| Methods | Parallel placebo-controlled randomised trial |
| Participants | SETTING: Outpatients at the General Hospital of the People’s Liberation Army, China |
| WHO PARTCIPATED: n=168 (in treatment group M/F 62/24; mean age 55.6 yrs, duration of disease 1mth -2yrs; in the control group M/F 59/23, mean age 53.8, duration of disease 1mth-2yrs). | |
| INCLUSION CRITERIA: IGT (WHO 1999) and hypertension plus high total cholesterol or high triglycerides or low HDL. | |
| EXCLUSION CRITERIA: IGT due to endocrinological disorders, liver disease, drugs, stress. | |
| CO-MORBIDITIES: hypertension, hypercholestemia or high triglycerides or low high density lipoprotein (HDL). | |
| CO-MEDICATIONS: none reported | |
| Interventions | INTERVENTION: Xiaoke huaya tablet (Zhi My, Gui JIan Yu etc), dosage: 0.5g three times per day plus lifestyle modification (diet & exercise) |
| CONTROL: lifestyle modification (diet & exercise alone) | |
| Outcomes | FBG (mmol/L), 2hr-GTT (mmol/L), HbA1c (%), triglycerides (mmol/L), total cholesterol (mmol/L), normalisation of FBG (n), incidence of diabetes (n) |
| Outcomes were measured at baseline and trial completion (8 wks). | |
| Study details | DURATION OF INTERVENTION: 8 weeks |
| DURATION OF FOLLOW-UP: 8 weeks | |
| RUN-IN PERIOD: none | |
| Publication details | LANGUAGE OF PUBLICATION: Chinese |
| COMMERCIAL FUNDING: No | |
| NON-COMMERCIAL FUNDING: Yes (Translational Funding Project) | |
| PUBLICATION STATUS (PEER REVIEW JOURNAL): Yes | |
| PUBLICATION STATUS (JOURNAL SUPPLEMENT): No | |
| PUBLICATION STATUS (ABSTRACT): Yes | |
| Stated aim of study | Quote “to validate the therapeutic effects of Xiaoke Huaya tablet in the impaired glucose tolerance population ” |
| Notes | |
Risk of bias table