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Efficacy Assessment of Chinese Herbal Medicine Jiangtang Tiaozhi Recipe Treating Participants With Glucose and Lipid Metabolism Disturbances

Primary Purpose

Type2 Diabetes, Dyslipidemias

Status

Recruiting

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

Jiangtang Tiaozhi recipe

Metformin

About this trial

This is an interventional treatment trial for Type2 Diabetes focused on measuring type 2 diabetes mellitus, dyslipidemias, Jiangtang Tiaozhi Recipe, randomized controlled trial

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Guang'anmen Hospital, China Academy of Chinese Medical SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Jiangtang Tiaozhi Recipe Group

Metformin Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change from Baseline HbA1c at 12 weeks

Changes from Baseline Fasting Blood Glucose at 4 weeks, 8 weeks,12 weeks

Change from Baseline Postprandial Blood Glucose at 12 weeks

Change from Baseline Low Density Lipoprotein at 12 weeks

Change from Baseline Triglyceride at 12 weeks

Secondary Outcome Measures

Changes from Baseline Body Mass Index at 4 weeks, 8 weeks,12 weeks

Changes from Baseline Waist Circumference at 4 weeks, 8 weeks,12 weeks

Change from Baseline Total Cholesterol at 12 weeks

Change from Baseline High Density Lipoprotein at 12 weeks

Change from Baseline TCM Symptom Score at 12 weeks

Full Information

NCT ID

NCT04623567

First Posted

November 2, 2020

Last Updated

September 14, 2023

Sponsor

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT04623567

Brief Title

Efficacy Assessment of Chinese Herbal Medicine Jiangtang Tiaozhi Recipe Treating Participants With Glucose and Lipid Metabolism Disturbances

Official Title

Efficacy Assessment of Chinese Herbal Medicine Jiangtang Tiaozhi Recipe Treating Participants With Glucose and Lipid Metabolism Disturbances and Associations Study Between Glucose and Lipid Metabolism Disturbances and Cardiovascular Risk Factors

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

December 22, 2021 (Actual)

Primary Completion Date

December 30, 2023 (Anticipated)

Study Completion Date

June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

Detailed Description

The diagnosis criteria of type 2 diabetes mellitus are in accordance to 1999 World Health Organization (WHO) diabetes diagnostic criteria. The diagnosis criteria of dyslipidemia are based on the Guidelines for the Prevention and Treatment of Dyslipidemia in Chinese adults (2016, revision edition). The outcomes mainly include HbA1c, fasting blood glucose, postprandial blood glucose, body weight, waist circumference, blood lipid and TCM symptom score.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type2 Diabetes, Dyslipidemias

Keywords

type 2 diabetes mellitus, dyslipidemias, Jiangtang Tiaozhi Recipe, randomized controlled trial

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Jiangtang Tiaozhi Recipe Group

Arm Type

Experimental

Arm Description

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

Arm Title

Metformin Group

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Jiangtang Tiaozhi recipe

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Metformin

Other Intervention Name(s)

Glucophage

Intervention Description

The metformin tablets (500mg) will be administrated.

Primary Outcome Measure Information:

Title

Change from Baseline HbA1c at 12 weeks

Time Frame

0 week, 12 weeks

Title

Changes from Baseline Fasting Blood Glucose at 4 weeks, 8 weeks,12 weeks

Time Frame

0 week, 4 weeks, 8 weeks,12 weeks

Title

Change from Baseline Postprandial Blood Glucose at 12 weeks

Time Frame

0 week, 12 weeks

Title

Change from Baseline Low Density Lipoprotein at 12 weeks

Time Frame

0 week, 12 weeks

Title

Change from Baseline Triglyceride at 12 weeks

Time Frame

0 week, 12 weeks

Secondary Outcome Measure Information:

Title

Changes from Baseline Body Mass Index at 4 weeks, 8 weeks,12 weeks

Time Frame

0 week, 4 weeks, 8 weeks,12 weeks

Title

Changes from Baseline Waist Circumference at 4 weeks, 8 weeks,12 weeks

Time Frame

0 week, 4 weeks, 8 weeks,12 weeks

Title

Change from Baseline Total Cholesterol at 12 weeks

Time Frame

0 week, 12 weeks

Title

Change from Baseline High Density Lipoprotein at 12 weeks

Time Frame

0 week, 12 weeks

Title

Change from Baseline TCM Symptom Score at 12 weeks

Time Frame

0 week, 12 weeks

Other Pre-specified Outcome Measures:

Title

Compositional and Functional Changes from Baseline Gut Microbiota at 12 weeks

Time Frame

0 week, 12 weeks

Title

Compositional and Functional Changes from Baseline Metabolites in blood and feces at 12 weeks

Time Frame

0 week, 12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jiaxing Tian, PhD

Phone

+8601088001166

tina_yai@126.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jiaxing Tian, PhD

Organizational Affiliation

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Official's Role

Principal Investigator

Facility Information:

Facility Name

Guang'anmen Hospital, China Academy of Chinese Medical Sciences

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100053

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Weidong Li

Phone

+8601088001552

gamhec@126.com

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

35185579

Citation

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.

Results Reference

derived

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Efficacy Assessment of Chinese Herbal Medicine Jiangtang Tiaozhi Recipe Treating Participants With Glucose and Lipid Metabolism Disturbances

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