The Organ Protection of Astragalus in Subjects With Metabolic Syndrome

Metabolic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01847807
• Other study ID #: MS2304
• Status: Completed
• Phase: Phase 3
• First received: May 2, 2013
• Last updated: October 7, 2015
• Start date: January 2011

Study information

• Verified date: October 2015
• Source: LanZhou University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 ?or?;

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X
• Syndrome

Intervention

Drug:
• low dose Astragalus

• high dose astagalus

Locations

Country	Name	City	State
China	Lanzhou University Second Hospital	Lanzhou	Gansu

Sponsors (1)

Lead Sponsor	Collaborator
LanZhou University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	kidney function		one year	Yes
Other	Central Blood Pressure		one year	Yes
Other	Ankle Brachial Index		one year	Yes
Primary	index of cardiac function	ues echocardiography to measure the cardiac function	one year	Yes
Secondary	blood pressure		one year	Yes