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

Rajarata University, Sri Lanka133 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

133

Conditions

Type 2 Diabetes Mellitus

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_SUPPLEMENT

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

Eligibility

Sex: ALLMin age: 30 YearsMax age: 65 Years

Medical Language ↔ Plain English

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)

Locations (1)

Teaching Hospital Anuradhapura

Anuradhapura, North Central Province, Sri Lanka

Outcomes

Primary Outcomes

Glycosylated Haemoglobin

HBA1c were analyzed at a centrally accredited lab using ion exchange high performance liquid chromatography standardized to NGSP

Time frame: After 3 months and after 7 months (there is one month wash over period as this is a cross over trial)

Secondary Outcomes

Liver Adverse Effects

liver functions are described in the table below with higher liver enzymes suggesting injury to the liver.

Time frame: 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.

Time frame: 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.

Time frame: Baseline, after 3 months, and after 7 months

Data from ClinicalTrials.gov

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