Clinical Trial of Chinese Formula AMP-1915 on Metabolic Syndrome
Primary Purpose
Metabolic Syndrome X
Status
Completed
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
AMP-1915
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Metabolic Syndrome X focused on measuring obesity, hyperlipidemia, hyperglycemia
Eligibility Criteria
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:
-
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
AMP-1915
Placebo
Arm Description
Instant noodles contained AMP-1915 2 g/pc with meal, 1 pc/day for 3 months.
Instant noodles with the same sharp and color as Experimental noodles with meal, 1 pc/day for 3 months.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
Full Information
NCT ID
NCT02605655
First Posted
October 22, 2015
Last Updated
January 5, 2016
Sponsor
Shanghai University of Traditional Chinese Medicine
1. Study Identification
Unique Protocol Identification Number
NCT02605655
Brief Title
Clinical Trial of Chinese Formula AMP-1915 on Metabolic Syndrome
Official Title
Phase 0 Clinical Trial of Chinese Formula AMP-1915 on Metabolic Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
April 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai University of Traditional Chinese Medicine
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome X
Keywords
obesity, hyperlipidemia, hyperglycemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AMP-1915
Arm Type
Experimental
Arm Description
Instant noodles contained AMP-1915 2 g/pc with meal, 1 pc/day for 3 months.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Instant noodles with the same sharp and color as Experimental noodles with meal, 1 pc/day for 3 months.
Intervention Type
Drug
Intervention Name(s)
AMP-1915
Other Intervention Name(s)
Huangqi San
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Instant noodles without drug
Primary Outcome Measure Information:
Title
Fasting blood glucose (FBG)
Description
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
Secondary Outcome Measure Information:
Title
Plasma lipid levels
Description
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
Title
Plasma Insulin concentration
Description
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
Title
Body weight
Description
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
Title
Plasma HbA1c
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guang Ji, MD
Organizational Affiliation
Shanghai University of TCM
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Clinical Trial of Chinese Formula AMP-1915 on Metabolic Syndrome
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