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 in female subjects of 13 to 45 years of age
试验速览
- 阶段
- Unknown
- 状态
- 进行中（未招募）
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
The study is a single centric, open label, Non-randomized, Phase IV Post marketing surveillance study on 120 subjects. There are four visits in the study with one being telephonic follow-up. On screening visit i.e., Day 0, the subjects will be screened based on inclusion and exclusion criteria. An informed consent/assent form will be given to all subjects/parent at the screening visit containing all study information in it. Eligible subjects will be enrolled into the study after the informed consent procedure and laboratory investigations reports. Blood will be withdrawn for laboratory investigations (CBC, ESR, Serum Creatinine & SGPT) on Day 0 and Day 90. Investigator will explain the subject about all study-related procedures, the telephonic follow-up on Day 45 (Visit 3) and end of study on Day 90 (Visit 4). All eligible subjects will be then provided with IP - Sachi Saheli syrup and tablets by investigator/study co-ordinator on Day 1 (Visit 2). The instructions will be given to the subject to use the IP at home from Day 1 to Day 90 i.e., Take 10 ml of Sachi Saheli syrup twice daily after meal, preferably morning and night and 1 tablet twice a day orally after meal, preferably morning and night. An Investigator Assessment Questionnaire and Subjective Assessment Quality of Life Questionnaire will be performed on Day 0 and Day 90 to evaluate the efficacy of IP- Sachi Saheli Syrup and Tablet.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 13.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
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.
时间窗: Day 1- day 90
1. To evaluate the increase in blood hemoglobin level in female subjects as compared to baseline.
时间窗: Day 1- day 90
次要结局
- 1. To assess the safety of investigational product Sachi Saheli.(2. Incidence of adverse events reported or observed during the study period.)