Brief Summary

This study is a randomized, positive drug parallel-controlled clinical trial in participants with glucose and lipid metabolism disturbances. A total of 96 participants will be recruited for the study, all of whom are diagnosed as type 2 diabetes mellitus combined with dyslipidemia. The subjects will be divided randomly into two groups and treated with either Jiangtang Tiaozhi Recipe or metformin. After 12 weeks of treatment, therapeutic effect of Jiangtang Tiaozhi Recipe will be evaluated based on the changes of HbA1c, fasting blood glucose, postprandial blood glucose, blood lipid, waist circumference, body mass index.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

participants targeted

Target at P75+ for phase_1

Timeline

Completed

Started Dec 2021

Typical duration for phase_1

Geographic Reach

1 country

1 active site

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.5 years study duration

First Submitted

Initial submission to the registry

November 2, 2020

Completed

8 days until next milestone

First Posted

Study publicly available on registry

November 10, 2020

Completed

1.1 years until next milestone

Study Start

First participant enrolled

December 22, 2021

Completed

2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed

6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed

Last Updated

September 18, 2023

Status Verified

September 1, 2023

Enrollment Period

2 years

First QC Date

November 2, 2020

Last Update Submit

September 14, 2023

Conditions

Type2 Diabetes Dyslipidemias

Keywords

type 2 diabetes mellitusdyslipidemiasJiangtang Tiaozhi Reciperandomized controlled trial

Outcome Measures

Primary Outcomes (5)

Change from Baseline HbA1c at 12 weeks
0 week, 12 weeks
Changes from Baseline Fasting Blood Glucose at 4 weeks, 8 weeks,12 weeks
0 week, 4 weeks, 8 weeks,12 weeks
Change from Baseline Postprandial Blood Glucose at 12 weeks
0 week, 12 weeks
Change from Baseline Low Density Lipoprotein at 12 weeks
0 week, 12 weeks
Change from Baseline Triglyceride at 12 weeks
0 week, 12 weeks

Secondary Outcomes (5)

Changes from Baseline Body Mass Index at 4 weeks, 8 weeks,12 weeks
0 week, 4 weeks, 8 weeks,12 weeks
Changes from Baseline Waist Circumference at 4 weeks, 8 weeks,12 weeks
0 week, 4 weeks, 8 weeks,12 weeks
Change from Baseline Total Cholesterol at 12 weeks
0 week, 12 weeks
Change from Baseline High Density Lipoprotein at 12 weeks
0 week, 12 weeks
Change from Baseline TCM Symptom Score at 12 weeks
0 week, 12 weeks

Other Outcomes (2)

Compositional and Functional Changes from Baseline Gut Microbiota at 12 weeks
0 week, 12 weeks
Compositional and Functional Changes from Baseline Metabolites in blood and feces at 12 weeks
0 week, 12 weeks

Study Arms (2)

Jiangtang Tiaozhi Recipe Group

EXPERIMENTAL

Jiangtang Tiaozhi formula granule (30g per bag), 1 bag per time, twice a day, take it with warm water after meals.

Drug: Jiangtang Tiaozhi recipe

Metformin Group

ACTIVE COMPARATOR

500mg metformin tablet per time, 3 times a day, take it with meals.

Drug: Metformin

Interventions

Jiangtang Tiaozhi recipeDRUG

The Jiangtang Tiaozhi recipe is a combination of several Chinese herbs, which has been granted a patent (No. ZL 2013 1 0373659.7)

Jiangtang Tiaozhi Recipe Group

MetforminDRUG

The metformin tablets (500mg) will be administrated.

Also known as: Glucophage

Metformin Group

Eligibility Criteria

Age18 Years - 70 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Aged 18 to 70 years at the time of their consent;
Diagnosed with type 2 diabetes;
TG≥1.7 mmol/L or LDL-C≥3.4 mmol/L;
BMI≥24.0 kg/m2 or male waist circumference≥90 cm, female waist circumference≥80 cm;
Failed to reach the normal standards of blood glucose and lipids after diet control and exercise therapy before enrollment;
TCM Syndrome differentiation as excess heat in the stomach and intestines syndrome;
Signed informed consent.

You may not qualify if:

Type 1 diabetes, gestational diabetes, other special types of diabetes.
Diabetic complications were the main symptoms, that is, patients with serious heart, lung, liver, kidney, brain complications or other serious primary diseases.
Patients with diabetic ketoacidosis, hyperosmolar nonketotic diabetic coma, severe infection, and surgery in recent one month.
Have a history of serious gastrointestinal diseases, or are suffering from serious gastrointestinal diseases, such as peptic ulcer, gastrointestinal bleeding, gastroparesis, pyloric stenosis, gastric shunt, etc..
Psychiatric patients, alcoholism and/or psychoactive substances, drug abusers and addicts.
Pregnant, preparing for pregnancy or lactation.
Patients who participated in other clinical studies within one month prior to participating in this study or were participating in other clinical studies.
According to the judgment of the researcher, other diseases or conditions that reduce the possibility of enrollment or complicate the enrollment, such as frequent changes in working environment and unstable living environment, are likely to cause loss of follow-up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Guang'anmen Hospital of China Academy of Chinese Medical Scienceslead

Study Sites (1)

Guang'anmen Hospital, China Academy of Chinese Medical Sciences

Beijing, Beijing Municipality, 100053, China

RECRUITING

Related Publications (1)

Wu H, Fang X, Jin D, Miao R, Wei J, Zhao T, Dai D, Liao J, Wang J, Lian F, Tian J. Efficacy and Mechanism of the Jiangtang Tiaozhi Recipe in the Management of Type 2 Diabetes and Dyslipidaemia: A Clinical Trial Protocol. Front Pharmacol. 2022 Feb 4;13:827697. doi: 10.3389/fphar.2022.827697. eCollection 2022.
PMID: 35185579DERIVED

MeSH Terms

Conditions

DyslipidemiasDiabetes Mellitus, Type 2

Interventions

Metformin

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesDiabetes MellitusGlucose Metabolism DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

Jiaxing Tian, PhD
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiaxing Tian, PhD

CONTACT

+8601088001166 tina_yai@126.com

Study Design

Study Type: interventional
Phase: phase 1
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Attending Physician, Department of Endocrinology

Study Record Dates

First Submitted

November 2, 2020

First Posted

November 10, 2020

Study Start

December 22, 2021

Primary Completion

December 30, 2023

Study Completion

June 30, 2024

Last Updated

September 18, 2023

Record last verified: 2023-09

Locations

CN(1)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (5)

Secondary Outcomes (5)

Other Outcomes (2)

Study Arms (2)

Jiangtang Tiaozhi Recipe Group

Metformin Group

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Locations