An experimental study to ascertain the effectiveness of homoeopathic medicines in the management of irritable bowel syndrome
Overview
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Rajkot Homoeopathic Medical College
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- To ascertain the effectiveness of Homoeopathic
Overview
Brief Summary
It is said that all the disease begins in gut. Disturbed gut is responsible for development of
different diseases and it can also affect the person’s day to day life. Out of all the
gastrointestinal disorders Irritable Bowel Syndrome is one of the most common functional
disorder. Global burden of disease, studies have shown that IBS affects people world wide.It
is estimated that 1 out of 10 people from world suffers from IBS.[1]
Burden of IBS varies from 7%-24% across the globe, in south east Asia and middle east
countries it is about 7%.[1] Prevalence of IBS in Asian countries is rising which shows that,
cases of IBS varies between 4.2%-7.5% in India.[2] Prevalence of IBS is common in both
sexes but females are at higher risk. IBS is significantly lower in >50 years of age as
compared to <50 years.
IBS significantly affects the individual and their quality of life. Notably it has been found
that developing countries adopting westernized diet, lifestyle and behavior that might
associated with increased risk of developing IBS. Psychological factors like stress, anxiety,
depression may frequently present with IBS and it exacerbate the condition.
IBS has varied presentation, so the management focus towards the amelioration of the
symptoms. At present, the drugs available for the treatment have only a modest effect on the
symptoms improvement.
Homoeopathy being wholestic mode of treatment, it does not focus only on the diseased
part, but it consider the person as a whole including mind and body. It believes that signs
and symptoms are the outward reflection of internal derangment of vital force. Totality is
formed by combing all these individulized symptoms and signs, then medicine is prescribed
which helps to streghten the deranged vital force. In this way it can help in relieving pain
and decreasing frequency of IBS
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Investigator Blinded
Eligibility Criteria
- Ages
- 20.00 Year(s) to 50.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Cases of both the sexes, irrespective of religion and caste.
- •Pre-diagnosed and new cases diagnosed with Rome III criteria.
- •Patient who will give consent to participate in the study with at least 6 follow-ups.
Exclusion Criteria
- •Age- less than 20 and more than 50
- •Pregnancy
- •Cases with advanced & irreversible pathology
- •Cases with irregular follow-ups.
Outcomes
Primary Outcomes
To ascertain the effectiveness of Homoeopathic
Time Frame: There will be improvement in cases of IBS after prescribing suitable Homoeopathic Medicines will be achieved within 9 months of period.
Medicines in cases of Irritable bowel syndrome using G.S.R.S.(Gastrointestinal Symptoms Rating Scale) for IBS.
Time Frame: There will be improvement in cases of IBS after prescribing suitable Homoeopathic Medicines will be achieved within 9 months of period.
Secondary Outcomes
- Significant improvement, sense of well being with no complaints or relapse of symptoms.(Moderate improvement, patient relieved from presenting complaints in frequency & intensity.)
Investigators
Hasti Bharatbhai Dekivadiya
Rajkot Homoeopathic Medical College