Skip to content

The effect of Nigella Sativa on oligomenorrhea and amenorrhea in patients with polycystic ovary syndrome

A comparison between the effects of modified Nigella Sativa capsules and a placebo on menstruation occurrence, and the menstrual bleeding duration and volume in polycystic ovary patients with oligomenorrhea and amenorrheae: a randomized double blind clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT2016041827455N1
Enrollment
68
Registered
2016-06-19
Start date
2015-12-28
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 1:Nigella Sativa capsule, 4 capsules 500 mg, 2 in the morning and 2 nights during the month, except during the period. if the bleeding did not happen in a month,the drug would
Treatment - Drugs
Group 1:Nigella Sativa capsule, 4 capsules 500 mg, 2 in the morning and 2 nights during the month, except during the period. if the bleeding did not happen in a month,the drug would be cut off for
Group 2: control group who received placebo from starch capsules, 4 capsules 500 mg, 2 in the morning and 2 nights during the month, except during the period if the bleeding did not happen in a month

Sponsors

School of Traditional Medicine, Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 38 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Diagnosis of Polycystic Ovary syndrome by gynecologist, according to the National Institute of Health’s criteria; women aged 18-38 years old with irregular periods; having informed consent; Non-consumer of any hormonal medication and Metformin for at least three months prior the study. Exclusion criteria: Using anti-hypertensive, anti-cholesterol, anti- diabetic, insulin-sensitizing,medication; using aspirin and other anti-clotting medications, oral contraceptive and the anti-prostaglandin medications, parallel consumption of other herbal medications for disease treatment; patient with uncontrolled high blood pressure history, brain stroke, heart attack, cancer, cardiovascular disorders, liver disease, renal and thyroid disorders, type 1 or 2 diabetes; pregnancy and lactation; smoking.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
0ccurance of Menstrual bleeding. Timepoint: Before the intervention,1, 2, 3 and 4 months after the intervention. Method of measurement: Ask the patient.;Duration of menstural bleeding. Timepoint: Before intervention and 1,2,3, 4 month after intervention. Method of measurement: Ask the patient and complete tracking form.;Menstrual blood volume. Timepoint: Before intervention and1,2, 3, 4 month after intervention. Method of measurement: Pictorial Blood Loss Assessment Chart (PBAC).

Secondary

MeasureTime frame
Menstrual cycle length. Timepoint: Before intervention and1,2, 3, 4 month after intervention. Method of measurement: Ask the patient and complete tracking form.;Serum LH. Timepoint: Before intervention and 3 month after intervention. Method of measurement: Serum analysis by ELIZA.;Total Testosterone. Timepoint: Before intervention and 3 month after intervention. Method of measurement: Serum analysis by ELIZA.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSeyedeh Atieh Naeimi

School of Traditional Medicine, Shahid Beheshti University of Medical Sciences

naimi@guilan.ac.ir+98 21 8877 3521

Outcome results

None listed

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