A Prospective Single arm study to evaluate the effectiveness of Folliculinum 30C in reducing premenstrual syndrome symptoms using PMMS in women aged 15 to 35
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 75
- 试验地点
- 1
研究概览
简要总结
Premenstrual syndrome is a common condition affecting women of reproductive age and is characterised by recurring physical emotional and behavioural symptoms during the luteal phase which interfere with daily functioning Conventional treatment options often produce adverse effects or offer limited relief creating a need for safer holistic approaches Folliculinum a homoeopathic sarcode prepared from potentised oestrogen is believed to help restore hormonal balance and improve emotional and physical well being in women experiencing PMS symptoms This study proposes a prospective randomized controlled trial to evaluate the effectiveness of Folliculinum 30C in reducing PMS symptoms in women aged fifteen to thirty five A total of seventy five participants fulfilling ACOG criteria will be selected from OPD IPD and peripheral centres of JIMS Homoeopathic Medical College and Hospital Participants will be randomly allocated into two groups the trial group receiving Folliculinum 30C and the control group receiving placebo with counselling Symptom changes will be assessed using the Premenstrual Syndrome Scale at baseline two months and four months Ethical clearance has been obtained and strict inclusion exclusion criteria will be followed Data will be analysed using non parametric statistical methods The study aims to generate evidence supporting the clinical usefulness of Folliculinum 30C as a safe and effective mode of treatment in premenstrual syndrome
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 15.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- Female
入选标准
- •Participants clinically diagnosed as per ACOG criteria premenstrual symptoms not linked to any organic lesions typically occur during the luteal phase of ovulatory cycles and resolve afterward must be severe enough to impact daily life or require medical attention, they may be classified as Premenstrual Dysphoric Disorder PMDD between the age group 15 to 35 years having Regular Menses for past 6 months presenting with a Pelvic USG scan finding of within normal pelvic pathology for female reproductive organs.
排除标准
- •Participants presenting with organic pelvic lesions or irregular menstrual cycles as well as those with psychiatric comorbidities such as depression or anxiety requiring pharmacological treatment were excluded from the study Individuals currently undergoing hormonal therapy were also not considered eligible Additionally participants with thyroid disorders or other systemic conditions including fibroids PCOD or cysts in the uterus or ovaries—were excluded Those already receiving complementary and alternative medicine (CAM) therapies were also not included in the study sample.
研究者
Dr Pindi Sowmya
JIMS Homoeopathic Medical College and Hospital