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NCT Number: NCT06093932

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

Recruiting

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Key information

Conditions

Hypertension,Essential Cardiovascular Diseases Essential Hypertension Hypertension Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Vascular Diseases Vascular Remodeling

Age range

35 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Xiyuan Hospital of China Academy of Chinese Medical Sciences, Beijing, Beijing Municipality, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

  8. 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)

  9. 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)

  10. 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)

  11. 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)

  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)

  13. 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)

  14. 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)

  15. 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)

  16. 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

  17. 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)

  18. 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)

  19. 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)

  20. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Anlu Wang, Doctor

CONTACT

[email protected]

010-62835342

Qiyu Liu, Doctor

CONTACT

[email protected]

010-18810722937

Sponsors and collaborators

Lead sponsor

Xiyuan Hospital of China Academy of Chinese Medical Sciences

Other

Collaborators

  • Shandong University of Traditional Chinese Medicine
  • Suzhou Hosptial of Traditional Chinese Medicine

Registry information

Official study title

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

Acronym: ESCIHP

Important dates

Study start
2024
Primary completion
2024
Study completion
2027
First posted
Oct 23, 2023
Registry last updated
Aug 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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