Efficacy Evaluation of Unani Formulation in the Management of Baul Fil-Firash (Nocturnal Enuresis) A Randomized single blind placebo-controlled Study
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in the frequency of involuntary voiding of urine during night
研究概览
简要总结
Baul Fil-Firash (Nocturnal Enuresis) Composed of Arabic words- “Al-Baul†and “Al-Firash†Which stand for urine and bed respectively.
Nocturnal Enuresis (Baul Fil-Firash) refers to involuntary voiding in night in children aged 5 years or more without any other urinary tract symptoms. The prevalence of Nocturnal Enuresis is more than 10% among 6 years old and 5% among 10 years old & 0.5-1% among teenagers & young adults. Nocturnal Enuresis has a Negative impact on Child`s health and imposes a long-term burden on families. It causes negative psychological consequences & behavioural problems.
Although Nocturnal Enuresis has a high rate of spontaneous remission but it affects quality of life and self-confidence of children. Anti-cholinergic drugs and muscle relaxants are used in the management but relapse is noticed in majority of children after discontinuation of drugs.
Despite being a common problem, evidence of safe and effective treatment is not available. Unani physicians are treating this disease successfully from decades so clinical trials on Scientific parameters are required to evaluate efficacy of the Unani compound formulation.
Nocturnal Enuresis refers to the symptoms of intermittent incontinence during sleep at least twice a week in children older than 5 years of age for at least 3 months.
In other words, any type of wetting episodes that occur in discrete amount during sleep is called Nocturnal Enuresis.
In Unani system of Medicine Nocturnal enuresis is mentioned as Baul Fil-Firash / Baul Bistari / Khwab me Peshab Nikal Jana.
It is the condition in which there is voiding during sleep*. (Neend me Peshab khata ho jana).* It is due to altered temperament of bladder and flaccidity in muscles of urinary bladder (Masana ki Sardi aur Azla ka Isterkha) This condition is seen more among boys.
As mentioned in various Unani literature cause of Baul Fil-Firash is “Isterkha†of urinary bladder which means loosening of muscle tone of Bladder. Another cause is Ratubat which means Moistening of bladder and altered temperament of bladder which causes loosening of muscle fibre.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 6.00 Year(s) 至 14.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient who are fulfilling DSM-5 Criteria as mentioned below:
- •Involuntary or intentional, repeated voiding of urine into bed or clothes.
- •The behaviour should be clinically significant as manifested by either a frequency of twice a week for at least 3 consecutive months or the presence of clinically significant distress or impairment in social, academic (occupational), or other important areas of functioning.
- •Chronological age is at least 5-years.
- •The behaviour is not due exclusively to the direct physiological effect of a substance (e.g. a diuretic or an antipsychotic medication) or another medical condition(e.g.Diabetes, Spina bifida, a seizure disorder).
排除标准
- •Patient below 5 years
- •Patient above 14 years
- •Patient with anatomical malformation such as hypospadias
- •Mental Impairment
- •Urinary Tract Infection
- •Known case of diabetes insipidus
- •Diabetes mellitus type 1 and type 2
- •Patient guardian who fails to give consent
- •Patient who fails to follow up.
结局指标
主要结局
Change in the frequency of involuntary voiding of urine during night
时间窗: 45 days
次要结局
- Change in other symptoms like shamefulness, fear, Aggressiveness, Irritability(45 days)
研究者
Dr Saiyeda Zainab Fatima
State Unani Medical College