Methods | Parallel randomised controlled trial |
Participants | SETTING: China |
WHO PARTCIPATED: 95 participants (48 in intervention, M/F 32/16, mean age 53.5yrs; 47 in control, M/F 29/18, mean age 53.5yrs) | |
INCLUSION CRITERIA: IGT (WHO 1999); >30yrs<60yrs; not taking any medication that influences glucose levels for at lease one month; willingness to comply with the trial and examination; | |
EXCLUSION CRITERIA: Level 3 hypertension; serious heart, liver or kidney dysfunction; mental diseases; allergic condition; pregnancy or lactation. | |
DIAGNOSTIC CRITERIA: IGT WHO 1999 | |
CO-MORBIDITIES: none stated | |
CO-MEDICATIONS: none stated | |
Interventions | INTERVENTION: Qiweitangping capsule (huang qi, huang qin, zi su zi, dang shen, da huang, da zao, shu di huang, chai hu, dan shen, yu jin, yin chen, tian hua fen, shi gao, che qian zi, shan yao, we wei zi, shan zhu yu, zhi mu, gou qi zi, ge gen, bai he, gua lou, wu yao, di huang, hua jiao, wang bu liu xing, gan cao) 3 capsule twice daily |
CONTROL: placebo 3 capsules twice daily oral | |
Outcomes | FBG (mmol/L), 2hr-GTT (mmol/L), BMI (kg/m2), WHR |
All outcomes were measured at baseline and trial completion (24 months). | |
Adverse effects: one participant from treatment and one from the control developed abdominal discomfort. Both were resolved without any treatment | |
Study details | DURATION OF INTERVENTION: 24 months |
DURATION OF FOLLOW-UP: 24 months | |
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 intervention effects of Qiweitangping capsule on impaired glucose tolerance (IGT) and on the morbidity of diabetes mellitus (DM)and the effect of conversing IFF to normal glucose tolerance (NGT) ” |
Notes |
Risk of bias table