A Single Group Study to Evaluate the Effects of a Topical... | NCT06939972

NCT06939972

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
Topical Product Application	Experimental	Participants will apply a topical product containing Camphor (4%) and Menthol (4%) to areas experiencing pain, such as the lower abdomen or lower back, during menstrual cycles.	Dietary Supplement: Topical Analgesic with Camphor and Menthol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Topical Analgesic with Camphor and Menthol	Dietary Supplement	Participants will apply the product directly to the lower abdomen or back during menstrual cycles, following specific application instructions. The product provides analgesic and cooling effects to reduce discomfort.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Reduction in Menstrual Cramps and Pain	Change in participant-reported menstrual cramps and associated pain severity, as assessed by a study-specific questionnaire.	Baseline, Day 5 of Cycle 1 (cycle 1 is 4 weeks), and Day 5 of Cycle 2 (cycle 2 is 4 weeks)

Secondary Outcomes

Measure	Description	Time Frame
Participant Perception of Product Effectiveness	Evaluation of participants' perceptions of the product's effectiveness in alleviating menstrual cramps and symptoms, as assessed by a study-specific questionnaire.	Baseline, Day 5 of Cycle 1 (cycle 1 is 4 weeks), and Day 5 of Cycle 2 (cycle 2 is 4 weeks)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Female, aged 18-35.
Has had a regular menstrual cycle for the past six months and is to predict their menstrual cycle and the timing of their menstruation.
Mild to moderate self-reported discomfort during menstruation related to pelvic cramps and back pain.
Generally healthy and not living with any uncontrolled chronic disease.
Has a menstrual cycle between 21 and 35 days in length.
Willing to maintain current diet, sleep, and activity level for the duration of the study.
Resides 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.
Current use of any blood thinning medication.
Anyone with known severe allergic reactions.
Anyone with any allergies requiring the use of an Epi-Pen.
Anyone with any allergies or sensitivities to any of the study product ingredients.
Anyone who is pregnant, breastfeeding, or trying to conceive currently or at any point until the end of the study period.
Anyone unwilling to follow the study protocol.
Anyone taking prescription medications for acute or chronic pain.
Anyone with a diagnosis of a condition relating to the menstrual cycle or reproductive system-e.g., polycystic ovary syndrome (PCOS), premenstrual dysphoric disorder (PMDD), endometriosis, etc.
Anyone diagnosed with other conditions that may cause lower back, abdominal, or pelvic discomfort- e.g., fibromyalgia, Crohn's, IBS, UC, chronic constipation, frequent UTIs, bacterial vaginosis (BV), or history or kidney stones.
Anyone who has changed their birth control in the past three months.
Anyone who has had any surgeries or invasive treatments in the past six months or has any planned up until the end of the study period.
Anyone with any major illness in the past three months.
Anyone currently experiencing symptoms associated with perimenopause.
Anyone taking part in any other clinical trials or studies during this study's duration.
Anyone with a history of substance abuse.
Anyone who is currently a smoker or has been in the past three months.

ID	Term
D004412	Dysmenorrhea
D006261	Headache
D005221	Fatigue

ID	Term
D008599	Menstruation Disturbances
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D017699	Pelvic Pain

ID	Term
D000700	Analgesics
D002164	Camphor
D008610	Menthol

ID	Term
D018689	Sensory System Agents
D018373	Peripheral Nervous System Agents
D045505	Physiological Effects of Drugs
D020228	Pharmacologic Actions