Methods | PARALLEL RANDOMIZED CONTROLLED CLINICAL TRIAL |
Participants | INCLUSION CRITERIA: Newly diagnosed Type 2 diabetes mellitus |
EXCLUSION CRITERIA: Not reported | |
DIAGNOSTIC CRITERIA: Not reported | |
CO-MORBIDITIES: Not reported | |
CO-MEDICATIONS: Apparently none | |
Interventions | NUMBER OF STUDY CENTRES: Single |
COUNTRY/ LOCATION: India | |
SETTING: Outpatients attending a Medical College Hospital | |
INTERVENTION(ROUTE,TOTALDOSE/DAY, FREQUENCY):Treatment group received Inolter (each capsule of Inolter contains Mormordica charantia 1OO mg, Trigonella Faenum Graecum 100 mg, Asphalt 100 mg, Gymnema Sylvestre 100 mg, Eugenia Jambolina 100 mg). Dose and frequency of administration not mentioned |
|
CONTROL (ROUTE, TOTAL DOSE/DAY, FREQUENCY): Controls received identical looking placebo - dose and frequency of administration not mentioned. Diet and exercise were continued for both groups |
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TREATMENT BEFORE STUDY: None for diabetes | |
TITRATION PERIOD: Not reported | |
Outcomes |
PRIMARY OUTCOME(S) (as stated in the publication): Glycaemic control (FBS, HbA1c) and changes in lipid profile |
SECONDARY OUTCOMES (as stated in the publication): None mentioned | |
ADDITIONAL OUTCOMES: None reported | |
Notes | No withdrawals reported |
Risk of bias | ||
---|---|---|
Bias | Authors’ judgement | Support for judgement |
Random sequence generation (selection bias) |
Unclear risk | not described |
Allocation concealment (selection bias) | Unclear risk | not described |
Blinding (performance bias and detection bias) All outcomes |
Low risk | coded and identical looking active medication or placebo |
Incomplete outcome data (attrition bias) All outcomes |
Low risk | no withdrawals reported |
Selective reporting (reporting bias) | Unclear risk | no protocol available |
Other bias | Low risk | nothing detected |