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Home » Trials » SLCTR/2017/010

Effectiveness of Cinnamomum zeylanicum (Ceylon cinnamon) in

lowering blood glucose in type 2 diabetes mellitus: a Randomized
Double Blind Placebo Controlled Clinical Trial

-
SLCTR Registration Number

SLCTR/2017/010

Date of Registration

05 Apr 2017

The date of last modification

Mar 03, 2019

Application Summary

Scientific Title of Trial

Effectiveness of Cinnamomum zeylanicum (Ceylon cinnamon) in lowering blood glucose in type 2 diabetes
mellitus: a Randomized Double Blind Placebo Controlled Clinical Trial

Public Title of Trial

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Effect of Ceylon cinnamon in lowering blood glucose for type 2 diabetes mellitus

Disease or Health Condition(s) Studied

Type 2 Diabetes Mellitus

Scientific Acronym

None

Public Acronym

None

Brief title

Ceylon cinnamon in type 2 diabetes

Universal Trial Number

U1111-1194-6431

Any other number(s) assigned to the trial and issuing authority

EC-16-197 (ERC: Colombo)

Trial Details

What is the research question being addressed?

Does Ceylon cinnamon lower blood glucose in patients with type 2 Diabetes Mellitus?

Type of study

Interventional

Study design

Allocation

Randomized controlled trial

Masking

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Double blinded

Control

Placebo

Assignment

Parallel

Purpose

Treatment

Study Phase

Phase 2-3

Intervention(s) planned

The study will be carried out at Medical Clinics of the University Medical Unit, National Hospital of Sri Lanka.

Consenting participants meeting inclusion/exclusion criteria will be randomized into 3 arms using stratified
block randomization.

Arm 1 (intervention arm) will receive a capsule containing 250mg Cinnamomum zeylanicum extract as the
active ingredient, to be taken orally once daily before breakfast for a period of 4 months.

Arm 2 (intervention arm) will receive a capsule containing 500mg Cinnamomum zeylanicum extract as the
active ingredient, to be taken orally once daily before breakfast for a period of 4 months.

Arm 3 (control arm) will receive an identical matching placebo. The placebo will be manufactured to have a
similar appearance, shape, weight, and color as the cinnamon capsules

The investigators and patients would be blind to the treatment allocations.

Standard management will continue for participants in all 3 arms.

Inclusion criteria

1. Male and female patients aged 18 – 70 years

2. Diagnosed type 2 diabetes mellitus during the last 5 years
3. Currently only on metformin or a sulphonyluria or both for the last 3 months
4. HbA1c 6.5-8.0%
5. Fasting blood glucose (FBG) 126-200 mg/dl

Exclusion criteria

1. Known allergy to cinnamon.

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2. Alcohol consumption >20g/day

3. Diagnosed Alcoholic Liver Disease, cirrhosis or abnormal baseline liver function tests.
4. Patients who are currently on hypoglycemic agents other than metformin or a sulphonyluria)
5. Insulin therapy
6. Raised baseline serum creatinine level (>1.5mg/dl in males or >1.2 mg/dl in females)
7. Lactation, pregnancy or unwillingness to use an effective form of birth control for women of child bearing
years.
8. Symptoms suggestive of peptic ulcer disease
9. Past history of peptic ulceration.
10. Any diagnosed malignancy
11. Cardiac, liver or respiratory failure
12. Any other unrelated chronic illness
13. Any condition in the opinion of the primary investigator that would contraindicate the patient's
participation.

Primary outcome(s)

[
1.
At baseline and monthly for a period of
Change in HbA1c from baseline in treatment and placebo arms four months.

]
[
2.
At baseline and monthly for a period of
Change in Fasting Blood Glucose (FBG) from baseline in treatment
four months.
and placebo arms
]

Secondary outcome(s)

[
1. At baseline and
monthly for a period of
Percentage of patients with HbA1c <7.0%
four months.

]
[
2. At baseline and
monthly for a period of
Percentage of patients with FBG < 126 mg/dl
four months.

]
3. [

Change in insulin resistance and Beta-cell function from baseline (measured by the At baseline and
Homeostasis Model of Assessment (HOMA) calculations based on fasting blood monthly for a period of
glucose and fasting serum insulin). four months.
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]
[
4.
At baseline and
Change in BMI and other anthropometric parameters (weight, waist circumference, hip monthly for a period of
circumference, waist:hip ratio) from baseline four months.

]
[
5. At baseline and
monthly for a period of
Change in Blood Pressure (systolic and diastolic) from baseline
four months.

]
[
6. At baseline and
monthly for a period of
Change in the Lipid Profile (Total cholesterol, LDL, HDL and TAG) from baseline
four months.

Target number/sample size

210 (70 in each arm)

Countries of recruitment

Sri Lanka

Anticipated start date

2017-05-01

Anticipated end date

2017-12-31

Date of first enrollment

Date of study completion

Recruitment status

Pending

Funding source
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University of Colombo (Grant ref. no. AP/03/2012/CG/08)

Regulatory approvals

State of Ethics Review Approval

Status

Approved

Date of Approval

2017-03-23

Approval number

EC-16-197

Details of Ethics Review Committee

Name: Ethics Review Committee, Faculty of Medicine, University of Colombo

Institutional Address: No. 25, Kynsey Road, Colombo 00800
Sri Lanka
Telephone: +94-11-2695300 (Extension: 240)
Email: ethicscommitteemfc@gmail.com

Contact & Sponsor Information

Contact person for Scientific Queries/Principal Investigator

Prof. Priyadarshani Galappatthy

Professor in Pharmacology

Department of Pharmacology, Faculty of Medicine, University of Colombo, No 25, Kynsey Road,

Colombo 08,
Sri Lanka

Tel: 0112695300

Mob: 0718655651

p.galappatthy@pharm.cmb.ac.lk

http://med.cmb.ac.lk/index.php/department-of-parmacol-staff?id=264

Contact Person for Public Queries

Dr. Priyanga Ranasinghe

Lecturer

Department of Pharmacology, Faculty of Medicine, University of Colombo, No 25, Kynsey Road,

Colombo 08,
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Sri Lanka

Tel: 0112695300

Mob: 0772770202

priyanga@pharm.cmb.ac.lk

http://med.cmb.ac.lk/index.php/department-of-parmacol-staff?id=269

Primary study sponsor/organization

University of Colombo

Kumaratunga Munidasa Mawatha,

Colombo 03
Sri Lanka

Tel: 0112581835

acpbuoc@gmail.com

http://www.cmb.ac.lk/

Secondary study sponsor (If any)

None

Trial Completion details

Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?

IPD sharing plan description

Not Available

Study protocol available

Protocol version and date

Not Available

Protocol URL

Not Available

Results summary available

No

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Date of posting results

Date of study completion

Final sample size

Date of first publication

Link to results

Brief summary of results

Trial Options

View
Publications
Progress Reports
Protocol Change

© Sri Lanka Clinical Trials Registry 2008 − 2022

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