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NCT Number: NCT05072990

Type 2 Diabetes Mellitus With Obesity and Dyslipidemia Treated by Chinese Herbal Medicine

This study is a retrospective review of participants who visited Department of Endocrinology, Guang'anmen Hospital and accepted traditional Chinese medicine formula for at least sis months, from January 2015 to December 2020. All the participants should be diagnosed as type 2 diabetes mellitus, obesity and dyslipidemia. Therapeutic effect of traditional Chinese medicine will be evaluated based on the changes of blood glucose, body mass index, blood lipids, and blood pressure.

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Key information

About this study

The diagnostic criteria for type 2 diabetes mellitus and obesity are based on the Guideline for the prevention and treatment of type 2 diabetes mellitus in China (2020 edition). The diagnostic criteria of dyslipidaemia are based on the Chinese Guidelines on Prevention and Treatment of Dyslipidaemia in Adults (2016, revision edition).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Meet at least three of the requirements below; 1) Fasting Plasma Glucose > 6.1 mmol/L or 2-hour Postprandial Blood Glucose > 7.8 mmol/L or diagnosed as type 2 diabetes mellitus; 2) Body Mass Index > 25 kg / m2; 3) Total Cholesterol > 5.2 mmol / L; Or Triglyceride > 1.70 mmol / L; Or Low-Density Lipoprotein > 3.12 mmol / L; Or High-Density Lipoprotein < 1.04 mmol/L. 4) Systolic blood pressure > 130 mmHg or Diastolic blood pressure > 85 mmHg or diagnosed as hypertension;
  • Received 6 months of continuous Chinese herbal medicine treatment;
  • During the period of receiving Chinese herbal medicine, the patients continued to take western medicine according to the doctor's advice as before.
  • During the period of receiving Chinese herbal medicine, diet and exercise continued according to the original routine, and the tests would be reviewed in the same institution.
  • Aged 18 to 80 years at the time of their consent;
  • Signed informed consent.

Exclusion criteria

  • Patients who had serious heart, lung, liver, kidney and brain diseases; serious infectious or hemorrhagic diseases; serious nervous system diseases, mental instability; or could not cooperate with treatment were excluded.

Treatment and study plan

Chinese herb medicine

Drug

Patients took 200 ml Chinese herb decoction twice a day before breakfast and dinner.

Primary outcomes

  1. Change from Baseline HbA1c at 3 months, 6 months

    Time frame: 0 month, 3 months, 6 months

  2. Changes from Baseline Fasting Blood Glucose at 3 months, 6 months

    Time frame: 0 month, 3 months, 6 months

  3. Changes from Baseline Low Density Lipoprotein at 3 months, 6 months

    Time frame: 0 month, 3 months, 6 months

  4. Changes from Baseline Triglyceride at 3 months, 6 months

    Time frame: 0 month, 3 months, 6 months

  5. Changes from Baseline Body Mass Index at 3 months, 6 months

    Time frame: 0 month, 3 months, 6 months

Secondary outcomes

  1. Changes from Postprandial Blood Glucose at 6 months

    Time frame: 0 month, 6 months

  2. Changes from Total Cholesterol at 6 months

    Time frame: 0 month, 6 months

  3. Changes from High Density Lipoprotein at 6 months

    Time frame: 0 month, 6 months

  4. Changes from Systolic Blood Pressure at 6 months

    Time frame: 0 month, 6 months

  5. Changes from Diastolic Blood Pressure at 6 months

    Time frame: 0 month, 6 months

Sponsors and collaborators

Lead sponsor

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Other

Registry information

Official study title

Type 2 Diabetes Mellitus With Obesity and Dyslipidemia Treated by Chinese Herbal Medicine: a Retrospective Study

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 11, 2021
Registry last updated
Sep 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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