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

Focus Consumer Healthcare

Status and phase: Completed; Phase 1

Conditions: Menstrual Pain; Premenstrual Syndrome

Treatments: Other: Pamprin Botanicals; Combination Product: Pamprin Botanicals + Pamprin Menstrual Pain Relief

Study type: Interventional

Funder types: Industry

Identifiers

NCT05845970

20268

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

100 participants in 1 patient group

Single Group

Experimental group

Description:

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.

Treatment:

Other: Pamprin Botanicals

Combination Product: Pamprin Botanicals + Pamprin Menstrual Pain Relief