Health Condition 1: N944- Primary dysmenorrhea
Conditions
Interventions
None listed
Sponsors
Regional Ayurveda Research Institute
Eligibility
Inclusion criteria
Inclusion criteria: 1. Menstruating females aged between 12 to 24 years. 2. Females who has never given birth to a live child (Nulliparous). 3. Females who has completed at least 1 year from the date of menarche. 4. Females with self-reported history of pain associated with menstruation for at least 3 out of last 6 menstrual cycles. 5. Females with the history of regular menstrual cycles (equal or less than 9 days variation between shortest & longest cycle) of 24 to 38 days length with bleeding duration of equal or less than 8 days & normal flow during last 3 cycles. 6. Females willing to participate in the study and agreeing to provide written informed assent and/or consent (as applicable) for participation in the study for next 5 months.
Exclusion criteria
Exclusion criteria: 1. Females with known/pre-diagnosed/having the history of (during the past 6 months) Gynaecological or pelvic pathologies, e.g. Uterine fibroids, gynecological malignancy, female hormonal disorders, PCOD, endometriosis, pelvic inflammatory disease, metrorrhagia, menorrhagia, leucorrhoea, gynaecological surgery, etc. 2. Females with known/pre-diagnosed/having the history of (during the past 6 months) systemic disorder likely to impact the menstrual physiology, e.g. Thyroid dysfunction, mental disorder, and moderate anaemia (Hb less than 10 gm percent), etc. 3. Females with known/pre-diagnosed/having the history of (during the past 6 months) Hypertension and diabetes mellitus. 4. Females with known/pre-diagnosed/having the history of (during the past 6 months) - Hepatic impairment defined as raised serum SGOT, SGPT, and total bilirubin more than 2 times of upper normal limits. 5. Females with known/pre-diagnosed/having the history of (during the past 6 months) Renal impairment defined as serum creatinine above the normal limit. 6. Females diagnosed with any of the above conditions during screening laboratory test by Serum SGOT, SGPT, Total-Direct-Indirect Bilirubin, Creatinine, FBS, Serum TSH, Hb percentage, & clinical assessment. 7. Females suffering with persistent pelvic pain throughout the menstrual cycle. 8. Females with pre-diagnosed concurrent neurological, pulmonary, endocrine, or unstable cardio-vascular disease. 9. Females currently using or having the history of using any intrauterine device, and/or taking oral contraceptive pills during last 3 cycles. 10. Females planning to conceive within the next 6 months. 11. Females on prolonged medication for any other medical condition.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in severity of primary dysmenorrhoea assessed by change in â??WaLIDDâ?? score.Timepoint: At baseline, 1st, 2nd, 3rd, and 4th cycle. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in duration and intensity of pain (12 hourly) associated with primary dysmenorrhoea assessed by change in â??VASâ?? score.Timepoint: At baseline, 1st, 2nd, 3rd, and 4th cycle.;Change in frequency of rescue medicine use.Timepoint: At the end of 4th cycle.;Change in psychosomatic status assessed by the change in â??Moos Menstrual Distress Questionnaireâ?? score.Timepoint: At baseline, 3rd & 4th cycle.;Change in perceived stress level assessed by the change in â??Perceived Stress Scale (10 Items)â?? score.Timepoint: At baseline, 3rd & 4th cycle. | — |
Countries
India
Contacts
Public ContactArvind Kumar
CCRAS-RARI, Itanagar, Arunachal Pradesh
Outcome results
None listed