Irritable Bowel Syndrome is a common functional gastrointestinal disorder characterized by abdominal pain, bloating, altered bowel habits. It is frequently associated with psychological comorbidities such as anxiety, depression. While conventional medical management often focuses on symptom control, it may not address the underlying causes or individual variations in presentation. Homoeopathy considers the totality of symptoms, the mental and emotional aspects in its approach to treatment. Hence this study is undertaken to understand the effectiveness of Mental Symptoms in managing the cases of Irritable Bowel Syndrome.

Epidemiology: Throughout the world about 10-20% of adults and adolescents have symptoms consistent with IBS and most studies show female predominance. IBS is a disorder that affects all ages, although most patients first symptoms before age of 45 years. Women are diagnosed with IBS two to three times as compared to men. Early institution-based studies from India showed that IBS was 2-4 times more common among male adults compared to female adults but subsequent population-based studies revealed mixed findings. In conclusion, the prevalence of IBS in a Northern Indian community is 4%. The predominant subtype of IBS in this community is IBS M. 

Severity of symptoms varies and can significantly impair quality of life, resulting in high healthcare costs. Altered gastrointestinal (GI) motility, visceral hyperplasia disturbance of brain gut interaction, abnormal central processing autonomic and hormonal events, genetic and environmental. factors and psychosocial disturbances are variably involved depending on the individual. No clear diagnostic markers exist for IBS; thus, the diagnosis of the disorder is based on clinical presentation. In 2016 the Rome III criteria for the diagnosis of IBS were updated to Rome IV. Homoeopathic science emphasizes on the psychosomatic aspects along with physical particulars. The study comprises of, management with the help of individualised homoeopathic remedy, when we study an Individual, we not only study the bodily configuration but also the intellectual and emotional as revealed to us though his reaction to the environment. Thus, the characteristics in physical and intellectual and emotional spheres, reveal the individual to us. Homoeopathic remedies can address physical symptoms as well as emotional and psychological factors, promoting overall well-being. In Homoeopathy, the mental state and mental symptoms of an individual are both considered important in the selection of the appropriate remedy. Mental state refers to the underlying emotional and psychological characteristics of an individual. Whereas mental symptoms refer to thoughts, feelings, and behaviour that an individual experiences as a result of their mental state. The mental symptoms which form the most important core of Homoeopathic prescribing always are an expression of the continued internal conflict. The conflict produced leads to anguish which is expressed peripherally as mental symptoms. This study bridges the gap by assessing the impact of Mental Symptoms in the Homoeopathic management of Irritable Bowel Syndrome providing clinical evidence for effectiveness. It will show the utility of Mental Symptoms in the management of Irritable Bowel Syndrome among the age group of 18-45 years.

Primary Objective: 

 1. To assess the utility of Mental Symptoms in the Homoeopathic Management of Irritable Bowel Syndrome. 

 Secondary Objective: 

1. To compare pre-treatment and post-treatment Irritable Bowel Severity Scoring System (IBS-SSS) score in the cases of Irritable Bowel Syndrome.

2. To analyze and evaluate the Mental Symptoms based on Kent’s philosophy in the cases of Irritable Bowel Syndrome. 

3. To study different clinical presentations of Irritable Bowel Syndrome.

1. Type of study design: Experimental Non-controlled study 

 2. Study setting: Cases will be collected from Outpatient department of the institute.  

 3. Duration of the study: 18 months. 

 Study population: Clinically pre-diagnosed patients of Irritable Bowel Syndrome of the age group 18-45 years and those fulfilling the Rome IV criteria with absence of alarm symptoms. 

 a) Inclusion Criteria: 

 1. Patients of Irritable Bowel Syndrome of subtypes- IBS-Constipation, IBS-Diarrhoea, IBS-Mixed 

 2. Pre-diagnosed patients of Irritable Bowel Syndrome of age group 18-45 years 

 3. Patients of all the genders 

 1. Patients of Irritable Bowel Syndrome-Unsubtyped. 

 2. Patients of Irritable Bowel Syndrome with red flag symptoms such as weight loss, nocturnal symptoms, family history of colon cancer, anemia, rectal bleeding, fever. 

 3. Patients of Irritable Bowel Syndrome on any other medication within prior 1 month of study. 

 4. Immunocompromised patients. 

 5. Pregnant and lactating females.

Subject withdrawal criteria: 

 1. Patients of Irritable Bowel Syndrome with an irregular follow up. 

 2. Patients who are not willing to continue further, for homoeopathic treatment during ongoing research study 

 3. Patients of Irritable Bowel Syndrome with red flag symptoms such as weight loss, nocturnal symptoms, family history of colon cancer, anemia, rectal bleeding, fever. 

 4. Patients of Irritable Bowel Syndrome taking any other medication during the study. 

 5) Method of selection of comparison or control group: Not Applicable 

 6) Matching criteria: Not Applicable 

     Irritable Bowel Syndrome

     Recurrent abdominal pain on average at 1 day per week in the last three months associated with 2 or more of the following criteria- 

     1. Related to defecation.

     2. Associated with change in the frequency of defecation.

     3. Associated with the change in the form of stool.

    no definite clinical findings on the examination.

    Mental symptoms:

    Classification according to Dr Kent-

     1. emotion

     2. intellect 

    3. subconscious

   

 1. Standardized Homoeopathic Case taking. 

 2. Improvement of the patient will be determined from the help of pre validated Irritable Bowel Syndrome – Severity Scoring System

Outcome will be assessed in terms of: 

 A. Clinical outcome as per the Remedy Reaction pertaining to 

 1) Mental generals 

 2) Physical generals (concomitants, personal history) 

 3) Physical particulars (chief complaint) 

 B. Statistical outcome will be assessed on Irritable Bowel Syndrome- Severity Scoring Scale

 1) Improved: controls 

 2) Not improved: mild, moderate, severe scores

1) SAMPLE SIZE: 37 patients will be selected.

2) Sampling technique: Non-Probability Purposive Sampling

3) Methods of data collection relevant to objective: 

 1. Clinically Pre-Diagnosed patients of Irritable Bowel Syndrome  will be enrolled from the Outpatient Department of the Institute. 

 2. Non probability Purposive Sampling based on Inclusion and Exclusion criteria will be done. 

 3. Detailed Case Taking will be done as per the Organon Guidelines. 

 4. Follow up criteria: Chief complaints i.e. Particular symptoms Physical Generals (if any), Mental Generals (if any).   

 1. Clinically Pre-Diagnosed patients of Irritable Bowel Syndrome will be enrolled from the Outpatient Department of the Institute. 

 2. Non-probability Purposive Sampling based on Inclusion and Exclusion criteria. 

 3. Detailed Case Taking will be done as per the Organon Guidelines. 

 4. Follow up criteria: i. Mental generals ii. Physical generals iii. Chief complaints (particulars) 

 5) Data management and analysis Procedure: 

 1. Selection of symptoms: characteristic symptoms will be analyzed and evaluated in the order of characteristic mental generals, characteristic physical generals, characteristic particulars. 

 2. Selection of remedy: Remedy selection will be based on totality. 

 3.The Posology: Potency and repetition will be done as per the susceptibility of each case.

 Duration: 

 1. Duration of study: 18 months. 

 2. Duration of each case: Each case will be studied for 6 months 

 3. Duration of Follow up: Each case will be followed up at the interval of 15 days or earlier, if required. 

 4. Statistical outcome assessment will be done at baseline, 1 month, 3 months, and 6 months 10 days of treatment. 

 6) Plan for Statistical analysis :- 

 Statistical techniques:- 

 1. Data collected will be compiled on to a MS Office excel worksheet & will be subjected to statistical analysis using an appropriate package like SPSS software. Descriptive statistics like frequency (n) & percentage (%) of categorical data, mean & Standard deviation of numerical data in each time interval will be depicted. 

 2. Normality of numerical data will be checked using Shapiro – Wilk test or Kolmogorov-Smirnov test. Depending on the normality of data, statistical tests will be determined. 

 3. Intra group comparisons for a numerical continuous data following a normal distribution will be done using paired t test (for 2 observations) else a non parametric substitute like Wilcoxon signed rank test (for 2 observations) will be used. 

 4. Frequency (n) & percentage (%) of various categories in each time interval will be compared using chi square test 

 5. Keeping alpha error at 5% and Beta error at 20%, power at 80%, p<0.05 will be considered statistically significant.