrug
The basic treatment for heart disease
| Study group | Role | What they receive |
|---|---|---|
| Research group | Experimental | The patients receiving Atropine and the extra Chinese herb formulas treatment Receives: Drug: Safflower (Carthamus Tinctorius) IgG4 | Serum | Allergy; Drug: Atropine Sulfate |
| Control group | Active comparator | The patients receiving the basic treatment of atropine Receives: Drug: Atropine Sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
typical symptoms in patients with hypertensive bradyarrhythmia
The five indexes of typical symptoms in patients with hypertensive bradyarrhythmia (palpitation, angina, shortness of breath, dizzy, lumbar debility) were evaluated and scored both before treatment and after treatment according to "Guiding principles for clinical research of new Chinese Medicine".
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2020
- Study start20 Jan 2020
- Primary completion20 Mar 2020
- Study completion20 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertensive Heart DiseaseStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jun Xiao
- Sponsor type
- University, hospital or other
- Collaborators
- Qingdao Fifth People's Hospital
- Responsible party
- Sponsor-investigator, Jun Xiao, Macrohard Institute of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04505228
- Sponsor's protocol ID
- qdms17337nsh
- Status last verified
- Aug 2020
- First submitted
- 2 Aug 2020
- Last updated
- 10 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Personalized Chinese Herb Formulas Are Evaluated for Their Effectiveness to Relieve Symptoms in Hypertensive Bradyarrhythmia
- ClinicalTrials.gov ID
- NCT04505228
- Acronym / sponsor ID
- qdms17337nsh
- Conditions
- Hypertensive Heart Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Jun XiaoUniversity, hospital or other
- Collaborators
- Qingdao Fifth People's Hospital
- Study start
- 20 Jan 2020 (actual)
- Primary completion
- 20 Mar 2020 (actual)
- Study completion
- 20 Jun 2020 (actual)
- First posted
- 10 Aug 2020 (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.
72 patients who have been diagnosed with hypertensive bradyarrhythmia were selected and randomly divided into research group and control group. The research group received regular medication against hypertension and the personalized formulas based on syndrome differentiation, meanwhile the control group only received the regular medication. The five symptoms (palpitation, short of breath, angina, dizzy and lumbar debility) were graded and used for evaluation of treatment.
Detailed description
To test the effect of Chinese herb against the hypertensive heart disease, we designed this randomized controlled clinical trial. 72 patients who have been diagnosed with hypertensive bradyarrhythmia were selected and randomly divided into research group and control group. The five symptoms (palpitation, short of breath, angina, dizzy and lumbar debility) were graded. The research group received regular medication against hypertension and the personalized formulas based on syndrome differentiation, meanwhile the control group only received the regular medication. 2 weeks after treatment, all the symptoms were graded again.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Research group | Experimental | Drug: Safflower (Carthamus Tinctorius) IgG4 | Serum | Allergy, Drug: Atropine SulfateThe patients receiving Atropine and the extra Chinese herb formulas treatment |
| Control group | Active comparator | Drug: Atropine SulfateThe patients receiving the basic treatment of atropine |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of hypertensive bradyarhhythmia
Key exclusion criteria (3 listed)
- With other elementary diseases
- With pregnant
- With receiving other treatment within past half year from the beginning of trial.
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 |
|---|---|---|
| Safflower (Carthamus Tinctorius) IgG4 | Serum | AllergyAlso: XuefuzhuyuThe designed Chinese herb formulas | Drug | Research group |
| Atropine SulfateThe basic treatment for heart disease | Drug | Control group, Research group |
Primary outcome
typical symptoms in patients with hypertensive bradyarrhythmia
Time frame: 2 weeks
The five indexes of typical symptoms in patients with hypertensive bradyarrhythmia (palpitation, angina, shortness of breath, dizzy, lumbar debility) were evaluated and scored both before treatment and after treatment according to "Guiding principles for clinical research of new Chinese Medicine".
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 10 Aug 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Safflower (Carthamus Tinctorius) IgG4 | Serum | Allergy and Atropine Sulfate in people with Hypertensive Heart Disease, run by Jun Xiao at 1 site 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 1 inclusion and 3 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 10 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
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?
typical symptoms in patients with hypertensive bradyarrhythmia (time frame: 2 weeks). 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 10 Aug 2020.