The Effect of Biscuit Containing Kothala Himbutu on Blood Glucose in Patients With Diabetes. A Randomized Control Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: Kothala Himbutu Biscuit
* Dietary Supplement: Placebo Biscuit


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Kothala Himbutu biscuit<br>A biscuit containing Kothala Himbutu (Salacia reticulata) extract. This biscuit is available in the supermarkets. Four biscuits twice a day for 3 months. | Drug: Kothala Himbutu Biscuit<br>* Kothala Himbutu biscuit (containing Salacia reticulata extract) as a snack. This herb has been used by traditional physicians to control blood sugar.<br>* Other names: Munchee Kothala Himbutu biscuit;|
| Placebo Comparator: placebo biscuit<br>An identical biscuit without the herbal extract from Kothala Himbutu (Salacia reticulate) | Dietary Supplement: Placebo Biscuit<br>* Placebo biscuit without the herbal extract of Kothala Himbutu (Salacia reticulate)<br>* Other names: Munchee biscuit;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycosylated Haemoglobin | HBA1c were analyzed at a centrally accredited lab using ion exchange high performance liquid chromatography standardized to NGSP | After 3 months and after 7 months (there is one month wash over period as this is a cross over trial) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Liver Adverse Effects | liver functions are described in the table below with higher liver enzymes suggesting injury to the liver. | Baseline, after 3 months, and after 7 months | 
| Renal Adverse Effects -1 | Renal functions are described in the table below with Lower estimated Glomerular Filtration Rate (eGFR) suggesting injury to the kidney. | baseline, after 3 months and after 7 months | 
| Renal Adverse Effects - 2 | Renal functions are described in the table below with higher serum creatinine suggesting injury to the kidney. | Baseline, after 3 months, and after 7 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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biscuit containing Salacia reticulate, randomised controlled trial