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Clinical Trials/CTRI/2024/06/068767
CTRI/2024/06/068767
Not yet recruiting
Phase 2

An experimental study to ascertain the effectiveness of homoeopathic medicines in the management of irritable bowel syndrome

Rajkot Homoeopathic Medical College1 site in 1 country40 target enrollmentStarted: June 24, 2024Last updated:

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

Sponsor
Rajkot Homoeopathic Medical College
Sponsor Class
Private medical college
Responsible Party
Principal Investigator
Principal Investigator

Hasti Bharatbhai Dekivadiya

Rajkot Homoeopathic Medical College

Study Sites (1)

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