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

NCT07092878 | Recruiting

• 1 other identifier: 78-373
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Dysmenorrhea

Keywords

primary dysmenorrhea; sleep; mood

Outcome Measures

Primary Outcomes (4)

• 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.

  2 months

• 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).

  2 months

• 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.

  2 months

• 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).

  2 months

Secondary Outcomes (1)

• Hemoglobin

  2 months

Study Arms (2)

CTT

EXPERIMENTAL

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

Dietary Supplement: Chamomile (Matricaria recutita)

Non-CTT

PLACEBO COMPARATOR

Participants in the control group will consume a chamomile-flavored beverage (non-CTT), which is flavored with commercial chamomile flavoring.

Dietary Supplement: Chamomile

Interventions

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.

CTT

Chamomile DIETARY_SUPPLEMENT

A chamomile-flavored beverage

Also known as: Chamomile flavored beverage

Non-CTT

Eligibility Criteria

• Age: 18 Years - 30 Years
• Gender Eligibility Details: Respondents who meet the following criteria are invited to participate in phase two of the study: 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 (including pain relievers), and no ongoing non-pharmacological management for dysmenorrhea.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Pregnant
• Breastfeeding

Sponsors & Collaborators

• Universiti Tunku Abdul Rahman: lead

Study Sites (1)

UTAR

Kampar, Perak, 31900, Malaysia

RECRUITING

MeSH Terms

Interventions

Chamomile extract

Central Study Contacts

Chin Xuan Tan, PhD

CONTACT

+605-4688888; tancx@utar.edu.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Participants in the intervention group will consume a chamomile with L-theanine (CTT) beverage, which will contain 480 mg of chamomile extract and 200 mg of L-theanine. In contrast, those in the control group will consume a chamomile-flavored beverage (non-CTT), which will be flavored with commercial chamomile flavoring.

Study Record Dates

• First Submitted: July 13, 2025
• First Posted: July 30, 2025
• Study Start: March 1, 2025
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: July 30, 2025

Record last verified: 2025-07

Locations

MY (1)