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Completed

NCT Number: NCT05845970

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

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.

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Key information

Conditions

Menstrual Pain Dysmenorrhea Menstruation Disturbances Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Pelvic Pain Premenstrual Syndrome Signs and Symptoms

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Citruslabs

Santa Monica, California, 09404, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pamprin Botanicals

Other

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.

Pamprin Botanicals + Pamprin Menstrual Pain Relief

Combination Product

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).

Primary outcomes

  1. Changes in common menstrual cycle symptoms [Time Frame: 2 menstrual cycles (approximately 60 days)]

    Time frame: 60 days

    Menstrual cycle symptoms will be measured via study-specific questionnaires.

Secondary outcomes

  1. Changes in blood biomarkers during the menstrual cycle [Time Frame: 2 menstrual cycles (approximately 60 days)]

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Focus Consumer Healthcare

Industry

Collaborators

  • Citruslabs

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 6, 2023
Registry last updated
Feb 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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