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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Dyslipidemias; Type2 Diabetes
• Intervention / Treatment: Drug: Jiangtang Tiaozhi recipe; Drug: Metformin

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.

• Study Type: Interventional
• Enrollment (Estimated): 96
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Jiaxing Tian, PhD; Phone Number: +8601088001166; Email: tina_yai@126.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100053
      • Recruiting
      • Guang'anmen Hospital, China Academy of Chinese Medical Sciences
      • Contact: Weidong Li; Phone Number: +8601088001552; Email: gamhec@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Jiangtang Tiaozhi Recipe Group; 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; The Jiangtang Tiaozhi recipe is a combination of several Chinese herbs, which has been granted a patent (No. ZL 2013 1 0373659.7)
Active Comparator: Metformin Group; 500mg metformin tablet per time, 3 times a day, take it with meals.	Drug: Metformin; The metformin tablets (500mg) will be administrated.; Other Names: Glucophage

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Investigators: Principal Investigator: Jiaxing Tian, PhD, Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 22, 2021
• Primary Completion (Estimated): December 30, 2023
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: November 2, 2020
• First Submitted That Met QC Criteria: November 5, 2020
• First Posted (Actual): November 10, 2020

Study Record Updates

• Last Update Posted (Actual): September 18, 2023
• Last Update Submitted That Met QC Criteria: September 14, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: randomized controlled trial; type 2 diabetes mellitus; dyslipidemias; Jiangtang Tiaozhi Recipe
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Lipid Metabolism Disorders; Diabetes Mellitus, Type 2; Dyslipidemias; Hypoglycemic Agents; Physiological Effects of Drugs; Metformin
• Other Study ID Numbers: CD2020-4-4155

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No