Evaluation of PHR160 spray effect on improvement of severe asthmatic patients.

Phase 3

• Conditions: Severe asthma.; J45. 998

• Registration Number: IRCT20220610055122N1
• Lead Sponsor: Ahvaz University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 7 February 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Patients with severe asthma

Exclusion Criteria

pregnancy
history of reflux
history of sinusitis
History of allergic rhinitis
History of advanced liver and kidney failure
Allergy and contraindications of herbal compounds such as menthone, saffron, crocin, safranel

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quality of life score (based on quality of life questionnaire in asthmatic patients). Timepoint: Before the intervention and one month later. Method of measurement: questionnaire.;The distance covered in the 6-minute walk test (in meters). Timepoint: Before the intervention and one month later. Method of measurement: 6-minute walking test.;Forced expiratory volume in the first second (FEV1). Timepoint: Before the intervention and one month later. Method of measurement: spirometry.;Forced vital capacity (FVC). Timepoint: Before the intervention and one month later. Method of measurement: spirometry.;Forced expiratory flow 25%-75%. Timepoint: Before the intervention and one month later. Method of measurement: spirometry.;The number of exacerbations. Timepoint: Before the intervention and one month later. Method of measurement: Calculation of the number of exacerbations of the disease.