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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
Shanghai University of Traditional Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolic Syndrome X focused on measuring obesity, hyperlipidemia, hyperglycemia

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    October 22, 2015
    Last Updated
    January 5, 2016
    Sponsor
    Shanghai University of Traditional Chinese Medicine
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    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

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    Clinical Trial of Chinese Formula AMP-1915 on Metabolic Syndrome

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