Health Condition 1: N944- Primary dysmenorrhea
Conditions
Interventions
Intervention1: Fixed-dose Combination of Camylofin Dihydrochloride 50 mg + Paracetamol 325 mg Tablet: The investigational product will be administered orally, 3 times a day for 4 days.
Control Interve
Sponsors
Pure Cure Healthcare Pvt Ltd
Mudra Clincare
Eligibility
Inclusion criteria
Inclusion criteria: 1. All female subjects willing to fill and sign ICFs [Informed Consent Forms] 2. Female subjects aged between 18 to 40 years will be screened to enroll in the study. 3. Female subjects having at least 6 months previous history of confirmed diagnosis of Primary dysmenorrhoea. 4. Subjects who are able to and willing to provide written informed consent. 5.Cooperative and understanding skills. 6. Subjects willing and assessed to be able to participate in all aspects of the core study, including investigational product administration, completion of evaluations, and compliance with protocol requirements.
Exclusion criteria
Exclusion criteria: Hypersensitivity/ history of allergy to any of the Investigational product s components. Subjects, unwilling to participate in the clinical trial study. Recent use of psycho-active medication, drug or alcohol addiction. Females, pregnant or breastfeeding subjects. Subjects with prostatic hypertrophy Subjects with glaucoma Subjects with paralytic ileus Subjects with renal or hepatic disorders Subjects with a previous history of heart problems or stroke Participation in other clinical trials in the last three months and doing study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the change in pain intensity using VAS (Visual Analogue Scale) score and number of participants reporting relief from pain as a dichotomous measureTimepoint: From day 1 to day 4 after administration of the investigational product | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of participants reporting adverse events (AEs)Timepoint: From day 1 to day 4 after administration of the investigational product;Number of participants requiring additional medicationsTimepoint: From baseline to the end of the study;Number of participants having interference with daily activitiesTimepoint: From baseline to the end of the study;Global assessment by participantsTimepoint: At the end of the study;Global assessment by a physicianTimepoint: At the end of the study;Product acceptability rating by participants and physicianTimepoint: At the end of the study | — |
Countries
India
Contacts
Public ContactDr Sayali Sadgune
Mudra Clincare
Outcome results
None listed