NCT02605655

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Jun 2014

Shorter than P25 for early_phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 22, 2015

Completed
25 days until next milestone

First Posted

Study publicly available on registry

November 16, 2015

Completed
Last Updated

January 7, 2016

Status Verified

November 1, 2014

Enrollment Period

6 months

First QC Date

October 22, 2015

Last Update Submit

January 5, 2016

Conditions

Metabolic Syndrome X

Keywords

obesityhyperlipidemiahyperglycemia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Plasma lipid levels

    Change from baseline lipid levels at 3 months

  • Plasma Insulin concentration

    Change from baseline insulin concentration at 3 months

  • Body weight

    Change from baseline body weight at 3 months

  • Plasma HbA1c

    Change from baseline Plasma HbA1c at 3 months

Study Arms (2)

AMP-1915

EXPERIMENTAL

Instant noodles contained AMP-1915 2 g/pc with meal, 1 pc/day for 3 months.

Drug: AMP-1915

Placebo

PLACEBO COMPARATOR

Instant noodles with the same sharp and color as Experimental noodles with meal, 1 pc/day for 3 months.

Other: Placebo

Interventions

AMP-1915DRUG

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
AMP-1915
PlaceboOTHER

Instant noodles without drug

Placebo

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Metabolic SyndromeObesityHyperlipidemiasHyperglycemia

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsDyslipidemiasLipid Metabolism Disorders

Study Officials

  • Guang Ji, MD

    Shanghai University of TCM

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2015

First Posted

November 16, 2015

Study Start

June 1, 2014

Primary Completion

December 1, 2014

Study Completion

April 1, 2015

Last Updated

January 7, 2016

Record last verified: 2014-11