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

Phase 3

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Kothala Himbutu Biscuit; Dietary Supplement: Placebo Biscuit

• Registration Number: NCT02290925
• Lead Sponsor: Rajarata University, Sri Lanka

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.

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-11-07
• Study First Submitted QC: 2014-11-11
• Study First Posted: 2014-11-14
• Primary Completion: 2017-04
• Study Completion: 2017-04
• Results First Submitted: 2018-10-25
• Status Verified: 2019-03
• Results First Submitted QC: 2019-03-25
• Results First Posted: 2019-03-27
• Last Update Submitted: 2019-05-02
• Last Update Posted: 2019-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 133

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Kothala Himbutu biscuit	Kothala Himbutu Biscuit	A biscuit containing Kothala Himbutu (Salacia reticulata) extract. This biscuit is available in the supermarkets. Four biscuits twice a day for 3 months.
placebo biscuit	Placebo Biscuit	An identical biscuit without the herbal extract from Kothala Himbutu (Salacia reticulate)

Primary Outcome Measures

Name	Time	Method
Glycosylated Haemoglobin	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 Outcome Measures

Name	Time	Method
Liver Adverse Effects	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.
Renal Adverse Effects -1	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.
Renal Adverse Effects - 2	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.

Trial Locations

Locations (1)

Teaching Hospital Anuradhapura; 🇱🇰 Anuradhapura, North Central Province, Sri Lanka