Polycystic Ovary SyndromePhase 3PCOSNCT03778099
The Effect of Cinnamon on Ovulation Induction in Women With Polycystic Ovary Syndrome
A Phase 3 study testing Cinnamon Cap 500 MG in people with Polycystic Ovary Syndrome and Ovulation, run by King Abdulaziz University at 1 site in Saudi Arabia.
Trial summary
Title: The effect of cinnamon supplementation on ovulation induction in women with polycystic ovary syndrome, Jeddah 2019: Randomized Double-Blind Placebo-controlled trial Phase: III Population: 118 women with polycystic ovary syndrome will be recruited from Obstetrics and Gynecology clinics in King Abdul-Aziz… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome, Ovulation
- What is being tested?
- Cinnamon Cap 500 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 20 Sep 2018to 3 Feb 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Married women aged 18-40 seeking to become pregnant, meeting the Rotterdam criteria for polycystic ovary syndrome
Who cannot join
- Current pregnancy or lactation.
- Current use of treatment of infertility.
- Established diagnosis of diabetes mellitus.
- Use of Insulin-sensitizing treatment within the past three months.
- Hormonal treatment involving estrogen or progesterone within the past three months.
- Known hypersensitivity to cinnamon.
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- Use of statin medication.
- Any other supplements that contain cinnamon within the past month.
- BMI <18.5 or BMI >35.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Cinnamon on Ovulation Induction in Women With Polycystic Ovary Syndrome, Jeddah 2019: Randomized Double-blind Placebo-controlled Trial
Title: The effect of cinnamon supplementation on ovulation induction in women with polycystic ovary syndrome, Jeddah 2019: Randomized Double-Blind Placebo-controlled trial
Phase: III
Read more
Population: 118 women with polycystic ovary syndrome will be recruited from Obstetrics and Gynecology clinics in King Abdul-Aziz University Hospital, Jeddah 2019.
Subject Participation Duration: Each participant will be followed for three months.
Intervention: 2g of cinnamon capsules daily will be provided.
Objectives:
Primary Objective:
- To compare the effectiveness of cinnamon supplement in combination with clomiphene citrate versus clomiphene citrate alone on ovulation in women with PCOS, in King Abdul-Aziz University Hospital in Jeddah 2019.
- To measure the difference in insulin resistance after three months of cinnamon supplementation in women with PCOS in King Abdul-Aziz University Hospital, Jeddah 2019.
- To determine the effect of cinnamon and CC on menstrual cyclicity, approximated by menstrual frequency, during the study period, in women with PCOS in King Abdul-Aziz University Hospital, Jeddah 2019
- To evaluate the quality of life in women with PCOS in King Abdul-Aziz University Hospital, Jeddah 2019.
Secondary Objectives:
- To measure the pregnancy rate in women with PCOS in King Abdul-Aziz University Hospital, Jeddah 2019
Description of Study Design:
The participants will be randomized in 1:1 fashion. Allocation concealment will be ensured using similar bottles labeled by letters A and B, to receive either the combination of cinnamon supplement and clomiphene citrate or clomiphene citrate with placebo.
First visit: Patients will be evaluated during the early follicular phase for progesterone level and HOMA-IR and QUICK-I. Follow up: 3 months.
Last Visit: Patients will be re-evaluated to compare the difference.
- Conditions
- Polycystic Ovary Syndrome, Ovulation
- Being tested
- Cinnamon Cap 500 MG, Placebo
- Keywords
- PCOS, Ovulation, Cinnamon
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cinnamon Cap 500 MGDrug
The Cinnamomum cassia (C. aromaticum) capsules will be purchase from Spring Valley company (distributed by Wal-Mart Stores, Inc. USA) by the investigator.
PlaceboDrug
450 mg of starch and 50 mg of cinnamon powder
| Study group | Role | What they receive |
|---|---|---|
| Cinnamon Group | Experimental | Two capsules of cinnamon 500mg twice per day after meals (2g/day). All capsules will be given simultaneously with the clomiphene citrate medication (standard treatment for infertility in women with PCOS). Participants will be asked to keep their normal lifestyle including daily food and physical activity level. Receives: Drug: Cinnamon Cap 500 MG |
| Placebo Group | Placebo comparator | Placebo capsules will contain 450 mg of starch and 50 mg of cinnamon powder (to improve blindness regarding taste and odor). Color, shape, and size of placebo capsules will be exactly the same as the cinnamon capsules.
2g/day along with clomiphene citrate Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ovulation Confirmation by Progesterone level
Progesterone level > 3ng/mL or pregnancy confirmed
Measured: 3 months
Changes in insulin resistance
HOMA-IR
Measured: 3 months
Menstrual frequency
No. of menses/ No. of months
Measured: 3 months
Quality of life: Infertility quality of life questionnaire
The 36 FertiQoL items are rated according to 5 types of response scales.
The response scales are:
Very poor (0), poor (1), neither poor nor good (2), very good (4) Very dissatisfied (0), dissatisfied (1), neither satisfied nor dissatisfied (2), satisfied (3), very satisfied (4) Always (0), very often (1), quite often (2), Seldom (3), never (4) An extreme amount (0), very much (1), a moderate amount (2), a little (3), not at all (4) Completely (0), a great deal (1), moderately (2), not much (3), not at all (4)
Scores on the response scales are reversed, summed and scaled to range from 0 to 100. Higher scores on the subscales and total scores indicate better quality of life.
Measured: 6 months
Secondary outcomes (1)
Pregnancy Rate
Number of pregnancies including live births, induced abortions, and fetal deaths / Number of women aged 18 - 40 years) × 1,000
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start20 Sep 2018
- Primary completion10 Jan 2020
- Study completion3 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Abdulaziz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Wael Alzhrani, King Abdulaziz University
- Investigators
- Wael H Alzhrani, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03778099
- Sponsor's protocol ID
- W-001
- Acronym
- PCOS
- Status last verified
- Mar 2020
- First submitted
- 10 Dec 2018
- Last updated
- 3 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Cinnamon on Ovulation Induction in Women With Polycystic Ovary Syndrome, Jeddah 2019: Randomized Double-blind Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT03778099
- Acronym / sponsor ID
- PCOS / W-001
- Conditions
- Polycystic Ovary Syndrome, Ovulation
- Keywords
- PCOS, Ovulation, Cinnamon
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- King Abdulaziz UniversityUniversity, hospital or other
- Study start
- 20 Sep 2018 (actual)
- Primary completion
- 10 Jan 2020 (actual)
- Study completion
- 3 Feb 2020 (actual)
- First posted
- 19 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Title: The effect of cinnamon supplementation on ovulation induction in women with polycystic ovary syndrome, Jeddah 2019: Randomized Double-Blind Placebo-controlled trial
Phase: III
Population: 118 women with polycystic ovary syndrome will be recruited from Obstetrics and Gynecology clinics in King Abdul-Aziz University Hospital, Jeddah 2019.
Subject Participation Duration: Each participant will be followed for three months.
Intervention: 2g of cinnamon capsules daily will be provided.
Objectives:
Primary Objective:
- To compare the effectiveness of cinnamon supplement in combination with clomiphene citrate versus clomiphene citrate alone on ovulation in women with PCOS, in King Abdul-Aziz University Hospital in Jeddah 2019.
- To measure the difference in insulin resistance after three months of cinnamon supplementation in women with PCOS in King Abdul-Aziz University Hospital, Jeddah 2019.
- To determine the effect of cinnamon and CC on menstrual cyclicity, approximated by menstrual frequency, during the study period, in women with PCOS in King Abdul-Aziz University Hospital, Jeddah 2019
- To evaluate the quality of life in women with PCOS in King Abdul-Aziz University Hospital, Jeddah 2019.
Secondary Objectives:
- To measure the pregnancy rate in women with PCOS in King Abdul-Aziz University Hospital, Jeddah 2019
Description of Study Design:
The participants will be randomized in 1:1 fashion. Allocation concealment will be ensured using similar bottles labeled by letters A and B, to receive either the combination of cinnamon supplement and clomiphene citrate or clomiphene citrate with placebo.
First visit: Patients will be evaluated during the early follicular phase for progesterone level and HOMA-IR and QUICK-I. Follow up: 3 months.
Last Visit: Patients will be re-evaluated to compare the difference.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cinnamon Group | Experimental | Drug: Cinnamon Cap 500 MGTwo capsules of cinnamon 500mg twice per day after meals (2g/day). All capsules will be given simultaneously with the clomiphene citrate medication (standard treatment for infertility in women with PCOS). Participants will be asked to keep their normal lifestyle including daily food and physical activity level. |
| Placebo Group | Placebo comparator | Drug: PlaceboPlacebo capsules will contain 450 mg of starch and 50 mg of cinnamon powder (to improve blindness regarding taste and odor). Color, shape, and size of placebo capsules will be exactly the same as the cinnamon capsules. 2g/day along with clomiphene citrate |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Married women aged 18-40 seeking to become pregnant, meeting the Rotterdam criteria for polycystic ovary syndrome
Key exclusion criteria (9 listed)
- Current pregnancy or lactation.
- Current use of treatment of infertility.
- Established diagnosis of diabetes mellitus.
- Use of Insulin-sensitizing treatment within the past three months.
- Hormonal treatment involving estrogen or progesterone within the past three months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cinnamon Cap 500 MGThe Cinnamomum cassia (C. aromaticum) capsules will be purchase from Spring Valley company (distributed by Wal-Mart Stores, Inc. USA) by the investigator. | Drug | Cinnamon Group |
| Placebo450 mg of starch and 50 mg of cinnamon powder | Drug | Placebo Group |
Primary outcome
Ovulation Confirmation by Progesterone level
Time frame: 3 months
Progesterone level > 3ng/mL or pregnancy confirmed
Changes in insulin resistance
Time frame: 3 months
HOMA-IR
Menstrual frequency
Time frame: 3 months
No. of menses/ No. of months
Quality of life: Infertility quality of life questionnaire
Time frame: 6 months
The 36 FertiQoL items are rated according to 5 types of response scales. The response scales are: Very poor (0), poor (1), neither poor nor good (2), very good (4) Very dissatisfied (0), dissatisfied (1), neither satisfied nor dissatisfied (2), satisfied (3), very satisfied (4) Always (0), very often (1), quite often (2), Seldom (3), never (4) An extreme amount (0), very much (1), a moderate amount (2), a little (3), not at all (4) Completely (0), a great deal (1), moderately (2), not much (3), not at all (4) Scores on the response scales are reversed, summed and scaled to range from 0 to 100. Higher scores on the subscales and total scores indicate better quality of life.
1 secondary outcome
Pregnancy Rate
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wael H Alzhrani principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cinnamon Cap 500 MG in people with Polycystic Ovary Syndrome and Ovulation, run by King Abdulaziz University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ovulation Confirmation by Progesterone level (time frame: 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2020.