Clinical Trial of Chinese Formula AMP-1915 on Metabolic Syndrome

Early Phase 1

Completed

• Conditions: Metabolic Syndrome X
• Interventions: Drug: AMP-1915; Other: Placebo

• Registration Number: NCT02605655
• Lead Sponsor: Shanghai University of Traditional Chinese Medicine

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2014-06
• Status Verified: 2014-11
• Primary Completion: 2014-12
• Study Completion: 2015-04
• Study First Submitted: 2015-10-22
• Study First Submitted QC: 2015-11-13
• Study First Posted: 2015-11-16
• Last Update Submitted: 2016-01-05
• Last Update Posted: 2016-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AMP-1915	AMP-1915	Instant noodles contained AMP-1915 2 g/pc with meal, 1 pc/day for 3 months.
Placebo	Placebo	Instant noodles with the same sharp and color as Experimental noodles with meal, 1 pc/day for 3 months.

Primary Outcome Measures

Name	Time	Method
Fasting blood glucose (FBG)	Change from baseline FBG at 3 months	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.

Secondary Outcome Measures

Name	Time	Method
Plasma HbA1c	Change from baseline Plasma HbA1c at 3 months	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.
Body weight	Change from baseline body weight at 3 months	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.
Plasma lipid levels	Change from baseline lipid levels at 3 months	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.
Plasma Insulin concentration	Change from baseline insulin concentration at 3 months	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.