Effectiveness and safety of Thai traditional medicine (Yaprabchombhutaweeb) on allergic rhinitis

Phase 3

Recruiting

• Conditions: Allergic rhinitis; Yaprabchombhutaweeb, randomized controlled trial, Thai traditional medicine, allergic rhinitis, anti- histamine

• Registration Number: TCTR20180906003
• Lead Sponsor: Agricultural Research Development Agency (Public Organization)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-06
• Study Completion: 2019-04-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1. Male or female with age 18-60 years
2. Patients that diagnosed allergic rhinitis or
3. Patients who had a history of allergic cause and one or more of the following symptoms: nasal congestion, runny nose, itchy nose, or sneezing and
4. Patients who presented watery rhinorrhea or runny nose with one or more of the following symptoms: nasal congestion, itchy nose, sneezing, itchy watery eye

Exclusion Criteria

1. Patients with complication of allergic rhinitis such as rhinosinusitis or upper respiratory tract infection, fever (body temperature > 38.5 oC )
2. Patients with abnormal nasal structure and needed current medication such as Nasal Polyp
3. Patients with allergic rhinitis requiring topical or oral medications containing anti-histamine drug within 7 days before starting date of study
4. Patients who requiring medications that interfere with Yaprabchomphutaweeb or loratadine such as phenytoin, propranolol, rifampicin
5. Patients with other conditions that would interfere with the assessments such as uncontrolled COPD
6. Patients who present symptom of peptic ulcer or GERD
7. Pregnant women
8. Nursing or breast feeding women
9. Patients with renal impairment or abnormal of liver enzyme
10. The drinker or smoker

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Success rate (no symptoms or TNSS-4 score improve > 80%), improvement rate (TNSS-4 score improve >50 At week 4 Total nasal symptom scores -4 scale (TNSS-4) questionnaire assessed by physician

Secondary Outcome Measures

Name	Time	Method
The difference of Total nasal symptom scores 4 scale, quality of life score, ADRs, AEs, time to cure At week 1, 2, 4 TNSS-4, Rcq-36 questionnaire (QOL of chronic allergic rhinitis patient), ADR, AEs