Dysmenorrhea Primary, Vitamin E, Mefenamic Acid
Conditions
Keywords
Menstrual cycle, Pain, Vitamin E, Mefenamic acid
Brief summary
The goal of this clinical trial is to determine whether adding vitamin E to mefenamic acid reduces menstrual pain more effectively than mefenamic acid alone in women with primary dysmenorrhea. Primary dysmenorrhea refers to painful menstrual cramps that occur without an underlying pelvic disease. The main question this study aims to answer is: • Does the combination of vitamin E and mefenamic acid reduce menstrual pain more than mefenamic acid alone? Researchers will compare two groups of women aged 15-35 years who experience primary dysmenorrhea. One group will receive mefenamic acid together with vitamin E, while the other group will receive mefenamic acid alone. A total of 60 participants will be enrolled and randomly assigned to one of the two treatment groups. Participants in the combination group will take mefenamic acid 400 mg with vitamin E 400 IU at the start of their menstrual cycle. Participants in the comparison group will take mefenamic acid 400 mg alone at the start of their menstrual cycle. Pain will be measured using a Visual Analogue Scale (VAS), where 0 represents no pain and 10 represents severe pain. Pain scores will be recorded at the time of enrollment and again during the second menstrual cycle after starting treatment. The study will evaluate whether the average pain score during the second menstrual cycle is lower in women who receive vitamin E together with mefenamic acid compared with those who receive mefenamic acid alone. The findings may help determine whether adding vitamin E can improve the management of primary dysmenorrhea.
Interventions
DRUGMefenamic acid
All participants will be given 250 mg of Mefenamic acid (Tablet Ponstan), twice daily, for 5 days: two days before the start of menstruation to three days in menstrual cycle
All participants will be given 200 mg of Vitamin E (Evion capsule), twice daily, for 5 days: two days before the start of menstruation to three days in menstrual cycle
Sponsors
Nishtar Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
15 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
* Primary Dysmenorrhea for ≥3-months
Exclusion criteria
* Patients already taking Vitamin E therapy * Having secondary dysmenorrhea like fibroid, endometriosis, adenomyosis and ovarian cyst on ultrasound
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Score | After enrollment, two days before menstruation to three days in menstrual cycle | Pain will be assessed using Visual analogue Scale, for five days, two days before menstruation to three days in menstrual cycle. Mean Pain Score = (VAS Day 1 + Day 2 + Day 3 + Day 4 + Day 5) ÷ 5 Mean Pain Score in the Baseline Cycle (without treatment) and Cycle 2 (with study medication) will be recorded. Change in Pain=Mean VAS (Cycle 2)-Mean VAS (Baseline Cycle) |
Countries
Pakistan
Contacts
STUDY_CHAIRShazia S Assistant Professor, FCPS
Nishtar Medical University
Outcome results
None listed