Skip to content

A randomized, double-blind, placebo-controlled, multicenter clinical study of Lianggan Qingxin Jiangya capsule in the treatment of grade 1 hypertension with liver fire syndrome

A randomized, double-blind, placebo-controlled, multicenter clinical study of Lianggan Qingxin Jiangya capsule in the treatment of grade 1 hypertension with liver fire syndrome

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000031573
Enrollment
Unknown
Registered
2020-04-04
Start date
2020-04-20
Completion date
Unknown
Last updated
2020-04-06

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 65 Years

Inclusion criteria

Inclusion criteria: 1. The age is between 18 and 65 years old. 2. At the same time, it accords with the diagnostic standard of western medicine for hypertension and the standard of TCM syndrome differentiation of liver-fire inflammation. 3. According to the stratification of blood pressure level and cardiovascular risk of hypertension, the blood pressure of patients with essential hypertension, low-risk and moderate-risk patients conforms to any one of the following three items: (1) systolic blood pressure 140-159mmHg and / or diastolic blood pressure 90-99mmHg. No antihypertensive drugs were taken in the past, and no complications such as heart, brain and kidney were found. (2) those who had been clearly diagnosed as essential hypertension and whose blood pressure was not up to standard after improving their lifestyle or other forms of non-drug treatment for 3 months and maintained at 140-159/90-99mmHg; (3) those who have been clearly diagnosed as essential hypertension and whose blood pressure is not up to standard after improving their lifestyle or other forms of non-drug treatment and oral antihypertensive drugs for 3 months, and who remain in 140-159/90-99mmHg, refuse to add other western antihypertensive drugs; 4. The course of hypertension must be more than 3 months. 5. Those who give informed consent and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Those who have received clinical trials of other new drugs in the past 3 months; 2. Patients with moderate and severe diabetes or those with myocardial infarction or stroke history within half a year; 3. Pregnant or preparing for pregnancy and lactating women; 4. Those who have been allergic to a variety of drugs or who are allergic to a variety of drugs in the past; 5. Combination of abusers and addicts of mental illness, alcoholism and or psychoactive substances; 6. At the same time, patients with the following organ damage or diseases: angina pectoris, heart failure, transient cerebral insufficiency, hypertensive encephalopathy, retinopathy (with or without optic papilla edema), plasma creatinine concentration above 2.0mg/dl renal failure, liver failure, aortic dissection or aortic aneurysm, obvious symptoms of arterial occlusive disease. Note: any one or more of the above items should be excluded and cannot be selected.

Design outcomes

Primary

MeasureTime frame
TCM syndrome score of liver-fire inflammation syndrome of hypertension;Blood pressure;

Secondary

MeasureTime frame
Blood lipids;Blood sugar;Urinary microalbumin;Uric acid;Homocysteine (HCY);Hypersensitive c-reactive protein;Differences in species composition and abundance of intestinal microflora;Trimethylamine oxide;

Countries

China

Contacts

Public ContactLi Yunlun

Affiliated Hospital of Shandong University of Traditional Chinese Medicine

li.yunlun@163.com+86 13869102760

Outcome results

None listed

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