Investigating the Effect of Passiflora incarnate tablets on the Severity and quality of Cyclic Breast Pain in Women

Investigating the Effect of Passiflora incarnate tablets on the Severity and quality of Cyclic Breast Pain in Women Attending Healthcare Centers Affiliated with Shahrkord University of Medical Sciences: A Randomized clinical trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20100524004015N3

Enrollment

Registered

2025-09-30

Start date

2025-10-07

Completion date

Unknown

Last updated

2025-10-13

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

Conditions

Mastodynia. Mastodynia

Interventions

Intervention 1: The intervention group will be those receiving passionflower tablets (one 500 mg tablet, half an hour before bedtime) for two months. Intervention 2: The control group will be those re

Eligibility

Sex/Gender

Female

Age

18 Years to 54 Years

Inclusion criteria

Inclusion criteria: Willingness to participate in the study Has a history of recurrent breast pain with an intensity equal to or greater than 4 on a visual analog scale Having a regular menstrual cycle of 21 to 35 days Ages 18 to 54 years

Exclusion criteria

Exclusion criteria: Having malignant breast diseases Use of any chemical or herbal medicine to relieve or treat breast pain, two months before the start of the study Addiction to tobacco, drugs, and alcohol Pregnancy or planning to become pregnant Taking medications containing phytoestrogens Being breast-feeding Being in menopause according to clinical or laboratory criteria History of breast cancer in the individual or a first-degree relative Having psychological disorders and taking antidepressants Having neurological diseases and taking medications that depress the central nervous system Having insomnia problems and taking sleeping pills Taking anticoagulant medications Having high blood pressure and taking blood pressure medications Use of sex steroid hormones Planning for any surgery during the study

Design outcomes

Primary

Measure	Time frame
Breast pain in people whose pain intensity is equal to or greater than 4 according to the visual analog scale. Timepoint: Measuring the intensity and quality of periodic breast pain at the beginning of the study (before the start of the intervention) and one month and two months after the start of the study. Method of measurement: Short form of the McGill questionnaire and visual analogue scale.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSheida Yazdani

Shahre-kord University of Medical Sciences

Sheida_yazdani.samani@gmail.com+98 910 687 7488

Outcome results

None listed

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