A double-blind, randomized, placebo-controlled trial of Individualised Homoeopathic Medicines in Adults with Chronic Spontaneous urticaria
Trial Snapshot
- Phase
- Phase 2/3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 130
- Locations
- 1
- Primary Endpoint
- To determine the group differences in the Hives severity score (HSS) of adults with CSU at baseline and after 4 months of intervention.
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. A double-blind, randomized (2:1), placebo- controlled trial will be conducted on 130 patients suffering from chronic spontaneous urticaria at the outpatient department of D. N. De Homoeopathic Medical College and Hospital. Assessment will be done by the HIVE SEVERITY SCORE (HSS) using UAS7 questionnaire as primary outcome and ISS (Itch Severity Score), CU-Q2oL questionnaire and MYMOP (Measure Yourself Medical Outcome Profile) as Secondary outcome, every month up to 4 months. Comparative analysis will be carried out to detect group differences between placebo and IHMs group .
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.Cases suffering from already diagnosed CSU (EB00.1 is the ICD-11 code) with UAS7 score: mild =7-15; moderate= 16-27 2.Age between 18 and 65 years.
- •3.Participants of either sex.
Exclusion Criteria
- •1.Participant having UAS7 score: less than 7 and more than 27 2.Non- Providing written informed consent voluntarily.
- •3.Patients using regular conventional anti-allergic medication and/or glucocorticoid steroids.
- •4.Vulnerable population- Unconscious, non-ambulatory, too sick for consultation, differently abled, terminally ill or critically ill patients, mentally incompetent people.
- •5.Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled systemic illness or life-threatening illness affecting quality of life or any organ failure.
- •6.Patient having a history of severe anaphylactic shock.
- •7.Pregnancy, puerperium, lactation.
- •8.Patient under tobacco chewing and/or smoking, alcoholism and/or any other form(s) of substance abuse and/or dependence.
- •9.Immune-compromised state AIDS, Hepatitis &c.
- •10.Undergoing homoeopathic treatment for any chronic disease within last 6 months.
- •11.Simultaneous participation in any other clinical trial.
Outcomes
Primary Outcomes
To determine the group differences in the Hives severity score (HSS) of adults with CSU at baseline and after 4 months of intervention.
Time Frame: Baseline, and every week , upto 4 months.
Secondary Outcomes
- Itch Severity Score (ISS) using UAS7 questionnaire(Baseline, and every week , upto 4 months.)
- CU-Q2oL questionnaire(Every month , upto 4 months.)
- Measure Yourself Medical Outcome-Profile version 2 (MYMOP-2) questionnaire(Every month , upto 4 months.)
Investigators
Pooja Kumari Pandey
D.N.De Homoeopathic Medical college and Hospital