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

NCT ID: NCT05845970

Last Updated: 2024-02-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-08
• Study Completion Date: 2023-07-01

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.

Conditions

Menstrual Pain; Premenstrual Syndrome

Study Design

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

Study Groups

Single Group

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.

Group Type: EXPERIMENTAL

Pamprin Botanicals

Intervention Type: 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

Intervention Type: 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).

Interventions

Pamprin Botanicals

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.

Intervention Type: OTHER

Pamprin Botanicals + Pamprin Menstrual Pain Relief

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).

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

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.

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

Sponsors

Citruslabs

INDUSTRY

Sponsor Role: collaborator

Focus Consumer Healthcare

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Citruslabs

Santa Monica, California, United States

Countries

United States

Other Identifiers

20268

Identifier Type: -

Identifier Source: org_study_id