Health Condition 1: - Health Condition 2: N944- Primary dysmenorrhea
Conditions
Interventions
Intervention1: vitamin d and e supplementation: Participants in the intervention group will receive Vitamin D and Vitamin E supplementation along with standard NSAID therapy.
Vitamin D3 will be admini
Sponsors
NIDHI
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion Criteria Female participants aged thirteen to thirty years. Participants having regular menstrual cycles, with cycle length between twenty one to thirty five days and menstrual flow lasting three to seven days. Participants with a history of moderate to severe primary dysmenorrhoea, with menstrual pain score of six or more on the Numeric Rating Scale, present in at least four of the past six menstrual cycles. Participants with a history of use of additional medications for pain relief during dysmenorrhoea in the preceding six months. Participants reporting absence from school, college, or workplace due to menstrual pain. Participants having minimum educational qualification up to primary school level, defined as completion of fourth standard.
Exclusion criteria
Exclusion criteria: Participants with secondary dysmenorrhoea due to pelvic pathology such as endometriosis, uterine fibroids, or congenital Mullerian anomalies. Participants with a known history of chronic systemic diseases, including renal, hepatic, or metabolic disorders. Participants who have received vitamin D supplementation or vitamin E supplementation in the preceding three months. Participants currently receiving hormonal therapy or hormonal contraceptives within the preceding three months. Participants with a known hypersensitivity or allergy to the study medications. Participants who are pregnant. Participants who are unwilling to participate or unable to comply with the study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in pain intensity measured using Numeric Rating Scale (NRS) Timepoint: Time points include baseline at enrolment, follow up assessments at the end of each menstrual cycle, and final assessment after completion of twelve weeks of intervention. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in premenstrual symptom severity assessed using PMSS / PSST Timepoint: Time point: Baseline, 4 weeks, 8 weeks, and 12 weeks | — |
Countries
India
Contacts
Public ContactDr Sudwita sinha
AIIMS PATNA
Outcome results
None listed