The Hypoglycemic Effect of Cyclocarya Paliurus Extract on Hyperglycemic Populations

NCT ID: NCT04184440

Last Updated: 2019-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-31

Study Completion Date

2020-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hyperglycemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be divided randomly into three groups,among which the intervention will start and end simultaneously.
Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors
The allocation of three groups is completed by the primary researcher,and unknown to participants and other reachers. It is the same in the size,color,shape and taste of capsules administrated by three groups.

Study Groups

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placebo

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

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DIETARY_SUPPLEMENT

The participants are divided randomly into three groups,one of which are asked to take placebo for three months .

Cyclocarya paliurus extract

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

Group Type EXPERIMENTAL

Cyclocarya paliurus extract

Intervention Type DIETARY_SUPPLEMENT

The participants are divided randomly into three groups,one of which are asked to Cyclocarya paliurus extract for three months .

Cyclocarya paliurus compounds

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

Group Type EXPERIMENTAL

Cyclocarya paliurus compounds

Intervention Type DIETARY_SUPPLEMENT

The participants are divided randomly into three groups,one of which are asked to take Cyclocarya paliurus compounds for three months .

Interventions

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Cyclocarya paliurus extract

The participants are divided randomly into three groups,one of which are asked to Cyclocarya paliurus extract for three months .

Intervention Type DIETARY_SUPPLEMENT

Cyclocarya paliurus compounds

The participants are divided randomly into three groups,one of which are asked to take Cyclocarya paliurus compounds for three months .

Intervention Type DIETARY_SUPPLEMENT

placebo

The participants are divided randomly into three groups,one of which are asked to take placebo for three months .

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Huazhong University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Liegang Liu

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Shiyan Taihe Hospital

Shiyan, Hubei, China

Site Status

Countries

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China

Central Contacts

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Liegang Liu, PhD

Role: CONTACT

+86-27-83650522

Hongjie Liu, master

Role: CONTACT

Facility Contacts

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Liegang Liu, PhD

Role: primary

+86-27-83650522

Hongjei Liu, master

Role: backup

Other Identifiers

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QQLY2019

Identifier Type: -

Identifier Source: org_study_id

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