A double-blind, randomized, placebo-controlled trial of individualized homoeopathic medicines in improving the quality of life in adults with chronic spontaneous urticaria
Trial Snapshot
- Phase
- Phase 2/3
- Status
- Recruiting
- Sponsor
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Chronic Urticaria Quality of Life (CU-Q2oL) questionnaire
Study Overview
Brief Summary
Chronic Spontaneous Urticaria (CSU) is characterized by persistent itchy hives and /or angioedema that recur for more than 6 weeks and a duration of several years. Angioedema is the rapid swelling of sub cutaneous, mucosa and submucosal tissue that can appear anywhere on the body. In India, between 15 and 20 percent of people develop urticaria at some point in their lives. After adolescence, urticaria is more common and twice as common in women as in men. Due to its high prevalence and the possibility of severe allergic reactions, including anaphylaxis in certain circumstances, urticaria has become a significant worldwide health concern in recent years. It affects strong negative influence on patient’s well beings and health- related quality of life. Under such circumstances, we intend to undertake this research project to evaluate the efficacy and safety of homoeopathic medicines in the treatment of CSU in adults. This double-blind, randomized (2:1), placebo-controlled trial will be conducted on 50 adults who are suffering from chronic spontaneous urticaria at the outpatient’s department of D. N. De Homoeopathic Medical College and Hospital, the efficacy of individualized homoeopathic medicines (IHMs) will be compared with identical looking placebos. Assessment will be done by Chronic Urticaria Quality of Life (CU-Q2oL questionnaire [Primary outcome], Urticaria Control Test (UCT), and MYMOP-2 [Secondary outcome] every month up to 3 months. Statistical analysis will be carried out to detect group differences. Results will be published in scientific journals.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1.Patients of chronic urticaria diagnosed clinically.
- •(EB00.1 is the ICD-11 code) 2.Patients having UAS7 score mild 7-15; moderate 16-27 3.Patients of either sex or transgenders.
- •4.Patients of the age between 18 and 65 years.
- •5.Participants having prior experience or knowledge of the treatment.
- •E.g.- primed to expect ‘homoeopathic aggravation’ and available treatment options for the disease conditions, intimated through Patient Information Sheet.
Exclusion Criteria
- •1.Participation having UAS7 score: less than 7 and more than 27
- •Participation in a clinical trial within the last 3 months.
- •Non Providing written informed consent voluntarily.
- •Patients using regular conventional anti-allergic medication and/or glucocorticoid steroids.
- •Vulnerable population- Unconscious, non-ambulatory, too sick for consultation, differently abled, terminally ill or critically ill patients, mentally incompetent people.
- •Patients having history of severe anaphylactic shock.
- •Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled or life-threatening illness affecting quality of life or any organ failure.
- •Pregnancy, puerperium, lactation.
- •Patient under tobacco chewing and/or smoking, alcoholism and/or any other form(s) of substance abuse and/or dependence.
- •10.Self-reported immune-compromised state AIDS, Hepatitis &c.
- •11.Undergoing homoeopathic treatment for any chronic disease within last 6 months.
Outcomes
Primary Outcomes
Chronic Urticaria Quality of Life (CU-Q2oL) questionnaire
Time Frame: Every month up to 3 months
Secondary Outcomes
- Urticaria Control Test (UCT)(Every month up to 3 months)
- Measure Yourself Medical Outcome Profile version 2 (MYMOP-2)(Every month up to 3 months)
Investigators
Dr Reshmiara Khatun
D. N. De Homoeopathic Medical College and Hospital