Efficacy of Thai Herbal Anti-cold 78 formula (ACF78) in the reduction of nasal symptoms in patients with allergic rhinitis.

Phase 2

• Conditions: allergic rhinitis; herbal medicine

• Registration Number: TCTR20200220002
• Lead Sponsor: Routine to researh unit,Faculty of Medicine Siriraj Hospital Mahidol University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-02-20
• Study Completion: 2020-05-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

1.Age 18-60 years who has been diagnosed with allergic rhinitis by a specialized medicine.
2.Positive reaction to one or more main allergens as evaluated in skin prick test or history within 1 year.
3.Inform consent was obtained before initiation.

Exclusion Criteria

1.Presence of severe pathology within the nasal cavity for example chronic sinusitis, neoplasm, nasal polyp, deviated nasal septum.
2.Presence of abnormal liver function (AST or ALT ≥100 IU/L) or abnormal renal function (BUN ≥30 mg/dL or creatinine ≥1.8 mg/dL (male), 1.5 mg/dL (female)).
3.Active medical disorders such as cancer, infection, hematologic, renal, hepatic or cardiovascular.
4.History of allergic reactions from herbs, herbal medicines or pollen.
5.History of anaphylaxis.
6.Women who are pregnancy, lactation or plan to pregnancy.
7.History have been vaccinated by allergen immunotherapy within 2 years or have been taken antihistamine within 7 days
8.Use systematic corticosteroid within the last 3 months or nasal corticosteroid within the last 15 days.
9.Patients who were using any traditional Thai or Chinese therapy for 1 month before entering the study.
10.Chronic use of parallel medications (e.g., tricyclic antidepressants).
11.Presence of body temperature more than 37.5 degrees.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical evaluation 2 weeks Total symptom score,Quality of life questionnaire 2 weeks Rcq-36 ,Total nasal resistance 2 weeks active anterior rhinomanometry

Secondary Outcome Measures

Name	Time	Method
ab evaluation 2 weeks blood analysis,Side effect record 2 weeks Naranjo’s algorithm,diary