An Early Phase 1 interventional study of AMP-1915 and Placebo in Metabolic Syndrome X, sponsored by Shanghai University of Traditional Chinese Medicine. Completed. Open to participants aged 40 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-01-07.
Sponsored by Shanghai University of Traditional Chinese Medicine · Early Phase 1, Interventional, and Treatment
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.
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.
1,964 studies on the registry are indexed under Metabolic Syndrome; 330 are open to participants now.
This study's enrollment of 60 is close to the median of 60 across 1,460 interventional studies indexed under Metabolic Syndrome.
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Instant noodles contained AMP-1915 2 g/pc with meal, 1 pc/day for 3 months.
Drug: AMP-1915
Instant noodles with the same sharp and color as Experimental noodles with meal, 1 pc/day for 3 months.
Other: Placebo
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.
Also known as: Huangqi San
Instant noodles without drug
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.
Time frame: Change from baseline FBG at 3 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Change from baseline Plasma HbA1c at 3 months
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This study is completed, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.
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Shanghai University of Traditional Chinese Medicine