Clinical trial NCT02290925: The Effect of Biscuit Containing Kothala Himbutu on Blood Glucose in Patients With Diabetes. A Randomized Control Study
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Keywords: biscuit containing Salacia reticulate
randomised controlled trial
Lead sponsor: Rajarata University, Sri Lanka
Sponsor class: OTHER
First posted: 2014-11-14
Enrollment: 133
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Patients with diabetes were screened and Type I Diabetes was excluded. The minimum run-in period was eight weeks and if the variability of HbA1c is more than 20%, excluded, to exclude patients with fluctuating glycaemia. As this is a crossover trial some degree of stability of the glycemic control is necessary to prevent excessive variation of HbA1c interfering with the study outcome. Participants were randomized to receive the KH or placebo biscuit. Oral hypoglycemic was continued and adjusted. Participants consumed KH or placebo biscuit for a period of 3 months as mid-morning and afternoon snack. Subsequently in the washout period of 1 month the participants did not consumed any biscuits. After, crossing over they continued biscuits for another 3 months. HbA1c was done at recruitment, after run-in period, at 3 months and on completion of the study. When there was deterioration of the glycaemic control patient was prescribed insulin, and withdrawn from the study.
Primary purpose: TREATMENT

Brief 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.

Detailed 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 2 Diabetes Mellitus. A single center randomized triple blind placebo controlled two period two sequence crossover clinical trial.

Eligibility criteria: Inclusion Criteria:

1. Type 2 diabetes for minimum period of 6 months
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. Chronic kidney disease with estimated Glomerular filtration rate less than 30ml/hour
2. Severe valvular heart disease or heart failure.
3. Those on Insulin therapy
4. Severe liver disease (AST \> 10 X times the upper limit)

Primary outcomes:
measure: Glycosylated Haemoglobin
timeFrame: After 3 months and after 7 months (there is one month wash over period as this is a cross over trial)
Secondary outcomes:
measure: Liver Adverse Effects
timeFrame: Baseline, after 3 months, and after 7 months
measure: Renal Adverse Effects -1
timeFrame: baseline, after 3 months and after 7 months
measure: Renal Adverse Effects - 2
timeFrame: Baseline, after 3 months, and after 7 months
Other outcomes:
Locations:
city: Anuradhapura
country: Sri Lanka
facility: Teaching Hospital Anuradhapura
state: North Central Province
Study officials:
affiliation: Faculty of Medicine & Allied Sciences, Rajarata University of Sri Lanka
name: Nadeesha Wickramasinghe, BSc
role: STUDY_DIRECTOR
References: