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临床试验/CTRI/2024/11/077150
CTRI/2024/11/077150招募中2/3 期

Effect of Individualized Homoeopathic Medicine on Pain Intensity and Quality of Life in Patients with Primary Dysmenorrhoea Using Kent’s Repertory: A Single Group Pre-Post Interventional Study

Dr Santana Maity1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2024年11月20日最近更新:

试验速览

阶段
2/3 期
状态
招募中
发起方
入组人数
42
试验地点
1
主要终点
WaLIDD score for assessing severity of pain during Primary Dysmenorrhoea

研究概览

简要总结

Dysmenorrhoea is a Greek term and literally means "painful monthly bleeding" where the words ‘dys’ meaning difficult, painful or abnormal, ‘meno’ meaning month and ‘rrhoea’ meaning flow. But a more realistic and practical definition of Dysmenorrhoea (ICD-11 code:GA34.3) includes cases of painful menstruation of sufficient magnitude so as to incapacitate day to day activities.Dysmenorrhea is considered as one of the most common gynaecological disorders among females of childbearing age. Although it is a common condition, it is usually underdiagnosed, since most females do not seek medical attention.Dysmenorrhoea is of two types: primary and secondary. Primary Dysmenorrhoea (PD) refers to presence of painful menses where there is no underlying pathology that can account for pain. On the other hand, Secondary Dysmenorrhoea (SD) is defined as menstrual pain occurring in the presence of pelvic pathology.The worldwide prevalence of Primary Dysmenorrhoea ranges from 45% to 95% females of   reproductive age and a greater prevalence (70% to 90%) was noted among young females of age less than 24 years and in India the prevalence is 70.2%.

Primary dysmenorrhoea usually appears 6-12 months after menarche because it occurs only during ovulatory cycles and begins to decline beyond 30 years of age with peak prevalence between 18-24 years of age.The clinical manifestations of Primary Dysmenorrhoea have tremendous negative effect on quality of life among young females. A study in India shows approximately 50% of dysmenorrheic girls remained absent from school or colleges.

The goal of the treatment of Primary Dysmenorrhoea is to provide adequate relief from menstrual pain and improvement in quality of life of young females.

Despite of relief from pain by the standard pharmacological treatment by Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) and Oral contraceptive Pills (OCPs), patients suffering from Primary Dysmenorrhoea still report perplexing residual symptoms like indigestion, headaches, drowsiness, irregular bleeding drastically affecting their Quality of life (QoL). Several studies reported these symptoms as the adverse effects of NSAID and OCP  if used for a long period of time.

Therefore, many women often opt for homoeopathic treatment to cope with the condition and chiefly avoid conventional treatment for side effects. Homoeopathy is a holistic system of medicine and acts generously on psychosomatic spheres for the case of Primary Dysmenorrhoea. There are very few studies conducted in India as well as worldwide, to determine effectiveness of homoeopathic medicines in the treatment of Primary Dysmenorrhea and related quality of life, which had shown both positive and negative results.

In dearth of evidence, the rationale of this study is aimed to evaluate the effect of individualized homoeopathic medicines on pain intensity and quality of life of patients suffering from Primary Dysmenorrhoea using Kent’s repertory which is being used for its ample content of general rubrics along with medicines, easy accessibility and extensive use throughout the world.

Research Question: Is individualized homoeopathic medicine effective on reducing pain intensity and improving quality of life in patients suffering from Primary Dysmenorrhoea?

Hypothesis:

Null Hypothesis(H0): There is no significant role of individualized homoeopathic medicine in the reduction of pain intensity and improvement of quality of life in the patients of Primary Dysmenorrhoe

Alternative Hypothesis (HA**):** Individualized homoeopathic medicines have a significant role in reduction of pain intensity and improvement of quality of life in the patients of Primary Dysmenorrhoea

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
12.00 Year(s) 至 30.00 Year(s)(—)
性别
Female

入选标准

  • Female aged between 12 to 30 years presenting with typical history of Primary Dysmenorrhoea Female patients who are suffering from atleast 6 months with spasmodic pain of sufficient magnitude during menses lasting not more than 72 hours, without any diagnosed ovarian or uterine pathology.
  • Patients willing to give written consent/assent to participate in the study.

排除标准

  • Diagnosed or suspected cases of secondary dysmenorrhea due to any abnormal pelvic pathology in Ultrasonography of lower abdomen.
  • Patients having unevaluated gynaecological abnormalities; e.g. unexplained vaginal bleeding, cervical dysplasia, pelvic inflammatory diseases within one month.
  • Patients using oral contraceptive pills, hormone replacement therapy or corticosteroids or having a history of their use in previous 3 months Diagnosed cases of uncontrolled systemic diseases, unstable psychiatric illness or other life-threatening illnesses or any vital organ failure.
  • Undergoing any homoeopathic treatment for a chronic condition(s) within last 1 month.
  • Substance abuse and/or dependence.

结局指标

主要结局

WaLIDD score for assessing severity of pain during Primary Dysmenorrhoea

时间窗: Each patient will get follow-up for at least 3 months at the interval of 1 month

次要结局

  • EQ-5D-5L questionnaire for assessing the impact on quality of life(Each patient will get follow-up for at least 3 months at the interval of 1 month)

研究者

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

Dr Santana Maity

Mahesh Bhattacharyya Homoeopathic Medical College and Hospital

研究点 (1)

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