A Single Centric, Open Label, Non-Randomized, Phase IV Post Marketing Surveillance Study to Evaluate the Efficacy and Safety of Product Sachi Saheli in order to improve the quality of life during the menstruation cycle
Phase 4
- Conditions
- Health Condition 1: N946- Dysmenorrhea, unspecified
- Registration Number
- CTRI/2021/07/034539
- Lead Sponsor
- Divisa Herbal Care
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1.Age between 13 to 45 (Female subjects only)
2.Subjects suffering from Dysmenorrhea and/or Leucorrhea
3.Willingness to take part in study and able to attend all scheduled visits
4.Subjects suffering from issues like loss of appetite, anemia, general weakness and period irregularities
Exclusion Criteria
1.Pregnant, breast-feeding, subjects undergone any surgery and else taken part in any clinical trial
2.Not willing to sign the ICF or give the consent
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. To evaluate the increase in blood hemoglobin level in female subjects as compared to baseline. <br/ ><br>2. To determine the total number of subjects with symptomatic relief of lower back pain, leucorrhea and general weakness assessed through Investigator Assessment Questionnaire and Subjective Assessment Questionnaires. <br/ ><br> <br/ ><br>Timepoint: Day 1- day 90 <br/ ><br>
- Secondary Outcome Measures
Name Time Method 1. To assess the safety of investigational product Sachi Saheli. <br/ ><br>2. Incidence of adverse events reported or observed during the study period. <br/ ><br>Timepoint: Day 1-day 90