Effects of Adlay Extract Formula on Dysmenorrhea in Women

NCT06637553 | Completed Early Phase 1 DMC

• 1 other identifier: N201708023
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

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.

Conditions

Dysmucorrhea; Menstrual Pain

Keywords

Dysmenorrhea; Adlay formula

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

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

Combination Product: Adlay formula

Interventions

Adlay formula COMBINATION_PRODUCT

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

Treatment

Placebo COMBINATION_PRODUCT

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

Placebo

Eligibility Criteria

• Age: 20 Years - 40 Years
• Gender Eligibility Details: Dysmenorrhea only in female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Taipei Medical University: lead

Study Sites (1)

Taipei Medical Univeersity

Taipei, Xinyi, 110, Taiwan

Location

MeSH Terms

Conditions

Dysmenorrhea

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: distinguished professor

Study Record Dates

• First Submitted: October 4, 2024
• First Posted: October 15, 2024
• Study Start: October 14, 2017
• Primary Completion: July 30, 2018
• Study Completion: September 28, 2018
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)