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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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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

Tracking Information
First Submitted Date  ICMJE November 2, 2020
First Posted Date  ICMJE November 10, 2020
Last Update Posted Date November 10, 2020
Estimated Study Start Date  ICMJE November 1, 2020
Estimated Primary Completion Date June 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 5, 2020)
  • Change from Baseline HbA1c at 12 weeks [ Time Frame: 0 week, 12 weeks ]
  • Changes from Baseline Fasting Blood Glucose at 4 weeks, 8 weeks,12 weeks [ Time Frame: 0 week, 4 weeks, 8 weeks,12 weeks ]
  • Change from Baseline Postprandial Blood Glucose at 12 weeks [ Time Frame: 0 week, 12 weeks ]
  • Change from Baseline Low Density Lipoprotein at 12 weeks [ Time Frame: 0 week, 12 weeks ]
  • Change from Baseline Triglyceride at 12 weeks [ Time Frame: 0 week, 12 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 5, 2020)
  • Changes from Baseline Body Mass Index at 4 weeks, 8 weeks,12 weeks [ Time Frame: 0 week, 4 weeks, 8 weeks,12 weeks ]
  • Changes from Baseline Waist Circumference at 4 weeks, 8 weeks,12 weeks [ Time Frame: 0 week, 4 weeks, 8 weeks,12 weeks ]
  • Change from Baseline Total Cholesterol at 12 weeks [ Time Frame: 0 week, 12 weeks ]
  • Change from Baseline High Density Lipoprotein at 12 weeks [ Time Frame: 0 week, 12 weeks ]
  • Change from Baseline TCM Symptom Score at 12 weeks [ Time Frame: 0 week, 12 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: November 5, 2020)
  • Compositional and Functional Changes from Baseline Gut Microbiota at 12 weeks [ Time Frame: 0 week, 12 weeks ]
  • Compositional and Functional Changes from Baseline Metabolites in blood and feces at 12 weeks [ Time Frame: 0 week, 12 weeks ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Efficacy Assessment of Chinese Herbal Medicine Jiangtang Tiaozhi Recipe Treating Participants With Glucose and Lipid Metabolism Disturbances
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Type2 Diabetes
  • Dyslipidemias
Intervention  ICMJE
  • 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)
  • Drug: Metformin
    The metformin tablets (500mg) will be administrated.
    Other Name: Glucophage
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Jiangtang Tiaozhi recipe
  • Active Comparator: Metformin Group
    500mg metformin tablet per time, 3 times a day, take it with meals.
    Intervention: Drug: Metformin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: November 5, 2020)
96
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2023
Estimated Primary Completion Date June 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jiaxing Tian, PhD +8601088001166 tina_yai@126.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04623567
Other Study ID Numbers  ICMJE CD2020-4-4155
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Jiaxing Tian, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Study Sponsor  ICMJE Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jiaxing Tian, PhD Guang'anmen Hospital of China Academy of Chinese Medical Sciences
PRS Account Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP