A randomized controlled trial for the clinical effect of Wu-Mei-Wan Decoction in the treatment of primary hypertension with upper heat and lower cold syndrome

Not Applicable

• Conditions: Essential hypertension

• Registration Number: ITMCTR2000003155
• Lead Sponsor: Affiliated Hospital of Shandong University of TCM

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

(1) Patients, who were diagnosed with the criteria of essential hypertension, who belonged to the types of upper heat and lower cold syndrome,who after the lifestyle intervention,and diagnosed the upper heat and lower cold syndrome of essential hypertension grade I;
(2) In the past 2 weeks, the blood pressure was stable, without the treatment of traditional Chinese medicine or proprietary Chinese medicine, without the treatment of western medicine or after the treatment of western medicine, the blood pressure was still in hypertensive grade 1 patients;
(3) aged 18-75 years old;
(4) Volunteer to participate in the experiment and sign the informed consent, and cooperate with various investigations and tests.

Exclusion Criteria

1. secondary hypertension, refractory hypertension, malignant hypertension, acute and subacute hypertension, white coat hypertension and unstable blood pressure;
2. pregnant and lactating women, women of child-bearing age do not agree to use contraceptive measures during the experiment;
3. Have mental illness, can't cooperate very well;
4. confirmed to have serious heart disease, severe neurosis and heart, liver, kidney insufficiency;
5. With severe endocrine, hematopoietic system, liver, kidney and other primary diseases, malignant tumors, mental patients;
6. Uncorrected hyperthyroidism, hypothyroidism; Patients with nephrotic syndrome, diabetes mellitus and acute hepatobiliary disease;
7. people who have suffered from serious cerebrovascular accidents, heart diseases, severe trauma, major surgery and other primary diseases with unstable general conditions and poor prognosis within 6 months;
8. Data were collected on cases of other diseases that were under medical treatment and affected experimental drug observers;
9. those who have participated in clinical trials of other drugs within three months;
10. Other conditions that the researchers considered inappropriate for inclusion were eliminated.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quality of life score;Mean dynamic blood pressure;NOS3, TNF, IL6, TP53, CCL2;symptom score of TCM;

Secondary Outcome Measures

Name	Time	Method
Routine blood;Routine urine;LDL-C;triglycerides;HDL-C;Routine stool;triglycerides;ECG;Liver function;Blood sugar;Renal function;