Effects of Adlay Extract Formula on Dysmenorrhea in Women (ECCEMPW)

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.

Study Overview

• Status: Completed
• Conditions: Menstrual Pain; Dysmucorrhea
• Intervention / Treatment: Combination product: Placebo; Combination product: Adlay formula

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 Type: Interventional
• Enrollment (Actual): 77
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Taiwan
  • Xinyi
    • Taipei, Xinyi, Taiwan, 110
      • Taipei Medical Univeersity

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Same weight as the treatment dissolved in 200cc of hot water once daily for 3 menstrual cycle	Combination product: Placebo; Same weight as the adlay formula but did not include the active compound
Experimental: Treatment; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Pain levels will be measured at baseline and after each menstrual cycle during the 3-month intervention period

Collaborators and Investigators

• Sponsor: Taipei Medical University

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2017
• Primary Completion (Actual): July 30, 2018
• Study Completion (Actual): September 28, 2018

Study Registration Dates

• First Submitted: October 4, 2024
• First Submitted That Met QC Criteria: October 10, 2024
• First Posted (Actual): October 15, 2024

Study Record Updates

• Last Update Posted (Actual): October 15, 2024
• Last Update Submitted That Met QC Criteria: October 10, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Dysmenorrhea; Adlay formula
• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Menstruation Disturbances; Pelvic Pain; Dysmenorrhea
• Other Study ID Numbers: N201708023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is not a plan to make IPD available

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No