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

Rajarata University, Sri Lanka

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes Mellitus

Treatments: Dietary Supplement: Placebo Biscuit; Drug: Kothala Himbutu Biscuit

Study type: Interventional

Funder types: Other

Identifiers

NCT02290925

RAJ-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 133 patients

Sex: All

Ages: 30 to 65 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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133 participants in 2 patient groups, including a placebo group

Kothala Himbutu biscuit

Experimental group

Description:

A biscuit containing Kothala Himbutu (Salacia reticulata) extract. This biscuit is available in the supermarkets. Four biscuits twice a day for 3 months.

Treatment:

Drug: Kothala Himbutu Biscuit

placebo biscuit

Placebo Comparator group

Description:

An identical biscuit without the herbal extract from Kothala Himbutu (Salacia reticulate)

Treatment:

Dietary Supplement: Placebo Biscuit