Health Condition 1: N943- Premenstrual tension syndrome
Conditions
Interventions
None listed
Sponsors
Central Council For Research In Ayurvedic Sciences
Eligibility
Inclusion criteria
Inclusion criteria: 1.Female participants of reproductive age group (18-40) with regular menstrual cycle (between 21 and 35 days) having moderate symptoms as per PSST tool(Premenstrual Symptoms Screening Tool). 2.Symptoms should occur during the luteal phase. 3.Willing to participate in the study
Exclusion criteria
Exclusion criteria: 1.Patients diagnosed with Uterine fibroids , polyps and congenital uterine anomalies. 2.Diagnosed patients with diabetes mellitus, poorly controlled Hypertension(Blood pressure more than 160/100 mm of Hg) or hormonal disorders. 3.Patients with concurrent hepatic disorderdefined as aspartate amino transferase and/or alanine amino transferase greater than 2 times the upper normal limit or renal disorders defined as serum Creatinine greater than the upper limit of laboratory value) 4.Patients who are undergoing any hormonal treatment or using contraceptive pills. 5.Psychiatric disorders and malignant conditions 6.Pregnant/lactating females. 7.Patients who have completed participation in any other clinical trial during the past six (06) months. 8.Any other condition that the Investigator thinks may jeopardize the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in the Premenstrual Symptoms Screening tool PSST tool.Timepoint: Baseline, Visit 2 Visit 3 Visit 4 Visit 5 | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in values of LFT and RFTTimepoint: Baseline, Visit 4;Changes in values of Serum Progesterone, SerumEstradiol ,FSH and LHTimepoint: Baseline, Visit 4;Improvement in Psychological General Well-Being using PGWBI ScoreTimepoint: Baseline, Visit 2 Visit 3 Visit 4 Visit 5 | — |
Countries
India
Contacts
Public ContactDr Anumol K
Regional Ayurveda Research Institute Vijayawada CCRAS Ministry of AYUSH
Outcome results
None listed