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Comparing the Effect of Clove Oil and Oral Contraceptive LD on Improvement of Clinical and Paraclinical Parameters of Polycystic Ovarian Syndrome

Comparing the Effect of Clove Oil (Syzygium aromaticum) and Oral Contraceptive LD on Improvement of Clinical and Paraclinical Parameters of Polycystic Ovarian Syndrome (PCOS): A Triple Blind Randomized Controlled Trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20131009014957N14
Enrollment
64
Registered
2023-06-03
Start date
2023-12-01
Completion date
Unknown
Last updated
2023-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polycystic Ovarian Syndrome. Polycystic ovarian syndrome

Interventions

Intervention 1: Intervention group: Receiving 28 soft capsules of clove oil (containing Eugenol) one daily after lunch, along with 21 placebo LD tablets containing an ineffective substance (exactly th

Sponsors

Tabriz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: The diagnosis of PCOS according to the Rotterdam criteria Age 18 to 45 years Being literate BMI between 18.5 and 30 Not using hormonal contraceptives or any other type of hormonal medication currently and during the last three months

Exclusion criteria

Exclusion criteria: Relative and absolute contraindications of LD pills (having blood pressure above 140/90, smoking and alcohol consumption, pregnancy or breastfeeding, alcohol consumption, smoking, suspicion of breast cancer, coronary heart disease, endometrial carcinoma, etc.) Women suffering from amenorrhea Women undergoing infertility treatment at the time of study Previous surgery on one or both ovaries Allergy to clove oil Disorders that cause hyperandrogenism (having Cushing's syndrome, adrenal hyperplasia, androgen-producing tumors, etc.) Thyroid disorders

Design outcomes

Primary

MeasureTime frame
The serum levels of dehidroepyandrosteron(DHEA) and total testosterone. Timepoint: Baseline and 12 weeks after the intervention. Method of measurement: By the ELISA method using the relevant kits.;Hirsutism score. Timepoint: Baseline and 12 weeks after the intervention. Method of measurement: Using the Ferriman–Gallwey scoring system.

Secondary

MeasureTime frame
The normalization of menstrual cycles. Timepoint: At the beginning of the study and in each 28-day cycle for 3 cycles during the intervention. Method of measurement: Using the menstrual disorders questionnaire.;The serum levels of fasting Blood glucose and insulin. Timepoint: Baseline and 12 weeks after the intervention. Method of measurement: By spectrophotometry and ELISA method.;The serum levels of gonadotropins (FSH and LH). Timepoint: Baseline and 12 weeks after the intervention. Method of measurement: By ELISA method using the relevant kits.;Anthropometric indices (waist circumference, hip circumference, body bass index). Timepoint: Baseline and 12 weeks after the intervention. Method of measurement: Using anthropometric tools.;Quality of life score. Timepoint: Baseline and 12 weeks after the intervention. Method of measurement: Using the health-related quality of life questionnaire of women with polycystic syndrome made by Cronin et al.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAzizeh Farshbaf-Khalili

Tabriz University of Medical Sciences

farshbafa@tbzmed.ac.ir+98 41 3335 2295

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026