Synopsis on Comparative effectiveness of individualized homoeopathic medicines with urtica urens in cases of chronic urticaria: An open label randomized clinical trial
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- To compare the effectiveness of individualized homoeopathic medicine with empirically selected medicine urtica urens in the management of chronic urticaria using urticaria activity score (UAS7) and chronic urticaria -Quality of life questionnaire (CU-Q2oL.)
Study Overview
Brief Summary
Chronic urticaria is one of the common skin disease we encounter in our day to day clinical practice. Its prevalence is between 0.5 to 1% in the total population with a predominance of females. Homoeopathy plays an important role in treating patient suffering from chronic urticaria. So an open label randomized clinical trial showing the comparative effectiveness of individualized homoeopathic medicine with urtica urens in cases of chronic urticaria will be conducted in National Institute of Homoeopathy, Kolkata. Study has a target to achieve a sample of 40 patients. Primary outcome will be assessed by UAS7(Urticaria activity score) and CU-QoL2(Chronic urticaria quality of life questionnaire) at baseline and after 4 months .Secondary outcome will be assessed by biochemical parameters such as Serum IgE, CBC, ESR ,etc. The score obtained by the patients will be compared and result will be analysed as per appropriate statistical methods and inference will be drawn thereafter.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Open Label
Eligibility Criteria
- Ages
- 15.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patient of chronic urticaria diagnosed clinically and by blood investigations if necessary 2) Patient of both sexes, all religions and of different socioeconomic status 3) Patient in the age group 15 to 65 years of age 4) Patient able to read and write Bengali/English/Hindi.
- •Patient willing to give written informed consent to participate in the study 6) Patient already undergoing regular conventional treatment for chronic urticaria may be recruited only if the medications are stopped completely 2 weeks prior to the treatment.
Exclusion Criteria
- •Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled life threatening illness 2) Substance abuse and/or dependence 3) Severe immune-compromised patients 4) Patients having history of severe anaphylactic shock 5) Pregnant women and lactating mothers.
Outcomes
Primary Outcomes
To compare the effectiveness of individualized homoeopathic medicine with empirically selected medicine urtica urens in the management of chronic urticaria using urticaria activity score (UAS7) and chronic urticaria -Quality of life questionnaire (CU-Q2oL.)
Time Frame: Baseline and after 4 months
Secondary Outcomes
- Biochemical parameters such as Serum IgE , Complete Blood count, ESR level, etc.(Baseline and after 4 months)