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A single-center, double-blinded, randomized, and placebo-controlled clinic trial on Yangxuetongmai Formula in the treatment of primary hypotension

A single-center, double-blinded, randomized, and placebo-controlled clinic trial on Yangxuetongmai Formula in the treatment of primary hypotension

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2024000314
Enrollment
Unknown
Registered
2024-08-27
Start date
2024-06-01
Completion date
Unknown
Last updated
2024-09-16

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

Conditions

Primary Hypotension

Interventions

Control group:Placebo
Treatment group:Yangxuetongmai Formula

Sponsors

The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
16 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Aged 16 to 75 years, gender is not limited; (2) Meets the diagnostic standard of primary hypotension; (3) Volunteer to participate in the clinical trial, understand and sign the informed consent.

Exclusion criteria

Exclusion criteria: (1) Patients with severe heart dysfunction, atrial fibrillation, aortic stenosis, arteritis and other diseases that may lead to reduced blood pressure; (2) Patients who are using antihypertensive drugs, diuretics, sedatives and other medications that may cause blood pressure fluctuations; (3) Patients who had taken TCM preparations within 2 weeks before the study, including TCM decoction, granule, Chinese patent medicine, etc.; (4) Patients with severe mental disorders, malignant tumors, severe blood diseases, acute phase of infectious diseases; (5) Patients with abnormal liver and kidney function (alanine aminotransferase, aspartate aminotransferase or serum creatinine > 2 times the upper limit of normal); (6) Women with positive pregnancy test, planned pregnancy or lactation; (7) Patients who have participated in clinical studies of other drugs within the last 1 month.

Design outcomes

Primary

MeasureTime frame
Blood pressure ;

Secondary

MeasureTime frame
Fatigue Severity Scale (FSS) score;Scoring of Four Diagnostic Information of Traditional Chinese Medicine;SF-36 Quality of Life score;

Countries

China

Contacts

Public ContactMao Jingyuan

The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

jymao@126.com+86 138 2049 8886

Outcome results

None listed

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