Primary DysmenorrheaNCT07092878
Effects of Chamomile With L-theanine Beverage Among Young Women Experiencing Primary Dysmenorrhea
A study testing Chamomile (Matricaria recutita) and Chamomile in people with Primary Dysmenorrhea, run by Universiti Tunku Abdul Rahman at 1 site in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 years, women only
- Conditions the study is for
- Primary Dysmenorrhea
- What is being tested?
- Chamomile (Matricaria recutita) and Chamomile
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Mar 2025to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Pregnant
- Breastfeeding
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Malaysia1 site, 1 recruiting
- Recruiting
UTAR
Kampar, Perak, 31900
Chin Xuan Tan, PhD, +605-4688888, tancx@utar.edu.my
About this study
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.
Read the 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.
- Conditions
- Primary Dysmenorrhea
- Being tested
- Chamomile (Matricaria recutita), Chamomile
- Keywords
- primary dysmenorrhea, sleep, mood
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
ChamomileDietary supplement
Also called Chamomile flavored beverage
A chamomile-flavored beverage
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Chamomile |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 2 months
Secondary outcomes (1)
Hemoglobin
Hemoglobin is measured in mmol/L
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study start1 Mar 2025
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary DysmenorrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiti Tunku Abdul Rahman
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tan Chin Xuan, Universiti Tunku Abdul Rahman
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07092878
- Sponsor's protocol ID
- 78-373
- Status last verified
- Jul 2025
- First submitted
- 13 Jul 2025
- Last updated
- 30 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Chamomile With L-theanine Beverage Among Young Women Experiencing Primary Dysmenorrhea
- ClinicalTrials.gov ID
- NCT07092878
- Acronym / sponsor ID
- 78-373
- Conditions
- Primary Dysmenorrhea
- Keywords
- primary dysmenorrhea, sleep, mood
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universiti Tunku Abdul RahmanUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 30 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| CTT | Experimental | Dietary Supplement: Chamomile (Matricaria recutita)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. |
| Non-CTT | Placebo comparator | Dietary Supplement: ChamomileParticipants in the control group will consume a chamomile-flavored beverage (non-CTT), which is flavored with commercial chamomile flavoring. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Pregnant
- Breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chamomile (Matricaria recutita)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. | Dietary supplement | CTT |
| ChamomileAlso: Chamomile flavored beverageA chamomile-flavored beverage | Dietary supplement | Non-CTT |
Primary outcome
Pain intensity
Time frame: 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
Time frame: 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).
Sleep quality
Time frame: 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
Time frame: 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).
1 secondary outcome
Hemoglobin
Time frame: 2 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2025.
- Individual participant dataSharing planned: Undecided. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chamomile (Matricaria recutita) and Chamomile in people with Primary Dysmenorrhea, run by Universiti Tunku Abdul Rahman at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chin Xuan Tan, PhD (+605-4688888 ext. 4529, tancx@utar.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: 2 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2025.