Efficacy of Songling Xuemaikang Capsules on Grade 1 Hypertension: a Randomized Controlled Trial (ESCIHP)

August 17, 2024 updated by: Xiyuan Hospital of China Academy of Chinese Medical Sciences

Efficacy of Songling Xuemaikang Capsules on Grade 1 Hypertension: a Randomized, Multicenter, Double-blind, Placebo-controlled Trial

The purpose of this study is:

  1. To evaluate the efficacy of Songling Xuemaikang Capsules(SLXMKC) with grade 1 hypertension.
  2. To reveal the potiential effects of SLXMKC on vascular function and structure of patients with grade 1 hypertension.
  3. To explore the underlying mechanisms of the therapeutic effects of SLXMKC on the intervention of grade 1 hypertension.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100091
        • Recruiting
        • Xiyuan Hospital of China Academy of Chinese Medical Sciences
        • Contact:
    • Jiangsu
      • Suzhou, Jiangsu, China, 215002
        • Not yet recruiting
        • Suzhou Hosptial of Traditional Chinese Medicine
        • Contact:
    • Shandong
      • Jinan, Shandong, China, 250013
        • Not yet recruiting
        • Affiliated Hospital of Shandong University of Traditional Chinese Medicine
        • Contact:
      • Jining, Shandong, China, 272000
        • Not yet recruiting
        • China Academy of Chinese Medical Sciences Xiyuan Hospital Jining Hospital
        • Contact:
    • Shanxi
      • Taiyuan, Shanxi, China, 030024
        • Not yet recruiting
        • China Academy of Chinese Medical Sciences Xiyuan Hospital Shanxi Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age between 35-65 years old, male or female;
  • Grade 1 essential hypertension;
  • Taking no antihypertensive drugs or taking antihypertensive drugs irregularly in the past ;
  • Sign the informed consent;

Exclusion Criteria:

  • Significant liver and kidney dysfunction, ALT and AST upper the twice of normal range, Scr≥2.0mg/dl, eGFR<60ml/(min·1. 73m2);
  • Gastrointestinal diseases, which may affect drug absorption;
  • Be allergic to the clinical trial medicine;
  • Pregnant or breastfeeding women, men who plan to give birth within half a year;
  • Combined with other serious primary diseases or malignant tumors;
  • Hyperlipidemia with or without taking lipid-lowering drugs;
  • Combined with left ventricular hypertrophy, ABI < 0.9, CIMT ≥ 0.9mm or atherosclerotic plaque;
  • Hypertensive comorbidities (cerebrovascular disease, other cardiovascular diseases, renal disease, peripheral artery disease, retinopathy, diabetes);
  • Other serious conditions in which is not fit for the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Lifestyle intervention + Songling Xuemaikang Capsules
  1. Therapeutic Hypertensive Lifestyle Modifications, everyday, duration: 12 weeks
  2. Songling Xuemaikang Capsules, 3 capsules at a time, three times a day, duration: 12 weeks
Drug: Songling Xuemaikang Capsules
3 capsules at a time, three times a day, duration: 12 weeks
Behavioral: Lifestyle intervention
everyday, duration: 12 weeks
Placebo Comparator: Lifestyle intervention + placebo
  1. Therapeutic Hypertensive Lifestyle Modifications, everyday, duration: 12 weeks
  2. placebo, 3 capsules at a time, three times a day, duration: 12 weeks
Behavioral: Lifestyle intervention
everyday, duration: 12 weeks
Drug: Placebo
3 capsules at a time, three times a day, duration: 12 weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from Baseline in the Mean 24h Systolic Blood Pressure at 4,12 weeks
Time Frame: Baseline and Week 4,12
Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)
Baseline and Week 4,12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from Baseline in the ba-PWV at 4,12 weeks
Time Frame: Baseline and Week 4,12
Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)
Baseline and Week 4,12
Change from Baseline in the skin capillary density(SCD) at 4,12 weeks
Time Frame: Baseline and Week 4,12
Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)
Baseline and Week 4,12
Change from Baseline in the Mean 24h Diastolic Blood Pressure at 4,12 weeks
Time Frame: Baseline and Week 4,12
Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)
Baseline and Week 4,12
Change from Baseline in the Mean daytime Systolic Blood Pressure at 4,12 weeks
Time Frame: Baseline and Week 4,12
Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)
Baseline and Week 4,12
Change from Baseline in the Mean daytime Diastolic Blood Pressure at 4,12 weeks
Time Frame: Baseline and Week 4,12
Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)
Baseline and Week 4,12
Change from Baseline in the Mean nighttime Systolic Blood Pressure at 4,12 weeks
Time Frame: Baseline and Week 4,12
Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)
Baseline and Week 4,12
Change from Baseline in the Mean nighttime Diastolic Blood Pressure at 4,12 weeks
Time Frame: Baseline and Week 4,12
Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)
Baseline and Week 4,12
Change from Baseline in the Mean 24h PP at 4,12 weeks
Time Frame: Baseline and Week 4,12
Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)
Baseline and Week 4,12
Change from Baseline in the BP load at 4,12 weeks
Time Frame: Baseline and Week 4,12
Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)
Baseline and Week 4,12
Change from Baseline in the Official PP at 4,12 weeks
Time Frame: Baseline and Week 4,12
Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)
Baseline and Week 4,12
Change from Baseline in the Official SBP at 4,12 weeks
Time Frame: Baseline and Week 4,12
Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)
Baseline and Week 4,12
Change from Baseline in the Official DBP at 4,12 weeks
Time Frame: Baseline and Week 4,12
Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)
Baseline and Week 4,12
Change from Baseline in the Official BP Compliance Rate at 4,12 weeks
Time Frame: Baseline and Week 4,12
Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)
Baseline and Week 4,12
Change from Baseline in the Home SBP at 4,12 weeks
Time Frame: Baseline and Week 4,12
Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)
Baseline and Week 4,12
Change from Baseline in the Home DBP at 4,12 weeks
Time Frame: Baseline and Week 4,12
Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)
Baseline and Week 4,12
Proportion of patients with grade 2 or higher hypertension or target organ damage at 12 weeks
Time Frame: Week 12
Proportion= Number of target patients/Total patients
Week 12
Change from Baseline in the CIMT at 4,12 weeks
Time Frame: Baseline and Week 4,12
Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)
Baseline and Week 4,12
Change from Baseline in the Hypertension Symptom Quantitative Score at 4,12 weeks
Time Frame: Baseline and Week 4,12
Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)
Baseline and Week 4,12
Change from Baseline in the Patient Health Questionnaire-9 Quantitative Score at 4,12 weeks
Time Frame: Baseline and Week 4,12
Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)
Baseline and Week 4,12
Change from Baseline in the Generalized Anxiexy Disorde-7 Quantitative Score at 4,12 weeks
Time Frame: Baseline and Week 4,12
Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)
Baseline and Week 4,12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Xiyuan Hospital of China Academy of Chinese Medical Sciences

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Shandong University of Traditional Chinese Medicine
China Academy of Chinese Medical Sciences Xiyuan Hospital Shanxi Hospital
Suzhou Hosptial of Traditional Chinese Medicine
China Academy of Chinese Medical Sciences Xiyuan Hospital Jining Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Hao Xu, Prof., Xiyuan Hospital of China Academy of Chinese Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 7, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 17, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 17, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 23, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 20, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 17, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2023XL012-3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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