HypertensionPhase 4NCT04035824
Gastrodia and Uncaria Recipe in Treating Stage-one Hypertension: an Evidence-based Optimization Study
A Phase 4 study testing Gastrodia and Uncaria granule in people with Hypertension, run by Shanghai Institute of Hypertension at 1 site in China.
Trial summary
Gastrodia and Uncaria Recipe is a well-known effective prescription in Traditional Chinese Medicine (TCM) to treat hypertension of liver yang hyperactivity type, which manifests symptom of headache or dizziness. However, it lacks consolidated evidence by multi-center randomized controlled trials. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Gastrodia and Uncaria granule
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 605 participants
- Where
- 1 siteChina
- Study dates
- 8 Oct 2019to 24 Apr 2024
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female sex, aged 18-80 years.
- Not taking anti-hypertensive drugs for at least two weeks, or taking anti-hypertensive drugs for more than two weeks.
- Office blood pressure averages of three consecutive readings per visit, at two screening visits all meet the limits: systolic blood pressure ranges from 140 to 159 mmHg, and diastolic blood pressure <100 mmHg.
- 24h ambulatory mean systolic blood pressure >= 130mmHg.
- Agreed to participant, able to join follow-up and to come to hospital at each visit.
- Signed informed consent.
Who cannot join
- Secondary hypertension, confirmed or suspected.
- Failed at ambulatory blood pressure monitoring: effective reading < 70%, or the number of awakening BP reading <20, or sleep time BP reading <7.
- Taking drugs that must be used for other diseases but have a potential effect on blood pressure, such as males taking alpha blockers for prostatic hypertrophy.
- Having the onset of cardiovascular and cerebrovascular diseases such as stroke, myocardial infarction or heart failure within 6 months.
- Having a history of atrial fibrillation or frequent arrhythmia.
- Having abnormal lab test results: liver function (ALT, AST, TBL) ≥ 2 times the upper normal limit, or serum creatinine ≥ 176umol/L, or serum potassium ≥ 5.5mmol/L.
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- Pregnant or breastfeeding (for females).
- Complicating other diseases that are not suitable for the trial, such as thyroid disease with active medication, acute infectious diseases, chronic mental illness, and tumors.
- Possible poor compliance with the research process.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evidence-based Optimization of Gastrodia and Uncaria Recipe in Treating Stage-one Hypertension: a Multi-center, Randomized, Double-blind, Placebo Controlled Trial
Gastrodia and Uncaria Recipe is a well-known effective prescription in Traditional Chinese Medicine (TCM) to treat hypertension of liver yang hyperactivity type, which manifests symptom of headache or dizziness. However, it lacks consolidated evidence by multi-center randomized controlled trials. The hypothesis of this study is that Gastrodia and Uncaria granule may have significant anti-hypertensive effect on patients with stage-one hypertension and liver-yang hyperactivity syndrome than placebo.
This study is a randomized, controlled, multi-center, double-blind clinical trial. This study aims to recruit 500 hypertension patients who 1) are untreated or taking anti-hypertensive medicine for at least two weeks and 2) have an office systolic blood pressure of 140-159 mmHg, an office diastolic blood pressure of <100 mmHg, and a 24-hour ambulatory mean systolic blood pressure of >=130 mmHg. The patients will be stratified according to center, sex, and the TCM type of liver yang hyperactivity/ liver yang non-hyperactivity, and are then randomly assigned to the treatment of Gastrodia and Uncaria granules or placebo for 2 months. The blood pressure lowering effect is evaluated by 24-hour ambulatory systolic blood pressure (primary outcome) / diastolic blood pressure, as well as by home and office blood pressures.
- Conditions
- Hypertension
- Being tested
- Gastrodia and Uncaria granule, Placebo of Gastrodia and Uncaria granule
- Keywords
- Gastrodia and Uncaria, Stage one Hypertension, Liver yang hyperactivity
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastrodia and Uncaria granuleDrug
Patients allocated to the intervention group take 10g of Gastrodia and Uncaria granule each time, twice per day, and for two months.
Placebo of Gastrodia and Uncaria granuleDrug
Patients allocated to the control group take 10g of placebo of Gastrodia and Uncaria granule each time, twice per day, and for two months. The placebo has similar appearance and smell to genuine drug but has no effective anti-hypertensive agents.
| Study group | Role | What they receive |
|---|---|---|
| Gastrodia and Uncaria granule | Active comparator | Gastrodia and Uncaria granule, Chengdu Jiuzhitang Jinding Pharmaceutical Co., Ltd Receives: Drug: Gastrodia and Uncaria granule |
| Placebo | Placebo comparator | Placebo of Gastrodia and Uncaria granule, Chengdu Jiuzhitang Jinding Pharmaceutical Co., Ltd Receives: Drug: Placebo of Gastrodia and Uncaria granule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 24-hour ambulatory systolic blood pressure
The difference of change of 24h ambulatory systolic blood pressure after 8-week treatment between treatment and control group
Measured: 8 weeks
Secondary outcomes (4)
Change in office blood pressure
The difference of change of office systolic and diastolic blood pressure between treatment and control group
Measured: 4 and 8 weeks
Change in 24-hour ambulatory systolic blood pressure by stratum
The difference of change of 24h ambulatory systolic blood pressure after 8-week treatment between liver yang hyperactivity and liver yang non-hyperactivity stratum
Measured: 8 weeks
Change in 24-hour ambulatory diastolic blood pressure, daytime and nighttime blood pressure
The difference of blood pressure change of 24-hour mean ambulatory diastolic, daytime and nighttime systolic and diastolic between treatment and control group.
Measured: 8 weeks
Change in home blood pressure
Difference of change of home systolic and diastolic blood pressure after 8-week treatment between treatment and control group.
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 posted29 Jul 2019
- Study start8 Oct 2019
- Primary completion12 Apr 2024
- Study completion24 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 605 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Institute of Hypertension
- Sponsor type
- University, hospital or other
- Collaborators
- Ruijin Hospital, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Responsible party
- Principal investigator, Yan Li, Shanghai Institute of Hypertension
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04035824
- Sponsor's protocol ID
- 2018YFC1704902
- Status last verified
- Jan 2025
- First submitted
- 24 Jul 2019
- Last updated
- 7 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evidence-based Optimization of Gastrodia and Uncaria Recipe in Treating Stage-one Hypertension: a Multi-center, Randomized, Double-blind, Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT04035824
- Acronym / sponsor ID
- 2018YFC1704902
- Conditions
- Hypertension
- Keywords
- Gastrodia and Uncaria, Stage one Hypertension, Liver yang hyperactivity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 605 participants (actual)
- Lead sponsor
- Shanghai Institute of HypertensionUniversity, hospital or other
- Collaborators
- Ruijin Hospital, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Study start
- 8 Oct 2019 (actual)
- Primary completion
- 12 Apr 2024 (actual)
- Study completion
- 24 Apr 2024 (actual)
- First posted
- 29 Jul 2019 (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.
Gastrodia and Uncaria Recipe is a well-known effective prescription in Traditional Chinese Medicine (TCM) to treat hypertension of liver yang hyperactivity type, which manifests symptom of headache or dizziness. However, it lacks consolidated evidence by multi-center randomized controlled trials. The hypothesis of this study is that Gastrodia and Uncaria granule may have significant anti-hypertensive effect on patients with stage-one hypertension and liver-yang hyperactivity syndrome than placebo.
This study is a randomized, controlled, multi-center, double-blind clinical trial. This study aims to recruit 500 hypertension patients who 1) are untreated or taking anti-hypertensive medicine for at least two weeks and 2) have an office systolic blood pressure of 140-159 mmHg, an office diastolic blood pressure of <100 mmHg, and a 24-hour ambulatory mean systolic blood pressure of >=130 mmHg. The patients will be stratified according to center, sex, and the TCM type of liver yang hyperactivity/ liver yang non-hyperactivity, and are then randomly assigned to the treatment of Gastrodia and Uncaria granules or placebo for 2 months. The blood pressure lowering effect is evaluated by 24-hour ambulatory systolic blood pressure (primary outcome) / diastolic blood pressure, as well as by home and office blood pressures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gastrodia and Uncaria granule | Active comparator | Drug: Gastrodia and Uncaria granuleGastrodia and Uncaria granule, Chengdu Jiuzhitang Jinding Pharmaceutical Co., Ltd |
| Placebo | Placebo comparator | Drug: Placebo of Gastrodia and Uncaria granulePlacebo of Gastrodia and Uncaria granule, Chengdu Jiuzhitang Jinding Pharmaceutical Co., Ltd |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male and female sex, aged 18-80 years.
- Not taking anti-hypertensive drugs for at least two weeks, or taking anti-hypertensive drugs for more than two weeks.
- Office blood pressure averages of three consecutive readings per visit, at two screening visits all meet the limits: systolic blood pressure ranges from 140 to 159 mmHg, and diastolic blood pressure <100 mmHg.
- 24h ambulatory mean systolic blood pressure >= 130mmHg.
- Agreed to participant, able to join follow-up and to come to hospital at each visit.
Key exclusion criteria (9 listed)
- Secondary hypertension, confirmed or suspected.
- Failed at ambulatory blood pressure monitoring: effective reading < 70%, or the number of awakening BP reading <20, or sleep time BP reading <7.
- Taking drugs that must be used for other diseases but have a potential effect on blood pressure, such as males taking alpha blockers for prostatic hypertrophy.
- Having the onset of cardiovascular and cerebrovascular diseases such as stroke, myocardial infarction or heart failure within 6 months.
- Having a history of atrial fibrillation or frequent arrhythmia.
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 |
|---|---|---|
| Gastrodia and Uncaria granulePatients allocated to the intervention group take 10g of Gastrodia and Uncaria granule each time, twice per day, and for two months. | Drug | Gastrodia and Uncaria granule |
| Placebo of Gastrodia and Uncaria granulePatients allocated to the control group take 10g of placebo of Gastrodia and Uncaria granule each time, twice per day, and for two months. The placebo has similar appearance and smell to genuine drug but has no effective anti-hypertensive agents. | Drug | Placebo |
Primary outcome
Change in 24-hour ambulatory systolic blood pressure
Time frame: 8 weeks
The difference of change of 24h ambulatory systolic blood pressure after 8-week treatment between treatment and control group
4 secondary outcomes
Change in office blood pressure
Time frame: 4 and 8 weeks
Change in 24-hour ambulatory systolic blood pressure by stratum
Time frame: 8 weeks
Change in 24-hour ambulatory diastolic blood pressure, daytime and nighttime blood pressure
Time frame: 8 weeks
Change in home blood pressure
Time frame: 8 weeks
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 Jan 2025.
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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 Phase 4 study testing Gastrodia and Uncaria granule in people with Hypertension, run by Shanghai Institute of Hypertension 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 6 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: finished, as of the sponsor's last update on 7 Jan 2025. 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. Some participants in this study may receive a placebo. 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?
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?
Change in 24-hour ambulatory systolic blood pressure (time frame: 8 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 7 Jan 2025.