Primary Dysmenorrhoea
Conditions
Interventions
This cross over study has three regimens of treatment. Participants will receive the following two drugs, as a single agent with a placebo or in combination. 1. Nifedipine (a calcium channel blocker)
Sponsors
Department of Obstetrics & Gynaecology, Faculty of Medical Sciences, University of Sri Jayewardenepura
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients who are having clinically Primary Dysmenorrhoea (ICD-10, N94.4) 2. Non pregnant women in reproductive age group
Exclusion criteria
Exclusion criteria: 1. Known secondary cause for dysmenorrhoea 2. Current history, examination and investigations suggestive of a secondary cause for dysmenorrhoea 3. Pelvic pain in between menstrual periods 4. Previous pelvic surgery 5. Contraindications for Nifedipine 6. Hypertension (essential or secondary) 7. Contra indications for Mefenemic Acid 8. Any other chronic pains and conditions that might affect the quality of life such as migraine 9. Use of hormonal contraception 10. Use of other forms of treatment for dysmenorrhoea including Ayurvedic and herbal medicine 11. Women with palpitations 12.Women with cardiac diseases 13. Women who are lactating
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Experience of pain due to dysmenorrhoea (using a visual analogue scale) 2. Quality of life (SF 36 questionnaire, validated in English, Sinhala and Tamil) 3. Any side effects attributable to the treatment (using a specific structured questionnaire [1.At the end of each day of the cycle: by the patient 2.At the end of each menstrual cycle by the patient) 3.At the end of each regime (3 menstrual cycles): by the investigator] | — |
Secondary
| Measure | Time frame |
|---|---|
| None [None] | — |
Countries
Sri Lanka
Contacts
Public ContactDr. Dhammike Silva
Senior Lecturer/ Consultant Obstetrician & Gynaecologist
Outcome results
None listed