Assessment of Likelihood Ratio for Four Characteristic Carcinosin Symptoms in Insomnia Cases
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- To assess the prevalence of selected symptoms of carcinosin in population that suffering from insomnia and improved by carcinosin ,assessment done through ISI [insomnia severity index].
研究概览
简要总结
The patient’s information shall be recorded in a standardized case-taking proforma used in NIH, Kolkata (Appendix). Following preliminary screening for insomnia and detailed screening using the specified inclusion and exclusion criteria of the screening proforma (Appendix), eligible patients will be included in the study, followed by recording of baseline scoring data. All eligible patients presenting with insomnia will be prospectively evaluated for the presence of the four characteristic symptoms of Carcinosin, as identified from the Homoeopathic Materia Medica and verified by repertorisation (Appendix). The presence or absence of these characteristic symptoms in each case will be documented systematically. If the patient’s symptom totality shows similarity with Carcinosin and the characteristic symptoms are present, Carcinosin will be prescribed as the indicated remedy. If sufficient similarity is not found, other homoeopathic medicines will be prescribed according to individual indications. The final selection of the medicine will be based on detailed case taking in adherence with standard homoeopathic guidelines - including analysis and evaluation of symptoms, miasmatic diagnosis, framing of symptom totality, and final conclusion with reference to Homoeopathic Materia Medica (Appendix). Individualized dose and potency will be selected based on the susceptibility of the patient. Subsequent prescriptions will be generated in accordance with Kent’s observations on the second prescription and other relevant homoeopathic principles, and will be recorded in follow-up sheets (Appendix). The scoring data will be re-evaluated after 6 months of treatment. Based on the presence or absence of the four characteristic symptoms and the corresponding treatment outcomes, a 2×2 contingency table will be constructed to calculate the Likelihood Ratio (LR) for each characteristic symptom of Carcinosin in insomnia cases, thereby determining its prognostic value in remedy selection.
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
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Participant suffering from insomnia verified by DSM5 criteria Severity Clinical Insomnia Severity Index (ISI) score more than or equal to 14 (moderate to severe insomnia) participants aged 18 to 60 years, all sexes.
- •Subjects of all socioeconomic status, all religions Ability to understand either Bengali, Hindi, and or English participants giving written consent to participate in this study Subjects who agree to undergo laboratory investigation whenever required.
排除标准
- •Participants with unstable psychiatric disorder like severe intellectual disability or autism with severe behavioral disturbances, substance-induced severe psychiatric disorders.
- •Pregnant women and lactating women.
- •Immune compromised state like HIV AIDS (low CD4 count), Cancer (hematologic or solid tumors) on active treatment, Chronic kidney failure (end-stage renal disease) Concurrent medications: Use of hypnotics, sedatives, or stimulants that may interfere with sleep assessment.
- •Participants who has taken homoeopathic medicines for any chronic illness within 3 months.
结局指标
主要结局
To assess the prevalence of selected symptoms of carcinosin in population that suffering from insomnia and improved by carcinosin ,assessment done through ISI [insomnia severity index].
时间窗: At baseline 3 months and 6 months
次要结局
- To evaluate the effectiveness of homoeopathic medicines in insomnia(To evaluate the effectiveness of carcinosin or other indicative medicine on quality of life through ORIDL [Outcome Related to Impact on Daily Living].)
研究者
Dr VARSHA KUMARI
National Institute of Homoeopathy