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

Last updated: August 17, 2024
Sponsor: Xiyuan Hospital of China Academy of Chinese Medical Sciences
Overall Status: Active - Recruiting

Phase

4

Condition

Williams Syndrome

High Blood Pressure (Hypertension - Pediatric)

Stress

Treatment

Lifestyle intervention

Placebo

Songling Xuemaikang Capsules

Clinical Study ID

NCT06093932
2023XL012-3
  • Ages 35-65
  • All Genders

Study Summary

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

Inclusion

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 thepast ;

  • Sign the informed consent;

Exclusion

Exclusion Criteria:

  • Significant liver and kidney dysfunction, ALT and AST upper the twice of normalrange, 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 oratherosclerotic 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 Design

Total Participants: 100
Treatment Group(s): 3
Primary Treatment: Lifestyle intervention
Phase: 4
Study Start date:
April 07, 2024
Estimated Completion Date:
December 31, 2027

Connect with a study center

  • Xiyuan Hospital of China Academy of Chinese Medical Sciences

    Beijing, Beijing 100091
    China

    Active - Recruiting

  • Suzhou Hosptial of Traditional Chinese Medicine

    Suzhou, Jiangsu 215002
    China

    Site Not Available

  • Affiliated Hospital of Shandong University of Traditional Chinese Medicine

    Jinan, Shandong 250013
    China

    Site Not Available

  • China Academy of Chinese Medical Sciences Xiyuan Hospital Jining Hospital

    Jining, Shandong 272000
    China

    Site Not Available

  • China Academy of Chinese Medical Sciences Xiyuan Hospital Shanxi Hospital

    Taiyuan, Shanxi 030024
    China

    Site Not Available

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