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

Xiyuan Hospital of China Academy of Chinese Medical Sciences

Status and phase: Enrolling; Phase 4

Conditions: Hypertension,Essential

Treatments: Drug: Placebo; Drug: Songling Xuemaikang Capsules; Behavioral: Lifestyle intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06093932

2023XL012-3

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 35 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups, including a placebo group

Lifestyle intervention + Songling Xuemaikang Capsules

Experimental group

Description:

1. Therapeutic Hypertensive Lifestyle Modifications, everyday, duration: 12 weeks 2. Songling Xuemaikang Capsules, 3 capsules at a time, three times a day, duration: 12 weeks

Treatment:

Behavioral: Lifestyle intervention

Drug: Songling Xuemaikang Capsules

Lifestyle intervention + placebo

Placebo Comparator group

Description:

1. Therapeutic Hypertensive Lifestyle Modifications, everyday, duration: 12 weeks 2. placebo, 3 capsules at a time, three times a day, duration: 12 weeks

Treatment:

Behavioral: Lifestyle intervention

Drug: Placebo