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Observation on the therapeutic effect of Pingmai Zhixuan Pills on elderly hypertension

Observation on the therapeutic effect of Pingmai Zhixuan Pills on elderly hypertension and its mechanism of action

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025001337
Enrollment
Unknown
Registered
2025-07-05
Start date
2022-05-17
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

Hypertension

Interventions

Control Group:oral amlodipine besylate tablet group:Oral administration of amlodipine besylate tablets 5 mg each time once a day for 3 consecutive months.
Intervention Group:Oral Pingmai Zhixuan Pill Group:Take Pingmai Zhixuan Pills orally, 6g each time, twice a day, for a course of 3 months

Sponsors

Kaifeng Traditional Chinese Medicine Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1) Age 60-80 years old; 2) Western medicine diagnostic criteria: meet the latest "Hypertension Guidelines" in May 2020 Grade 1 (mild) hypertension criteria that is 2-3 consecutive blood pressure measurements within 1-4 weeks with systolic blood pressure of 140-159 mmHg and/or diastolic blood pressure of 90-99 mmHg in the clinic; 3) Chinese medicine diagnostic criteria: meet the diagnostic criteria of liver yang hyperactivity syndrome in Chinese medicine and refer to the "Guidelines for Clinical Research of New Chinese Medicines (Trial)" for diagnosis. Main symptoms: dizziness headache irritability; Secondary symptoms: flushed face red eyes dry mouth bitter mouth constipation red urine red tongue with yellow fur and stringy pulse. 4) Voluntary participation in this study and signing of informed consent.

Exclusion criteria

Exclusion criteria: 1) Patients with secondary hypertension; 2) Patients with heart liver kidney brain and other diseases (amlodipine besylate tablets should be used with caution in patients with angina pectoris myocardial infarction heart failure liver dysfunction and renal failure); 3) Patients with intellectual disabilities or mental and behavioral abnormalities who cannot cooperate with treatment and observation; 4) Patients who are allergic to the components of the drug in this study and have drug contraindications; 5) Patients with spleen and stomach deficiency and cold and yin deficiency constitution.

Design outcomes

Primary

MeasureTime frame
TCM symptom score;24-hour Blood Pressure;Duchenne hypertension quality of life score;Total effective rate of drug efficacy;

Countries

China

Contacts

Public ContactTao Zhu

Kaifeng Traditional Chinese Medicine Hospital

zt889158@126.com+86 186 3788 9158

Outcome results

None listed

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