Clinical Evaluation Of The Effectiveness Of Homoeopathic Medicine Viburnum Opulus 30c In Improving Quality Of Life Of Unmarried Females With Primary Dysmenorrhoea Using WaLIDD Score
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Assessment of improvement in quality of life will be done by comparing WaLIDD Score before and after the treatment.
研究概览
简要总结
Dysmenorrhoea is defined as painful pelvic cramping associated with menses, which may be associated with low back and thigh pain, headache, nausea, diarrhea, and fatigue. Symptoms often start a few days before menses and last through the first few days of bleeding. Many women are affected by this condition, with estimates ranging from 16%-97%. Primary dysmenorrhoea, not explained by an alternative diagnosis, is thought to be secondary to elevated prostaglandin levels that cause uterine hyper contractility and subsequent ischemia. Associated symptoms, including pain and nausea, can also be explained by high prostaglandin levels. Secondary causes of dysmenorrhoea must be ruled out, including infection, cervical stenosis, adenomyosis, fibroids, or endometriosis. The standard approach to treatment of dysmenorrhoea includes NSAIDs and hormonal contraception, both of which help to suppress prostaglandin production. Research supports the use of many self-care and complementary approaches that should also be considered.Conventional management strategies primarily include non-steroidal anti- inflammatory drugs (NSAIDs) and hormonal therapy. However, these treatments are often associated with side effects, and not all individuals experience adequate relief. This has led to increased interest in complementary and alternative therapies, including Homoeopathy, which offers a holistic and individualized approach to treatment.Viburnum opulus, also known as Cramp Bark, is a well-established homoeopathic remedy traditionally indicated for uterine cramps and spasmodic dysmenorrhoea. While there is anecdotal and materia medica-based support for its use, limited clinical evidence exists, especially in the context of standardized outcome measures.Despite the high prevalence of primary dysmenorrhoea among adolescent and young adult females, there is a limited body of clinical research supporting the use of specific Homoeopathic remedies like Viburnum opulus 30C in its management. While Viburnum opulus is historically indicated in materia medica for menstrual cramps and spasmodic dysmenorrhoea, few scientifically validated studies exist that quantify its efficacy using standardized assessment tools such as the WaLIDD score. Additionally, there is a lack of evidence-based homoeopathic protocols for primary dysmenorrhoea specifically among unmarried females in the Indian population. This demographic is often underrepresented in clinical research, despite experiencing high rates of dysmenorrhoea. Therefore, this study aims to fill the gap by applying a standardized and validated scoring tool(WaLIDD), evaluating a single, clinically-indicated homoeopathic remedy and focusing on a specific yet commonly affected demographic group.Cases will be taken from the outpatient, inpatient and peripheral centers of White Memorial Homoeo Medical College and Hospital. A minimum 30 cases are selected based on participant screening questionnaire.Cases will be taken in detail and recorded in case record formulated as per WMHMC & hospital. Clinical examination and investigation done if necessary. Homoeopathic medicine Viburnum opulus 30c will be administered. Patients are advised to take four pills (size 40 globules) medicated with Viburnum opulus 30C, three times daily before food, starting from the onset of symptoms until the menstrual flow ceases. Repetition in subsequent cycles: If improvement is observed, the medicine should be taken only during the menstrual phase, and discontinued once symptoms no longer appear during menstruation.Analysis will be done comparing the value of WaLIDD score before and after treatment.The statistical analysis will be done using normality tests, descriptive statistics, paired t-test. After analysis data will be interpret and results will be summarized.
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 25.00 Year(s)(—)
- 性别
- Female
入选标准
- •Menstrual cycle:Regular menstrual cycle (21-35 days)and duration of flow 4-5 days.
- •Patient with WaLIDD Score above 4 Patient with consent and parent consent.
- •Patients with indicated symptoms of Viburnum Opulus.
排除标准
- •Age group below 15 and above 25 years.
- •Marital status : Married Secondary Dysmenorrhoea due to underlying medical conditions (e.g.: endometriosis, fibroids, pelvic inflammatory disease, PCOS etc) Presence of other gynaecological conditions.
- •Current use of hormonal contraceptives.
结局指标
主要结局
Assessment of improvement in quality of life will be done by comparing WaLIDD Score before and after the treatment.
时间窗: 6 m0nths
Outcome will be classified as follows:
时间窗: 6 m0nths
Mild improvement: 1-33%
时间窗: 6 m0nths
Moderate improvement: 34-66%
时间窗: 6 m0nths
Marked improvement: 67-99%
时间窗: 6 m0nths
次要结局
未报告次要终点
研究者
Dr VISMITH GLORY S V
White Memorial Homoeo Medical College and Hospital
