An Investigation Into the Efficacy of a Botanical Supplement to Provide Period Relief

Phase 1

Completed

• Conditions: Premenstrual Syndrome; Menstrual Pain
• Interventions: Other: Pamprin Botanicals; Combination Product: Pamprin Botanicals + Pamprin Menstrual Pain Relief

• Registration Number: NCT05845970
• Lead Sponsor: Focus Consumer Healthcare

Brief Summary

Women often experience significant pain during their periods which can significantly impact on quality of life. In this study, two products that are used to alleviate period pain will be examined. One test product is botanically based, and the other is a traditional over-the-counter pain reliever with additional components added to support less painful periods. The trial will be a cross-over trial where participants will use the botanical product before, during, and after their first period. Participants will use the botanical product alongside a traditional over-the-counter period product during their second period. Participants will answer surveys and have blood drawn at a third-party lab to answer the main objectives of this trial.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-08
• Study First Submitted: 2023-04-03
• Study First Submitted QC: 2023-04-25
• Study First Posted: 2023-05-06
• Primary Completion: 2023-06-01
• Study Completion: 2023-07-01
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-27
• Last Update Posted: 2024-02-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• Female between 18-40 years of age.
• Must be in good health with no significant chronic conditions and a BMI under 35.
• Must experience period pain and other PMS symptoms.
• Must have a regular menstrual cycle with a bleed week.
• If using hormonal contraception, must do so for at least three months
• If using oral contraception, must allow for bleed week.
• Must be able to predict their bleed week.
• Willing to abstain from strenuous exercise 24 hours before each of the three blood draws in this trial.

Exclusion Criteria

• Suffers from pre-existing conditions that would prevent them from adhering to the protocol.
• Anyone with known severe allergic reactions.
• Anyone with a previous negative experience with acetaminophen.
• Unwilling to follow the study protocol.
• Currently pregnant, breastfeeding, or wanting to become pregnant for the duration of the study.
• Anyone who uses other supplements for period pain and PMS symptoms.
• Current use of an extended activity hormonal contraception (examples include Depo-provera or Nexplanon.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Group	Pamprin Botanicals	Single-group crossover trial with 100 total participants. Participants will use Pamprin Botanicals during their first period and both Pamprin Botanicals and over-the-counter Pamprin Menstrual Relief during their second period.
Single Group	Pamprin Botanicals + Pamprin Menstrual Pain Relief	Single-group crossover trial with 100 total participants. Participants will use Pamprin Botanicals during their first period and both Pamprin Botanicals and over-the-counter Pamprin Menstrual Relief during their second period.

Primary Outcome Measures

Name	Time	Method
Changes in common menstrual cycle symptoms [Time Frame: 2 menstrual cycles (approximately 60 days)]	60 days	Menstrual cycle symptoms will be measured via study-specific questionnaires.

Secondary Outcome Measures

Name	Time	Method
Changes in blood biomarkers during the menstrual cycle [Time Frame: 2 menstrual cycles (approximately 60 days)]	60 days	hs-CRP and cortisol will be measured via blood draws. Blood draws will occur at Baseline, Day 5 of bleeding during their first menstrual cycle during the study, and Day 5 of bleeding during their second menstrual cycle during the study.

Trial Locations

Locations (1)

Citruslabs; 🇺🇸 Santa Monica, California, United States