CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 133 enrolled
Drug / intervention
Kothala Himbutu Biscuit +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02290925
NCT02290925Phase 3Completed
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The Effect of a Biscuit Containing the Extract of Salacia Reticulata on Glycaemia in Patients With Type 2 Diabetes Mellitus Randomized Triple Blind Placebo Controlled Two Period Two Sequence Crossover Clinical Trial

Rajarata University, Sri Lanka·interventional·Posted Nov 14, 2014·Updated May 14, 2019

In Brief

A Phase 3 clinical trial evaluating Kothala Himbutu Biscuit and Placebo Biscuit for Type 2 Diabetes Mellitus. Completed, enrolled 133 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes Mellitus
CountriesSri Lanka
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedNov 14, 2014
Enrollment StartMay 1, 2014
Primary CompletionApr 1, 2017
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 11.6 years ago

Interventions

Kothala Himbutu Biscuitdrug

Kothala Himbutu biscuit (containing Salacia reticulata extract) as a snack. This herb has been used by traditional physicians to control blood sugar.

Placebo Biscuitdietary

Placebo biscuit without the herbal extract of Kothala Himbutu (Salacia reticulate)