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To evaluate the safety and efficacy of CURAPOD-M in Menstrual Pain Reduction

A Prospective Single-Arm Clinical Study to Evaluate the Safety & Efficacy of CURPAOD-M in Reducing Menstrual Pain and Improving Quality of Life in Women with Active Menstruation. - NIL

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/06/113189
Enrollment
75
Registered
2026-06-30
Start date
Unknown
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention1: CURAPOD-M (Litemeds Menstrual Pain Management Device): CURAPOD-M is a non-invasive, compact, portable, and wearable therapeutic solution designed to provide effective relief from primar

Sponsors

Litemed India Private Limited
Lead Sponsor

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

MeasureTime 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

MeasureTime 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

Public ContactKaushik M Gawali

Litemed India Private Limited

drsurya.maguluri@litemed.co.in7981029973

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Aug 10, 2026