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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Non-CTT | Placebo Comparator | Participants in the control group will consume a chamomile-flavored beverage (non-CTT), which is flavored with commercial chamomile flavoring. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin | Hemoglobin is measured in mmol/L | 2 months |
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Inclusion Criteria:
Exclusion Criteria:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chin Xuan Tan, PhD | Contact | +605-4688888 | 4529 | tancx@utar.edu.my |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UTAR | Recruiting | Kampar | Perak | 31900 | Malaysia |
This project is financially supported by a beverage company and may contain commercially sensitive data. If other researchers require the IPD, they must obtain approval from the beverage company through the principal investigator.
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| ID | Term |
|---|---|
| C000713170 | Chamomile extract |
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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.
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| Chamomile | Dietary Supplement | A chamomile-flavored beverage |
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