Health Condition 1: N00-N99- Diseases of the genitourinary system
Conditions
Interventions
Intervention1: Meniphib Tablet: An off white, round, flat, scored, uncoated tablet inscribed with B.P. on one side administered orally. One tablet is to be taken twice daily with Plain water for 90 da
Sponsors
Bhargava Phytolab
Eligibility
Inclusion criteria
Inclusion criteria: 1)Subject is willing and able to give written informed consent 2)Female subjects aged � 18 and � 45 years not attained menopause 3)Subject having clinical diagnosis as per investigators judgment for Premenstrual Syndrome 4)Subjects of childbearing potential should have a negative pregnancy test at Screening 5)Female subjects of childbearing potential should be willing to practice appropriate birth control during the entire duration of the study Appropriate birth control is defined in the study as any medically recommended method (or combination of methods) except oral birth control pills as per standard of care 6)Subject is willing, able and likely to comply with all study procedures and restrictions
Exclusion criteria
Exclusion criteria: 1)Subject is pregnant or breast-feeding at the time of screening, or planning to be pregnant during the study 2)History of current or past Psychiatric Disorders 3)History consistent with endometriosis 4)Diagnosis of ill-defined, obscure pelvic lesions, particularly, undiagnosed ovarian enlargement, hepatic disease as manifested by medical history 5)History of mammary carcinoma 6)History of pulmonary embolism or phlebothrombosis 7)Undiagnosed vaginal bleeding 8)Subject suffering from porphyria 9)Subject suffering from uncontrolled diabetes mellitus 10)History of malignant melanoma 11)Subject suffering from cholecystitis or pancreatitis 12)Cardiovascular or renal disease 13)Subject taking birth control pills will be excluded from the study. 14)Subject taking diuretics prostaglandin inhibitors or pyridoxine (putative treatments for MRMD) will similarly be excluded from the study 15)Subject taking psychotropic agents 16)Subjects who had an administration of other investigational product or medical device for clinical trial 4 weeks prior to participation of clinical trial 17)Any other condition that in the investigators judgment might interfere with study objectives
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy will be assessed as below To assess the change improvement in Premenstrual Syndrome using Premenstrual Syndrome Scale (PMSS) Timepoint: Day 0 to Day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| Physicianââ?¬â?¢s Global evaluation through CGI-I scale Safety and tolerability of the study drug(s) will be assessed by the Clinical AEs occurring during entire duration of study. Timepoint: Day 0 to Day 90 | — |
Countries
India
Contacts
Public ContactDr Devesh Kumar
IR Innovate Research Private Limited
Outcome results
None listed