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NCT Number: NCT02290925

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

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Teaching Hospital Anuradhapura

Anuradhapura, North Central Province, 50000, Sri Lanka

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Kothala Himbutu Biscuit

Drug

Kothala Himbutu biscuit (containing Salacia reticulata extract) as a snack. This herb has been used by traditional physicians to control blood sugar.

Other names: Biscuit contining Salacia reticulata extract, Kothala Himbutu Biscuit manufactured by Ceylon Biscuits Ltd, Munchee Kothala Himbutu biscuit

Placebo Biscuit

Dietary Supplement

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

Other names: Biscuit, Munchee biscuit

Primary outcomes

  1. Glycosylated Haemoglobin

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

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

Secondary outcomes

  1. Liver Adverse Effects

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

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

  2. Renal Adverse Effects -1

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

    Renal functions are described in the table below with Lower estimated Glomerular Filtration Rate (eGFR) suggesting injury to the kidney.

  3. Renal Adverse Effects - 2

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

    Renal functions are described in the table below with higher serum creatinine suggesting injury to the kidney.

Sponsors and collaborators

Lead sponsor

Rajarata University, Sri Lanka

Other

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Nov 14, 2014
Registry last updated
May 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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