RecruitingPhase 4NCT06093932

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

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


Sponsor

Xiyuan Hospital of China Academy of Chinese Medical Sciences

Enrollment

100 participants

Start Date

Apr 7, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 35 YearsMax Age: 65 Years

Inclusion Criteria4

  • 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 Criteria9

  • 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.

Interventions

DRUGSongling Xuemaikang Capsules

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

BEHAVIORALLifestyle intervention

everyday, duration: 12 weeks

DRUGPlacebo

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


Locations(5)

Xiyuan Hospital of China Academy of Chinese Medical Sciences

Beijing, Beijing Municipality, China

Suzhou Hosptial of Traditional Chinese Medicine

Suzhou, Jiangsu, China

Affiliated Hospital of Shandong University of Traditional Chinese Medicine

Jinan, Shandong, China

China Academy of Chinese Medical Sciences Xiyuan Hospital Jining Hospital

Jining, Shandong, China

China Academy of Chinese Medical Sciences Xiyuan Hospital Shanxi Hospital

Taiyuan, Shanxi, China

View Full Details on ClinicalTrials.gov

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NCT06093932


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