The Organ Protection of Astragalus in Subjects With Metabolic Syndrome

October 7, 2015 updated by: Jing Yu, LanZhou University

The Cardiac and Kidney Protection of Astragalus in Subjects With Metabolic Syndrome

Metabolic syndrome have the damages on tissues and organs in heart、kindey and vessels. In this study, prospective randomized, controlled, parallel designed ,different doses of Astragalus Mongolia, Gansu Longxi produce treat on the MS patients, and then use real-time quantitative PCR and Western Blotting to detect the index of oxidative stress 、angiotensin-converting enzyme 2 mRNA expression and proteins.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

210

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Gansu
      • Lanzhou, Gansu, China, 730030
        • Lanzhou university second hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. age 18 years or older, meet the diagnostic criteria of MS
  2. non-allergic with the astragalus
  3. agree to conduct clinical trials and those who signed the informed consent

Exclusion Criteria:

  1. patients with resistant hypertension
  2. renal disease requiring dialysis
  3. heart failure NYHA ⅢorⅣ;
  4. complications of diabetes
  5. arteritis
  6. cancer
  7. thyroid disease
  8. unstable coronary heart disease
  9. peripheral vascular disease
  10. acute cerebral vascular disease11.pregnancy、 planned pregnancy
  11. patients with anti-oxidants
  12. acute infection
  13. other organic dysfunction, such as the liver, respiratory system, blood system, and other rheumatic diseases.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: High-dose Astragalus group
treatment with 10 gram astragalus
Drug: high dose astagalus
ACTIVE_COMPARATOR: Low-dose Astragalus group
treatment with 5 gram astragalus
Drug: low dose Astragalus
NO_INTERVENTION: MS control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
index of cardiac function
Time Frame: one year
ues echocardiography to measure the cardiac function
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
blood pressure
Time Frame: one year
one year

Other Outcome Measures

Outcome Measure
Time Frame
kidney function
Time Frame: one year
one year
Central Blood Pressure
Time Frame: one year
one year
Ankle Brachial Index
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LanZhou University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (ACTUAL)

June 1, 2015

Study Registration Dates

First Submitted

May 2, 2013

First Submitted That Met QC Criteria

May 6, 2013

First Posted (ESTIMATE)

May 7, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

October 9, 2015

Last Update Submitted That Met QC Criteria

October 7, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MS2304

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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