Phase 3
Completed N=133
The Effect of Biscuit Containing Kothala Himbutu on Blood Glucose in Patients With Diabetes. A Randomized Control Study
Source: ClinicalTrials.gov NCT02290925 ↗Enrolled (actual)
133
Serious AEs
0.4%
Results posted
Mar 2019
Primary outcomePrimary: Glycosylated Haemoglobin — 8.36; 8.16; 8.23; 8.53 percentage of glycosylated hemoglobin
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The investigators intend to conduct a triple blind randomized clinical trial to investigate the effect of a biscuit containing herbal extract, available in the market on the fasting blood sugar control in patients with diabetes mellitus and also to find out whether there are any side effects on other vital organs such as kidneys and liver.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Glycosylated Haemoglobin |
8.36; 8.16; 8.23; 8.53 | — |
| SECONDARY Liver Adverse Effects |
38; 37; 39; 36; 37; 34 | — |
| SECONDARY Renal Adverse Effects -1 |
77.1; 76.0; 75.0; 75.0; 75.0; 76 | — |
| SECONDARY Renal Adverse Effects - 2 |
0.94; 0.94; 0.98; 0.96; 0.97; 0.93 | — |
Eligibility Criteria
Inclusion Criteria
- Type 2 diabetes for minimum period of 6 months
- Aged between 30 and 65 years
- Stable glycaemic control over the preceding 2-3 months. They will be initially selected from a range of HBA1C varying from 6.5 - 14 and the individual subject should not have a variation of >20% between the previous HBA1C and the HBA1C done at the commencement of the study
Exclusion Criteria
- Chronic kidney disease with estimated Glomerular filtration rate less than 30ml/hour
- Severe valvular heart disease or heart failure.
- Those on Insulin therapy
- Severe liver disease (AST > 10 X times the upper limit)
Data sourced from ClinicalTrials.gov (NCT02290925). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.