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

ConditionHypertension,Essential
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age35-65
SponsorXiyuan Hospital of China Academy of Chinese Medical Sciences

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Songling Xuemaikang Capsules

    Drug

    3 capsules at a time, three times a day, duration: 12 weeks

  • Lifestyle intervention

    Behavioral

    everyday, duration: 12 weeks

  • Placebo

    Drug

    3 capsules at a time, three times a day, duration: 12 weeks

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Lifestyle intervention + Songling Xuemaikang CapsulesExperimental treatment 2 interventions
Group B: Lifestyle intervention + placeboPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

Change from Baseline in the Mean 24h Systolic Blood Pressure at 4,12 weeks

Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)

Time frame
Baseline and Week 4,12

Secondary outcomes

1

Change from Baseline in the ba-PWV at 4,12 weeks

Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)

Time frame
Baseline and Week 4,12
2

Change from Baseline in the skin capillary density(SCD) at 4,12 weeks

Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)

Time frame
Baseline and Week 4,12
3

Change from Baseline in the Mean 24h Diastolic Blood Pressure at 4,12 weeks

Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)

Time frame
Baseline and Week 4,12
4

Change from Baseline in the Mean daytime Systolic Blood Pressure at 4,12 weeks

Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)

Time frame
Baseline and Week 4,12

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Xiyuan Hospital of China Academy of Chinese Medical Sciences

Lead sponsor

Suzhou Hosptial of Traditional Chinese Medicine

Collaborator

Shandong University of Traditional Chinese Medicine

Collaborator

Source ClinicalTrials.gov
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