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Completed

NCT Number: NCT01844050

Traditional Chinese Medicine in Individualized Treatment of Patients With Diabetes Symptoms

Based on the Individualized treatment of diabetes symptoms to evaluate the method of syndrome differentiation treatment of Traditional Chinese medicine.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai University of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, 201108, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Newly diagnosed type 2 diabetes poorly controlled by diet and exercise therapy, and must with any of diabetes symptoms.
  • After the diet and exercise therapy, 7.0mmol/l≤FPG≤11.1mmol/l or 8.0mmol/l<2h PG<16mmol/l
  • Any type of TCM syndrome, but can be performed within the chosen Chinese herbal medicine.
  • Subject is willing to participate and capable of giving informed consent.

Exclusion criteria

  • Those patients used any drugs for treatment of diabetes within one month.
  • Patients with any severe complications of cardiac, cerebric, vascular, hepatic, renal, blood system.
  • Patients suffer from acute metabolic disorder including diabetic ketoacidosis or hyperosmotic non-ketotic coma within one month.
  • Women who were pregnant, lactating or planned pregnant.
  • Allergic constitution and has a history of drug allergy.
  • Combined with severe acute or chronic infections.

Treatment and study plan

Chinese herbal medicine

Drug

According to the traditional Chinese medicine syndrome of subject to make up a prescription within the 35 kinds of chosen Chinese herbal medicine, and the dosage without limitation.

Placebo

Drug

Primary outcomes

  1. Change from Baseline Total score of diabetes symptoms at 4 weeks

    Time frame: 0 weeks(baseline), 2 weeks, 4 weeks

Secondary outcomes

  1. Change from Baseline Fasting Blood Glucose at 4 weeks

    Time frame: 0 weeks(baseline), 2 weeks, 4 weeks

  2. Change from Baseline blood glucose at 2 hours after meal at 4 weeks

    Time frame: 0 weeks(baseline), 2 weeks, 4 weeks

Sponsors and collaborators

Lead sponsor

Shanghai University of Traditional Chinese Medicine

Other

Collaborators

  • Longhua Hospital
  • Shanghai Putuo District Center Hospital

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
May 1, 2013
Registry last updated
Jun 12, 2019

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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