Coronary Heart DiseasePhase 4NCT01825759
Danshen Dropping Pill for Coronary Heart Disease Heart and Artery Structure and Function
A Phase 4 study testing danshen dripping pill in people with Coronary Heart Disease and Essential Hypertension, run by West China Hospital at 1 site in China.
Trial summary
The Impact of Compound danshen dropping pill for coronary heart disease (CHD) heart and artery structure and function in patients with hypertension Read more about this study
- Who is it for?
- Ages 35 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronary Heart Disease, Essential Hypertension
- What is being tested?
- danshen dripping pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Jan 2013to Dec 2014
- Phase
- Phase 4
- 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 35 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Inclusion Criteria:coronary heart disease，primary hypertension， -
Exclusion Criteria:secondary hypertension，diabetes mellitus，chronic renal disease，cardiac insufficiency
-
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
West China Hospital
Chengdu, Sichuan
chen xi ping, master, 028-85423352, panpei74@163.com
About this study
Official title: The Impact of Compound Danshen Dropping Pill for Coronary Heart Disease With Hypertension Patient Heart and Artery Structure and Function
The Impact of Compound danshen dropping pill for coronary heart disease (CHD) heart and artery structure and function in patients with hypertension
Read the detailed description
Compound danshen dropping pill for coronary heart disease (CHD) heart and artery structure and function in patients with hypertension.We can accorand the pwv ,IMT and MDA to assess the impact of heart and artery structure and function.
- Conditions
- Coronary Heart Disease, Essential Hypertension
- Being tested
- danshen dripping pill
- Medical subject headings
- Coronary Disease, Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
danshen dripping pillDrug
Also called compound danshen dripping pill
| Study group | Role | What they receive |
|---|---|---|
| danshen dripping pill | Experimental | danshen dripping pill 27mg ten pills by mouth every 8 hours for one year Receives: Drug: danshen dripping pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulse wave velocity
Measured: one year
Secondary outcomes (1)
ankle-brachial index
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2013 (estimated)
- Study startJan 2013
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaoping Chen, West China Hospital
- Investigators
- chen xi ping, master, Study director, organizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01825759
- Sponsor's protocol ID
- West China Hospital
- Status last verified
- Mar 2013
- First submitted
- 26 Mar 2013
- Last updated
- 8 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Compound Danshen Dropping Pill for Coronary Heart Disease With Hypertension Patient Heart and Artery Structure and Function
- ClinicalTrials.gov ID
- NCT01825759
- Acronym / sponsor ID
- West China Hospital
- Conditions
- Coronary Heart Disease, Essential Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 8 Apr 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 Impact of Compound danshen dropping pill for coronary heart disease (CHD) heart and artery structure and function in patients with hypertension
Detailed description
Compound danshen dropping pill for coronary heart disease (CHD) heart and artery structure and function in patients with hypertension.We can accorand the pwv ,IMT and MDA to assess the impact of heart and artery structure and function.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| danshen dripping pill | Experimental | Drug: danshen dripping pilldanshen dripping pill 27mg ten pills by mouth every 8 hours for one year |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| danshen dripping pillAlso: compound danshen dripping pill | Drug | danshen dripping pill |
Primary outcome
Pulse wave velocity
Time frame: one year
1 secondary outcome
ankle-brachial index
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2013.
- ABILink provided by the sponsor.
- IMTLink provided by the sponsor.
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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.
chen xi ping, master study director
organizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing danshen dripping pill in people with Coronary Heart Disease and Essential Hypertension, run by West China Hospital 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?
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 Apr 2013. 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?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact chen xi ping, master (028-85423352, panpei74@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulse wave velocity (time frame: one year). 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 Apr 2013.