Health Condition 1: N946- Dysmenorrhea, unspecified Health Condition 2: E282- Polycystic ovarian syndrome Health Condition 3: N944- Primary dysmenorrhea Health Condition 4: N945- Secondary dysmenorrhea
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Females aged between 12 to 40 years at the time of screening. 2. Currently menstruating with active menstruating cycle. 3. Menstrual pain intensity with equal or more than 4 VAS score during the previous cycle. 4. History of menstrual pain of at least 3 menstrual cycles. 5. Conditions included are Primary Dysmenorrhea, Secondary Dysmenorrhea, POCS/PCOD, Irregular cycles due to hormonal imbalance, ovulatory or anovulatory cycles. 6. Expecting menstrual pain during menstruation. 7. Willingness to use the interventional device for complete duration of the most cycle. 8. Able to maintain a menstrual diary. 9. Provides written informed consent form.
Exclusion criteria
Exclusion criteria: i. Subject who participated in other study for less than 3 months. ii. Uterine fibroids (symptomatic fibroids) iii. Adenomyosis iv. Severe Endometriosis v. Pelvic inflammatory disease vi. Pelvic malignancy vii. Pregnancy viii. Post-menopause women ix. Active pelvic infection x. Recent pelvic surgery (less than 6 months) xi. Known photosensitive disorders xii. Presence of implanted electronic/medical devices xiii. Active dermatological conditions on the lower abdominal region.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of CURAPOD M in reducing menstrual pain intensity during the menstrual phase of the menstrual cycle To assess the improvement in Quality of Life during MenstruationTimepoint: Change in menstrual pain intensity measured using the visual analog scale during the treatment during menstrual cycle compared to the baseline menstrual cycle | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the reduction in use of rescue pain medication. To evaluate patient satisfaction & usability of the device.Timepoint: Baseline, Day 7, Day 35, Day 63 | — |
Countries
India
Contacts
Litemed India Private Limited