Back to resultsAn Investigation Into the Efficacy of a Botanical Supplement to Provide Period Relief
Primary Purpose
Menstrual Pain, Premenstrual Syndrome
Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Pamprin Botanicals
Pamprin Botanicals + Pamprin Menstrual Pain Relief
Sponsored by
About this trial
This is an interventional treatment trial for Menstrual Pain
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.
Sites / Locations
- Citruslabs
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single Group
Arm 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.
Outcomes
Primary Outcome Measures
Changes in common menstrual cycle symptoms [Time Frame: 2 menstrual cycles (approximately 60 days)]
Menstrual cycle symptoms will be measured via study-specific questionnaires.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT05845970
First Posted
April 3, 2023
Last Updated
April 25, 2023
Sponsor
Focus Consumer Healthcare
Collaborators
Citruslabs
1. Study Identification
Unique Protocol Identification Number
NCT05845970
Brief Title
An Investigation Into the Efficacy of a Botanical Supplement to Provide Period Relief
Official Title
An Investigation Into the Efficacy of a Botanical Supplement to Provide Period Relief
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 8, 2023 (Actual)
Primary Completion Date
June 1, 2023 (Anticipated)
Study Completion Date
July 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Focus Consumer Healthcare
Collaborators
Citruslabs
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Menstrual Pain, Premenstrual Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Model Description
Single arm crossover study
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single Group
Arm Type
Experimental
Arm 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.
Intervention Type
Other
Intervention Name(s)
Pamprin Botanicals
Intervention Description
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
Combination Product
Intervention Name(s)
Pamprin Botanicals + Pamprin Menstrual Pain Relief
Intervention Description
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 Outcome Measure Information:
Title
Changes in common menstrual cycle symptoms [Time Frame: 2 menstrual cycles (approximately 60 days)]
Description
Menstrual cycle symptoms will be measured via study-specific questionnaires.
Time Frame
60 days
Secondary Outcome Measure Information:
Title
Changes in blood biomarkers during the menstrual cycle [Time Frame: 2 menstrual cycles (approximately 60 days)]
Description
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.
Time Frame
60 days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Citruslabs
City
Santa Monica
State/Province
California
ZIP/Postal Code
09404
Country
United States
12. IPD Sharing Statement
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An Investigation Into the Efficacy of a Botanical Supplement to Provide Period Relief
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