Effectiveness of Individualized Homoeopathic Medicine in The Management of Premenstrual Syndrome in Women of Reproductive Age Group A Prospective, Single arm, Open Label Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Premenstrual Symptoms Screening Tool
研究概览
简要总结
This study aims to evaluate the effectiveness of individualized homoeopathic treatment in women of reproductive age suffering from Premenstrual Syndrome (PMS). PMS, a common psycho-neuro-endocrine disorder, significantly impairs quality of life yet remains underdiagnosed in India due to social stigma and lack of awareness. The study is designed as a prospective, single-arm, open-label clinical trial conducted at Nehru Homoeopathic Medical College, New Delhi, with a sample size of 40 participants meeting defined inclusion and exclusion criteria. Diagnosis and assessment will be done using validated tools – the Premenstrual Symptoms Screening Tool (PSST) and the Premenstrual Tension Syndrome Observer Rating Scale (PMTS-OR). Participants will receive individualized homoeopathic medicines, selected through detailed case-taking, repertorization, and Materia Medica confirmation. Potency and repetition will be tailored to susceptibility and clinical response, with monthly follow-ups over three cycles. The primary outcome is the reduction in PMS severity scores, while secondary outcomes include functional improvement and identification of commonly indicated remedies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 15.00 Year(s) 至 49.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Women of Reproductive age Group 15 years to 49 years 2.Regular menstrual cycle for 21 to 35 days for at least 3 consecutive months 3.Confirmed Diagnosis of PMS Diagnosis confirmed using at least one of the following Premenstrual Symptoms Screening Tool with moderate to severe symptoms Or ACOG criteria 1 or more than 1 affective and 1 or more than 1 somatic symptom in the 5 days before menses, resolving within 4 days of onset, in at least 2 consecutive cycles 4.History of Premenstrual symptoms for at least 3 months
- •Willing and able to provide informed consent
- •Able to read and understand the language of the symptom scales used 7.No Current Hormonal Therapy.
排除标准
- •1.Current Use of Hormonal or Psychotropic Medications 2.History of Clinical Depression, generalized anxiety, bipolar disorder, or other psychiatric illness.
- •3.Diagnosis of Premenstrual Dysphoric Disorder 4.Other known diagnosed Gynecological Disorders Presence of conditions like PCOS, endometriosis, uterine fibroids, or PID that may affect or mimic PMS symptoms.
- •5.Known or previously diagnosed cases of chronic systemic illnesses (such as thyroid disorders, diabetes mellitus, renal, cardiac, or hepatic diseases) based on medical history or current medication records will be excluded.
- •6.Currently pregnant, planning to conceive, or breastfeeding during the study period.
- •7.History of alcohol dependence, tobacco use, or drug abuse.
- •8.Participation in Other Clinical Trials.
- •9.Individuals with a self-reported immunocompromised state e.g., HIV, ongoing immunosuppressive therapy.
结局指标
主要结局
Premenstrual Symptoms Screening Tool
时间窗: PSST will be evaluated at baseline and at 6 months
次要结局
- Premenstrual Tension Syndrome Observer Rating Scale(At baseline and at 6 months)
研究者
Dr Alka Meena
Nehru Homoeopathic Medical College and Hospital