DysmucorrheaEarly Phase 1ECCEMPWNCT06637553
Effects of Adlay Extract Formula on Dysmenorrhea in Women
A Early Phase 1 study testing Adlay formula in people with Dysmucorrhea and Menstrual Pain, run by Taipei Medical University at 1 site in Taiwan.
Trial summary
Due to the Westernization of diet in Taiwan, the risk of many chronic diseases has increased. Some diseases and improper treatments are closely related to menstrual pain and functional impairment in women. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dysmucorrhea, Menstrual Pain
- What is being tested?
- Adlay formula
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 77 participants
- Where
- 1 siteTaiwan
- Study dates
- 14 Oct 2017to 28 Sep 2018
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women aged 20-40
- Women who have experienced menstrual pain in recent years, especially on the first or second day of menstruation
- Women whose menstrual pain affects their daily life
- Women with a regular menstrual cycle of 21-35 days, with menstruation lasting 3-7 days
Who cannot join
- Pregnant or breastfeeding women, or those planning pregnancy or using birth control
- Women with severe gynecological diseases
- Women who have undergone uterine surgery or recent pelvic surgery
- Women with major diseases such as cancer, heart disease, or thyroid disorders
- Women who have used pain relief medication for menstrual pain in the past month
Trial locations and contacts
1 site in 1 country.
About this study
Due to the Westernization of diet in Taiwan, the risk of many chronic diseases has increased. Some diseases and improper treatments are closely related to menstrual pain and functional impairment in women. Women's menstrual pain can affect daily life and work, and many plant-based extracts have been found to have beneficial effects on alleviating menstrual pain. Therefore, the development of functional health food that can improve menstrual pain is of great significance for health promotion and the market.
Coix seed has long been understood to have properties beneficial for menstrual health. Scientific research has demonstrated its effectiveness in alleviating menstrual pain. The primary ingredient, "coix seed extract," has been extensively studied, and its efficacy has been confirmed through numerous clinical and animal experiments. This study aims to scientifically investigate the effect of coix seed compound extract on menstrual pain in women and to understand its underlying mechanism and potential benefits.
Read the detailed description
This study investigates the efficacy of coix seed compound extract in alleviating menstrual pain and its potential impact on inflammatory markers. The study will enroll women aged 20-40 with a history of moderate to severe menstrual pain, especially on the first or second day of menstruation. The study includes participants with regular menstrual cycles of 21-35 days.
Participants who meet the inclusion criteria will undergo a series of blood tests throughout the study. Blood samples (10cc each) will be collected three times-once before the intervention, and twice during the treatment period-to assess inflammatory markers, including IL-6 and cytokines. The samples will be analyzed for blood biochemical parameters and stored for future evaluations.
The intervention involves the daily administration of 20 grams of coix seed compound extract dissolved in 200cc of hot water, starting one day before menstruation and continuing for the duration of each menstrual cycle during the study period. The compound includes a mixture of coix seed extract, grape seed extract, and cranberry extract, which are recognized as safe food ingredients.
Potential side effects are expected to be minimal due to the natural composition of the extract. However, participants will be monitored for any adverse reactions. In the event of side effects, participants will be advised to discontinue the extract and consult with the research team.
- Conditions
- Dysmucorrhea, Menstrual Pain
- Being tested
- Adlay formula, Placebo
- Keywords
- Dysmenorrhea, Adlay formula
- Medical subject headings
- Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adlay formulaCombination product
The extract will be administered at a dose of 20 grams dissolved in 200cc of hot water once daily
PlaceboCombination product
Same weight as the adlay formula but did not include the active compound
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Same weight as the treatment dissolved in 200cc of hot water once daily for 3 menstrual cycle Receives: Combination Product: Placebo |
| Treatment | Experimental | The extract will be administered at a dose of 20 grams dissolved in 200cc of hot water once for 3 menstrual cycledaily Receives: Combination Product: Adlay formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain relief
Pain relief will be assessed using the Visual Analog Scale (VAS), which measures pain intensity on a scale from 0 (no pain) to 10 (worst pain imaginable). Participants will report their pain levels at specific time points.
Measured: Pain levels will be measured at baseline and after each menstrual cycle during the 3-month intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start14 Oct 2017
- Primary completion30 Jul 2018
- Study completion28 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysmucorrheaStudies of the same condition, open and under way.
- More trials run by Taipei Medical UniversityThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shih-Min Hsia, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06637553
- Sponsor's protocol ID
- N201708023
- Acronym
- ECCEMPW
- Status last verified
- Oct 2024
- First submitted
- 4 Oct 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Adlay Extract Formula on Dysmenorrhea in Women
- ClinicalTrials.gov ID
- NCT06637553
- Acronym / sponsor ID
- ECCEMPW / N201708023
- Conditions
- Dysmucorrhea, Menstrual Pain
- Keywords
- Dysmenorrhea, Adlay formula
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- 14 Oct 2017 (actual)
- Primary completion
- 30 Jul 2018 (actual)
- Study completion
- 28 Sep 2018 (actual)
- First posted
- 15 Oct 2024 (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.
Due to the Westernization of diet in Taiwan, the risk of many chronic diseases has increased. Some diseases and improper treatments are closely related to menstrual pain and functional impairment in women. Women's menstrual pain can affect daily life and work, and many plant-based extracts have been found to have beneficial effects on alleviating menstrual pain. Therefore, the development of functional health food that can improve menstrual pain is of great significance for health promotion and the market.
Coix seed has long been understood to have properties beneficial for menstrual health. Scientific research has demonstrated its effectiveness in alleviating menstrual pain. The primary ingredient, "coix seed extract," has been extensively studied, and its efficacy has been confirmed through numerous clinical and animal experiments. This study aims to scientifically investigate the effect of coix seed compound extract on menstrual pain in women and to understand its underlying mechanism and potential benefits.
Detailed description
This study investigates the efficacy of coix seed compound extract in alleviating menstrual pain and its potential impact on inflammatory markers. The study will enroll women aged 20-40 with a history of moderate to severe menstrual pain, especially on the first or second day of menstruation. The study includes participants with regular menstrual cycles of 21-35 days.
Participants who meet the inclusion criteria will undergo a series of blood tests throughout the study. Blood samples (10cc each) will be collected three times-once before the intervention, and twice during the treatment period-to assess inflammatory markers, including IL-6 and cytokines. The samples will be analyzed for blood biochemical parameters and stored for future evaluations.
The intervention involves the daily administration of 20 grams of coix seed compound extract dissolved in 200cc of hot water, starting one day before menstruation and continuing for the duration of each menstrual cycle during the study period. The compound includes a mixture of coix seed extract, grape seed extract, and cranberry extract, which are recognized as safe food ingredients.
Potential side effects are expected to be minimal due to the natural composition of the extract. However, participants will be monitored for any adverse reactions. In the event of side effects, participants will be advised to discontinue the extract and consult with the research team.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Combination Product: PlaceboSame weight as the treatment dissolved in 200cc of hot water once daily for 3 menstrual cycle |
| Treatment | Experimental | Combination Product: Adlay formulaThe extract will be administered at a dose of 20 grams dissolved in 200cc of hot water once for 3 menstrual cycledaily |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women aged 20-40
- Women who have experienced menstrual pain in recent years, especially on the first or second day of menstruation
- Women whose menstrual pain affects their daily life
- Women with a regular menstrual cycle of 21-35 days, with menstruation lasting 3-7 days
Key exclusion criteria (5 listed)
- Pregnant or breastfeeding women, or those planning pregnancy or using birth control
- Women with severe gynecological diseases
- Women who have undergone uterine surgery or recent pelvic surgery
- Women with major diseases such as cancer, heart disease, or thyroid disorders
- Women who have used pain relief medication for menstrual pain in the past month
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 |
|---|---|---|
| Adlay formulaThe extract will be administered at a dose of 20 grams dissolved in 200cc of hot water once daily | Combination product | Treatment |
| PlaceboSame weight as the adlay formula but did not include the active compound | Combination product | Placebo |
Primary outcome
Pain relief
Time frame: Pain levels will be measured at baseline and after each menstrual cycle during the 3-month intervention period
Pain relief will be assessed using the Visual Analog Scale (VAS), which measures pain intensity on a scale from 0 (no pain) to 10 (worst pain imaginable). Participants will report their pain levels at specific time points.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available
Related trials for Dysmucorrhea
Recruiting
Identification of Biomarkers in Cervical Mucus
Cervical Mucus Dysfunction, Infertility, Female
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Adlay formula in people with Dysmucorrhea and Menstrual Pain, run by Taipei Medical University at 1 site in Taiwan.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 15 Oct 2024. 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 Taiwan. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain relief (time frame: Pain levels will be measured at baseline and after each menstrual cycle during the 3-month intervention period). 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 15 Oct 2024.