Explore the Effect of Gynostemma Pentaphyllum on Patients With Metabolic Syndrome (GPMS)

July 7, 2022 updated by: First Affiliated Hospital Xi'an Jiaotong University

An Intervention Study of Gynostemma Pentaphyllum in Patients With Metabolic Syndrome

Previous research shows that gypenoside could keep blood lipid and blood sugar under control in an effective way. In this study, we intend to explore whether gypenosides have clinical improvement effects on metabolic diseases such as diabetes, hyperlipidemia, and non-alcoholic fatty liver and their cardiovascular protective potential. It is designed to recruit 150 patients with metabolic syndrome diagnosed who meet the criteria for enrollment, and randomly divide them into three groups. Gynostemma powder, with two different saponins content (12% and 8%) from Pingli County, Shaanxi Province, and spinach powder with almost no saponins were used to conduct the intervention on patients. Patients will be followed up regularly at the beginning of each month from the first enrollment until the third month. At each follow-up, data of patient's anthropometric indicators as well as clinical inspection indicators related to metabolism (blood routine, liver function, etc.) will be recorded. In addition, patient's blood, hair, urine, and stool samples will be collected to further explore the mechanism of diseases.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710061
        • Recruiting
        • First Affiliated Hospital of Xi'an JiaoTong University
        • Contact:
          • Bingyin Shi
          • Phone Number: 0086-13700298366

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Low-density lipoprotein (LDL) cholesterol ≥130 mg/dL (3.4 mmol/L ), or conforms to the diagnosis criteria for metabolic syndrome (based on the MetS diagnostic criteria developed by IDF and AHA in 2009), that is, having three or more of the following traits:

    1. waist circumference ≥90 cm in men or ≥80 cm in women;
    2. Elevated TG (drug treatment for elevated TG is an alternate indicator) ≥150 mg/dL (1.7 mmol/L);
    3. Reduced HDL-c (drug treatment for reduced HDL-c is an alternate indicator) < 40 mg/dL (1.03 mmol/L) in males < 50 mg/dL (1.29 mmol/L) in females;
    4. Elevated blood pressure (anti-hypertensive drug treatment in a patient with a history of hypertension is an alternate indicator). Systolic ≥ 130 and/or diastolic ≥ 85 mmHg;
    5. Elevated fasting glucose (drug treatment for elevated glucose is an alternate indicator) ≥ 100 mg/dL (5.6 mmol/L).
  • Be over 18 years old or younger than 80 years old, no gender limit.
  • Have a good follow-up compliance and can be followed up for more than 3 months;
  • From 2 weeks before enrollment to the end of the entire trial, the treatment regimen will not change.

Exclusion Criteria:

  • Pregnant and lactating women;
  • Allergic or toxic reactions to gynostemma and other drugs;
  • Infectious diseases such as viral hepatitis, AIDS, syphilis, tuberculosis are active;
  • After drug treatment, still showing high blood sugar (fasting blood glucose higher than 200mg/dL, 11.1mmol/L) or hyperlipidemia, or hypertension (higher than 180/110 mmHg);
  • Any conditions judged by the investigator that affect enrollment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: High-dose group
Participants will be allowed to drink Gynostemma pentaphyllum powder containing 12% saponin, 2 g each time, 3 times a day for 3 months.
Drug: Gynostemma
Patients in the high-dose group and low-dose group will take gynostemma powder with a saponin content of 12% and 8% respectively, 3 times a day for 3 months.
Experimental: Low-dose group
Participants will be allowed to drink Gynostemma pentaphyllum powder containing 8% saponin, 2 g each time, 3 times a day for 3 months.
Drug: Gynostemma
Patients in the high-dose group and low-dose group will take gynostemma powder with a saponin content of 12% and 8% respectively, 3 times a day for 3 months.
Placebo Comparator: Placebo group
Participants will be allowed to drink a placebo of spinach powder with almost no saponin content, 2 g each time, 3 times a day for 3 months.
Other: Spinach
For the spinach powder group, each patient will take spinach powder with nearly no saponin content, 3 times a day for 3 months.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
change of weight
Time Frame: From date of randomization to the last follow-up, once a month, assessed up to 3 months.
Kg
From date of randomization to the last follow-up, once a month, assessed up to 3 months.
change of blood lipid level
Time Frame: From date of randomization to the last follow-up, once a month, assessed up to 3 months.
mmol/L
From date of randomization to the last follow-up, once a month, assessed up to 3 months.
change of blood glucose level
Time Frame: From date of randomization to the last follow-up, once a month, assessed up to 3 months.
mmol/L
From date of randomization to the last follow-up, once a month, assessed up to 3 months.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
change of waistline and hipline
Time Frame: From date of randomization to the last follow-up, once a month, assessed up to 3 months.
cm
From date of randomization to the last follow-up, once a month, assessed up to 3 months.
change of blood pressure
Time Frame: From date of randomization to the last follow-up, once a month, assessed up to 3 months.
mmHg
From date of randomization to the last follow-up, once a month, assessed up to 3 months.
change of glucose tolerance
Time Frame: The date of first enrollment and 3 months after the intervention.
mmol/L
The date of first enrollment and 3 months after the intervention.
change of serum insulin level
Time Frame: The date of first enrollment and 3 months after the intervention.
pmol/L
The date of first enrollment and 3 months after the intervention.
change of serum C peptide level
Time Frame: The date of first enrollment and 3 months after the intervention.
pmol/L
The date of first enrollment and 3 months after the intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
First Affiliated Hospital Xi'an Jiaotong University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Bingyin Shi, First Affiliated Hospital Xi'an Jiaotong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 30, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 15, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 3, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 12, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 11, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 7, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • XJTU1AF2021LSK-273

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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