The Hypoglycemic Effect of Cyclocarya Paliurus Extract on Hyperglycemic Populations

Huazhong University of Science and Technology

Status: Unknown

Conditions: Hyperglycemia

Treatments: Dietary Supplement: Cyclocarya paliurus extract; Dietary Supplement: Cyclocarya paliurus compounds; Dietary Supplement: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04184440

QQLY2019

Details and patient eligibility

About

This is a randomized double-blind controlled trial，aiming to investigate the hypoglycemic effect of Cyclocarya paliurus extract and Cyclocarya paliurus compounds on hyperglycemic populations without modifying their original treatment plans.

Enrollment: 150 estimated patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• pre-diabetic or type 2 diabetic patients who are treated with only one oral antidiabetic agent and whose fasting plasma glucose is lower than 8.4 mmol;
• age:20-65 years;
• BMI :20-35kg/m2.

Exclusion criteria

• type 1 diabetic patients;
• type 2 diabetic patients with insulin treatment；
• pregnant or lactating women；
• adverse effect on intervention；
• acute or chronic inflammatory conditions;
• severe hepatic,kidney or other complications;
• other situations ineligible to intervention.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 3 patient groups, including a placebo group

placebo

Placebo Comparator group

Description:

corn starch；capsule，2 g/day，2 times/day；3 months

Treatment:

Dietary Supplement: placebo

Cyclocarya paliurus extract

Experimental group

Description:

aqueous extract of Cyclocarya paliurus；capsule，2 g/day，2 times/day；3 months

Treatment:

Dietary Supplement: Cyclocarya paliurus extract

Cyclocarya paliurus compounds

Experimental group

Description:

mixed aqueous extract of Cyclocarya paliurus and other traditional Chinese herbal medicines including Astragalus propinquus Schischkin，Dioscorea oppositifolia L.，Dendrobium nobile Lindl.，Salvia miltiorrhiza Bge. and Inulin；capsule，2 g/day，2 times/day；3 months

Treatment:

Dietary Supplement: Cyclocarya paliurus compounds