Effect of single drug in premenstrual problem
Phase 3
Completed
- Conditions
- Health Condition 1: null- PREMENSTRUAL SYNDROME
- Registration Number
- CTRI/2018/03/012328
- Lead Sponsor
- ational Institute of Unani Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
Inclusion Criteria
Patients with regular cycle and a cycle length of 21- 35 days presenting with signs and symptoms of premenstrual syndrome
Symptoms only during the premenstrual period with marked relief at onset of menstruation
PMTS-O with VAS scale
Exclusion Criteria
Patients on hormonal replacement therapy, oral contraceptive, undergone hysterectomy
Diagnosed cases of pschyiatric disorder, lactating mother
Present with any organic pelvic pathology, irregular menstrual cycle
Patients with any systemic and metabolic diseases
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Patient presenting with â?¥1 of the following symptoms. <br/ ><br>Depression, irritability, anxiety, angry outburst, confusion, social withdrawal, breast tenderness, abdominal bloating and pain , headache, swelling of extremities <br/ ><br>Timepoint: 15 days prior to expected date of mentruation for 2 cycles
- Secondary Outcome Measures
Name Time Method Premenstrual tension scale- self rating with VAS scale(PMTS-SR with VAS)12, SF-12 SCORE <br/ ><br>Timepoint: 15 days prior to expected date of mentruation for 2 cycles