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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05118698
Other study ID # XJTU1AF2021LSK-273
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 1, 2022
Est. completion date March 1, 2023

Study information

Verified date May 2022
Source First Affiliated Hospital Xi'an Jiaotong University
Contact Yanan Wang, professor
Phone 0086-13359242141
Email y_wang@xjtufh.edu.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date March 1, 2023
Est. primary completion date October 30, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
China First Affiliated Hospital of Xi'an Jiaotong University Xi'an Shaanxi

Sponsors (1)

Lead Sponsor Collaborator
First Affiliated Hospital Xi'an Jiaotong University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary change of weight Kg From date of randomization to the last follow-up, once a month, assessed up to 3 months.
Primary change of blood lipid level mmol/L From date of randomization to the last follow-up, once a month, assessed up to 3 months.
Primary change of blood glucose level mmol/L From date of randomization to the last follow-up, once a month, assessed up to 3 months.
Secondary change of waistline and hipline cm From date of randomization to the last follow-up, once a month, assessed up to 3 months.
Secondary change of blood pressure mmHg From date of randomization to the last follow-up, once a month, assessed up to 3 months.
Secondary change of glucose tolerance mmol/L The date of first enrollment and 3 months after the intervention.
Secondary change of serum insulin level pmol/L The date of first enrollment and 3 months after the intervention.
Secondary change of serum C peptide level pmol/L The date of first enrollment and 3 months after the intervention.
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