Clinical Trial of Chinese Formula AMP-1915 on Metabolic Syndrome

Shanghai University of Traditional Chinese Medicine

Status and phase: Completed; Early Phase 1

Conditions: Metabolic Syndrome X

Treatments: Other: Placebo; Drug: AMP-1915

Study type: Interventional

Funder types: Other

Identifiers

NCT02605655

ShanghaiUTCM-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 40 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

AMP-1915

Experimental group

Description:

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

Treatment:

Drug: AMP-1915

Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo