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

Type 2 Diabetes Mellitus Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02290925
• Other study ID #: RAJ-001
• Status: Completed
• Phase: Phase 3
• Start date: May 2014
• Est. completion date: April 2017

Study information

• Verified date: March 2019
• Source: Rajarata University, Sri Lanka
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 133
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

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.

Dietary Supplement:
• Placebo Biscuit
Placebo biscuit without the herbal extract of Kothala Himbutu (Salacia reticulate)

Locations

Country	Name	City	State
Sri Lanka	Teaching Hospital Anuradhapura	Anuradhapura	North Central Province

Sponsors (1)

Lead Sponsor	Collaborator
Rajarata University, Sri Lanka

Country where clinical trial is conducted

Sri Lanka, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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