Evaluating the Efficacy of Feminocare Capsule in the Management of Primary Dysmenorrhea: A Single-Arm Interventional Clinical Trial

Dysmenorrhea is a prevalent menstrual disorder that significantly affects women’s quality of life and work productivity, characterized by painful menstruation severe enough to disrupt daily activities. This condition impacts between 58.2% and 89.5% of women of reproductive age. This study is a single-arm clinical intervention designed to evaluate the efficacy of the Feminocare capsule in managing primary dysmenorrhea. A total of 60 female patients aged 18-45 years with primary dysmenorrhea, attending the outpatient department of Pankajakasthuri Ayurveda Medical College and Hospital in Kattakada, Thiruvananthapuram, will be enrolled. Data collection will involve a structured case proforma and the Visual Analogue Scale (VAS) for pain assessment. Additionally, ultrasonography of the abdomen and pelvis and routine blood investigations will be conducted to exclude any pelvic pathology. The intervention will consist of administering Feminocare capsules at a dose of two tablets three times daily after meals for a period of 120 days.

The primary objective of this study is to assess the efficacy of Feminocare in reducing pain associated with primary dysmenorrhea. The secondary objective includes evaluating its effect on related symptoms such as nausea, vomiting, dizziness, and diarrhea. Inclusion criteria are limited to women aged 18-45 years with regular menstrual cycles and primary dysmenorrhea, while patients with irregular menstruation, pelvic pathology, dysfunctional uterine bleeding, or structural deformities of the reproductive system will be excluded. The primary outcome measure will be the change in the mean pain score assessed by VAS, while secondary outcomes include changes in associated symptoms such as nausea, dizziness, diarrhea, and vomiting.

The anticipated outcome is that Feminocare will significantly reduce both pain levels and associated symptoms in primary dysmenorrhea, potentially improving the quality of life and functional capacity in affected women. This study may provide supportive evidence for Feminocare as an effective therapeutic option for managing primary dysmenorrhea.