An Early Phase 1 interventional study of Adlay formula and Placebo in Dysmucorrhea and Menstrual Pain, sponsored by Taipei Medical University. Completed at 1 site in Taiwan. Open to female participants aged 20 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-15.
Sponsored by Taipei Medical University · Early Phase 1, Interventional, and Treatment
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.
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.
401 studies on the registry are indexed under Dysmenorrhea; 94 are open to participants now.
This study's enrollment of 77 is above the median of 60 across 336 interventional studies indexed under Dysmenorrhea.
Browse Dysmenorrhea studies →Taipei Medical University is the lead sponsor of 256 studies on the registry; 59 are open to participants now.
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Exclusion Criteria:
Same weight as the treatment dissolved in 200cc of hot water once daily for 3 menstrual cycle
Combination Product: Placebo
The extract will be administered at a dose of 20 grams dissolved in 200cc of hot water once for 3 menstrual cycledaily
Combination Product: Adlay formula
The extract will be administered at a dose of 20 grams dissolved in 200cc of hot water once daily
Same weight as the adlay formula but did not include the active compound
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.
Time frame: Pain levels will be measured at baseline and after each menstrual cycle during the 3-month intervention period
Plan to share: No — There is not a plan to make IPD available
No publications or documents are linked to this record.
This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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