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| Name | Class |
|---|---|
| Ruijin Hospital | OTHER |
| Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gastrodia and Uncaria granule | Active Comparator | Gastrodia and Uncaria granule, Chengdu Jiuzhitang Jinding Pharmaceutical Co., Ltd |
|
| Placebo | Placebo Comparator | Placebo of Gastrodia and Uncaria granule, Chengdu Jiuzhitang Jinding Pharmaceutical Co., Ltd |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gastrodia and Uncaria granule | Drug | Patients allocated to the intervention group take 10g of Gastrodia and Uncaria granule each time, twice per day, and for two months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in office blood pressure | The difference of change of office systolic and diastolic blood pressure between treatment and control group | 4 and 8 weeks |
| Change in 24-hour ambulatory systolic blood pressure by stratum |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin Hospital | Shanghai | Shanghai Municipality | 200025 | China |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C045345 | gastrodin |
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| Placebo of Gastrodia and Uncaria granule | Drug | 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. |
|
The difference of change of 24h ambulatory systolic blood pressure after 8-week treatment between liver yang hyperactivity and liver yang non-hyperactivity stratum
| 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. | 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. | 8 weeks |