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. Author manuscript; available in PMC: 2013 Jul 22.
Published in final edited form as: Cochrane Database Syst Rev. 2011 Dec 7;(12):CD008288. doi: 10.1002/14651858.CD008288.pub2
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
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