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

Study Overview
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Brief Summary
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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.

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

Conditions
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Menstrual Pain, Premenstrual Syndrome

Intervention / Treatment
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* Other: Pamprin Botanicals
* Combination Product: Pamprin Botanicals + Pamprin Menstrual Pain Relief


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Crossover Assignment
Interventional Model Description: Single arm crossover study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Group<br>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. | Other: Pamprin Botanicals<br>* Participants will take Pamprin Botanicals only. Participants will take 450mg of Pamprin Botanicals two days before their predicted period and then take it every day during their period. Participants can also take Pamprin Botanicals two days after the bleeding has concluded.<br>Combination Product: Pamprin Botanicals + Pamprin Menstrual Pain Relief<br>* Participants will repeat taking Pamprin Botanicals two days before their second predicted period and continue to take it each day during their period. However, during the second period, participants will also take Pamprin Menstrual Pain Relief per the over-the-counter directions (2 tablets every 6 hours with water).<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in blood biomarkers during the menstrual cycle [Time Frame: 2 menstrual cycles (approximately 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. | 60 days |