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Traditional Chinese Medicine in Individualized Treatment of Patients With Diabetes Symptoms

S

Shanghai University of Traditional Chinese Medicine

Status

Completed

Conditions

Type 2 Diabetes Mellitus

Treatments

Drug: Chinese herbal medicine
Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT01844050
S06DZ19728 (Other Identifier)
06DZ19728-2

Details and patient eligibility

About

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

Enrollment

120 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

120 participants in 2 patient groups, including a placebo group

Chinese herbal medicine
Experimental group
Description:
Individualized Treatment with Chinese herbal
Treatment:
Drug: Chinese herbal medicine
Placebo
Placebo Comparator group
Description:
Individualized Treatment with placebo Chinese herbal which Containing 2% of Chinese herbal medicine.
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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