A Prospective, Single-Arm, Single-Centre Clinical Study To Evaluate The Safety And Efficacy Of Prinkwellness Vaginal Suppositories For The Management Of Menstrual Cramps

Brief Summary:

Prinkwellness vaginal suppositories were investigated as a targeted treatment for menstrual cramps (dysmenorrhea). These suppositories delivered active ingredients, anti-inflammatory agents, muscle relaxants, and analgesics, directly to the cervix and uterine tissues, potentially enhancing efficacy while minimizing systemic side effects.

Dysmenorrhea, a common gynecological condition that affects a significant proportion of women during their reproductive years and often results in severe pain and discomfort in the lower abdomen that interferes with daily activities and qualilty of Life. Existing treatment options, such as NSAIDs and hormonal contraceptives, have certain limitations, which created a need for alternative therapies that are effective as well as safe. The Prinkwellness vaginal suppositories are a blend of natural ingredients.

Preclinical studies and initial trials indicate that Prinkwellness vaginal suppositories significantly reduced menstrual pain and improved quality of life.

Purpose of the Study:

The study aimed to evaluate the safety and efficacy of Prinkwellness vaginal suppositories in relieving menstrual pain. It assessed pain reduction, improvement in quality of life, and potential adverse effects to determine whether this product could serve as an effective alternative therapeutic option for managing dysmenorrhea in a large and diverse population.

Results:

A total of 100 women were enrolled in the study, and 90 women completed all the study-related procedures. The remaining 10 women were withdrawn from the study as they were lost to follow-up. Women in the age group of 18-50 years who met the study eligibiility criteria were enrolled after obtaining free given informed consent. All the participants had normal physiological examination. The participants were screened and enrolled on Day 1 and the first follow-up visit was at Day 30 with EOS on Day 60. The participants used 100 mg of the product once in the first menstrual cycle followed by 120 mg once in the second menstrual cycle.

Primary Efficacy Endpoint: The use of Prinkwellness vaginal suppositories significantly reduced menstrual pain as measured by the VAS with mean pain score of 8.02 at visit 1, which significantly reduced to 5.08 at visit 2 and further decreased to 1.68 at visit 3.

Secondary Efficacy Endpoint: The QoL was measured using SF-36 Questionnaire. The results of SF-36 indicate a positive trend in perceived health from visit 1 to visit 3. The general health improved from visit 1 to visit 3. The mean scores for all the activities increased from visit 1 to visit 3 indicating considerable overall reduction in limitations in performing the physical activities from visit 1 to visit 3. The participants also reported improved emotional health with less interference from emotional problems on social activities, and iinformed that they experienced less body pain from visit 1 to visit 3. Also they informed about increase in positive feelings and a general decrease in feeling tired. The mean score of impact of physical health and emotional problems on social activities decreased with a mean score of 1.96 at visit 1, increasing to 3.35 at visit 2 and further increasing to 5.3 at visit 3 with higher number indicating less interference.

Most of the participants used the product correctly and expressed satisfaction with the results. They experienced improved product usability from visit 1 to visit 3, found it easy to use, noted faster onset time and longer duration of relief. 90% of the participants showed compliance to the product suggesting that they followed the product usage instructions without difficulty.

No adverse events or serious adverse events were reported during the study..