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A randomized double-blind placebo-controlled clinical study of Qingda granules for the treatment of isolated diastolic hypertension (grade 1 low-intermediate risk) with Hyperactive Liver Yang Syndrome

A randomized double-blind placebo-controlled clinical study of Qingda granule for the treatment of isolated diastolic hypertension (grade 1 low-intermediate risk) with Hyperactive Liver Yang Syndrome

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2024000880
Enrollment
Unknown
Registered
2024-12-28
Start date
2025-01-01
Completion date
Unknown
Last updated
2025-01-06

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

Conditions

Isolated diastolic hypertension

Interventions

control group:Qingda granule simulant combined with lifestyle intervention
experimental group:Qingda Granules Combined with Lifestyle Intervention

Sponsors

Xiyuan Hospital of China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Meet the diagnostic criteria of simple diastolic hypertension measured by blood pressure in the unified clinic with a hypertension classification of grade 1 and a risk stratification of low to moderate risk (refer to the Chinese Guidelines for the Prevention and Treatment of Hypertension Revised Edition 2024); (2) Did not take or did not take blood pressure medicine regularly within one month; (3) Chinese medicine diagnosis is in accordance with the syndrome of hyperactivity of liver and yang; (4) Between 20 and 75 years old (including boundary value)not limited to gender; (5)The person voluntarily participates in this study and signs the informed consent.

Exclusion criteria

Exclusion criteria: (1) Patients with severe liver and kidney diseases (2) Combined unstable angina pectoris myocardial infarction acute cerebrovascular disease patients with heart failure severe psychiatric diseases hematopoietic diseases malignant neoplasms and other major illnesses patients; (3) Women who are pregnant or preparing for pregnancy in the last 6 months and women who are breastfeeding; (4) Secondary hypertension; (5) Have participated in or are participating in other clinical researchers in the past three months; (6) Suspected or definite allergy to the study drug. Those who met any of these were excluded.

Design outcomes

Primary

MeasureTime frame
Office diastolic blood pressure and home diastolic blood pressure change from baseline values before treatment, after 2 and 4 weeks of treatment;

Secondary

MeasureTime frame
Ambulate blood pressure control before treatment, after 4 weeks of treatment;The change of the total score of TCM syndrome score before treatment, after 2 and 4 weeks of treatment;Office systolic blood pressure and home systolic blood pressure change from baseline values before treatment, after 2 and 4 weeks of treatment;The changes of hypertension hormones(Renin\Angiotensin II\ALD)before treatment, after 4 weeks of treatment;The changes of vasoactive substances(TXB2\ADM\PGI2\CGRP)before treatment, after 4 weeks of treatment;The change of VAS vertigo score before treatment, after 2 and 4 weeks of treatment;The change of duchenne hypertension life scale before treatment, after 2 and 4 weeks of treatment;The change of the score of TCM single syndrome score before treatment, after 2 and 4 weeks of treatment;

Countries

China

Contacts

Public ContactLinzi Long

Xiyuan Hospital of China Academy of Chinese Medical Sciences

qixiang830803@163.com15801152337

Outcome results

None listed

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