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A multicenter randomized, double-blind, placebo-controlled trial for Teng-Fu Jiang-Ya tablets combined with Valsartan/Amlodipine in the Treatment of primary hypertension (grade 2) with liver yang hyperactivity syndrome

A multicenter randomized, double-blind, placebo-controlled trial for Teng-Fu Jiang-Ya tablets combined with Valsartan/Amlodipine in the Treatment of primary hypertension (grade 2) with liver yang hyperactivity syndrome

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2000003098
Enrollment
Unknown
Registered
2020-03-08
Start date
2020-07-01
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

Essential Hypertension

Interventions

Sponsors

Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged between 18-75 years old; 2. Patients who meet the western diagnostic standard of grade 2 hypertension and the TCM syndrome differentiation standard of hyperactivity of liver Yang syndrome; 3. The patients with grade 2 essential hypertension and moderate risk are identified according to the blood pressure level and cardiovascular risk stratification of hypertension, whose blood pressure meet any one of the following three criteria: (1) Systolic blood pressure 160-179mmHg and/or diastolic blood pressure 100-109 mmHg, no previous use of any antihypertensive drugs, no complications such as heart, brain and kidney; (2) Patients who have been clearly diagnosed as essential hypertension and whose blood pressure is still not up to the standard after 3 months of improved lifestyle or other forms of non-drug therapy, maintaining the blood pressure at 160-179/100-109mmhg; (3) Patients who have been clearly diagnosed as essential hypertension and whose blood pressure is still not up to the standard after 3 months of improved lifestyle or other forms of non-drug therapy and oral antihypertensive medication, maintaining the blood pressure at 160-179/100-109mmhg; 4. Patients whose course of hypertension must be more than 3 months; 5. Patients with informed consent and signing informed consent.

Exclusion criteria

Exclusion criteria: 1. With various secondary hypertension; 2. Patients Received other new drugs in the past 3 months; 3. Patients with moderate or severe diabetes or patients with myocardial infarction or cerebral apoplexy within half a year; 4. Pregnant or pregnant women and women in lactation; 5. Patients who are allergic to a variety of drugs or allergic constitution; 6. Patients with mental illness, alcoholism and/or psychoactive substance abuse and dependence; 7. With combining with the following organ damage or disease, angina pectoris, heart failure, transient brain, hypertensive encephalopathy, retinopathy (with or without apparent papillary edema), plasma creatinine concentration of 2.0 mg/dl or more renal function failure, liver failure, or aortic aneurysm, aortic dissecting aneurysm artery occlusive disease symptoms. 8. At present, patients who have taken valsartan 80mg/amlodipine 5mg and other ARB/CCB compound drugs, and whose blood pressure is still level 2 and above.

Design outcomes

Primary

MeasureTime frame
Blood fat;Urinary microalbumin;Blood pressure;Blood sugar;Homocysteine(HCY);Hypersensitive c-reactive protein;Syndrome score of TCM;Uric acid;

Countries

China

Contacts

Public ContactYunlun Li

Affiliated Hospital of Shandong University of Traditional Chinese Medicine

li.yunlun@163.com+86 13869102760

Outcome results

None listed

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