A CLINICAL TRIAL TO STUDY THE EFFECTS OF FIXED-DOSE COMBINATION OF PARACETAMOL 500MG AND PAMABROM 25mg WITH PARACETAMOL ALONE IN THE TREATMENT OF PATIENTS WITH PREMENSTRUAL SYNDROME
- Registration Number
- CTRI/2010/091/001274
- Lead Sponsor
- Akums Drugs & Pharmaceuticals Limited ., Delhi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
■All patients with duly filled in ICFs [Informed Consent Forms]
■Ages: > 18 till menopause
■Genders Eligible for Study: only women
■Established diagnosis of the premenstrual syndrome
?Patients unwilling to sign on ICF
?Participation in other trials,
?Concomitant therapy,
?Pregnancy or breast feeding,
?Inadequate contraception,
?Dementia,
?Alcohol or drug dependence,
?Concomitant serious medical condition,
?Hypersensitivity to Pamabrom or paracetamol,
?Fever,
?Pituitary disease, and
?Concomitant use of sex hormones except oral contraceptives for which the doses will be unchanged.
?Any other serious diseases having fatal progression.
?Any of the following endocrinological diseases: diabetes mellitus, hypo-/hyperthyreosis, pituitary tumor.
?Clearly kidney or liver disease, abnormal kidney or liver function.
?Any of the following gynecological diseases: endometriosis, mammary carcinoma, intraductal papilloma, galactorrhea, mammary fibroadenoma.
?Prior to the start of the study any planned surgical intervention of the breasts (including cyst puncture), of the uterus and/ or adnexa.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The main efficacy variable prospectively sought in the protocol will be change from baseline to end point in the combined scores of the six self assessment items:<br>1.Irritability, <br>2.Mood alteration, <br>3.Anger, <br>4.Headache, <br>5.Other menstrual symptoms including bloating, and <br>6.Breast fullness. <br>Women will rate each item using a visual analogue scale (25) validated for the assessment of the premenstrual syndrome, ranging from 0 (no symptoms) to 10 (unbearable), measured in millimetres on the linear scale. <br>Timepoint: 3 cycles
- Secondary Outcome Measures
Name Time Method Secondary variables will be clinical global impression items:<br>o1 (severity of condition), <br>o2 (global improvement or deterioration), and <br>o3 (overall treatment assessment, risk or benefit) and <br>Responder rate, defined as >50% reduction in self-assessed symptoms from baselineTimepoint: 3 cycles