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

NCT02290925 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 133

Last updated 2019-05-14

Study results available
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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.

Conditions

Interventions

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)

Sponsors & Collaborators

  • Rajarata University, Sri Lanka

    lead OTHER

Principal Investigators

  • Nadeesha Wickramasinghe, BSc · Faculty of Medicine & Allied Sciences, Rajarata University of Sri Lanka

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
30 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2017-04-30
Completion
2017-04-30

Countries

  • Sri Lanka

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02290925 on ClinicalTrials.gov