CompletedPhase 2Phase 3ACTRN12612000128897

Clinical trial of a Chinese herbal medicine for the treatment of prediabetes and mild diabetes

Randomised controlled trial of Jiangtang Xiaozhi compared to placebo for the treatment of prediabetes and mild diabetes

Sponsor

Xiyuan Hospital

Enrollment

100 participants

Start Date

Jun 28, 2007

Study Type

Interventional

Conditions

Mild diabetes defined as those with diabetes diagnosed within 5 yrs of enrolment in the clinical trial, diet and exercise controlled and not taking any medications.Impaired glucose tolerance defined as having a fasting blood glucose <7.8 mmol and a 2 hour post prandial blood glucose >7.8 but <11.00

Summary

This trial assessed the effectiveness of a Chinese herbal medicine to normalise blood glucose and insulin levels. Participants were randomly divided into two groups. Group 1 received the Chinese Herbal Formula and Group 2 received a placebo which had no treatment effect.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 80 Yearss

Inclusion Criteria3

Participants must have either:
fasting blood glucose level of <7.0 mmol/L AND 2 hr plasma glucose level >7.8 <11.1 OR
be diagnosed with diabetes within the last five years and have their diabetes diet and exercised controlled and NOT taking any medication.

Exclusion Criteria1

individuals with conditions or treatments that would interfere with participation or completion of the protocol, or that had a confounding effect on the outcomes of the study

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Interventions

Jiangtang Xiaozhi at a dosage of 3 capsules 3 times per day for 16 weeks. Jiangtang Xiaozhi comprises six herbs and two excipients: Ligustrum lucidum, Astragalus membranaceus (Fisch.), Coptis chinen

Jiangtang Xiaozhi at a dosage of 3 capsules 3 times per day for 16 weeks. Jiangtang Xiaozhi comprises six herbs and two excipients: Ligustrum lucidum, Astragalus membranaceus (Fisch.), Coptis chinensis, Litchi chinensis, Ecklonia kurome Curcuma longa, Lactose, Magnesium stearate

Locations(1)

Australia

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ACTRN12612000128897