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A multicenter randomized, double-blind, placebo-controlled trial for GouTengXuanShen KeLi in treating Liver Yang Syndrome of normal high blood pressure

A multicenter randomized, double-blind, placebo-controlled trial for GouTengXuanShen KeLi in treating Liver Yang Syndrome of normal high blood pressure

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200061659
Enrollment
Unknown
Registered
2022-06-30
Start date
2022-06-17
Completion date
Unknown
Last updated
2023-09-04

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

Conditions

Normal high blood pressure

Interventions

Experimental group:GouTengXuanShen KeLi+ lifestyle intervention
Control group:Placebo + lifestyle intervention

Sponsors

Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged 18 - 65 years; 2. It conforms to the western diagnostic standard of normal high value hypertension and TCM syndrome differentiation standard of hyperactivity of liver Yang; 3. No clear history of essential hypertension, and no antihypertensive drugs in the past 3 months; 4. Informed consent and signing of informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with secondary elevated blood pressure; 2. Applicants who have received clinical trials of other new drugs in the last 3 months; 3. Pregnant or trying to get pregnant and breast-feeding women; 4. People who have been allergic to multiple drugs or have an allergic constitution; 5. Persons with combined mental illness, alcoholism and/or psychoactive substance substance abuse and dependence; 6. Excessive daily consumption of tea, coffee or caffeinated beverages; 7.1 Type diabetes, or type 2 diabetes with poor blood glucose control (fasting blood glucose > 11 mmol/L) or complications (kidney disease, peripheral neuropathy); 8. Gastrointestinal diseases or gastrointestinal surgery may affect drug absorption and other serious diseases of the digestive system; 9. Patients with the following organ damage or diseases: cerebrovascular diseases with a history of 12 months (cerebral hemorrhage, subarachnoid hemorrhage, cerebral thrombosis, cerebral infarction and transient ischemic attack); Acute coronary syndrome with a 3-month history; Decompensated heart failure (NYHA grade III ~ IV); Renal insufficiency (creatinine greater than the upper limit of normal); Abnormal liver function (ALT, AST > 1.5 times the upper limit of normal value); Active, recurrent ulcers of the digestive system or other diseases at risk of bleeding; Complicated with malignant tumor, hematologic disease or other systemic serious or progressive disease.

Design outcomes

Secondary

MeasureTime frame
The score of TCM syndrome;Duchenne revised hypertension quality of life scale;Blood fat;Blood sugar;Urinary microalbumin;Blood uric acid;Blood homocysteine;Hypersensitive C-reactive protein;

Primary

MeasureTime frame
Blood pressure;

Countries

China

Contacts

Public ContactYunlun Li

Affiliated Hospital of Shandong University of Traditional Chinese Medicine

swanxj@163.com+86 178 6296 8375

Outcome results

None listed

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