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

Dyslipidemias Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04623567
• Other study ID #: CD2020-4-4155
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: December 22, 2021
• Est. completion date: June 30, 2024

Study information

• Verified date: September 2023
• Source: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Contact: Jiaxing Tian, PhD
• Phone: +8601088001166
• Email: tina_yai[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: June 30, 2024
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Aged 18 to 70 years at the time of their consent;

2. Diagnosed with type 2 diabetes;

3. TG=1.7 mmol/L or LDL-C=3.4 mmol/L;

4. BMI=24.0 kg/m2 or male waist circumference=90 cm, female waist circumference=80 cm;

5. Failed to reach the normal standards of blood glucose and lipids after diet control and exercise therapy before enrollment;

6. TCM Syndrome differentiation as excess heat in the stomach and intestines syndrome;

7. Signed informed consent.

Exclusion Criteria:

1. Type 1 diabetes, gestational diabetes, other special types of diabetes.

2. Diabetic complications were the main symptoms, that is, patients with serious heart, lung, liver, kidney, brain complications or other serious primary diseases.

3. Patients with diabetic ketoacidosis, hyperosmolar nonketotic diabetic coma, severe infection, and surgery in recent one month.

4. 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..

5. Psychiatric patients, alcoholism and/or psychoactive substances, drug abusers and addicts.

6. Pregnant, preparing for pregnancy or lactation.

7. Patients who participated in other clinical studies within one month prior to participating in this study or were participating in other clinical studies.

8. 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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Dyslipidemias
• Type2 Diabetes

Intervention

Drug:
• Jiangtang Tiaozhi recipe
The Jiangtang Tiaozhi recipe is a combination of several Chinese herbs, which has been granted a patent (No. ZL 2013 1 0373659.7)
• Metformin
The metformin tablets (500mg) will be administrated.

Locations

Country	Name	City	State
China	Guang'anmen Hospital, China Academy of Chinese Medical Sciences	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Compositional and Functional Changes from Baseline Gut Microbiota at 12 weeks		0 week, 12 weeks
Other	Compositional and Functional Changes from Baseline Metabolites in blood and feces at 12 weeks		0 week, 12 weeks
Primary	Change from Baseline HbA1c at 12 weeks		0 week, 12 weeks
Primary	Changes from Baseline Fasting Blood Glucose at 4 weeks, 8 weeks,12 weeks		0 week, 4 weeks, 8 weeks,12 weeks
Primary	Change from Baseline Postprandial Blood Glucose at 12 weeks		0 week, 12 weeks
Primary	Change from Baseline Low Density Lipoprotein at 12 weeks		0 week, 12 weeks
Primary	Change from Baseline Triglyceride at 12 weeks		0 week, 12 weeks
Secondary	Changes from Baseline Body Mass Index at 4 weeks, 8 weeks,12 weeks		0 week, 4 weeks, 8 weeks,12 weeks
Secondary	Changes from Baseline Waist Circumference at 4 weeks, 8 weeks,12 weeks		0 week, 4 weeks, 8 weeks,12 weeks
Secondary	Change from Baseline Total Cholesterol at 12 weeks		0 week, 12 weeks
Secondary	Change from Baseline High Density Lipoprotein at 12 weeks		0 week, 12 weeks
Secondary	Change from Baseline TCM Symptom Score at 12 weeks		0 week, 12 weeks