Effects of Adlay Extract Formula on Dysmenorrhea in Women

NCT ID: NCT06637553

Last Updated: 2024-10-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 77 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-14
• Study Completion Date: 2018-09-28

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.

Conditions

Dysmucorrhea; Menstrual Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo

Same weight as the treatment dissolved in 200cc of hot water once daily for 3 menstrual cycle

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: COMBINATION_PRODUCT

Same weight as the adlay formula but did not include the active compound

Treatment

The extract will be administered at a dose of 20 grams dissolved in 200cc of hot water once for 3 menstrual cycledaily

Group Type: EXPERIMENTAL

Adlay formula

Intervention Type: COMBINATION_PRODUCT

The extract will be administered at a dose of 20 grams dissolved in 200cc of hot water once daily

Interventions

Adlay formula

The extract will be administered at a dose of 20 grams dissolved in 200cc of hot water once daily

Intervention Type: COMBINATION_PRODUCT

Placebo

Same weight as the adlay formula but did not include the active compound

Intervention Type: COMBINATION_PRODUCT

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Taipei Medical University

OTHER

Sponsor Role: lead

Responsible Party

Shih-Min Hsia

distinguished professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Taipei Medical Univeersity

Taipei, Xinyi, Taiwan

Countries

Taiwan

Other Identifiers

N201708023

Identifier Type: -

Identifier Source: org_study_id