se of Releeva 5 in menstrual irregularity
- Conditions
- Health Condition 1: N944- Primary dysmenorrhea
- Registration Number
- CTRI/2020/06/026204
- Lead Sponsor
- Tirupati Life Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 90
1.Female participants between the age of 18-45 years (both inclusive) with regular menstrual cycles (21â??35 days)
who are clinically diagnosed to have primary dysmenorrhea.
2.Subjects with stable vitals like pulse and blood pressure
3.Patient should have not participated in any other clinical trial during the past 3 months.
4.Participants who are willing to give written, signed and dated informed consent to participate in the study.
1.Secondary dysmenorrhea
2.Presence of any other Gynaecological diseases.
3.Pregnant or breastfeeding or planning to become pregnant during the study period.
4.Known case of Hypersensitivity to Investigational drug content.
5.Patients suffering from abnormal haematological or biochemical (renal & liver function) blood parameters.
6.Received any other investigational medicine within 7 days prior to screening which can interfere with investigational product activity
7.Suffering from any illness which will interfere with present study as decided by clinical investigator
8.Any condition decided as unfit for study by Clinical investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method