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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

Registration number：

ITMCTR2024000880

Date of Last Refreshed on：

2024-12-28

Date of Registration：

2024-12-28

Registration Status：

Prospective registration

Public title：

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

English Acronym：

Scientific title：

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

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

Applicant：

Xin Liu

Study leader：

Linzi Long

Applicant telephone：

19260269897

Study leader's telephone：

15801152337

Applicant Fax：

Study leader's fax：

Applicant E-mail：

ldxstar0217@163.com

Study leader's E-mail：

qixiang830803@163.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

No.1 Xiyuan Playground Haidian District Beijing

Study leader's address：

No.1 Xiyuan Playground Haidian District Beijing

Applicant postcode：

Study leader's postcode：

Applicant's institution：

Xiyuan Hospital of China Academy of Chinese Medical Sciences

Approved by ethic committee：

Approved No. of ethic committee：

2024XLA209-2

Approved file of Ethical Committee：

View

Name of the ethic committee：

Medical Ethics Committee of Xiyuan Hospital China Academy of Chinese Medical Sciences

Date of approved by ethic committee：

2024/12/6 0:00:00

Contact Name of the ethic committee：

Mingjie Zi

Contact Address of the ethic committee：

No.1 Xiyuan Playground Haidian District Beijing

Contact phone of the ethic committee：

010-62835646

Contact email of the ethic committee：

drzimingjie@169.com

Primary sponsor：

Xiyuan Hospital of China Academy of Chinese Medical Sciences

Primary sponsor's address：

No.1 Xiyuan Playground Haidian District Beijing

Secondary sponsor：

Country：

China

Province：

Beijing

City：

Institution
hospital：

Xiyuan Hospital of China Academy of Chinese Medical Sciences

Address：

No.1 Xiyuan Playground Haidian District Beijing

Source(s) of funding：

Self-financing

Target disease：

Isolated diastolic hypertension

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Pilot clinical trial

Objectives of Study：

1Evaluate the efficacy and safety of Qingda Granules in the treatment of patients with simple diastolic hypertension (grade 1 low to medium risk) with hyperactivity of liver yang and provide high-level evidence to support the prevention and treatment of IDH with Qingda Granules. 2Based on the fact that calcitonin gene-related peptide (CGRP) is an important vasodilator and prostacyclin (PGI) adrenomedullin (ADM) and thromboxane A (TXA2) are vasoconstrictor peptides Qingda Granules have a key role in the treatment of simple diastolic hypertension (grade 1 low-risk). From the perspective of vasoactive peptides regulating vasodilatory function the key role of Qingda Granules in simple diastolic hypertension was elucidated.

Description for medicine or protocol of treatment in detail：

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：

(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.

Study execute time：

From 2024-03-15

To      2027-03-14

Recruiting time：

From 2025-01-01

To      2025-12-01

Interventions：

50

Group：

experimental group

Sample size：

Intervention：

Qingda Granules Combined with Lifestyle Intervention

Intervention code：

50

Group：

control group

Sample size：

Intervention：

Qingda granule simulant combined with lifestyle intervention

Intervention code：

Total sample size ： 100

Countries of recruitment
and research settings：

Country：

China

Province：

Beijing

City：

Institution/hospital：

Xiyuan Hospital of China Academy of Chinese Medical Sciences

Level of the institution：

Tertiary A

Outcomes：

Outcome：

The change of VAS vertigo score before treatment, after 2 and 4 weeks of treatment

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

The changes of hypertension hormones（Renin、Angiotensin II、ALD）before treatment, after 4 weeks of treatment

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

The changes of vasoactive substances（TXB2、ADM、PGI2、CGRP）before treatment, after 4 weeks of treatment

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Office systolic blood pressure and home systolic blood pressure change from baseline values before treatment, after 2 and 4 weeks of treatment

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Ambulate blood pressure control before treatment, after 4 weeks of treatment

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

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

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

The change of the total score of TCM syndrome score before treatment, after 2 and 4 weeks of treatment

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

The change of the score of TCM single syndrome score before treatment, after 2 and 4 weeks of treatment

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

The change of duchenne hypertension life scale before treatment, after 2 and 4 weeks of treatment

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Sample Name：

blood

Tissue：

Fate of sample 

Destruction after use

Note：

Sample Name：

Urine

Tissue：

Fate of sample 

Destruction after use

Note：

Not yet recruiting

20
Min age years
75
Max age years

Recruiting status：

Participant age：

Gender：

Both

Randomization Procedure (please state who generates the random number sequence and by what method)：

By statistical experts who are not related to the statistical analysis of data management performed in this experiment the random coding was generated by randomization method in a 1:1 ratio between two groups using SAS 9.4 statistical software package. According to this random number the drugs were coded by persons unrelated to the study and used in order of case inclusion.

Blinding：

IPD sharing：

No

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

N/A

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

CRF and EDC

Data Managemen Committee：

Not yet

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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