| Methods | PARALLEL RANDOMIZED CONTROLLED CLINICAL TRIAL |
| Participants |
WHO PARTCIPATED: 40 type 2 diabetic patients aged between 30 to 60 years INCLUSIONCRITERIA: Adults within the age range of 30 - 60 years; secondary failure to OHA (patient had HbA1c levels > 8.5% even after supplementation of maximal dose of a combination of a sulphonylurea (15 mg glibenclamide or 160 mg gliclazide or 15 mg glipizide) and metformin 1500 mg/day) EXCLUSIONCRITERIA: Patientswith ketosis, diabetes related complications, hepatic or renal disease, pancreatitis, cardiac problems, uncontrolled hypertension,malnutrition and severe immune deficiency DIAGNOSTIC CRITERIA: Not reported CO-MORBIDITIES: Not reported CO-MEDICATIONS: Not reported |
| Interventions |
NUMBER OF STUDY CENTRES: 1 COUNTRY/ LOCATION: India SETTING: Outpatient Diabetic Speciality Clinic INTERVENTION (ROUTE, TOTAL DOSE/DAY, FREQUENCY): Hyponidd - a herb-mineral formulation that has 12 blended ingredients including Vijaysar (Pterocarpus marsupium), Gurmar (Gymneme Sylvestre), Jambu Beej (syzygium Cumine), Amla (Emblica Officianale), Haldi (Gurcuma Longa), Neem (Melia Azadirachta), Trivang Bhasma and Shilajit; 2 tablets three times daily for 12 weeks CONTROL (ROUTE, TOTAL DOSE/DAY, FREQUENCY): Identical looking placebo- 2 tablets three times a day for 12 weeks TREATMENT BEFORE STUDY: Not Reported TITRATION PERIOD: Not Reported |
| Outcomes |
PRIMARY OUTCOME(S) (as stated in the publication): Not stated SECONDARY OUTCOMES (as stated in the publication): Not Stated ADDITIONAL OUTCOMES: Fasting and post prandial plasma glucose, glycosylated haemoglobin, insulin measurements, C-peptide assays and lipid profile |
| Notes | 8 participants withdrew 4 from each group |
| Risk of bias | ||
|---|---|---|
| Bias | Authors’ judgement | Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk | “Patients were randomly allocated to either group A or B” |
| Allocation concealment (selection bias) | Unclear risk | not described |
| Blinding (performance bias and detection bias) All outcomes |
Low risk | “the drug and the placebo looked identical and were placed in different boxes coded A and B respectively” |
| Incomplete outcome data (attrition bias) All outcomes |
High risk | drop-outs excluded from analysis |
| Selective reporting (reporting bias) | Unclear risk | no protocol available |
| Other bias | Low risk | nothing detected |