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The Organ Protection of Astragalus in Subjects With Metabolic Syndrome

Primary Purpose

Metabolic Syndrome

Status

Completed

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

low dose Astragalus

high dose astagalus

About this trial

This is an interventional treatment trial for Metabolic Syndrome focused on measuring 5-10 gram astragalus per day

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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.

Sites / Locations

Lanzhou University Second Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

No Intervention

Arm Label

High-dose Astragalus group

Low-dose Astragalus group

MS control

Arm Description

treatment with 10 gram astragalus

treatment with 5 gram astragalus

Outcomes

Primary Outcome Measures

index of cardiac function

ues echocardiography to measure the cardiac function

Secondary Outcome Measures

blood pressure

Full Information

NCT ID

NCT01847807

First Posted

May 2, 2013

Last Updated

October 7, 2015

Sponsor

LanZhou University

1. Study Identification

Unique Protocol Identification Number

NCT01847807

Brief Title

The Organ Protection of Astragalus in Subjects With Metabolic Syndrome

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2015

Overall Recruitment Status

Completed

Study Start Date

January 2011 (undefined)

Primary Completion Date

June 2015 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

LanZhou University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metabolic Syndrome

Keywords

5-10 gram astragalus per day

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

210 (Actual)

8. Arms, Groups, and Interventions

Arm Title

High-dose Astragalus group

Arm Type

Active Comparator

Arm Description

treatment with 10 gram astragalus

Arm Title

Low-dose Astragalus group

Arm Type

Active Comparator

Arm Description

treatment with 5 gram astragalus

Arm Title

MS control

Arm Type

No Intervention

Intervention Type

Drug

Intervention Name(s)

low dose Astragalus

Intervention Type

Drug

Intervention Name(s)

high dose astagalus

Primary Outcome Measure Information:

Title

index of cardiac function

Description

ues echocardiography to measure the cardiac function

Time Frame

one year

Secondary Outcome Measure Information:

Title

blood pressure

Time Frame

one year

Other Pre-specified Outcome Measures:

Title

kidney function

Time Frame

one year

Title

Central Blood Pressure

Time Frame

one year

Title

Ankle Brachial Index

Time Frame

one year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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.

Facility Information:

Facility Name

Lanzhou University Second Hospital

City

Lanzhou

State/Province

Gansu

ZIP/Postal Code

730030

Country

China

12. IPD Sharing Statement

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The Organ Protection of Astragalus in Subjects With Metabolic Syndrome

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