Clinical study to find the effectiveness of Meniphib tablets in female patients suffering from premenstrual syndrome.
- Conditions
- Health Condition 1: N00-N99- Diseases of the genitourinary system
- Registration Number
- CTRI/2021/02/031249
- Lead Sponsor
- Bhargava Phytolab
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method