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NCT06093932RecruitingPhase 4

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

Source: ClinicalTrials.gov · Last updated 20 Aug 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
100 (estimated)
First submitted
17 Oct 2023
Start date
7 Apr 2024
Primary completion date
Dec 2024
Lead sponsor
Xiyuan Hospital of China Academy of Chinese Medical Sciences
NCT number
NCT06093932

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 100
  • From 7 Apr 2024 to the primary completion date, Dec 2024
  • 5 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Hyperlipidemia with or without taking lipid-lowering drugs;

Other illness

  • Gastrointestinal diseases, which may affect drug absorption;
  • Be allergic to the clinical trial medicine;
  • Combined with other serious primary diseases or malignant tumors;
  • 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.

Lab values

  • Significant liver and kidney dysfunction, ALT and AST upper the twice of normal range, Scr≥2.0mg/dl, eGFR\<60ml/(min·1. 73m2);

Other

  • Pregnant or breastfeeding women, men who plan to give birth within half a year;
  • Combined with left ventricular hypertrophy, ABI \< 0.9, CIMT ≥ 0.9mm or atherosclerotic plaque;

Who the study is looking for

  • 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;

Age in the registry: 35 years to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (5)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Coordinator of this site? Confirm its status
BeijingChinaRecruiting
Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Coordinator of this site? Confirm its status
JinanChinaNot yet recruiting
China Academy of Chinese Medical Sciences Xiyuan Hospital Jining Hospital
Coordinator of this site? Confirm its status
JiningChinaNot yet recruiting
Suzhou Hosptial of Traditional Chinese Medicine
Coordinator of this site? Confirm its status
SuzhouChinaNot yet recruiting
China Academy of Chinese Medical Sciences Xiyuan Hospital Shanxi Hospital
Coordinator of this site? Confirm its status
TaiyuanChinaNot yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.