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A multicenter, randomized, double-blind, placebo-controlled clinical study of Fuyuan granule in the intervention of borderline hypertension

A multicenter, randomized, double-blind, placebo-controlled clinical study of Fuyuan granule in the intervention of borderline hypertension

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2022000040
Enrollment
Unknown
Registered
2022-06-16
Start date
2022-08-01
Completion date
Unknown
Last updated
2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

borderline hypertension

Interventions

control group:Health education + placebo
Intervention group:Health education + Fuyuan granule

Sponsors

Eye Hospital, China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Age 18 ~ 65 years old; (2) Systolic blood pressure 120 ~ 139mmHg and / or diastolic blood pressure 80 ~ 89mmHg; (3) The blood pressure was not controlled by western medicine, traditional Chinese medicine or acupuncture (or the treatment method was stopped for 2 weeks); (4) Willing to be randomly assigned to active and passive intervention technology group and control group; (5) Able to perform mild to moderate exercise; (6) Volunteer to participate in the trial and sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Secondary hypertension; (2) Pregnant and lactating women; (3) Non dominant arm circumference > 50cm; (4) Body mass index = 40.0kg/m2; (5) Taking benzodiazepines, antipsychotics or oral glucocorticoids (fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram and escitalopram are allowed to be used stably within 3 months); (6) Diagnose coronary heart disease; (7)ALT and AST > 2 times the upper limit of normal value; Chronic kidney disease with Cr > 2 times the upper limit of normal value and EGFR < 60ml/min (refer to the normal value range of laboratory examination in the research center) (8) Known autonomic neuropathy; (such as shy Drager syndrome, orthostatic hypotension, white coat hypertension); (9) Male alcohol intake = 25g/ day (about 65ml Beijing Erguotou), or = 140g/ week; Female = 15g/ day (about 33ml Beijing Erguotou), or = 80g/ week; (10) Complicated with malignant tumor, blood, digestive or other serious or progressive diseases; (11) The investigator believes that it is not appropriate to participate in this clinical trial.

Design outcomes

Primary

MeasureTime frame
Office blood pressure;

Secondary

MeasureTime frame
Changes in cardiovascular risk assessment;Changes in Body mass scale;Changes in mean 24-hour ambulatory blood pressure and blood pressure variability;Changes in four blood lipids;

Countries

China

Contacts

Public ContactJinglu

Eye Hospital, China Academy of Chinese Medical Sciences

jinglu00@sina.cn13611351223

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026