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Investigation on the Efficacy and Safety of Ceylon Cinnamon (Cinammomum zeylanicum) and Metformin in Ameliorating Polycystic Ovary Syndrome (PCOS): A Randomized Controlled Trial

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SLCTR Registration Number

SLCTR/2022/009


Date of Registration

05 Apr 2022

The date of last modification

Apr 05, 2022



Application Summary


Scientific Title of Trial

Investigation on the Efficacy and Safety of Ceylon Cinnamon (Cinammomum zeylanicum) and Metformin in Ameliorating Polycystic Ovary Syndrome (PCOS): A Randomized Controlled Trial


Public Title of Trial

Investigation on the efficacy and safety of Ceylon cinnamon (Cinammomum zeylanicum) compared to metformin in ameliorating symptoms of Polycystic Ovary Syndrome (PCOS): A randomized controlled trial


Disease or Health Condition(s) Studied

Polycystic ovary syndrome (PCOS)


Scientific Acronym

None


Public Acronym

None


Brief title

Investigation on the efficacy and safety of Ceylon Cinnamon (CC) compared to metformin in ameliorating symptoms of Polycystic Ovary Syndrome (PCOS)


Universal Trial Number

U1111-1270-6211


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

2021/EC/59; UoP


Trial Details


What is the research question being addressed?

Is Cinnamon efficacious and safe compared to metformin in treatment of women with polycystic ovary syndrome (PCOS)?


Type of study

Interventional


Study design

Allocation

Randomized controlled trial


Masking

Double blinded : Participants, Investigators, Data analysts, Healthcare providers, Outcome assessors


Control

Standard therapy/practice


Assignment

Parallel


Purpose

Treatment


Study Phase

Phase 3


Intervention(s) planned

A total 86 women age range between 18-45 years old diagnosed with PCOS according to Rotterdam criteria. Block randomization will be used to ensure that the total sample size of 86 will be equally divided for two treatment options with 43 participants per each. Each block size will be a size of 4. the random selection will be done using list of random numbers generated using software of Microsoft excel to receive cinnamon capsule (CC) 1500mg per day or standard treatment of metformin (1500mg) daily for 12 weeks with routine life style recommendations. The nature of preparation administered to each patient will not be known to the medical staff or the patient. .

The target dosage of the study medicine of CC is 1500mg per day for three months duration. Capsule containing cinnamon bark powder will prepared with 500mg dosage. Therefore treatment will be administer three times per day with meals. For the preparation of capsule, single sourced, botanists verified cinnamon bark will be obtained from a single origin. The complete study will be conducted using single origin same batch of cinnamon. The bark samples will be grounded using a mechanical grinder an sieved (mesh size 50) and fill into capsules containing 500mg. Standard drug metformin will be administered as 1500mg/day by 500mg capsule three times per day with meals. All the participant will be advised to adhere routine lifestyle recommendations prescribed for PCOS. Patients will be supplied with packaged containers to hold sufficient doses for the patients to complete three months duration. To minimize the risk of gastrointestinal upset, participants will be advised to take the study treatment soon after meals. Investigational product may be acquired after preparation by the above HDDES extracts (pvt) ltd and both standard drug of metformin and cinnamon capsule will be manufactured and supplied by the reputed manufacturer, Celogen Lanka Private Limited, Lot No 7A Industrial Park, BOI, Pallekele, Kandy, Sri Lanka. An individual subject will complete the study in about 12 weeks, from screening at Day -1 to follow-up on day 7, 14, 21, monthly and after 3 months.


Inclusion criteria

  1. Aged between 18 to 45 years
  2. Women who diagnosed with PCOS according to the Rotterdam criteria
  3. Body Mass Index (BMI) equal or greater than 18
  4. Willingness to sign the consent form

Exclusion criteria

  1. Pregnant or lactation mothers
  2. Women who being under treatment for infertility or subfertility
  3. Women who diagnosis of hyperprolactinemia, thyroid disorders, Cushing syndrome, adrenal hyperplasia, hypertension and Diabetes
  4. Patients who were on any medication including oral contraceptive pills or over the counter medication and insulin-sensitizing agents or hormonal treatments involving estrogen, progesterone or any drug inducing insulin resistance within the past 3 months prior to the study enrolment.
  5. Women with acute infections and illness 6. Unconsented patients
  6. Patients diagnosed with psychiatric illnesses


Primary outcome(s)

1.

Improvement of menstrual cyclicity evidence by Proportion of resumption of normal menstrual cycle and menstrual frequency (number of menses/ month) The typical menstrual cycle pattern is 28 ± 7 days with menstrual flow lasting 4 ± 2 days and blood loss averaging 20 to 60 mL. Menstrual Cycle Patterns: will be assessed by cycle frequency, duration, regularity and volume. Frequency is defined as the interval between menstrual cycles, duration as the period from the beginning to the end of menstrual bleeding and regularity as variations of menstrual cycle length.

[

Day 1, 14, 21 , 2 months from visit 1 and final visit at 3 months from visit 1

]
2.

Change in serum androgen level (total testosterone, SHBG and LH/FSH ratio)

[

Day 1 and and final visit at 3 months from visit 1

]
3.

Change in serum androgen level (total testosterone, SHBG and LH/FSH ratio)

[

Day 1 and and final visit at 3 months from visit 1

]

Secondary outcome(s)

1.

Change in ovarian morphology and endometrial thickness evidence by the ultrasound scanning

[

Day 1, 14, 21 , 2 months from visit 1 and final visit at 3 months from visit 1

]
2.

Change in insulin sensitivity indices, would be measured by homeostasis model assessment insulin-resistant (HOMA-IR) calculations based on fasting blood glucose and fasting serum insulin

[

Day 1 and and final visit at 3 months from visit 1

]
3.

Improvement of glycemic and metabolic indices evidenced by fasting blood sugar, OGTT, HbAIC and triglyceride and cholesterol (LDL, HDL, and total)

[

Day 1 and and final visit at 3 months from visit 1

]
4.

Change in circulatory hormones including FSH, LH, E2, P4, AMH, chemerin

[

Day 1 and and final visit at 3 months from visit 1

]
5.

Change in weight evidence by BMI and change in body fat distribution evidenced by, waist circumference (WC), hip circumference (HC), and waist/hip ratio.

[

Day 1 and and final visit at 3 months from visit 1

]
6.

Change in insulin sensitivity indices, would be measured by homeostasis model assessment insulin-resistant (HOMA-IR) calculations based on fasting blood glucose and fasting serum insulin

[

Day 1 and and final visit at 3 months from visit 1

]
7.

Improvement of glycemic and metabolic indices evidenced by fasting blood sugar, OGTT, HbAIC and triglyceride and cholesterol (LDL, HDL, and total)

[

Day 1 and and final visit at 3 months from visit 1

]
8.

Change in circulatory hormones including FSH, LH, E2, P4, AMH, chemerin

[

Day 1 and and final visit at 3 months from visit 1

]
9.

Change in weight evidence by BMI and change in body fat distribution evidenced by, waist circumference (WC), hip circumference (HC), and waist/hip ratio.

[

Day 1 and and final visit at 3 months from visit 1

]
10.

[Include safety outcome here]

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Respective time/period of assessment

]

Target number/sample size

86 (43 in each group)


Countries of recruitment

Sri Lanka


Anticipated start date

2022-05-01


Anticipated end date

2024-05-01


Date of first enrollment


Date of study completion


Recruitment status

Pending


Funding source

None


Regulatory approvals

Not applicable



State of Ethics Review Approval


Status

Approved


Date of Approval

2022-01-13


Approval number

2021/EC/59


Details of Ethics Review Committee

Name: Ethics Review Committee, Faculty of Medicine, University of Peradeniya
Institutional Address:Faculty of Medicine, University of Peradeniya, Galaha Road, Kandy, Sri Lanka
Telephone:+94812396361
Email: chairpersoniers@gmail.com

Contact & Sponsor Information


Contact person for Scientific Queries/Principal Investigator

M.C. Gihan
Senior Lecturer and Consultant Obstetrics and Gynaecology)
Department of Obstetrics and Gynaecology, Faculty of Medicine, University of Peradeniya, Sri Lanka
+9481239452-5
+94773601051

champikagihan@yahoo.com

Contact Person for Public Queries

M.C. Gihan
Senior Lecturer and Consultant Obstetrics and Gynaecology)
Department of Obstetrics and Gynaecology, Faculty of Medicine, University of Peradeniya, Sri Lanka
+9481239452-5
+94773601051

champikagihan@yahoo.com


Primary study sponsor/organization

University of Peradeniya





Secondary study sponsor (If any)







Trial Completion details


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

Yes


IPD sharing plan description

The results of the above study will be published in local and international, peer-reviewed journals and presented at international conferences and clinical meetings. By signing the clinical study protocol, the Investigator agrees with the use of results of the clinical study for the purposes of national and international registration, publication and information for medical and pharmaceutical professionals. If necessary, the competent authorities will be notified of the Investigator’s name, address, qualifications and extent of involvement. Data will be shared among investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose. Data will be shared to achieve the aims in an approved proposal and for individual participant data meta-analysis. Data will be available by contacting principal investigator. To gain access, data requestors will need to sign a data access agreement. Data will be available for 5 years from the time of publication at the University data warehouse but without investigator support other than deposited meta-data. Information regarding submitting proposals and accessing data may be found by emailing at principal investigator. At the time of maintenance of placement of the data in a data repository, the link will be provided.


Study protocol available

No


Protocol version and date

Not Available


Protocol URL

Not Available


Results summary available

No


Date of posting results


Date of study completion


Final sample size


Date of first publication


Link to results


Brief summary of results