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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-30
SponsorUniversiti Tunku Abdul Rahman

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Pregnant

Breastfeeding

Trial design

Design model

Parallel

Treatments tested in this trial

  • Chamomile (Matricaria recutita)

    Dietary supplement

    Participants in the intervention group will consume the chamomile with L-theanine (CTT) beverage, which contains 480 mg of chamomile extract and 200 mg of L-theanine.

  • Chamomile

    Dietary supplement

    A chamomile-flavored beverage

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: CTTExperimental treatment 1 intervention
Group B: Non-CTTPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Pain intensity

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.

Time frame
2 months
2

Menstrual symptoms

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).

Time frame
2 months
3

Sleep quality

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.

Time frame
2 months
4

Mood

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).

Time frame
2 months

Secondary outcomes

1

Hemoglobin

Hemoglobin is measured in mmol/L

Time frame
2 months

Other outcomes

Sponsors and contacts

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