Effects of Chamomile With L-theanine Beverage Among Young Women Experiencing Primary Dysmenorrhea

Not Applicable

Recruiting

• Conditions: Primary Dysmenorrhea

• Registration Number: NCT07092878
• Lead Sponsor: Universiti Tunku Abdul Rahman

Brief Summary

This study aims to evaluate the effects of a beverage containing chamomile and L-theanine on menstrual symptoms, pain intensity, mood, and sleep quality among young adult females with primary dysmenorrhea.

Detailed Description

This study aims to evaluate the effects of a beverage containing chamomile and L-theanine on menstrual symptoms, pain intensity, mood, and sleep quality among young adult females with primary dysmenorrhea.

Study Timeline

• Study Start: 2025-03-01
• Status Verified: 2025-07
• Study First Submitted: 2025-07-13
• Study First Submitted QC: 2025-07-21
• Last Update Submitted: 2025-07-21
• Study First Posted: 2025-07-30
• Last Update Posted: 2025-07-30
• Primary Completion: 2025-07-31
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

• A VAS score of ≥4 cm for the past three consecutive menstrual cycles
• Regular monthly menstruation
• No history of allergies or psychological/gynecological illnesses
• Absence of secondary dysmenorrhea
• No current use of any medications
• No ongoing non-pharmacological management for dysmenorrhea.

Exclusion Criteria

• Pregnant
• Breastfeeding

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Sleep quality	2 months	The Pittsburgh Sleep Quality Index (PSQI) is used to assess the sleep quality of participants during the past week. The total PSQI score ranges from 0 to 21, with higher scores indicating poorer sleep quality.
Mood	2 months	The Profile of Mood States (POMS) is used to assess six mood subscales (vigor, tension, depression, anger, fatigue, and confusion) of participants during the past week. Each item is rated on a 5-point Likert scale, ranging from 0 (not at all), 1 (a little), 2 (moderately), 3 (quite a lot), and 4 (extremely).
Pain intensity	2 months	The pain intensity is assessed using the Visual Analogue Scale (VAS) and the Numeric Rating Scale (NRS). Participants mark the point on the scale (0 to 10) that best represents the average intensity of their menstrual pain. A higher score on the VAS and NRS indicates greater pain intensity.
Menstrual symptoms	2 months	The Cox Menstrual Symptom Scale (CMSS) is used to assess the severity of menstrual-related symptoms experienced by participants during their most recent menstrual cycle. Each item in the CMSS is rated on a scale from 0 (not noticeable), 1 (slightly bothersome), 2 (moderately bothersome), 3 (severely bothersome), to 4 (very severely bothersome).

Secondary Outcome Measures

Name	Time	Method
Hemoglobin	2 months	Hemoglobin is measured in mmol/L

Trial Locations

Locations (1)

UTAR; 🇲🇾 Kampar, Perak, Malaysia