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CTRI Number  CTRI/2025/07/091436 [Registered on: 22/07/2025] Trial Registered Prospectively
Last Modified On: 22/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Understanding Mind Of Children Suffering From Nocturnal Enuresis Of 5-18 Years, Helping in providing more effective Homoeopathic Management 
Scientific Title of Study   Exploring The Mental States In Children Suffering From Nocturnal Enuresis in Age Group 5-18 Years: An Observational Prospective Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  TANZIM PAKEEZ SHAIKH 
Designation  M.D. Scholar part 2 
Affiliation  C D Pachchigar College Of Homoeopathic Medicine And Hospital 
Address  Deaprtment of Paediatrics Division of MD 2nd floor CD Pachchigar College of Homoeopathic Medicine and Hospital Surat Gujarat

Surat
GUJARAT
395001
India 
Phone  9586762088  
Fax    
Email  tanzim7379@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Aditya Garg 
Designation  Associate Professor Department of Paediatrics 
Affiliation  C D Pachchigar College Of Homoeopathic Medicine And Hospital 
Address  Deaprtment of Paediatrics Division of MD 2nd floor CD Pachchigar College of Homoeopathic Medicine and Hospital Surat Gujarat

Surat
GUJARAT
395001
India 
Phone  724927543  
Fax    
Email  adityagarg7978@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Aditya Garg 
Designation  Associate Professor Department of Paediatrics 
Affiliation  C D Pachchigar College Of Homoeopathic Medicine And Hospital 
Address  Deaprtment of Paediatrics Division of MD 2nd floor CD Pachchigar College of Homoeopathic Medicine and Hospital Surat Gujarat

Surat
GUJARAT
395001
India 
Phone  724927543  
Fax    
Email  adityagarg7978@gmail.com  
 
Source of Monetary or Material Support  
Department of Paediatrics Division Of MD 2nd floor CD Pachchigar College of Homoeopathic Medicine and Hospital Surat 395001 Gujarat 
 
Primary Sponsor  
Name  C D Pachchigar College Of Homoeopathic Medicine And Hospital 
Address  Department of Paediatrics Division Of MD 2nd floor C D Pachchigar College of Homoeopathic Medicine and Hospital Surat Gujarat 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
TANZIM PAKEEZ SHAIKH  C D Pachchigar College of Homoeopathic Medicine and Hospital  Deaprtment of Paediatrics Division of MD 2nd floor CD Pachchigar College of Homoeopathic Medicine and Hospital Surat Gujarat
Surat
GUJARAT 
09586762088

tanzim7379@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee of C.D. Pachchigar College of Homoeopathic Medicine And Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N00-N99||Diseases of the genitourinary system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  Children between age group 5 to 18 years and both the sexes male and female. Children suffering from nocturnal enuresis 
 
ExclusionCriteria 
Details  Children below 5 years and above 18 years of age. Children suffering from any structural urological pathology. Children on any diuretic drugs. Children suffering from coexisting behavioral disorders. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The aim of the research is to explore individualized mental states in children aged 5 to 18 years suffering from nocturnal enuresis, to enhance the precision of homoeopathic remedy selection  9 Months 
 
Secondary Outcome  
Outcome  TimePoints 
Includes evaluating changes in quality of life parameters, identifying psychosocial factors associated with nocturnal enuresis & assessing response to individualized remedy selection  9 Months 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   07/08/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="9"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

1

NAME OF THE CANDIDATE AND ADDRESS:

TANZIM PAKEEZ SHAIKH

F402 ULTIMATE RESIDENCY, BESIDE ZAINAB HOSPITAL, ADAJAN PATIYA, SURAT-395009

2

NAME OF THE

INSTITUTION:

C. D. PACHCHIGAR COLLEGE OF HOMOEOPATHIC  MEDICINE  &   HOSPITAL; NEAR  NAVJIVAN CIRCLE, UDHANA MAGDALLA ROAD, SURAT- 395001

3

COURSE OF THE STUDY AND SUBJECT:

M.D. (HOMOEOPATHY) PAEDIATRICS

4

DATE OF

ADMISSION TO COURSE:

4th December 2023

5

TITLE OF THE TOPIC:

EXPLORING  THE  MENTAL  STATES  IN  CHILDREN  SUFFERING  FROM  NOCTURNAL  ENURESIS  IN AGE  GROUP  5-18  YEARS :  AN OBSERVATIIONAL PROSPECTIVE  STUDY


 

 

 

6

BRIEF RESUME OF INTENDED WORK:

6.1

NEED FOR STUDY:

 

Childhood is the state when the human being is growing and developing. It is the age to acquire good habits, values and lifestyles that would make children fit, responsible and productive adults and citizens. (1)

 

Children under 15 years of age comprise about 25 percentage of India’s population. (2)

 

Nocturnal enuresis, commonly known as bedwetting, is a prevalent pediatric condition affecting children worldwide. Its prevalence rates vary from 3.5 percentage to 56.4 percentage in different geographical regions and countries. (3)

 

Nocturnal enuresis without overt daytime voiding symptoms affects up to 20 percentage of children at the age of 5 yr; it ceases spontaneously in approximately 15 percentage of involved children every year thereafter. Its frequency among adults is less than 1 percentage. (1)

 

Unlike just addressing the disease, homoeopathy focuses on treating the entire child, considering both physical symptoms and mental well-being. Homoeopathic practitioners analyze a child’s inner disturbances by observing their emotions, intelligence, and behavior. This detailed mental state assessment helps understand the child’s current condition, development, and how they relate to their suffering. (4)

 

Homeopathy views health as a state of balance between the mind, body, and spirit. (5) Thus, when addressing a condition like nocturnal enuresis, it’s crucial to consider not just the physical symptoms but also the emotional and psychological aspects that may be contributing to the imbalance. Factors such as familial dynamics, stressors in the home environment, social interactions, and the child’s emotional response to bedwetting episodes can all play a significant role in understanding the root cause of the condition.

 


 

 

 

Disturbances in a person’s vital energy can cause problems. These disturbances might happen before birth , if the mother experiences any emotional disturbance like sudden fright or continuous stress during gestation. Even after birth when the mother is nursing the child things like a mother’s worries or sudden fright can affect her and her child’s well-being. These disturbances are serious and can have lasting effects. (6)

 

Dr. J T Kent stated that “Dr. Hahnemann made use of the information thus obtained when he stated that the mind is the key to the man. The symptoms of mind have been by all his followers to be the most important symptoms in remedy and in sickness” (7), therefore recognizing mental state in a child suffering from nocturnal enuresis will be very effectively helpful in choosing the remedy and curing the disease.

 

 

Understanding the mental states of children suffering from nocturnal enuresis can be invaluable in guiding effective intervention with help of homoeopathic treatment to the physician and the patient as well.


 

 

 

6.2

REVIEW OF LITERATURE:

INTRODUCTION:

 

Ø Nocturnal enuresis refers to the occurrence of involuntary voiding at night after 5 year, the age when volitional control of micturition is expected. By 5 years of age, 90–95 percentage of children are nearly completely continent during the day, and 80–85 percentage are continent at night. (1)

 

Nocturnal enuresis also known as bedwetting is a common health problem in children of age group 5-15 years. It is involuntary voiding of urine during sleep with a frequency of at least twice a week in children aged more than 5 years in the absence of any congenital or acquired defects of the central nervous system (3). It could be primary (estimated 75-90 percentage of children with enuresis; nocturnal urinary control never achieved) or secondary (10-25 percentage; the child was dry at night for at least a few months and then enuresis developed) in manifestation. Overall, 75 percentage of children with enuresis are wet only at night, while 25 percentage are incontinent both day and night. This distinction is important because children with both forms are more likely to have an abnormality of the urinary tract. (1)

 

In homoeopathy identifying mental states is crucial for determining the appropriate similimum. In children’s emotional traits, such as anxiety, fear, irritability or sadness often serve as key indicators in the process.

Mental state is a combination of different categories of mental symptoms which are Intellect, Emotions and Behavior, it also depends on the particular expression on the environmental circumstances. (4)

 

 

 

PREVALENCE :

In India the available data shows that the prevalence of nocturnal enuresis ranges from approximately 7 percentage to 12.6 percentage. The prevalence from other regions of the world ranges from 6 percentage  to 42 percentage. (3)

 

A study on prevalence of Nocturnal Enuresis shows that, overall prevalence of nocturnal enuresis was 11.4 percentage. The maximum prevalence was found in the age group of 8 -9 years (22.96 percentage). The

prevalence of nocturnal enuresis in boys (14.34 percentage) was significantly more than the prevalence in girls (8.31 percentage). The study showed that nocturnal enuresis was significantly associated with stress, poor school performance, sleep pattern (hard to awaken), family history, burning micturition etc. (3)

 

Approximately 60 percentage of children with nocturnal enuresis are males. The family history is positive in 50 percentage of cases.  (1)

 

Nocturnal enuresis without overt daytime voiding symptoms affects up to

20 percentage of children at the age of 5 year; it ceases spontaneously in approximately 15 percentage of involved children every year thereafter. Its frequency among adults is less than 1 percentage. (1)

 

A study shows the prevalence of enuresis as 12 percentage–25 percentage in 4-year-old, 8 percentage– 10 percentage in an 8-year-old and 2 percentage–3 pecentage in 12 years old. (8)

 

 

    AETIOLOGY

 

    Nocturnal Enuresis can be caused due to a number of causes which includes

Delayed maturation of the cortical mechanisms that allow voluntary control of the micturition reflex

Defective sleep arousal

Reduced antidiuretic hormone production at night, resulting in an increased urine output during night time

polyuria

Genetic factors, with chromosomes 12 and 13q the likely sites of the gene for enuresis

Bladder factors (lack of inhibition, reduced capacity, overactive)

Constipation

Organic factors, such as urinary tract infection, obstructive uropathy, or sickle cell anemia nephropathy

Sleep disorders

Sleep-disordered breathing secondary to enlarged adenoids

Psychological factors more often implicated in secondary enuresis. (1)

 

 

  A number of predisposing factors for bladder dysfunction have been suggested, including developmental delays and neuropsychiatric problems. Factors recognized to be associated with bladder dysfunction include delayed toileting and psychosocial stress (9). Also excessive nocturnal urine production in some children can be based on abnormal nocturnal plasma vasopressin releases. (10)

 

 

 

Nocturnal enuresis has been associated with a mismatch between nocturnal urine production, nocturnal bladder storage capacity, and the ability to arouse from sleep. Underlying these mechanisms are possibly disorders of central nervous system signal processing and the default mode network. (9)

 


 

 

Nocturnal enuresis is more common in males than in females (almost 2:1). This male preponderance is particularly true in younger age groups, cases with milder severity, and cases involving enuresis occurring only at night. (9)

 

Life stressors have, in some studies, been linked to bedwetting; however,

for most children with bedwetting, there have not been any major life events. It is reasonable to ask about any stressors (e.g., new baby in the home, recent move, loss of a loved one), particularly in children with secondary enuresis (i.e., who were previously continent at night). More importantly, physicians should ask about the impact of bedwetting on the child’s quality of life. (10)

 

      SYMPTOMS OF NOCTURNAL ENURESIS:

 

The main symptoms of enuresis include repeated bed-wetting, Wetting in the clothes, Wetting at least twice a week for approximately three months.

 

Many children with enuresis sleepwalk or talk in their sleep. A complete physical examination should include palpation of the abdomen and possibly a rectal examination after voiding to assess the possibility of a chronically distended bladder and constipation. (1)

 

The child with nocturnal enuresis should be examined carefully for neurologic and spinal abnormalities. There is an increased incidence of bacteriuria in enuretic females, and, if found, it should be investigated and treated , although this does not always lead to resolution of bedwetting. (1)

 

Other features of Nocturnal Enuresis can also be : Enuresis can occur during any stage of sleep, although it most commonly happens during non-rapid eye movement (NREM) sleep. Children, in general, are most difficult to arouse in the first third of the night and easiest to wake in the last third. However, enuretic children are typically more difficult to awaken than those with normal bladder control. These children are often described as "soaking the bed." A family history of enuresis is frequently found in enuretic children, suggesting a genetic predisposition. Additionally, the risk of enuresis is higher in children with developmental delays, attention-deficit/hyperactivity disorder (ADHD), or autism spectrum disorders. (1)

 

 

Major two types:

 

Primary Nocturnal Enuresis : Enuresis may be primary (estimated 75–90 percentage of children with enuresis; nocturnal urinary control never achieved).

Secondary Nocturnal Enuresis : Enuresis in which 10–25 percentage; the child was dry at night for at least a few months and then enuresis developed. (1)

 

 

          Diagnostic Criteria’s

 

The essential feature of enuresis is repeated voiding of urine during the day or at night into bed or clothes (Criterion A). Most often the voiding is involuntary, but occasionally it may be intentional.

 

To qualify for a diagnosis of enuresis, the voiding of urine must occur at least twice a week for at least 3 consecutive months or must cause clinically significant distress or impairment in social, academic (occupational), or other important areas of functioning (Criterion B).

 

The individual must have reached an age at which continence is

expected (i.e., a chronological age of at least 5 years or, for children

with developmental delays, a mental age of at least 5 years).

 

The urinary incontinence is not attributable to the physiological effects of

          a substance (e.g., a diuretic, an antipsychotic medication) or another

          medical condition (e.g., diabetes, spina bifida, ectopic ureter in a female,

          posterior urethral valves in a male, tethered cord, a seizure disorder). (9)

 

 

 

HOMOEOPATHY & MENTAL STATES: ADRESSING NOCTURNAL ENURESIS:

A person’s evolution reveals many distinct and vital aspects about him. Children are impacted by both ‘nature’ that is inherited biological features and ‘nurture’ that is environmental factors. (11)

 

Developmental psychology studies the physical, behavioral, cognitive, and personality changes that occur from conception to childhood and beyond. A child’s initial emotional expressions are typically related to physical or biological demands, such as protection or survival. As children get older, they may display more complex emotions such as grief, rage, and fear. (11)

 

 

These feelings are frequently fleeting, but if they intensify or endure long enough, they have the potential to develop into emotional "states" and "moods." At that point, these "states" may begin to affect how kids view and engage with the outside world. When these feelings start to dominate the child’s personality, they serve to be one of the indications for homoeopathic similimum. (11)

 


 

 

         

 

 

The Mental State is a combination of different categories of mental symptoms which is symptoms of the intellect, emotions and behavior, it also depends on the particular expression on the environmental circumstances. (4)

 

As given in Kents’s philosophy, Dr. Hahnemann and his followers believe that a person’s mental symptoms are key in homeopathy. They think that what a person thinks and feels is really important in understanding their condition. They say that our thoughts and emotions define who we are. (7)

 

Understanding aphorism 210 explaining that in so called physical diseases the emotional and mental states is always affected, these altered state is important for the selection of remedy if accurately observed by physician. (5)

 

 


 

 

 

 

 

 

  6.3

 

OBJECTIVE OF THE STUDY:

 

To explore mental states of children  suffering from Nocturnal Enuresis.

 

 

 

 

 

 

 
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