Primary HypertensionEarly Phase 1NCT01904695
Causal Inference Research of Resistant Hypertension Treatment With Chinese Approach in a Cohort Study
A Early Phase 1 study testing Herbs and Antihypertensive drugs in people with Primary Hypertension and Hypertension, Resistant to Conventional Therapy, run by China Academy of Chinese Medical Sciences at 1 site in China.
Trial summary
The research of clinical effectiveness assessment is to explore the causal relationship between treatment and outcome.Accordingly, based on the effectiveness of tan-yu treatment, the research takes the Resistant Hypertension (RH) as example to study the causal inference methods under real world. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Primary Hypertension, Hypertension, Resistant to Conventional Therapy
- What is being tested?
- Herbs and Antihypertensive drugs
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteChina
- Study dates
- Aug 2013to Dec 2015
- Phase
- Early Phase 1
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Essential hypertension subjects, aged 18-70 years, blood pressure > 140/90 mm Hg even used to be on 3 or more medications for a month and diagnosed as Phlegm and Stasis Syndrome will be included.
Who cannot join
- Patients will be excluded for the following conditions: with secondary resistant hypertension because of other disease like renal disease or pheochromocytoma; included in other clinical trial in one month; pregnant or breast-feed or preparing for pregnancy female; combined with disease like stroke, coronary atherosclerotic heart disease, diabetes, chronic renal failure or mental disease.
Trial locations and contacts
1 site in 1 country.
China1 site
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, 100700
About this study
Official title: Causal Inference Research of Resistant Hypertension Treatment With Recipe of Removing Both Phlegm and Blood Stasis in a Real World Study
The research of clinical effectiveness assessment is to explore the causal relationship between treatment and outcome.Accordingly, based on the effectiveness of tan-yu treatment, the research takes the Resistant Hypertension (RH) as example to study the causal inference methods under real world.
Read the detailed description
Background: Syndrome differentiation is one of the substantial characteristics in Traditional Chinese Medicine (TCM) but is still lack of scientific evidence.The inference methods of causal relationship between treatment and clinial effect under real-word study may help.
Objectives: This study aims to assess the efficacy of Phlegm and Stasis Syndrome differentiation method in treating resistant hypertension and explore causal inference in the real-world study.
Research design and methods: It is a multi-center,prospective,two-arm,cohort study including 200 patients with resistant hypertension (doctors' diagnosis based on the American Heart Association criteria 2008).Essential hypertension subjects,aged 18-70 years,blood pressure >140/90mmHg even used to be on 3 or more medications for a month and diagnosed as Phlegm and Stasis Syndrome will be included.Thiazide diuretics and/or two more antihypertensive agents for 8 weeks, Chinese herbs (for synchronic treating phlegm and blood stasis) and nonpharmacological recommendations were initiated in the observational group and the control group received the same interventions without Chinese herbs.
Outcome measures: The primary outcomes will be Systolic (SBP) and Diastolic (DBP) blood pressure reductions and changes in symptoms and signs.Cardiac event and death incident will be the secondary outcomes.Possible side effects and adverse reactions arising from the treatment like diarrhea will be recorded.
Discussion: This is a rigorous methodology pilot study and 200 patients are enough to calculate sample size in later formal trial.
- Being tested
- Herbs, Antihypertensive drugs
- Keywords
- resistant hypertension, causal inference, a chorot study, recipe of removing both phlegm and blood stasis
- Medical subject headings
- Essential Hypertension, Hypertension Resistant to Conventional Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HerbsDrug
Also called recipe of removing both phlegem and blood stasis
Herbs 180ml by mouth every 12 hours for 8 weeks
Antihypertensive drugsDrug
Also called Thiazide diuretics and ACE inhibitor and β-blocker
Thiazide diuretics and ACE inhibitor and β-blocker in different dosage determined by the physician for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Antihypertensive drugs & Herbs | Experimental | Thiazide diuretics and ACE inhibitor and β-blocker \& Herbs for 8 weeks Receives: Drug: Herbs; Drug: Antihypertensive drugs |
| Antihypertensive drugs | Active comparator | Thiazide diuretics and ACE inhibitor and β-blocker for 8 weeks Receives: Drug: Antihypertensive drugs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic (SBP) and diastolic (DBP) blood pressure reductions
Measured: Before treatment, 8 weeks during treatment
Secondary outcomes (3)
Cardiac event
Measured: Before treatment, 24 weeks follow-up
Death incident
Measured: Before treatment, 24 weeks follow-up
Scores for symptoms and signs
Measured: Before treatment, 8 weeks during treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2013 (estimated)
- Study startAug 2013
- Primary completionOct 2015
- Study completionDec 2015
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 Primary HypertensionStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Responsible party
- Principal investigator, Ya YUWEN, China Academy of Chinese Medical Sciences
- Investigators
- Ya YUWEN, PhD, Study director, China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01904695
- Sponsor's protocol ID
- 81202846
- Status last verified
- Sep 2016
- First submitted
- 14 Jul 2013
- Last updated
- 7 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Yuwen Y, Liu YQ, Wang YP, Dai JG, Liu DS, Wang YX, Han XJ. The add-on effect of a Chinese herbal formula for patients with resistant hypertension: study protocol for a pilot cohort study. J Integr Med. 2015 Mar;13(2):122-8. doi: 10.1016/S2095-4964(15)60162-5.
PubMed 25797643
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Causal Inference Research of Resistant Hypertension Treatment With Recipe of Removing Both Phlegm and Blood Stasis in a Real World Study
- ClinicalTrials.gov ID
- NCT01904695
- Acronym / sponsor ID
- 81202846
- Keywords
- resistant hypertension, causal inference, a chorot study, recipe of removing both phlegm and blood stasis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- China Academy of Chinese Medical SciencesUniversity, hospital or other
- Collaborators
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Study start
- Aug 2013
- Primary completion
- Oct 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 22 Jul 2013 (estimated)
- 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.
The research of clinical effectiveness assessment is to explore the causal relationship between treatment and outcome.Accordingly, based on the effectiveness of tan-yu treatment, the research takes the Resistant Hypertension (RH) as example to study the causal inference methods under real world.
Detailed description
Background: Syndrome differentiation is one of the substantial characteristics in Traditional Chinese Medicine (TCM) but is still lack of scientific evidence.The inference methods of causal relationship between treatment and clinial effect under real-word study may help.
Objectives: This study aims to assess the efficacy of Phlegm and Stasis Syndrome differentiation method in treating resistant hypertension and explore causal inference in the real-world study.
Research design and methods: It is a multi-center,prospective,two-arm,cohort study including 200 patients with resistant hypertension (doctors' diagnosis based on the American Heart Association criteria 2008).Essential hypertension subjects,aged 18-70 years,blood pressure >140/90mmHg even used to be on 3 or more medications for a month and diagnosed as Phlegm and Stasis Syndrome will be included.Thiazide diuretics and/or two more antihypertensive agents for 8 weeks, Chinese herbs (for synchronic treating phlegm and blood stasis) and nonpharmacological recommendations were initiated in the observational group and the control group received the same interventions without Chinese herbs.
Outcome measures: The primary outcomes will be Systolic (SBP) and Diastolic (DBP) blood pressure reductions and changes in symptoms and signs.Cardiac event and death incident will be the secondary outcomes.Possible side effects and adverse reactions arising from the treatment like diarrhea will be recorded.
Discussion: This is a rigorous methodology pilot study and 200 patients are enough to calculate sample size in later formal trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antihypertensive drugs & Herbs | Experimental | Drug: Herbs, Drug: Antihypertensive drugsThiazide diuretics and ACE inhibitor and β-blocker \& Herbs for 8 weeks |
| Antihypertensive drugs | Active comparator | Drug: Antihypertensive drugsThiazide diuretics and ACE inhibitor and β-blocker for 8 weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Essential hypertension subjects, aged 18-70 years, blood pressure > 140/90 mm Hg even used to be on 3 or more medications for a month and diagnosed as Phlegm and Stasis Syndrome will be included.
Key exclusion criteria (1 listed)
- Patients will be excluded for the following conditions: with secondary resistant hypertension because of other disease like renal disease or pheochromocytoma; included in other clinical trial in one month; pregnant or breast-feed or preparing for pregnancy female; combined with disease like stroke, coronary atherosclerotic heart disease, diabetes, chronic renal failure or mental disease.
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 |
|---|---|---|
| HerbsAlso: recipe of removing both phlegem and blood stasisHerbs 180ml by mouth every 12 hours for 8 weeks | Drug | Antihypertensive drugs & Herbs |
| Antihypertensive drugsAlso: Thiazide diuretics and ACE inhibitor and β-blockerThiazide diuretics and ACE inhibitor and β-blocker in different dosage determined by the physician for 8 weeks | Drug | Antihypertensive drugs, Antihypertensive drugs & Herbs |
Primary outcome
Systolic (SBP) and diastolic (DBP) blood pressure reductions
Time frame: Before treatment, 8 weeks during treatment
3 secondary outcomes
Cardiac event
Time frame: Before treatment, 24 weeks follow-up
Death incident
Time frame: Before treatment, 24 weeks follow-up
Scores for symptoms and signs
Time frame: Before treatment, 8 weeks during treatment
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 7 Sep 2016.
- Background: PubMed 25797643Yuwen Y, Liu YQ, Wang YP, Dai JG, Liu DS, Wang YX, Han XJ. The add-on effect of a Chinese herbal formula for patients with resistant hypertension: study protocol for a pilot cohort study. J Integr Med. 2015 Mar;13(2):122-8. doi: 10.1016/S2095-4964(15)60162-5.
- Individual participant dataSharing planned: No
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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.
Ya YUWEN, PhD study director
China Academy of Chinese Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Herbs and Antihypertensive drugs in people with Primary Hypertension and Hypertension, Resistant to Conventional Therapy, run by China Academy of Chinese Medical Sciences 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 1 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 7 Sep 2016. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Systolic (SBP) and diastolic (DBP) blood pressure reductions (time frame: Before treatment, 8 weeks during treatment). 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 NCT01904695, 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 7 Sep 2016.