跳至主要内容
临床试验/CTRI/2025/07/090698
CTRI/2025/07/090698尚未招募不适用

Efficacy of individualised homoeopathic medicines in the treatment of premenstrual syndrome assessed by premenstrual syndrome scale (PMSS) -a quasi-experimental time series design.

Dr Silaiezhil M1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2025年7月21日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
55
试验地点
1
主要终点
Change in PMSS (Premenstrual Syndrome Scale) total score from baseline (Month 3) to end of treatment (Month 6).

研究概览

简要总结

This quasi-experimental time-series study evaluates the efficacy of individualized homeopathic medicines in treating Premenstrual Syndrome (PMS) among 55 women aged 18-40, diagnosed using ACOG criteria. The study employs a two-phase design: a 3-month placebo phase with monthly Premenstrual Syndrome Scale (PMSS) assessments followed by a 3-month active treatment phase with individualized homeopathic remedies. The primary outcome measures the change in total PMSS scores from baseline to treatment completion, assessing overall symptom severity reduction. The study focuses on core PMS symptoms across physiological, psychological, and behavioral domains while excluding participants on hormonal or psychiatric medications. This design provides longitudinal data on homeopathic treatment effects while maintaining clinical practicality in a real-world setting.

研究设计

研究类型
Interventional
分配方式
Na
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 40.00 Year(s)(—)
性别
Female

入选标准

  • Diagnosed subjects of Premenstrual Syndrome (PMS) as per American College of Obstetrician and gynecology practice bulletin 2001 criteria.
  • Subjects who are voluntarily willing to participate and sign the written informed consent.

排除标准

  • Subjects who are on contraceptive pills or any other medications for Premenstrual Syndrome (PMS) 2) Women who are already on Psychiatric medications for depression, anxiety, schizophrenia or any other psychiatric illness.
  • Subjects who are a Known case of PCOD/ Hypothyroidism.
  • Subjects having uterine /ovarian/ pelvic pathology assessed with sonography of pelvis or transvaginal scan.

结局指标

主要结局

Change in PMSS (Premenstrual Syndrome Scale) total score from baseline (Month 3) to end of treatment (Month 6).

时间窗: 3 years

次要结局

未报告次要终点

研究者

发起方
Dr Silaiezhil M
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Silaiezhil M

Government Homoeopathic Medical College & Hospital

研究点 (1)

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