Introduction
Irritable bowel syndrome IBS is a functional
bowel disorder in which abdominal pain or discomfort is associated with
defecation or a change in bowel habit, and with features of disordered
defecation. It is coded in ICD 11 as DD91.0
The prevalence of IBS within the community is
between 10 percent and 25 percent the ratio of females to males in India
reversed, i.e. 1 is to 3 to that of the Western countries.
The disorder is usually found
in the age group of 15 to 50 years and
may also occur in children and elderly. In a study, prevalence of IBS in India was
seen in 12.27 percent of the study population with male-to-female ratio of 1.44
to 1.
Homoeopathic science
emphasizes on the psychosomatic aspects along with physical particulars. The
study comprises of, management with the help of individualized 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.
To ensure the good
improvement, Homeopathy treats in a gentle and most harmless way with permanent
restoration of health and annihilate the disease in a whole extent on easily
comprehensible principles. Thus, Homeopathy gives more importance to the diseased
individual than the disease itself. A homoeopathic physician considers the man
as a whole. He considers the life as a trinity of body, mind and soul.
There are various remedies in homoeopathy
which are useful in treatment of IBS, most commonly used homeopathic remedies
for IBS are nux vomica, sulphur, podophyllum, argentum nitricum, asafoetida,
colocynthis, lycopodium, silicea etc. Nux vomica is being used for IBS over
many years and is a great remedy for IBS, it demands more work in this area.
Hence the study is undertaken to known the effectiveness of NUX VOMICA in cases
of Irritable bowel syndrome.
OBJECTIVES
1 Primary Objectives To study the
effectiveness of Nux vomica in homoeopathic management of Irritable bowel
syndrome in adults
2 Other Objective To assess the patient pre-
treatment and post treatment for IBS on IBSSSS scale and to compare the pre-
treatment score and post treatment score on IBSSSS scale
3 Other Objective To study
drug picture of nux vomicas
METHODOLOGY
I STUDY DESIGN An Experimental
non-controlled study.
2 STUDY SETTING Cases will be
collected from the OPD of the institute.
3 STUDY POPULATION Diagnosed patients of irritable bowel
syndrome of age group 18 to 50 years of age and those fulfilling the Rome IV
criteria with absence of alarm symptoms.
4 DURATION OF STUDY
a. Duration of study 18 months
b. Duration of each case Each case will be
studied for 8 months or until remission of symptoms
c. Duration of follow up Each case will be
followed up after 15 days or as and when required
d. Clinical outcome assessment
will be done at base, 1 month, 3 months, 8 months and at termination of
treatment
5 METHODS OF SELECTION OF
STUDY SUBJECT ELIGIBILITY CRITERIA
A. INCLUSION CRITERIA
1. Patients fulfilling the
Rome IV criteria and symptoms similar to drug picture of nux vomica
2. Diagnosed patients of age
group 18 to 50 years
3. Patients of all the genders
4. Patients from different socio economic
backgrounds will be considered.
5. Patients willing to give
informed written consent.
B. EXCLUSION CRITERIA
1. Patients with alarm ,red
flag symptoms
a. Weight loss
b. Nocturnal symptoms
c. Family history of colon
cancer
d. Anemia
e. Rectal bleeding
f. Fever.
2. Pregnant and lactating
females.
3. Patients who are already
taking other medications.
4. Patients who are
immunocompromised
C. SUBJECT WITHDRAWAL CRITERIA
1 Patients who are not willing
to continue further, for homoeopathic treatment during ongoing research study
2 Patients with an irregular
follow up
3 In medical and surgical
emergencies
4 In case of alarm symptoms if
any occur during the study.
6 METHOD OF SELECTION OF COMPARISON OR CONTROL
GROUP AND MATCHING CRITERIA Not Applicable
7 OPERATIONAL DEFINITION:
Irritable bowel syndrome IBS is a functional bowel disorder in which abdominal
pain or discomfort is associated with defecation or a change in bowel habit and
with features of disordered defecation
It is coded in ICD 11 as DD91.0
8 SPECIFICATION OF INSTRUMENTS
AND RELATED MEASUREMENTS: Entire study will be single examiner study.
1. Case taking Proforma
2. Outcome assessment tool
Irritable Bowel Syndrome severity scoring scale IBSSSS Improvement of the
patient will be determined from the help of pre validated scale
Classification of IBS severity using this scale is
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Outcome assessment criteria
The
Outcome will be assessed in terms of:
Improved
If Irritable Bowel Syndrome severity
scoring scale is reduced than the previous Irritable Bowel Syndrome severity
scoring scale., after taking homeopathic medicines.
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Not Improved If Irritable Bowel Syndrome severity scoring
scale remains same after taking homeopathic medicines
Outcome assessment criteria
The Outcome will be assessed in terms of
Improved If Irritable Bowel Syndrome severity scoring
scale is reduced than the previous Irritable Bowel Syndrome severity scoring
scale., after taking homeopathic medicines.
Not Improved If Irritable
Bowel Syndrome severity scoring scale remains same after taking homeopathic
medicines.
SAMPLE SIZE
Though the sample
size calculated is 31, but in this study minimum 40 sample sizeis taken
SAMPLING
TECHNIQUE Non Probability Purposive Sampling.
3 METHODS
OF DATA COLLECTION RELEVANT TO OBJECTIVE
a. A. Non probability purposive sampling based on Inclusion and Exclusion criteria.
B. 40 cases will be
recorded from outpatient department of the institute.
C.
Detailed homoeopathic case taking will be done as per the proforma
will be used for collecting and analysing data prepared to arrive at
the appropriate similimum.
D.
Depending on the clinical presentation of the patient and totality erected, the
patient will be administered indicated individualised homoeopathic medicine.
E.
Posology will be selected as per the requirement of the case.
4 STUDY INSTRUMENT DATA COLLECTION TOOLS
1. Complete
Homeopathic Case taking proforma to form Totality with Special Emphasis on Individualizing case
2. IBSSSS
Scale will be used to assess the severity before and after the treatment
3. Appropriate reference books like Homoeopathic
Materia Medica, Medicine ,Surgery
books, Pathology books, different Homoeopathic Journals,
research paper 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 Homoeopathic remedy after
referring Materia Medica.
3.The
Posology Appropriate potency will be selected based on 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 be studied for 8 months or
until remission of symptoms.
c.
Duration of follow up Each
case will be followed up after 15 days or as and when required.
d.
Clinical outcome assessment
will be done at base, 1 month, 3 months, 8 months and at termination of
treatment
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 |