Health Condition 1: N944- Primary dysmenorrhea
Conditions
Interventions
Intervention1: Welme Wearable Menstural Pain Relief Device: The electrode patches are placed in the vicinity of groin on the painful area. Adjust the intensity as needed with the +/- button on the dev
Sponsors
Camex Wellness Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Women between the age 18 to 35 years 2. Subjects have a history of regular menstrual cycles that typically occurs between every 21 to 35 days 3. Subjects having a self reported history of primary dysmenorrhea are included with other causes of dysmenorrhea having been excluded. 4. Women reporting painful menstruation during the last 3 menstrual cycles. 5. Subject is willing and able to comply with the study protocol and provide written informed consent to participate in the study. 6. Subject must agree to consistently use effective contraception throughout the study. (Subject not treated with oral contraception should use any contraception other than oral).
Exclusion criteria
Exclusion criteria: 1.Participation in any other investigational study within 30 days prior and/or at the date of subject consent. 2. Woman with a significant medical condition such as: cancer, diabetes (Type I and II), irritable bowel disease IBD, immunodeficiency, autoimmune disease, etc. that in the investigator opinion, participation in the study would place the subjects at an unacceptable risk. 3. Subjects having a self-reported history of primary dysmenorrhea with other causes of dysmenorrhea having been excluded. 4. Pregnant woman 5. A woman who is diagnosed with secondary dysmenorrhea associated with uterine myomas, endometriosis, adenomyosis, etc. 6. A woman who has cardiac condition with cardiac pacemakers, implanted defibrillators, or other implanted metallic or electronic devices.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The difference between the reported Visual Analogue Scale before and after applying the device (active or sham). Each participant will rank the severity of her dysmenorrhea symptoms before and after the device use on the VAS scale from 0 to 100, where 0 determines- "No pain" and 100 determines "Very painful". Then, the difference between the two measurements will be calculated.Timepoint: 3 days before the beginning of the menstrual period and up to three days after termination of the menstrual period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Cox Menstrual system scale (CMSS)Timepoint: 3 days before the beginning of the menstrual period and up to three days after termination of the menstrual period.;Quality of life using SF-12Ã?®. The summary score will be determined as per the questionnaire manualTimepoint: 3 days before the beginning of the menstrual period and up to three days after termination of the menstrual period;The Participant Global Impression of Change (PGIC)Timepoint: 3 days before the beginning of the menstrual period and up to three days after termination of the menstrual period;To assess the adverse events (AEs)/Serious adverse Events (SAE)Timepoint: Total study duration;Usage of pain relievers during the menstrual period. Usage of pain relievers during the menstrual period as recorded in the subjects diaries. This will be measured by the number of pain relief pills taken during the entire menstrual periodTimepoint: 3 days before the beginning of the menstrual period and up to three days after termination of the menstrual period. | — |
Countries
India
Contacts
Public ContactRahul Chopra
Pharexcel Consulting Private Limited
Outcome results
None listed