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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04623567
Recruitment Status : Not yet recruiting
First Posted : November 10, 2020
Last Update Posted : November 10, 2020
Sponsor:
Information provided by (Responsible Party):
Jiaxing Tian, Guang'anmen Hospital of China Academy of Chinese Medical Sciences

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.

Condition or disease Intervention/treatment Phase
Type2 Diabetes Dyslipidemias Drug: Jiangtang Tiaozhi recipe Drug: Metformin Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : November 1, 2020
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Herbal Medicine

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 Name: Glucophage




Primary Outcome Measures :
  1. Change from Baseline HbA1c at 12 weeks [ Time Frame: 0 week, 12 weeks ]
  2. Changes from Baseline Fasting Blood Glucose at 4 weeks, 8 weeks,12 weeks [ Time Frame: 0 week, 4 weeks, 8 weeks,12 weeks ]
  3. Change from Baseline Postprandial Blood Glucose at 12 weeks [ Time Frame: 0 week, 12 weeks ]
  4. Change from Baseline Low Density Lipoprotein at 12 weeks [ Time Frame: 0 week, 12 weeks ]
  5. Change from Baseline Triglyceride at 12 weeks [ Time Frame: 0 week, 12 weeks ]

Secondary Outcome Measures :
  1. Changes from Baseline Body Mass Index at 4 weeks, 8 weeks,12 weeks [ Time Frame: 0 week, 4 weeks, 8 weeks,12 weeks ]
  2. Changes from Baseline Waist Circumference at 4 weeks, 8 weeks,12 weeks [ Time Frame: 0 week, 4 weeks, 8 weeks,12 weeks ]
  3. Change from Baseline Total Cholesterol at 12 weeks [ Time Frame: 0 week, 12 weeks ]
  4. Change from Baseline High Density Lipoprotein at 12 weeks [ Time Frame: 0 week, 12 weeks ]
  5. Change from Baseline TCM Symptom Score at 12 weeks [ Time Frame: 0 week, 12 weeks ]

Other Outcome Measures:
  1. Compositional and Functional Changes from Baseline Gut Microbiota at 12 weeks [ Time Frame: 0 week, 12 weeks ]
  2. Compositional and Functional Changes from Baseline Metabolites in blood and feces at 12 weeks [ Time Frame: 0 week, 12 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04623567


Contacts
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Contact: Jiaxing Tian, PhD +8601088001166 tina_yai@126.com

Locations
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China, Beijing
Guang'anmen Hospital, China Academy of Chinese Medical Sciences
Beijing, Beijing, China, 100053
Contact: Weidong Li    +8601088001552    gamhec@126.com   
Sponsors and Collaborators
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Investigators
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Principal Investigator: Jiaxing Tian, PhD Guang'anmen Hospital of China Academy of Chinese Medical Sciences
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Responsible Party: Jiaxing Tian, Attending Physician, Department of Endocrinology, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier: NCT04623567    
Other Study ID Numbers: CD2020-4-4155
First Posted: November 10, 2020    Key Record Dates
Last Update Posted: November 10, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jiaxing Tian, Guang'anmen Hospital of China Academy of Chinese Medical Sciences:
type 2 diabetes mellitus
dyslipidemias
Jiangtang Tiaozhi Recipe
randomized controlled trial
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Dyslipidemias
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Lipid Metabolism Disorders
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs