A Single Group Study to Evaluate the Effects of a Supplement on Premenstrual Syndrome

NCT ID: NCT06124326

Last Updated: 2024-08-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-31
• Study Completion Date: 2024-01-20

Brief Summary

This is a virtual single-group study that will last three menstrual cycles (approximately 12 weeks). During the first menstrual cycle, participants will take the supplement as needed (pro re nata) when they feel symptoms of PMS, such as cramping or bloating. For the second and third menstrual cycles, Participants will take 2 capsules per day with water for 1 week, starting 4 days before their menstrual cycle and finishing on Day 3 of their cycle. Questionnaires will be completed at the following time points:

• Baseline
• Day 7 of their first cycle during the trial (After using the product PRN during their period)
• 4 days before their second period during the trial (After using the product PRN for the previous month)
• Day 3 of their second period during the trial (After using the product for 7 days straight)
• Day 3 of their third period of the trial (After using the product for 7 days straight)

Conditions

Premenstrual Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Premenstrual Syndrome Supplement

During the first menstrual cycle, participants will take the supplement as needed (pro re nata) when they feel symptoms of PMS, such as cramping or bloating.

For the second and third menstrual cycles, Participants will take 2 capsules per day with water for 1 week, starting 4 days before their menstrual cycle and finishing on Day 3 of their cycle.

Group Type: EXPERIMENTAL

Premenstrual Syndrome Supplement

Intervention Type: DIETARY_SUPPLEMENT

Ginger, Curcumin, Organic Turmeric, Black Pepper, Magnesium, Zinc, Vitamin B6, Vitamin D.

Interventions

Premenstrual Syndrome Supplement

Ginger, Curcumin, Organic Turmeric, Black Pepper, Magnesium, Zinc, Vitamin B6, Vitamin D.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Female, aged 18-40
• Self-reported moderate discomfort during menstruation related to pelvic cramps, bloating, fatigue, or mood swings.
• Self-reported symptoms during their menstrual cycle with gas, heartburn, and acid reflux
• Generally healthy - don't live with any uncontrolled chronic disease
• Has a menstrual cycle between 21 and 35 days in length
• Able to predict their menstrual cycle and timing of their menstruation

Exclusion Criteria

• Any pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders.
• Current use of any blood thinning medication
• Anyone with known severe allergic reactions.
• Women who are pregnant, breastfeeding, or attempting to become pregnant
• Unwilling to follow the study protocol.
• Anyone with a diagnosis of a condition relating to the menstrual cycle or reproductive system? e.g., polycystic ovary syndrome (PCOS), premenstrual dysphoric disorder (PMDD), endometriosis, etc.
• Anyone currently on hormonal birth control, or has been on hormonal birth control in the last 3 months

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Citruslabs

INDUSTRY

Sponsor Role: collaborator

Rael

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Citruslabs

Santa Monica, California, United States

Countries

United States

Other Identifiers

20338

Identifier Type: -

Identifier Source: org_study_id