Safety and efficacy of Power gummies: That time of the month nutritional gummies in Pre Menstrual Syndrome-A multicentric randomized controlled clinical study.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- 1.Changes in symptom grading on VAS scale (0-10) irritability, anxiety, angry outburst, confusion, social withdrawal, breast tenderness, abdominal pain, headache, gastric disturbances like bloating, constipation, body pain, hot flushes, night sweat, swelling of extremities ,acne etc.
研究概览
简要总结
According to thefindings of the study, treatment with PMS Gummies was more effective thanCognitive Behavioral Therapy (CBT) and counseling in reducing the overallseverity of physical and emotional PMS symptoms, perceived stress, premenstrualtension in young women with PMS along with improvement in quality of sleep.There was significantreduction in abdominal cramps, breast tenderness, acne and GI symptoms such asbloating and constipation with the treatment of PMS Gummies in two menstrualcycles. PMS Gummies treatment led to reduced stress and anxiety level, improvedmood and quality of sleep.90% subjects in PMSGummies group did not require any rescue medication in second menstrual cycle. Thestrength of the study was the general representation of women in society as astudy participant. There were university students, working and homemaker youngwomen participation in this study. This provides pulse of effectiveness of PMSGummies in PMS management for young women with wide educational, socio economicdiversity as representation of society.An intervention likePMS Gummies having nutritional corrections approach along with herbal extractfortification could be an effective tool in management of PMS and relatedsymptoms. The present study confirms safety and effectiveness of PMS Gummies inmanagement of PMS.Aesthetic Nutritionsponsored clinical trial to evaluate safety and efficacy of Power Gummies: Thattime of the month gummies in reducing symptoms of pre-menstrual syndrome andachieving improved quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Patients age within the range of 18 to 40 years 2.Patients with regular/ irregular menstrual cycle with a cycle length of 21-35 days 3.Presenting with signs and symptoms of premenstrual syndrome.
- •Any three of the following- Irritability Anxiety Breast tenderness Abdominal pain Headache Mood swings Hot flushes PMS related acne.
排除标准
- •1.Patients on hormonal replacement therapy 2.Patients with known systemic and metabolic diseases in investigator discretion not proving fit for trial 3.Diagnosed cases of psychiatric disorder 4.Pregnant and lactating mothers.
结局指标
主要结局
1.Changes in symptom grading on VAS scale (0-10) irritability, anxiety, angry outburst, confusion, social withdrawal, breast tenderness, abdominal pain, headache, gastric disturbances like bloating, constipation, body pain, hot flushes, night sweat, swelling of extremities ,acne etc.
时间窗: Screening Day, Baseline Day, First assessment- 5-7 days after first menstrual cycle, and Second assessment-5-7 days after second menstrual cycle.
2.Changes in premenstrual tension scale (PMTS) score.
时间窗: Screening Day, Baseline Day, First assessment- 5-7 days after first menstrual cycle, and Second assessment-5-7 days after second menstrual cycle.
3.Changes in quality of sleep questionnaire score.
时间窗: Screening Day, Baseline Day, First assessment- 5-7 days after first menstrual cycle, and Second assessment-5-7 days after second menstrual cycle.
次要结局
- 1.Changes in perceived stress scale score.(2.Changes in antioxidant enzyme glutathione (GSH) levels.)