NCT07737366

Brief Summary

Premenstrual syndrome (PMS) is a common but complex condition defined as a combination of emotional, psychological, and physical symptoms that occur during the luteal phase of the menstrual cycle, usually between 2 and 14 days before the onset of menstruation, and that diminish with menstruation. Epidemiological studies have reported that 80-90% of women experience premenstrual syndrome symptoms, with approximately 20-40% reported to affect daily functioning and relationships. Symptoms associated with PMS include irritability, mood swings, anxiety, depression, bloating, breast tenderness, and headaches. Pharmacological treatments such as selective serotonin reuptake inhibitors (SSRIs) and non-pharmacological methods such as dietary changes, exercise, and cognitive behavioral therapy are used in the management of PMS symptoms. Complementary herbal therapies are gaining increasing interest among individuals who want to avoid the side effects of traditional pharmacological agents. Various agents such as Vitex agnus-castus (chaste tree), Hypericum perforatum (St John's wort), evening primrose oil, and conventional herbal formulations have been studied in the literature. Vitex agnus-castus was found to be effective in relieving PMS symptoms by regulating hormonal balance. The antidepressant effects of yellow cantharone have been evaluated, but findings on its efficacy are inconsistent. Evening primrose oil shows particularly favorable effects on cyclic mastalgia. Lavender tea is known to reduce depression, anxiety, and mood swings. There are no clinical studies evaluating the effect of lavender tea on menstrual bleeding. A randomized controlled trial has shown that abdominal massage with lavender oil reduces the severity of menstrual pain. In this context, it may be a potential complementary herbal treatment to relieve PMS symptoms. Therefore, women with PMS will be divided into two groups. The intervention group will use 2 grams of lavender tea 2 times a day, morning and evening, for 9 days during 2 menstrual cycles (5 days before and 4 days after the estimated onset of menstruation). The control group will create a waiting list. The study data will be provided by 'Personal Information Form', 'Premenstrual Syndrome Scale', 'Depression Anxiety Stress-21 Scale', 'Premenstrual Syndrome Specific Quality of Life Scale', Visual Analogue Scale (VAS), and pad follow-up to monitor bleeding. SPSS 25.0 software will be used to analyze the data obtained from the study. Although the effects of lavender tea on PMS are promising, more clinical studies are needed to confirm its effectiveness. With this study, the need for clinical studies on the effectiveness of lavender tea will be met and a natural and complementary treatment method that can alleviate PMS symptoms will be tested.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 9, 2025

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 9, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 18, 2025

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 27, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 30, 2026

Completed
Last Updated

July 30, 2026

Status Verified

July 1, 2026

Enrollment Period

Same day

First QC Date

July 27, 2026

Last Update Submit

July 27, 2026

Conditions

Keywords

premenstrual syndromeanxietydepressionstresspain measurementlavendercomplementary medicine

Outcome Measures

Primary Outcomes (3)

  • Premenstrual Syndrome Scale

    1. within 24 hours on the 4th day of menstruation (after the first 9 days of lavender tea use) 2. within 24 hours on the 4th day of menstruation (after the second 9 days of lavender tea use)

  • Depression Anxiety Stress-21 Scale

    1. within 24 hours on the 4th day of menstruation (after the first 9 days of lavender tea use) 2. within 24 hours on the 4th day of menstruation (after the second 9 days of lavender tea use)

  • Premenstrual Syndrome Specific Quality of Life Scale

    1. within 24 hours on the 4th day of menstruation (after the first 9 days of lavender tea use) 2. within 24 hours on the 4th day of menstruation (after the second 9 days of lavender tea use)

Secondary Outcomes (2)

  • Visual Analogue Scale (VAS)

    1. within 24 hours on the 4th day of menstruation (after the first 9 days of lavender tea use) 2. within 24 hours on the 4th day of menstruation (after the second 9 days of lavender tea use)

  • Number of pads

    1. within 24 hours on the 4th day of menstruation (after the first 9 days of lavender tea use) 2. within 24 hours on the 4th day of menstruation (after the second 9 days of lavender tea use)

Study Arms (2)

Experimental group (lavender herbal tea)

EXPERIMENTAL

Each participant will receive 36 bags of 2 grams of lavender tea of Turkish origin. The intervention group will be advised to use 2 grams of lavender tea brewed in 300 mL of hot water in the morning and evening for 9 days during 2 menstrual cycles (5 days before and 4 days after the estimated onset of menstruation). Participants will be advised to take some time and inhale the scent before drinking the herbal tea.

Other: Lavender herbal tea

Control group (wait-list)

NO INTERVENTION

The control group will not receive any intervention for 2 menstrual cycles (5 days before and 4 days after the estimated onset of menstruation).

Interventions

The participant will receive 36 lavender tea bags containing 2 grams of lavender tea originating from Turkey. The participant will be advised to use 2 grams of lavender herb brewed in 300 mL of hot water in the morning and evening for 9 days during 2 menstrual cycles (5 days before and 4 days after the estimated onset of menstruation).

Experimental group (lavender herbal tea)

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThis study is suitable for women with premenstrual syndrome.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Allergy to any herbal tea, food or medicine, Psychiatric illness or chronic illness, Use of psychiatric medication (such as anxiolytics and antidepressants), Regular medication use (such as antihypertensive, antidiabetic), Regular use of herbal teas or complementary medicines, Failure to meet the diagnostic criteria for PMS specified by ACOG, No regular menstruation in the last 3 months, Use of oral contraceptives during the last 3 months, Use of analgesics during menstruation while participating in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sakarya University

Sakarya, 54050, Turkey (Türkiye)

Location

Related Publications (10)

  • Babajani, S., Asgari, K., Orayzi, H., & Ghasemi, N. (2017). Effectiveness of cognitive-behavioral therapy on premenstrual syndrome through compliance to treatment in an iranian sample. Zahedan Journal of Research in Medical Sciences, 19(6). https://doi.org/10.5812/zjrms.12537

    BACKGROUND
  • Makvandi S, Mirzaiinajmabadi K, Tehranian N, Esmily H, Mirteimoori M. The Effect of Normal Physiologic Childbirth on Labor Pain Relief: an Interventional Study in Mother-Friendly Hospitals. Maedica (Bucur). 2018 Dec;13(4):286-293. doi: 10.26574/maedica.2018.13.4.286. Greek, Modern.

  • Savitri, R. and Hardyanti, O. (2019). The effectiveness of lavender aromatherapy in reducing the level of dysmenorrhea in adolescent girls. Journal of Maternity Care and Reproductive Health, 2(3). https://doi.org/10.36780/jmcrh.v2i3.95

    RESULT
  • Hashim, S., Elsayed, H., & Wasel, S. (2016). The effect of cinnamon on physical symptoms of premenstrual syndrome among adolescent girls. Mansoura Nursing Journal, 3(2), 83-96. https://doi.org/10.21608/mnj.2016.149415

    RESULT
  • Sener Cetin N, Solt Kirca A. The Effect of a Mindfulness-Based Stress Reduction Program on Premenstrual Symptoms: A Randomized Controlled Trial. J Midwifery Womens Health. 2023 Sep-Oct;68(5):604-610. doi: 10.1111/jmwh.13530. Epub 2023 Jun 19.

  • Mohebbi Dehnavi Z, Jafarnejad F, Sadeghi Goghary S. The effect of 8 weeks aerobic exercise on severity of physical symptoms of premenstrual syndrome: a clinical trial study. BMC Womens Health. 2018 May 31;18(1):80. doi: 10.1186/s12905-018-0565-5.

  • Dante G, Facchinetti F. Herbal treatments for alleviating premenstrual symptoms: a systematic review. J Psychosom Obstet Gynaecol. 2011 Mar;32(1):42-51. doi: 10.3109/0167482X.2010.538102. Epub 2010 Dec 21.

  • Rossignol AM, Bonnlander H. Caffeine-containing beverages, total fluid consumption, and premenstrual syndrome. Am J Public Health. 1990 Sep;80(9):1106-10. doi: 10.2105/ajph.80.9.1106.

  • Takeda T. Premenstrual disorders: Premenstrual syndrome and premenstrual dysphoric disorder. J Obstet Gynaecol Res. 2023 Feb;49(2):510-518. doi: 10.1111/jog.15484. Epub 2022 Nov 1.

  • Chumpalova P, Iakimova R, Stoimenova-Popova M, Aptalidis D, Pandova M, Stoyanova M, Fountoulakis KN. Prevalence and clinical picture of premenstrual syndrome in females from Bulgaria. Ann Gen Psychiatry. 2020 Jan 15;19:3. doi: 10.1186/s12991-019-0255-1. eCollection 2020.

MeSH Terms

Conditions

Premenstrual SyndromeAnxiety DisordersDepressionHemorrhage

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and SymptomsMental DisordersBehavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Control Group: No intervention will be applied to the participants in this group. Experimental Group: Participants in this group will consume 2 grams of lavender tea twice a day (morning and evening) for two menstrual cycles, starting 5 days before the estimated onset of menstruation in each cycle and continuing until 4 days after the onset of menstruation, for a total of 9 days.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2026

First Posted

July 30, 2026

Study Start

July 9, 2025

Primary Completion

July 9, 2025

Study Completion

October 18, 2025

Last Updated

July 30, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations