| Methods | Parallel randomised controlled trial |
| Participants | SETTING: Outpatients at the Foshan TCM Hospital, Guangdong Province, China |
| WHO PARTCIPATED: n=72 (36 in the intervention group, M/F 19/13, mean age 46.3yrs; 36 in the control group, M/F 20/13, mean age 47.1yrs) | |
| INCLUSION CRITERIA: IGT (WHO 1999) | |
| EXCLUSION CRITERIA: none reported | |
| CO-MORBIDITIES: none reported | |
| CO-MEDICATIONS none reported | |
| Interventions | INTERVENTION (ROUTE, TOTAL DOSE/DAY, FREQUENCY): Xiaoke Yuye (Huang qi, huang jing, he shou wu, zhi mu) 10ml three times per day, plus lifestyle modification (diet and exercise) |
| CONTROL: lifestyle modification (diet and exercise) | |
| Outcomes | Fasting blood glucose (mmol/L), 2hr-GTT (mmol/L), HbA1c (%), total cholesterol (mmol/L), BMI, normalisation of fasting blood glucose (n), incidence of diabetes (n) |
| All outcomes were measured at baseline and at trial completion (24 months) | |
| No adverse effects in the treatment group. | |
| Study details | DURATION OF INTERVENTION: 2 years |
| DURATION OF FOLLOW-UP: 2 years | |
| RUN-IN PERIOD: none | |
| Publication details | LANGUAGE OF PUBLICATION: Chinese |
| COMMERCIAL FUNDING: no | |
| NON-COMMERCIAL FUNDING: no | |
| PUBLICATION STATUS (PEER REVIEW JOURNAL): yes | |
| PUBLICATION STATUS (JOURNAL SUPPLEMENT): no | |
| PUBLICATION STATUS (ABSTRACT): yes | |
| Stated aim of study | Quote “To observe the effects of Xiaoke yuye on patients with impaired glucose tolerance.” |
| Notes | |
Risk of bias table