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Clinical Trials/CTRI/2022/11/047671
CTRI/2022/11/047671CompletedPhase 3

A Clinical evaluation of Siddha formulation Gandhaga rasayanam(Internal medicine) and Arugan thylam(External medicine) for Kaanakadi(Urticaria)

National Institute of Siddha1 site in 1 country30 target enrollmentStarted: November 25, 2022Last updated:
Conditions

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
30
Locations
1
Primary Endpoint
Effect of Gandhaga rasayanam(internal) and arugan thylam(external) in the management of urticaria will be assessed by based on urticaria activity score(UAS) and IgE in study subjects before and after the treatment.

Study Overview

Brief Summary

The aim to evaluate the effective of Gandhaga Rasayanam(internal) and Arugan thylam(external) in the management of kaanaakadi (urticaria).To assess the therapeutic efficacy of Siddha formulation Gandhaga Rasayanam and Arugan thylam in the management of kaanaakadi. This trial drug will be issued to the patient .The patient will be asked to visit OPD of Ayothidoss pandithar hospital National institute of Siddha with 40 patients once 10 days for clinical assessment.  Patient selected based on inclusion and exclusion criteria. Laboratory investigation taken before and after treatment. All the data entered into computer and analysed. All collected data will be statistically analysed by Research officer (statistics) for logical errors and incompleteness of data to avoid any bias.Then final report will be generated.The outcome will be assessed by based on Urticaria Activity Score and IgE before and after treatment.

Study Design

Study Type
Interventional
Allocation
Not Applicable
Masking
Not Applicable

Eligibility Criteria

Ages
15.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • •Patients with clinical symptoms of Itching Redness Pale pink oedematous wheal Wheals surrounded by flare Inflamation Erythematous macules (any 2 symptoms especially itchy,wheal) Recurrent episodes of urticaria.

Exclusion Criteria

  • •Any serious systemic illness Psoriasis Eczema Tinea infection Pregnancy Lactation Psychological factor Adverse reaction of any drug.

Outcomes

Primary Outcomes

Effect of Gandhaga rasayanam(internal) and arugan thylam(external) in the management of urticaria will be assessed by based on urticaria activity score(UAS) and IgE in study subjects before and after the treatment.

Time Frame: 48 Days

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Research institution and hospital

Study Sites (1)

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