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A randomized, double-blind, placebo-controlled trial of Xiantianma capsule combined with amlodipine besylate tablets in the treatment of hyperactivity of liver yang in middle and low-risk essential hypertension.

A randomized, double-blind, placebo-controlled trial of Xiantianma capsule combined with amlodipine besylate tablets in the treatment of hyperactivity of liver yang in middle and low-risk essential hypertension.

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300074597
Enrollment
Unknown
Registered
2023-08-10
Start date
2023-08-15
Completion date
Unknown
Last updated
2023-08-21

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

Conditions

essential hypertension

Interventions

treatment group: Xiantianma Capsule+Amlodipine Benzenesulfonate Tablets
control group: Xiantianma Capsule placebo+Amlodipine Benzenesulfonate Tablets

Sponsors

Guang 'anmen Hospital, Chinese Academy of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
25 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) The diagnosis of western medicine conforms to the diagnostic criteria of middle and low risk essential hypertension (grade 1-2); (2) A cardiovascular specialist with an associate senior professional title judged that it meets the diagnostic criteria of hyperactivity of liver yang; (3) Hypertension has not been treated or stopped using antihypertensive drugs for at least 2 weeks; (4) Age between 25 and 75, regardless of sex; (5) Patients voluntarily participate in the trial and sign the informed consent form, which has a high degree of obedience and cooperation.

Exclusion criteria

Exclusion criteria: (1) secondary hypertension; (2)The acute coronary syndrome, heart failure, serious arrhythmia, valvular heart disease, cardiomyopathy, stroke and other serious cardiovascular and cerebrovascular diseases; (3) Diabetes patients (fasting blood glucose > 11mmol /L), or diabetes-related complications (such as nephropathy or peripheral neuropathy); (4) taking beta blockers or sedative sleeping pills; (5) Shift workers; (6) Abnormal liver function [(alanine aminotransferase (ALT) and aspartate aminotransferase (AST) are more than 3 times the normal upper limit)], or severe abnormal renal function (estimated glomerular filtration rate < 30 ml/(min/1.73 m2); (7) Suffering from serious mental disorder, intellectual disorder or language disorder; Suffering from serious hematopoietic diseases; People with malignant tumors; (8)Being allergic to Chinese and western medicines in this study; (9) Patients during pregnancy and lactation; (10) Those who have participated in clinical trials of other drugs at the same time or in recent 2 months.

Design outcomes

Primary

MeasureTime frame
Systolic pressure in clinic;

Secondary

MeasureTime frame
Diastolic blood pressure and blood pressure control rate in consultation room;Ambulatory blood pressure monitoring;Integrals of TCM syndromes;Hypertension symptom score;Headache visual analogue scale;Sleep quality;quality of life;Anxiety and depression;Blood lipid and biochemical indexes;

Countries

China

Contacts

Public ContactKuiwu Yao

Guang 'anmen Hospital, Chinese Academy of Traditional Chinese Medicine

yaokuiwu@126.com+86 186 1036 6611

Outcome results

None listed

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