UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055134 |
|---|---|
| Receipt number | R000062988 |
| Scientific Title | The Effect of Lemon Balm Tea on Premenstrual Syndrome (PMS) and Menstrual Pain Relief in Female University Students: A Crossover Comparative Trial |
| Date of disclosure of the study information | 2024/08/02 |
| Last modified on | 2025/01/31 12:20:47 |
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Basic information
Public title
The Effect of Lemon Balm Tea on Premenstrual Syndrome (PMS) and Menstrual Pain Relief in Female University Students: A Crossover Comparative Trial
Acronym
The Effect of Lemon Balm Tea on Premenstrual Syndrome (PMS) and Menstrual Pain Relief in Female University Students: A Crossover Comparative Trial
Scientific Title
The Effect of Lemon Balm Tea on Premenstrual Syndrome (PMS) and Menstrual Pain Relief in Female University Students: A Crossover Comparative Trial
Scientific Title:Acronym
The Effect of Lemon Balm Tea on Premenstrual Syndrome (PMS) and Menstrual Pain Relief in Female University Students: A Crossover Comparative Trial
Region
| Japan |
Condition
Condition
healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate whether daily consumption of lemon balm tea has an effect on improving premenstrual syndrome (PMS).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
To evaluate daily psychological and physical symptoms of PMS before menstruation using the DRSP.
Key secondary outcomes
Evaluate depression, stress, and anxiety from one week before menstruation using the DASS-21.
Evaluate abdominal pain from one week before menstruation using the NRS.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Drink 120 mL of lemon balm tea once a day.
Interventions/Control_2
Drink 120 mL of hot water once a day as a placebo.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 28 | years-old | > |
Gender
Female
Key inclusion criteria
Those who have received sufficient explanation about the purpose and contents of this research, have the ability to consent, volunteered voluntarily after fully understanding, and agreed to participate in writing.
Key exclusion criteria
The exclusion criteria for participation in the study are as follows:
1. Individuals who refuse to participate in the study on their own will
2. Individuals who dislike the herbal tea being used
3. Pregnant or breastfeeding individuals
4. Individuals with chronic diseases (such as hypertension, and epilepsy)
5. Individuals who do not meet the diagnostic criteria for PMS (according to the American College of Obstetricians and Gynecologists)
6. Individuals deemed unsuitable by the principal investigator
Target sample size
42
Research contact person
Name of lead principal investigator
| 1st name | Nobuyuki |
| Middle name | |
| Last name | Wakui |
Organization
Hoshi University
Division name
Division of Applied Pharmaceutical Education and Research
Zip code
142-8501
Address
2-4-41 Ebara, Shinagawa-ku, Tokyo
TEL
03-5498-5760
n-wakui@hoshi.ac.jp
Public contact
Name of contact person
| 1st name | Nobuyuki |
| Middle name | |
| Last name | Wakui |
Organization
Hoshi University
Division name
Practical Education and Research Division
Zip code
142-8501
Address
2-4-41 Ebara, Shinagawa-ku, Tokyo
TEL
03-5498-5760
Homepage URL
n-wakui@hoshi.ac.jp
Sponsor or person
Institute
Hoshi University
Institute
Department
Personal name
Wakui Nobuyuki
Funding Source
Organization
Hoshi University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee of Hoshi Pharmacy University
Address
2-4-41 Ebara, Shinagawa-ku, Tokyo
Tel
03-3786-1011
y-hashiguchi@hoshi.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 08 | Month | 02 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 07 | Month | 25 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 25 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 04 | Day |
Last follow-up date
| 2025 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 08 | Month | 01 | Day |
Last modified on
| 2025 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062988
