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An evaluation study on the clinical efficacy of Tanyutongzhi antihypertensive decoction in the intervention of high normal blood pressure population

An evaluation study on the clinical efficacy of Tanyutongzhi antihypertensive decoction in the intervention of high normal blood pressure population

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2024000769
Enrollment
Unknown
Registered
2024-12-03
Start date
2025-05-28
Completion date
Unknown
Last updated
2026-03-30

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

Conditions

High Normal Blood Pressure

Interventions

Experimental group:Tanyutongzhi antihypertensive decoction
Control group:Placebo

Sponsors

Institute of Basic Research in Clinical Medicine China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Subjects voluntarily participate and sign the informed consent form; 2. Age range: 18 years old = age < 65 years old; 3. Individuals with prehypertensive blood pressure levels ranging from 130 to 139 mmHg (systolic) and 85 to 89 mmHg (diastolic); 4. =3 cardiovascular risk factors including at least one of abdominal obesity obesity or dyslipidemia; 5. Diagnosis according to Traditional Chinese Medicine (TCM) syndrome differentiation as a syndrome of intermingled phlegm and blood stagnation; 6. Subjects have not taken any antihypertensive medications (including western medicine Chinese patent medicine traditional Chinese herbs and intravenous formulations) or undergone any external therapeutic treatments for the purpose of lowering blood pressure such as acupuncture moxibustion acupoint application etc. within the past month.

Exclusion criteria

Exclusion criteria: 1. Diagnosed with primary or secondary hypertension; 2. History of cerebrovascular diseases such as cerebral hemorrhage ischemic stroke transient ischemic attack and cerebral infarction; 3. Coexisting conditions including coronary heart disease myocardial infarction angina pectoris heart failure and arrhythmic histories such as atrial fibrillation Wolff-Parkinson-White syndrome conduction blocks as well as other diseases requiring long-term use of medications that overlap with antihypertensive drugs regardless of the purpose of use; 4. Coexisting hypertensive target organ damage chronic kidney disease (CKD) stage =3 peripheral artery disease retinopathy diabetes hematological disorders autoimmune diseases hyperthyroidism malignancy cognitive impairment and psychiatric disorders; 5. History of surgery within the past year; 6. Severe liver dysfunction: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels exceeding 3 times the normal range; 7. Patients requiring hormone or antidepressant therapy due to coexisting conditions; 8. Pregnant or lactating women; 9. Individuals with allergic constitutions; 10. Participants concurrently involved in other drug clinical studies; 11. Other situations deemed unsuitable for participation in the trial by the investigator.

Design outcomes

Primary

MeasureTime frame
Antihypertensive efficiency;

Secondary

MeasureTime frame
Traditional Chinese Medicine Syndrome Score;Triglycerides;Hypertension progression rate;High-density lipoprotein cholesterol;Total cholesteral;Low-density lipoprotein cholesterol;1-year antihypertensive efficiency;

Countries

China

Contacts

Public ContactWang Liying

Institute of Basic Research in Clinical Medicine China Academy of Chinese Medical Science

coldmoon_ly@163.com+86 158 1090 9001

Outcome results

None listed

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