Health Condition 1: N943- Premenstrual tension syndrome
Conditions
Interventions
Intervention1: Lomens-P0: Dose: 1 tablet per day (1000mg/day, with Lomens-P0 500mg/day)
Treatment duration: 12 weeks
Control Intervention1: Placebo: contains pharmacological inactive ingredients.
Dos
Sponsors
GENENCELL CO LTD
Eligibility
Inclusion criteria
Inclusion criteria: 1. Women aged 19-45 years 2. Subject who voluntarily agrees to participate and signs in ICF 3. Women who have menstruation 4. Menstrual cycle range not longer than 31 or shorter than 24 days for at least last 6 months 5. Subjectâ??s next approaching menstrual cycle not falling within next 10 days from screening day. 6. Mild to moderate symptoms of premenstrual syndrome (score >=16), identified by the DSR and Follicular score less than 40 identified by the COPE. The scores will be calculated by averaging the scores of six days before 1st day of menstruation for 2 consecutive menstrual cycle from visit 1 to visit 2.
Exclusion criteria
Exclusion criteria: 1. Subject who took medicine or health functional food related to PMS 2. Subject with a history of uterine cancer and sex hormone-related cancer, or undiagnosed uterine bleeding 3. Subject with a severe migraine or diagnosed with thromboembolism, cerebrovascular disease, myocardial infarction, unstable angina, or a history of coronary angioplasty within a year 4. Subject with severe mental illness, such as depression and anxiety disorder, or who is currently taking neuro-psychotic drug such as antidepressants 5. Uncontrolled hypertension disease(160/100 mmHg and above) 6. Uncontrolled thyroid disease 7. Drug or alcohol abusers 8. Participated in another clinical trial within one month of the start of this clinical trial, or plan to participate in another clinical trial during the trial 9. Any condition that in the opinion of the investigator does not justify the subjectâ??s inclusion for the study 10. Subject who uses sanitary aids or extra equipment (e.g. Hot water bottle, Instant hot pack, Heating pad (electronical) to abdomen and lumbar, Instant ice pack to limbs) to relieve PMS 11. Subject who plans to conceive within 3 months, Breastfeeding women and pregnant woman 12. Actual or recent participation in psychotherapy due to premenstrual symptoms 13. Allergy with any of the ingredients of the IP 14. Women who are surgically sterilised, hysterectomised, or ovariectomised 15. Subjects on the treatment of infertility 16. Any gynaecological disease like cysts, fibroids, malignancy. 17. Woman reaching menopause 18. Subjects using hormonal contraception
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinically significant positive change from baseline to EOT in the Penn State daily Symptom Report (DSR)Timepoint: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinically significant positive change from baseline to EOT (End of treatment) in The Calendar of Premenstrual Experience (COPE) scoresTimepoint: 12 weeks | — |
Countries
India
Contacts
Public ContactSubham Dutta
Syncorp Clincare Technologies Pvt. Ltd.
Outcome results
None listed