CTRI/2024/02/063314Not yet recruitingUnknown
Comparative Evaluation of Therapeutic Efficacy of Autologous Serum Therapy versus Injection Histaglobulin in Chronic Idiopathic Urticaria: An Open-label Randomized Control Trial
AIIMS, Rishikesh1 site in 1 country92 target enrollmentStarted: March 11, 2024Last updated:
Conditions
Trial Snapshot
- Phase
- Unknown
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 92
- Locations
- 1
- Primary Endpoint
- To compare the therapeutic efficacy of AST and injection Histaglobulin in patients of chronic idiopathic urticaria on the basis of change in Urticaria Activity Score and Dermatology Life Quality Index from baseline after 12 weeks post completion of either modality.
Study Overview
Brief Summary
The recruitment will start after CTRI registration. Only patients of Indian ethnicity visiting Dermatology OPD AIIMS, Rishikesh for management of chronic urticaria who are willing to give consent for the study will be recruited .
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •18 years or above patient willing to give consent and not having any contraindication for the procedure.
Exclusion Criteria
- •Active microbial infection, Pregnancy or Lactation, Hypersensitivity to Histaglob injection, Immunosuppressed cases or uncontrolled Diabetes mellitus.
Outcomes
Primary Outcomes
To compare the therapeutic efficacy of AST and injection Histaglobulin in patients of chronic idiopathic urticaria on the basis of change in Urticaria Activity Score and Dermatology Life Quality Index from baseline after 12 weeks post completion of either modality.
Time Frame: At baseline, then at 10 weeks and after 12 weeks from the point of last injection given in either group
Secondary Outcomes
- To compare the reduction of antihistamine usage by patient on either of these modalities of therapy for chronic urticaria.(One year duration)
Investigators
Dr Sushantika
AIIMS, Rishikesh
Study Sites (1)
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