Efficacy of individualized homoeopathic medicines in the treatment of urinary incontinence in geriatric people: A double-blind, randomized, placebo-controlled trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI-SF)
研究概览
简要总结
Urinary incontinence (UI), defined as the involuntary loss of urine, is a significant health concern in the geriatric population. It not only impairs physical well- being but also leads to emotional distress, social withdrawal, and reduced quality of life. According to the statistical data from the National Association for Incontinence 200 million people were affected with urinary incontinence Worldwide . The prevalence of urinary incontinence in India ranges from 11.6 to 25.5% in rural tribal region Current treatment approaches include pelvic floor exercises, bladder training, anticholinergic medications, and surgical interventions. However, many elderly patients either cannot tolerate these treatments or experience limited benefit due to adverse drug reactions such as xerostomia, constipation, and mental confusion or the treatment might result in worsening of underlying comorbidities. Despite strong indications of individualized homoeopathic medicine in treatment of geriatric urinary incontinence in different homoeopathic literatures, the translations of those to the language of EBM is deficient. To fill up this gap this trial is undertaken. That is why the current work is aimed the effects of IHMs in centesimal scale through a double- blind, randomized (2:1), placebo-controlled, trial design ICIQ-UI-SF questionnaire for evaluation in UI in geriatric people after six months of intervention. Group differences will be detected using appropriate statistical tests. The results will be published in scientific journals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 60.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients suffering from urinary incontinence.
- •ICD-11 code MF50.2 Urinary incontinence.
- •Leakage of urine with or without control.
- •2.Age 60 – 75 years.
- •3.Participants of either sex or transgender.
- •4.Literate patients ability to read English, Hindi and or Bengali.
- •Illiterate patient will be interviewed by the investigators maintaining adequate privacy to fill up the scales questionnaires.
排除标准
- •1.Not willing to provide with written informed consent of voluntary participation. 2.Patients having neurological conditions, such as known multiple sclerosis, clinically significant peripheral neuropathy or spinal cord injury. 3.Patient who has been dealing with urinary symptoms with several modern medication in the past one month or any plan to have surgical treatment during the study. 4.Participants will be excluded if they had uterine prolapsed grade 3 or 4, vesicovaginal fistula; and any severe cardio-vascular diseases, uncontrolled diabetics. 5.Patient will be excluded if they had urinary tract infections, in urine microscopy.
- •the presence above of 10 leukocytes per mm3 of uncentrifuged urine or 10 leukocytes per hpf of the centrifuged sample, in a clinically suspected UTI. Patients with haematuria recurrent and persistent, proteinuria. 6.Patients with BHP who require intervention beyond conservative management.e.g., surgical or invasive procedures. Patient with serum prostate specific antigen, PSA more than 10 nmol per ml. 7.Vulnerable population – unconscious, too sick for consultation or ambulatory, differently abled, terminally ill patients, mentally incompetent people etc. 8.Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled or life-threatening illness affecting quality of life or any organ failure. 9.Self-reported immune-compromised state, and already undergoing homoeopathic treatment for chronic disease within last 4 weeks. 10.Patient under tobacco chewing and or smoking, alcoholism and or any other forms of substance abuse and or dependence.
结局指标
主要结局
International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI-SF)
时间窗: Baseline, and every month , upto 6 months
次要结局
- Quality of Life Assessment Questionnaire Concerning Urinary Incontinence (Contilife)(Baseline, and every month, up to 6 months)
研究者
Jagadish Ghosh
D N De Homoeopathic Medical College & Hospital