Efficacy of Individualized Homoeopathic medicines in treatment of Stress urinary incontinence (SUI) in women : A double blind randomized placebo controlled trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 132
- 试验地点
- 2
- 主要终点
- To evaluate the efficacy of Individualized Homoeopathic Medicines (IHMs) in reducing symptom frequency or intensity of stress UI (with or without urge) by comparing the significant statistical differences in symptoms score in “The Questionnaire for Urinary Incontinence Diagnosis (QUID)†between Homoeopathic intervention and Placebo group.
研究概览
简要总结
A Multi-centre Randomized Double Blind Placebo Controlled Clinical Trial of Individualized homoeopathy in women with Stress urinary incontinence (SUI) symptoms will be conducted at Dr Anjali Chatterji Regional Research Institute (H), Kolkata and DDPR Central Research Institute (H), Noida. The women in the age group of 25 to 70 years having Stress urinary incontinence (SUI) symptoms will be studied. The study shall have two arms viz. homoeopathic arm and placebo arm. Two series of medicines shall be used. One will comprise of Individualized Homoeopathic medicine in centesimal potencies manufactured by a licensed homoeopathic pharmaceutical company approved by the Council, the other will comprise of identical matching placebo. Standard Physiotherapy (Pelvic floor exercise & others) will be applied on both arm by Physiotherapist as per requirement. The main outcome measures (Primary) will be the assessment of SUI symptoms utilizing *‘*The Questionnaire for Urinary Incontinence Diagnosis (QUID ) score†The other outcome (secondary) Urinary incontinence-specific quality of life (QOL) will be assessed using the “Urinary Distress Inventory (UDI)†and Urinary Impact Questionnaire (UIQ) and overall health-related QOL by Short Form -36.
On conclusion of the study the data obtained shall be statistically analyzed with the help of a suitable statistical package to evaluate the effectiveness of Individualized homoeopathy in management of symptoms of SUI with improvement of Quality of life and the results shall be disseminated to the medical fraternity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 25.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- Female
入选标准
- •Age 25-70 years
- •Participants suffering from the symptoms of SUI having Stress scores ≥ 4 for SUI in QUID score.
- •Providing written informed consent to take part in the study.
排除标准
- •Pregnant and lactating mother
- •Unwilling to take part and not giving consent to join the study
- •Women with continuous urinary leakage with current UI drug therapy with neurological disorder.
- •Presence of pelvic organ prolapsed (POP), stages III or IV
- •Patient with Spinal cord injury,
- •Bladder abnormalities (interstitial cystitis or bladder pain syndrome, bladder cancer, Renal calculi or Urinary stone)
- •Detrusor under activity
- •Urogenital infections ( UTI.
- •Urinary tract infection, Bacterial cystitis, urethritis)
- •Advanced or uncontrolled Diabetes mellitus.
- •Other uncontrolled or life-threatening illness e.g. myocardial infarction, CVA (cerebro vascular accident) , Chronic Renal failure
- •Diagnosed cases of unstable mental or psychiatric illness
- •Non-ambulant patients.
- •Patients who are too sick for consultation
- •Substance abuse and or dependence
- •Self-reported immune-compromised state.
- •Undergoing homeopathic treatment for any chronic disease within two weeks.
结局指标
主要结局
To evaluate the efficacy of Individualized Homoeopathic Medicines (IHMs) in reducing symptom frequency or intensity of stress UI (with or without urge) by comparing the significant statistical differences in symptoms score in “The Questionnaire for Urinary Incontinence Diagnosis (QUID)†between Homoeopathic intervention and Placebo group.
时间窗: at base line and at every months of follow up for 6 months of treatment.
次要结局
- 2. To evaluate the effectiveness of IHMs on increasing symptom bother & greater impact on daily activities from UI symptoms by comparing the significant statistical changes in symptom scores in Incontinence Impact Questionnaire – Urinary Distress Inventory (UDI) & Urinary incontinence-specific quality of life (QOL) respectively.(3. To evaluate the quality of life (QoL) (physical, social, occupational & psychological) of patients suffering from SUI by comparing the significant statistical changes using Short Form 36 scores between HI & Placebo groups.)
研究者
Dr Suraia Parveen
Dr Anjali Chatterji Regional Research Institute For Homoeopathy, Kolkata.