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

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

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: Kothala Himbutu Biscuit; Dietary supplement: Placebo Biscuit

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 Type: Interventional
• Enrollment (Actual): 133
• Phase: Phase 3

Contacts and Locations

Study Locations

• Sri Lanka
  • North Central Province
    • Anuradhapura, North Central Province, Sri Lanka, 50000
      • Teaching Hospital Anuradhapura

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Kothala Himbutu Biscuit; 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 Comparator: placebo biscuit; An identical biscuit without the herbal extract from Kothala Himbutu (Salacia reticulate)	Dietary supplement: Placebo Biscuit; Placebo biscuit without the herbal extract of Kothala Himbutu (Salacia reticulate); Other Names: Biscuit; Munchee biscuit

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Rajarata University, Sri Lanka
• Investigators: Study Director: Nadeesha Wickramasinghe, BSc, Faculty of Medicine & Allied Sciences, Rajarata University of Sri Lanka

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): April 1, 2017

Study Registration Dates

• First Submitted: November 7, 2014
• First Submitted That Met QC Criteria: November 11, 2014
• First Posted (Estimate): November 14, 2014

Study Record Updates

• Last Update Posted (Actual): May 14, 2019
• Last Update Submitted That Met QC Criteria: May 2, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: randomised controlled trial; biscuit containing Salacia reticulate
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: RAJ-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Individual Patient Data (IPD) will be available for researchers.
• IPD Sharing Time Frame: 10 years after end of the study (March 2019)
• IPD Sharing Access Criteria: Any qualified researcher should submit the protocol and get the ERC clearence from institutional IRB (Ethics Review Committee, Faculty of Medicine & Allied Science, Rajarata University of Sri Lanka). After that they need to come to an written agreement with the researchers to analyze the data.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code