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

A DOUBLE-BLIND, DOUBLE ARM, RANDOMIZED, MULTICENTRIC, PROSPECTIVE, PHASE-III TRIAL TO INVESTIGATE THE EFFFICACY, SAFETY AND TOLERABILITYOF THE FIXED-DOSE COMBINATION OF PARACETAMOL 500MG AND PAMABROM 25mg WITH PARACETAMOL ALONE IN THE TREATMENT OF PATIENTS WITH PREMENSTRUAL SYNDROME

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/001274

Enrollment

200

Registered

2010-11-19

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Paracetamol and Pamabrom: 500mg and 25 mg respectively Control Intervention1: Paracetamol: 500mg

Eligibility

Inclusion criteria

Inclusion criteria: &#9632; All patients with duly filled in ICFs [Informed Consent Forms] &#9632; Ages: > 18 till menopause &#9632; Genders Eligible for Study: only women &#9632; Established diagnosis of the premenstrual syndrome

Exclusion criteria

Exclusion criteria: ? 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.

Design outcomes

Primary

Measure	Time frame
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: 1. Irritability, 2. Mood alteration, 3. Anger, 4. Headache, 5. Other menstrual symptoms including bloating, and 6. Breast fullness. 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. Timepoint: 3 cycles	—

Measure

Time frame

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: 1. Irritability, 2. Mood alteration, 3. Anger, 4. Headache, 5. Other menstrual symptoms including bloating, and 6. Breast fullness. 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. Timepoint: 3 cycles

—

Secondary

Measure	Time frame
Secondary variables will be clinical global impression items: o 1 (severity of condition), o 2 (global improvement or deterioration), and o 3 (overall treatment assessment, risk or benefit) and Responder rate, defined as >50% reduction in self-assessed symptoms from baselineTimepoint: 3 cycles	—

Countries

India

Contacts

Public ContactDr. Rajkumar Shah

drrajkumar2002@gmail.com

Outcome results