Efficacy Of Lesser Known Homoeopathic Medicines In Treatment Of Haemorrhoids – A Clinical Study
Overview
- Phase
- Phase 2/3
- Status
- Not yet recruiting
- Sponsor
- S S Agrawal Homoeopathic Medical College and General Hospital
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- To assess the efficacy of lesser known homoeopathic medicines in treatment of haemorrhoids.
Overview
Brief Summary
This clinical study titled “Efficacy of Lesser Known Homoeopathic Medicines in the Treatment of Haemorrhoids – A Clinical Study” aims to evaluate the effectiveness of lesser-known homoeopathic medicines—Aegle folia, Gratiola officinalis, Mancinella, and Strontium carbonicum—in the treatment of haemorrhoids. It is a prospective, interventional, open-label, single-arm clinical trial, where all participants will receive one of the selected homoeopathic remedies based on individualization and symptom totality. The study will be conducted on 80 patients, aged 15 to 65 years, of either gender, who are clinically diagnosed with internal or external haemorrhoids and are willing to undergo homoeopathic treatment. Patients requiring emergency surgery, pregnant/lactating women, or those under malignant disease condition will be excluded. The primary outcome will be measured using the Haemorrhoid Symptom Severity Scale (HSSS) before and after treatment. Secondary objectives include assessing incidence by age, sex, occupation, identifying the most effective medicine among the selected ones. The study will span nine months, including recruitment, treatment, and follow-up phases. The site of study will be S S AGRAWAL Homoeopathic Medical College and General Hospital OPD at Navsari. The trial has received ethical approval from the Institutional Ethics Committee. The study is led by Dr. Disha Patel , a Postgraduate Scholar from the Department of Homoeopathic Materia Medica.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 15.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1.Both sexes and all types of socio economical status.
- •2.Diagnostic criteria are mainly based on the clinical presentation.
- •3.Diagnosed cases of Haemorrhoids, taking treatment from other system of medicine and in homoeopathy treatment only those cases will be included where the treatment given with the four homoeopathic medicine being studied, feeling no relief or recurrence or under control but seeking Homoeopathic treatment.
Exclusion Criteria
- •1.Patients of age group below 15 years and above 65 years.
- •2.Pregnant women 3.Cases with complication like heavy bleeding , fissure in ano , fistula in ano , malignancy , crohn’s disease , ulcerative colitis and other diseases having rectal complaints secondary phenomena are excluded.
- •4.Patients having other severe systemic disorders .
- •5.The cases, who do not continue with treatment up to six visits, were dropped out of the study.
Outcomes
Primary Outcomes
To assess the efficacy of lesser known homoeopathic medicines in treatment of haemorrhoids.
Time Frame: 9 Months
Secondary Outcomes
- To compare the symptomatic relief before and after treatment with the help of Haemorrhoid Symptom severity scale.(9 Months)
Investigators
Disha Kumari Ratilal Patel
S. S. Agrawal Homoeopathic Medical College And General Hospital , Navsari