Usefulness and safety of self serum therapy in long-standing generalised itch and wheals of skin

Evaluation of effectiveness and safety of autologous serum therapy in chronic urticaria with special reference to autoreactive urticaria: a randomized, double-blind, placebo controlled clinical study - AST CU

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2012/12/003204

Enrollment

120

Registered

2012-12-11

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Chronic urticaria

Interventions

Intervention1: Autologous serum: 5 ml of venous blood of the patient was drawn with a sterile, disposable syringe from the antecubital vein in sterile BD Vacutainer for serum collection. The blood was

Eligibility

Inclusion criteria

Inclusion criteria: Adult patients ( >18 yrs) of either sex suffering from chronic urticaria attending the Dermatology out-patient department of a tertiary care teaching hospital in Eastern India were included

Exclusion criteria

Exclusion criteria: Pregnant, lactating women, patients suffering from immunosuppression due to drug or disease, advanced diseases of vital organs, inability to come for weekly follow-ups, addicted to alcohol or other substance abuse, machinery operators, vehicle drivers and in whom sleep/wake cycle alteration could be an issue were excluded from the study.

Design outcomes

Primary

Measure	Time frame
The primary outcome measures for effectiveness were Urticaria activity score (UAS )and Urticaria total severity score (TSS)Timepoint: baseline, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 and 24 weeks following randomization.	—

Secondary

Measure	Time frame
Dermatologic Life quality Index(DLQI)Timepoint: baseline, 8 and 24 weeks following randomisation;safety parameters: 1. Spontaneously reported adverse events by patients 2. Adverse events noted by investigators during clinical examinationsTimepoint: baseline, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 and 24 weeks following randomization.;Safety parameters: routine lab parameters (Haematocrit, LFT, Serum urea creatinine, FBS)Timepoint: baseline, 8 weeks following randomisation (end of intervention);The secondary effectiveness parameters were Patientsâ?? global assessment of disease activity improvement and Physiciansâ?? global assessment of disease activity improvementTimepoint: baseline, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 and 24 weeks following randomization.	—

Measure

Time frame

Dermatologic Life quality Index(DLQI)Timepoint: baseline, 8 and 24 weeks following randomisation;safety parameters: 1. Spontaneously reported adverse events by patients 2. Adverse events noted by investigators during clinical examinationsTimepoint: baseline, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 and 24 weeks following randomization.;Safety parameters: routine lab parameters (Haematocrit, LFT, Serum urea creatinine, FBS)Timepoint: baseline, 8 weeks following randomisation (end of intervention);The secondary effectiveness parameters were Patientsâ?? global assessment of disease activity improvement and Physiciansâ?? global assessment of disease activity improvementTimepoint: baseline, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 and 24 weeks following randomization.

—

Countries

India

Contacts

Public ContactNilay Kanti Das

Burdwan Medical College

drsilamrita@gmail.com09477737091

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026