NCT01847807

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
210

participants targeted

Target at P25-P50 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

May 2, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 7, 2013

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Last Updated

October 9, 2015

Status Verified

October 1, 2015

Enrollment Period

4.4 years

First QC Date

May 2, 2013

Last Update Submit

October 7, 2015

Conditions

Metabolic Syndrome

Keywords

5-10 gram astragalus per day

Outcome Measures

Primary Outcomes (1)

  • index of cardiac function

    ues echocardiography to measure the cardiac function

    one year

Secondary Outcomes (1)

  • blood pressure

    one year

Other Outcomes (3)

  • kidney function

    one year

  • Central Blood Pressure

    one year

  • Ankle Brachial Index

    one year

Study Arms (3)

High-dose Astragalus group

ACTIVE COMPARATOR

treatment with 10 gram astragalus

Drug: high dose astagalus

Low-dose Astragalus group

ACTIVE COMPARATOR

treatment with 5 gram astragalus

Drug: low dose Astragalus

MS control

NO INTERVENTION

Interventions

low dose AstragalusDRUG
Low-dose Astragalus group
high dose astagalusDRUG
High-dose Astragalus group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • patients with resistant hypertension
  • renal disease requiring dialysis
  • heart failure NYHA ⅢorⅣ;
  • complications of diabetes
  • arteritis
  • cancer
  • thyroid disease
  • unstable coronary heart disease
  • peripheral vascular disease
  • acute cerebral vascular disease11.pregnancy、 planned pregnancy
  • patients with anti-oxidants
  • acute infection
  • other organic dysfunction, such as the liver, respiratory system, blood system, and other rheumatic diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lanzhou University Second Hospital

Lanzhou, Gansu, 730030, China

Location

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
cheif of cardiology

Study Record Dates

First Submitted

May 2, 2013

First Posted

May 7, 2013

Study Start

January 1, 2011

Primary Completion

June 1, 2015

Last Updated

October 9, 2015

Record last verified: 2015-10

Locations

CN(1)