Effectiveness of Non-hormonal Treatment on Moderate to Severe Premenstrual Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Depressed mood
研究概览
简要总结
A double-blind, randomised, placebo-controlled, parallel trial was conducted involving 100 females aged 18-40, all of whom presented with premenstrual syndrome at the Department of Gynecology and Obstetrics, Avicenna Medical College Hospital, Lahore, Pakistan. Participants were randomly assigned to two groups of equal size: One group received vitamin D supplementation at a dose of 50,000 IU every two weeks along with a daily intake of 1,000 mg of calcium, whereas the comparison group was administered a placebo under the same conditions for 12 weeks. All the participants were examined on premenstrual syndrome with the Premenstrual Symptoms Screening Tool-Adolescent (PSST-A) questionnaire
详细描述
A double-blind, randomised, placebo-controlled, parallel trial was conducted involving 100 females aged 18-40, all of whom presented with premenstrual syndrome at the Department of Gynecology and Obstetrics, Avicenna Medical College Hospital, Lahore, Pakistan. Participants were randomly assigned to two groups of equal size: One group received vitamin D supplementation at a dose of 50,000 IU every two weeks along with a daily intake of 1,000 mg of calcium, whereas the comparison group was administered a placebo under the same conditions for 12 weeks. All the participants were examined on premenstrual syndrome with the Premenstrual Symptoms Screening Tool-Adolescent (PSST-A) questionnaire
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Participants aged 18-40 years with moderate to severe PMS
排除标准
- •Individuals exhibiting symptoms of malnutrition or requiring calcium+vitamin D supplementation.
- •Individuals with systemic diseases such as sepsis, hemodynamic instability, or acute meningitis; diarrhoea.
- •Individuals with known intolerance or sensitivity to calcium vitamin D or calcium vitamin D containing compounds.
- •smokers, Individuals with exposure to stressful situations or a history of mental illness.
研究组 & 干预措施
Participants taking calcium and Vitamin D
In this group participants received vitamin D supplementation at a dose of 50,000 IU every two weeks along with a daily intake of 1,000 mg of calcium for 12 weeks. Participants symptoms were assessed at baseline, one month, three months, and six months following the commencement of the study.
干预措施: vitamin D (cholecalciferol) supplementation (Dietary Supplement)
Participants taking placebo
In this group participants received placebo for 12 weeks. Participants symptoms were assessed at baseline, one month, three months, and six months following the commencement of the study.
干预措施: Placebo (Other)
结局指标
主要结局
Depressed mood
时间窗: 6 Months
Outcome was assessed by using Premenstrual Symptoms Screening Tool-Adolescent (PSST-A) questionnaire in both groups and analyzed.
次要结局
- Decreased interest in work activities(6 Months)
- Difficulty in concentration(6 Months)
研究者
Haleema Sadia
Dr Haleema Sadia
Avicenna Medical College Lahore