Clinical Trial of Chinese Formula AMP-1915 on Metabolic Syndrome

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Metabolic Syndrome X

Intervention / Treatment
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* Drug: AMP-1915
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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: -

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AMP-1915<br>Instant noodles contained AMP-1915 2 g/pc with meal, 1 pc/day for 3 months. | Drug: AMP-1915<br>* 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.<br>* Other names: Huangqi San;|
| Placebo Comparator: Placebo<br>Instant noodles with the same sharp and color as Experimental noodles with meal, 1 pc/day for 3 months. | Other: Placebo<br>* Instant noodles without drug<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obesity, hyperlipidemia, hyperglycemia