Clinical trial NCT06637553: Effects of Adlay Extract Formula on Dysmenorrhea in Women
Official title: Effects of Adlay Extract Formula on Dysmenorrhea in Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Dysmucorrhea
Menstrual Pain
Keywords: Dysmenorrhea
Adlay formula
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 77
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Pain relief
timeFrame: Pain levels will be measured at baseline and after each menstrual cycle during the 3-month intervention period
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical Univeersity
state: Xinyi
Study officials:
References: