This trial is active, not recruiting.

Condition type 2 diabetes mellitus
Treatments kothala himbutu biscuit, placebo biscuit
Phase phase 3
Sponsor Rajarata University, Sri Lanka
Collaborator University of Peradeniya
Start date May 2014
End date April 2017
Trial size 195 participants
Trial identifier NCT02290925, RAJ-001


The investigators intend to conduct a double 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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model crossover assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
A biscuit containing Kothala Himbutu (Salacia reticulata) extract. This biscuit is available in the supermarkets. Four biscuits twice a day for 3 months.
kothala himbutu biscuit Salacia reticulata
Kothala Himbutu biscuit (Salacia reticulata). This herb has been used by traditional physicians to control blood sugar.
(Placebo Comparator)
An identical biscuit without the herbal extract from Kothala Himbutu (Salacia reticulate)
placebo biscuit Biscuit
Placebo biscuit without the herbal extract of Kothala Himbutu (Salacia reticulate)

Primary Outcomes

change in glycosylated haemoglobin (non-inferiority)
time frame: before (0), after 3 months and after 7 months (there is one month wash over period as this is a cross over trial) Zero time period means just before starting the active ingredient or placebo
serious adverse effects
time frame: during the period patient is taking biscuit conatining an extract of Salacia reticulate, which is three months

Secondary Outcomes

Six point blood sugar series
time frame: one day during the 7 months patients are in the trial including wash out period

Eligibility Criteria

Male or female participants from 30 years up to 65 years old.

Inclusion Criteria: 1. Onset of diabetes mellitus after the age of 30 years 2. Aged between 30 and 65 years 3. 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: 1. Having severe disabling long-term complications of diabetes mellitus such as severe retinopathy, neuropathy and nephropathy. 1.1 Patients with advanced diabetic eye disease. 1.2. Severe Neuropathy (to be assessed by clinician). 1.3. Chronic kidney disease with estimated Glomerular filtration rate less than 30ml/hour 2. Severe valvular heart disease. 3. Currently or previously treated for any malignancy 4. Already on treatment with Kothala himbutu 5. Pregnant or lactating females 6. Patients on steroid treatment 7. Patients on steroid treatmentThose on Insulin therapy 8. Severe liver disease (AST > 5 X times the upper limit)

Additional Information

Official title The Effect of a Biscuit Containing the Extract of Salacia Reticulata on Glycaemia in Patients With Type II Diabetes Mellitus A Two Center Randomized Double Blind Placebo Controlled Two Period Two Sequence Crossover Clinical Trial
Description The effect of a biscuit containing the extract of Salacia reticulata (Kothala Himbutu) on the reduction of blood glucose levels in patients with Type II Diabetes Mellitus. A two center randomized double blind placebo controlled two period two sequence crossover clinical trial.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Rajarata University, Sri Lanka.