Status:

RECRUITING

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

Lead Sponsor:

Xiyuan Hospital of China Academy of Chinese Medical Sciences

Collaborating Sponsors:

China Academy of Chinese Medical Sciences Xiyuan Hospital Shanxi Hospital

Suzhou Hosptial of Traditional Chinese Medicine

Conditions:

Hypertension,Essential

Eligibility:

All Genders

35-65 years

Phase:

PHASE4

Brief 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 str...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

April 7 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2027

Estimated Enrollment :

100 Patients enrolled

Trial Details

Trial ID

NCT06093932

Start Date

April 7 2024

End Date

December 1 2027

Last Update

August 20 2024

Active Locations (5)

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Page 1 of 2 (5 locations)

1

Xiyuan Hospital of China Academy of Chinese Medical Sciences

Beijing, Beijing Municipality, China, 100091

2

Suzhou Hosptial of Traditional Chinese Medicine

Suzhou, Jiangsu, China, 215002

3

Affiliated Hospital of Shandong University of Traditional Chinese Medicine

Jinan, Shandong, China, 250013

4

China Academy of Chinese Medical Sciences Xiyuan Hospital Jining Hospital

Jining, Shandong, China, 272000