Clinical Trial of Chinese Formula AMP-1915 on Metabolic Syndrome

Metabolic Syndrome X Clinical Trial

Official title:

Phase 0 Clinical Trial of Chinese Formula AMP-1915 on Metabolic Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02605655
• Other study ID #: ShanghaiUTCM-01
• Status: Completed
• Phase: Phase 0
• First received: October 22, 2015
• Last updated: January 5, 2016
• Start date: June 2014
• Est. completion date: April 2015

Study information

• Verified date: November 2014
• Source: Shanghai University of Traditional Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether the Chinese formula AMP-1915 has effect on Metabolic Syndrome (MS) in MS patients. Half of patients received AMP-1915, while the other half received placebo.

Description:

In China, the herbal formulas have been used in the treatment of diabetes for centuries. Huangqisan, investigators named it AMP-1915, is one of traditional Chinese herbal formula used to relieve diabetes which was recorded in Shengji Zonglu (General Medical Collection of Royal Benevolence) published in 1117 A.D. AMP-1915 consists of three herbs: Radix Astragali (roots of Astragalus membranaceus (Fisch.) Bge. var. mongholicus (Bge.) Hsiao, A), Mori Cortex radices (root barks of Morus alba L., M) and Puerariae Lobatae Radix (roots of Pueraria lobata (Willd.) Ohwi., P). Recent studies have shown that these three herbs and their constituents have therapeutic effects on the metabolic disorders.

This randomized, double-blind, placebo-controlled trial was conducted in a community hospital of Shanghai, China. 60 adult participants were metabolic disorder patients according with at least two impaired metabolic profiles (obesity, hyperglycemia, hyperlipidemia or others). During 3-month treatment, participants were randomly divided in to two groups assigned to take AMP-1915 or placebo. AMP-1915 or placebo was mixed into instant noodles as daily meals with same color, shape, size and packaging. BMI, fasting blood glucose (FBG), triglyceride (TG), total cholesterol (TCH), high-density lipoprotein cholesterol (HDL-c), low-density lipoprotein cholesterol (LDL-c), insulin, HbA1c were measured before and after treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 65 Years

Eligibility

Inclusion Criteria:

• Overweight (BMI >= 20) or

• Hyperglycemia (FBG>=6.7 mmol/l) or

• Hyperlipidemia (TG >=1.7 mmol/l or TCH>=5.72 mmol/l or HDL-c <=1.00 mmol/l or LDL-c>=3.12 mmol/l)

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Metabolic Syndrome X
• Syndrome

Intervention

Drug:
• AMP-1915
A traditional Chinese Formula extract from Astragalus, Radix Puerariae and Cortex Mori is mixed into instant noodles. Patients are treated with AMP-1915 as meal.

Other:
• Placebo
Instant noodles without drug

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai University of Traditional Chinese Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fasting blood glucose (FBG)	Patients' FBG from both placebo and AMP-1915-treated group was collected before treatment as a baseline and after 3-month treatment.; The difference between these two time points presents the drug effect.	Change from baseline FBG at 3 months	No
Secondary	Plasma lipid levels	Patients' blood from both placebo and AMP-1915-treated group was collected before treatment as a baseline and after 3-month treatment. Triglyceride (TG), total cholesterol (TCH), high-density lipoprotein cholesterol (HDL-c), low-density lipoprotein cholesterol (LDL-c) were measured.; The difference between these two time points presents the drug effect, separately.	Change from baseline lipid levels at 3 months	No
Secondary	Plasma Insulin concentration	Patients' insulin concentration from both placebo and AMP-1915-treated group was collected before treatment as a baseline and after 3-month treatment.; The difference between these two time points presents the drug effect.	Change from baseline insulin concentration at 3 months	No
Secondary	Body weight	Patients' body weight from both placebo and AMP-1915-treated group was measured before treatment as a baseline and after 3-month treatment.; The difference between these two time points presents the drug effect.	Change from baseline body weight at 3 months	No
Secondary	Plasma HbA1c	Patients' Plasma HbA1c from both placebo and AMP-1915-treated group was measured before treatment as a baseline and after 3-month treatment.; The difference between these two time points presents the drug effect.	Change from baseline Plasma HbA1c at 3 months	No