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Comparison of the effect of a product from Traditional Medicine with Metformin on oligomenorrhea in polycystic ovary syndrome

Comparison of Traditional Medicine product and metformin and Traditional Medicine product with metformin on menstrual bleeding events in patients with polycystic ovary syndrome complaint oligomenorrhea

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT2015042521937N1
Enrollment
120
Registered
2015-07-21
Start date
2015-07-01
Completion date
Unknown
Last updated
2018-02-22

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: Group 3: Traditional product 2 capsules in the morning and 2 nights during the month, except during the period plus metformin 500 mg tablets after every meal during month. Intervention
Treatment - Drugs
Group 3: Traditional product 2 capsules in the morning and 2 nights during the month, except during the period plus metformin 500 mg tablets after every meal during month.
Group 2: Metformin 500 mg tablets after every meal during month
Group 1: Traditional medicine product 2 capsules in the morning and 2 nights during the month, except during the period

Sponsors

School of Traditional Medicine and Materia Medica Research Center Shahid Beheshti
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Patients with  PCOS their main complaint is oligomenorrhea. Age 40-18 years, patient satisfaction, the absence of any systemic disease such as hyperinsulinemia, hyperandrogenism, diabetes mellitus, Cushing syndrome, congenital adrenal hyperplasia, hyperprolactinemia and hyperthyroidism, hypertension, lack of pregnancy or within 6 weeks post-partum, lack of breastfeeding, non-hormonal drugs in the last month, no family history of breast and ovarian cancer. Exclusion criteria: Hormone therapy use, side effects, the need for other interventions and surgery, pregnancy occurred during the study, the patient's own request for exclusion.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Experience of menstural bleeding. Timepoint: Before intervention and 3, 4 month after intervention. Method of measurement: Question from patient.;Duration of bleeding. Timepoint: Before the intervention, month 3, 4. Method of measurement: Ask the patient.;Menstrual blood volume. Timepoint: Before the intervention, month 3,4. Method of measurement: Pictorial Blood Loss Assessment Chart (PBAC).

Secondary

MeasureTime frame
Added at 2016-07-02: interval between menstural periods. Timepoint: Added at 2016-07-02: Before the intervention and 1, 2, and 3 months after the intervention. Method of measurement: Added at 2016-07-02: Asking from patients.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMaryam Bahman

School of Traditional Medicine Traditional Medicine and Materia Medica Research Center Shahid Behesh

ma.bahman@sbmu.ac.ir+98 21 8877 3521

Outcome results

None listed

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