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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612000128897

Enrollment

100

Registered

2012-01-30

Start date

2007-06-28

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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 chinensis, Litchi chinensis, Ecklonia kurome Curcuma longa, Lactose, Magnesium stearate

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Healthy volunteers

Yes

Inclusion criteria

Participants must have either: 1. fasting blood glucose level of <7.0 mmol/L AND 2 hr plasma glucose level >7.8 <11.1 OR 2. be diagnosed with diabetes within the last five years and have their diabetes diet and exercised controlled and NOT taking any medication.

Exclusion criteria

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

Outcome results