Effects of a Female Hormone Balance Supplement on Premens... | NCT07018479

NCT07018479

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Name	Class
Citruslabs	INDUSTRY

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
FemmeBalance Supplement Group	Experimental	Two capsules daily of FemmeBalance, containing Sabal Serrulata, NAC, turmeric extract, chasteberry extract, vitamin B5, black pepper extract, and excipients.	Dietary Supplement: FemmeBalance Supplement Group

Interventions

Name	Type	Description	Arm Group Labels	Other Names
FemmeBalance Supplement Group	Dietary Supplement	Participants will take two capsules daily of the FemmeBalance supplement with their evening meal for four menstrual cycles	FemmeBalance Supplement Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in PMS Symptoms	Change in self-reported symptoms of premenstrual syndrome, including pelvic pain, mood swings, acne, hair loss, fluid retention, breast pain/tenderness, irritability, and episodes of crying or sadness, assessed using validated questionnaires (PSST and study-specific tools).	Baseline and Day 7 of each menstrual cycle over 4 cycles (~16 weeks)

Secondary Outcomes

Measure	Description	Time Frame
Participant Perception of Supplement Effectiveness	Self-reported participant feedback on perceived effectiveness of the supplement, collected through questionnaires. These responses are qualitative and not subject to statistical analysis.	Day 7 of each menstrual cycle over 4 cycles (~16 weeks)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Female, aged 18-40.
Self-reported symptoms of PMS for at least three consecutive months, including but not limited to pelvic pain, mood swings, acne, hair loss, fluid retention, breast pain/tenderness, irritability, and episodes of crying or sadness.
Generally healthy and not living with any uncontrolled chronic disease.
Has a regular menstrual cycle between 21 and 35 days in length.
Willing to maintain the same diet, sleep schedule, and activity level for the duration of the study (at least 16 weeks).
Own a smartphone with a camera.
Must reside in the United States.

Exclusion Criteria:

Any pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders.
Anyone with known severe allergic reactions that require the use of an Epi-pen or any allergies to any of the product ingredients.
Women who are pregnant, breastfeeding, or trying to conceive.
Anyone who is unwilling or unable to follow the study protocol.
Anyone previously diagnosed with premenstrual dysphoric disorder (PMDD), endometriosis, or any cancer of the reproductive system.
Anyone who is peri- or post-menopausal.
Anyone who is currently on hormonal birth control or who has been on hormonal birth control in the last three months.
Anyone who is taking any products, medication, or supplements that target the symptoms of PMS.
Anyone who has undergone any surgeries or invasive treatments in the last six months or who is planning on undergoing any in the study duration.
Anyone who has had any major illness in the last three months.
Anyone who is currently undergoing, or who plans to undergo in the study period, any procedures relating to reproductive health and/or the menstrual cycle, e.g., a hysterectomy, ovary removal, or similar procedure.
Anyone who suffers from amenorrhoea or irregular periods (<21 days or >35 days apart on average).
Anyone who is currently participating in or who plans to participate in another trial during the study period.
Anyone with a history of substance abuse.
Anyone who smokes or who has been a smoker in the past three months.

ID	Term
D008599	Menstruation Disturbances
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms