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

• Status: Not yet recruiting
• Trial end date: 2027-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Xiyuan Hospital of China Academy of Chinese Medical Sciences
• Collaborators: China Academy of Chinese Medical Sciences Xiyuan Hospital Jining Hospital; Shandong University of Traditional Chinese Medicine; Suzhou Hosptial of Traditional Chinese Medicine

Criteria

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.