Clinical efficacy evaluation of Qingda Granule in the treatment of hypertension (grade 1, low to medium-risk) patients: a multicenter, randomized, double-blind, double-simulated, parallel-controlled, non-inferiority clinical study

Phase 1

Recruiting

• Conditions: hypertension

• Registration Number: ITMCTR2000003400
• Lead Sponsor: Xiyuan Hospital, Chinese Academy of Chinese Medical Sciences

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: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Meet the diagnostic criteria for essential hypertension measured in the same clinic, the hypertension is graded as grade 1, and the risk stratification is low to medium risk (refer to the 2018 Revision of Chinese Guidelines for The Prevention and Treatment of Hypertension);
2. Did not take or did not take blood pressure medicine regularly within one month;
3. Between 20 and 75 years old (including boundary value);
4. Agree to sign the informed consent.

Exclusion Criteria

1. Patients with obvious liver and kidney diseases or with ALT and AST 1.5 times higher than ULN, Cr and BUN higher than ULN;
2. Patients with serious mental illness, hematopoietic disease, malignant tumor and other major diseases;
3. Women who are pregnant or preparing for pregnancy, and women who are breastfeeding;
4. Have participated in or are participating in other clinical researchers in the past three months;
5. Suspected or definite allergy to the study drug.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Systolic blood pressure decreased over 4 weeks after treatment;

Secondary Outcome Measures

Name	Time	Method
Blood pressure control at 4 weeks and 8 weeks after treatment (24-hour ambulate blood pressure monitoring);The change of the total score of TCM syndrome score compared with that before medication (day 0);The blood pressure reached the target rate at the end of 4 and 8 weeks after treatment;The changes of four hypertension hormones compared with those before medication (day 0);Diastolic blood pressure drops over 4 weeks of treatment;The change of Hamilton anxiety self-rated total score compared with that before medication (day 0);Treatment 8 weekend systolic and diastolic blood pressure drop values;