INTRODUCTION

Anal fissures are tears of the anal mucosa. They can cause extreme pain and bleeding. Acute anal fissures are classified as lasting less than 6 weeks where as chronic anal fissure lasts more than 6 weeks.  EPIDEMIOLOGICAL DATA The prevalence of anal fissure among patients is around 18 percentage Mixed dietary habits and history of constipation were found to be associated with the prevalence of fissure. Similarly, patients with no exercise or physical activity had more prevalence of fissure than patients who exercised on a regular basis The lifetime incidence of anal fissures is estimated to be around 58 percentage in females and 42 percentage in males Fissures are commonest in the midline posteriorly In males 90 percentage occur posteriorly and 10 percentage anteriorly  in the midline. In females, the incidence is 60 percentage and 40 percentage respectively. Causes of anal fissures commonly include constipation, chronic diarrhea, sexually transmitted diseases, tuberculosis, inflammatory bowel disease, HIV, anal cancer, childbearing, prior anal surgery, and anal sexual intercourse. The majority of acute anal fissures are thought to be due to the passage of hard stools, sexually transmitted infection, or anal injury due to penetration In this modern era, life style diseases are commonly encountered in daily clinical practice. Sedentary life styles, lack of proper exercise, low intake of dietary fibre and water, stress and emotional factors, all these causes make a person prone to different varieties of gastrointestinal disorders  Oral pain medication, which may be taken before any anticipated bowel movement The QoL was found to be markedly impaired in comparison to the general population, and the pain associated with the anal fissure appeared to impact all aspects of psychological and physical well- being Homoeopathy offers the safe, effective and permanent treatment, for such cases, and prevents recurrence.

Objectives

Primary Objective To study the effectiveness of Homoeopathic remedies in management of Acute Anal Fissure among adult females.

Other Objective To assess the patient pre-treatment and post-treatment for Acute Anal fissure among female on REALISE SCORE and to compare the pre- treatment score and post-treatment score on REALISE SCORE

Other Objective  To arrive at a group of remedies indicated in the management of Acute Anal Fissure among adult females.

MATERIALS AND METHODOLOGY

STUDY DESIGN An Experimental non controlled study

2 STUDY SETTING Cases of Acute Anal Fissure will be recruited from outpatient department of the institute

3 STUDY POPULATION Clinically diagnosed cases of Acute anal fissure among adult females.

4 DURATION OF STUDY  

a. Duration of study  18 months

b. Duration of each case Each case will studied for 7 weeks till remission of symptoms.

c. Duration of follow up The follow ups will taken at the interval of 7 days or early as when required.

d. Clinical outcome assessment will be done at base 4days, 7 days , 15days and till recovery.

5METHODS OF SELECTION OF STUDY SUBJECT 1.Inclusion Criteria: 1. Patient clinically diagnosed with acute anal fissure .

2. Patients with acute anal fissure complaints lasting less than 6 weeks 3.Patients belonging to female age group 18 to 45years

4. Patient willing to give informed written consent.

2. Exclusion Criteria 1. Patients suffering with chronic anal fissure and associated complications like in fistula in ano, anorectal abscess, malignancy, crohn’s disease, ulcerative colitis, rectal polyp etc.

2. Suspected immunocompromised patients 3. Females who are pregnant and lactating

3. Subject withdrawal criteria  1. Patients do not come for the follow up regularly. 2. Patients who are not taking their prescribed medicine timely. 3. Patients who are not willing to continue the homoeopathic treatment further. 4. Patients are diagnosed with other diseases or develop complications during the course of treatment, requiring intensive care. 6) METHOD OF SELECTION OF COMPARISON OR CONTROL GROUP AND MATCHING CRITERIA Not Applicable

SPECIFICATION OF INSTRUMENTS AND RELATED MEASUREMENTS 1.Homoeopathic Case Taking Proforma will be used in each case. 1. Pain Pain Scale: Visual Analog Scale 2.REALISE SCORE The questionnaire consisted of five items selected according to the most commonly reported symptoms for AF: the item pain, was scored from 0 to 10 using a visual analogue scalethe remaining four were scored from 1 to 5 points using a Likert-scale questions The REALISE score was the sum of all points, with a maximum possible of 30 points and a minimum of 4 points The outcome will be assessed in terms of  1. Improved: If REALISE score is reduced than the previous REALISE score, after taking homeopathic medicines 2. Not Improved: If REALISE score remains the same after taking homoeopathic medicines. The criteria will be assessed as per the clinical symptoms presented by the patient I) SAMPLE SIZE  40 subjects will be selected. SAMPLING TECHNIQUE: Non-Probability Purposive Sampling 3) METHODS OF DATA COLLECTION REVELANT TO OBJECTIVE 1. Non Probability purposive random sampling will be done 2. Informed written consent of 40 patients diagnosed with acute anal fissure in women will be recruited from outpatient department of the institute and their cases will be recorded. 3. Detailed Homoeopathic case taking will be done as per the Proforma for collecting and analysing data prepared to arrive at individualised homoeopathic medicine. 4. Depending on the clinical presentation of the patient and totality erected, the patient will be administrated indicated individualised homoeopathic medicine.  5.Posology will be selected as per the requirement of the case. 4) STUDY INSTRUMENT DATA COLLECTION TOOLS  1.Complete Homoeopathic Case taking proforma to form Totality with special Emphasis on Individualizing case. 2. REALISE score will be used to assess the severity of symptoms before and after the treatment. 3.Appropriate reference books like Homoeopathic Materia Medica, Medicine books, Pathology books, research papers will be considered 4. Appropriate Software will be used for repertorization of case. 5) DATA MANAGEMENT AND ANALYSIS PROCEDURE  1. Framing of totality of symptoms- Will be done as per the principles of Homoeopathy. 2. Selection of remedy- Individualized Homoeopathic Medicines based on totality of symptoms. 3. The Posology- Appropriate potency will be selected based on the susceptibility of each case. Potency will be changed when required.

4. Duration of study

A. Duration of study 18 months

B. .Duration of each case Each case will studied for 7 weeks till remission of symptoms.

C. .Duration of follow up The follow ups will taken at the interval of 7 days or early as when required.

D. Clinical outcome assessment will be done at base l 4days, 7 days , 15days and till recovery

6) PLAN FOR STATISTICAL ANALYSIS 1.Data collected will be compiled on to a MS Office Excel worksheet and will be subjected to statistical analysing using an appropriate package like SPSS (Statistical Package for Social Sciences) software. Descriptive statistics like frequency  of categorical data, mean and 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 upon normality of data, statistical tests will be determined.