Efficacy of Individualized Homoeopathic Medicines versus Asafoetida 30C in the management of Irritable Bowel Syndrome: A Single-Blind Randomized Controlled Trial
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Irritable Bowel Syndrome-Symptom Severity Scale (IBS-SSS)
Study Overview
Brief Summary
This is a Single-Blind Randomized Controlled Study to compare the efficacy of Individualized Homoeopathic Medicines and Asafoetida 30C in the management of Irritable Bowel Syndrome. 60 patients suffering from Irritable Bowel Syndrome fulfilling Rome IV criteria will be randomized into 2 groups, using Random number table method, consisting of 30 patients in each group. Study will be of 1 year duration. Improvement in symptoms of IBS will be assessed using IBS- Symptom Severity Scale and change in the quality of life of the patients will be assessed using EQ-5D Questionnaire.
RESEARCH QUESTION:
What is the efficacy of Individualized Homoeopathic Medicines (IHMs) as compared to Asafoetida 30C in the management of Irritable bowel syndrome?
Null hypothesis (H0): There is no significant difference between the two comparable groups, i.e. Individualized Homoeopathy Medicines (IHMs) and Asafoetida 30 in the management of Irritable Bowel Syndrome.
Alternative hypothesis (HA): There is significant difference between the two comparable groups, i.e. Individualized Homoeopathy Medicines (IHMs) and Asafoetida 30 in the management of Irritable Bowel Syndrome.
AIM
To assess the efficacy of Individualized Homoeopathic Medicines versus Asafoetida 30C in the management of irritable bowel syndrome.
OBJECTIVES
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To find the role of Individualized Homeopathic Medicines (IHMs) in the management of irritable bowel syndrome and to list down the most indicated remedies.
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To clinically verify the role of Asafoetida 30 C in the management of irritable bowel syndrome.
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To compare the efficacy of Individualized Homeopathic Medicines (IHMs) versus Asafoetida 30C in the management of irritable bowel syndrome.
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To assess the IBS patient taking treatment, based on change in signs and symptoms using Irritable Bowel Syndrome- Symptom Severity Scale (IBS-SSS) [Annexure-3] and change in Quality of life using EQ-5D Questionnaire.
Procurement of medicines: Pharmacy of Nehru Homoeopathic Medical College and Hospital.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 50.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Score of more than 75 on Irritable Bowel Syndrome- Symptom severity scale (IBS-SSS).
- •Patients giving written consent to participate in the study.
Exclusion Criteria
- •Patients with other severe systemic illnesses, malignant disorders, autoimmune diseases or any organic disease.
- •Patients above 50 years of age.
- •Any major surgery in the last 6 months.
- •Patients under other medication for the same complaint.
- •Patients with cognitive impairment.
- •Pregnant women and lactating mothers.
- •Patients who are already enrolled in some other study.
- •Patients who are not willing to give the consent.
Outcomes
Primary Outcomes
Irritable Bowel Syndrome-Symptom Severity Scale (IBS-SSS)
Time Frame: At baseline and after 12 weeks of intervention
Secondary Outcomes
- EQ-5D Questionnaire(At baseline and after 12 weeks of intervention)
Investigators
Dr Prabhjeet Kaur
Nehru Homoeopathic Medical College and Hospital