ALLERGIC RHINITIS PATIENTS Prasaprohyai extract, Allergic rhinitis, Clinical trial phase III
Conditions
Interventions
300 mg per day,10 mg per day
Experimental Drug,Active Comparator Drug
Prasaprohyai extract ,Loratadine
Sponsors
Thammasat University
Eligibility
Sex/Gender
All
Age
20 Years to 64 Years
Inclusion criteria
Inclusion criteria: (1) Male or female aged 20-64 years (2) Have a history of allergic rhinitis and still have symptoms of allergic rhinitis from both the history and physical examination (3) Was diagnosed by a modern physician with allergic rhinitis, and from the assessment, The TNSS score was in the moderate disease and moderately severe allergic rhinitis category. The total score is 5 points or more. (4) There is a laboratory test of the hematological value. The liver and kidneys were normal. (5) Able to stop using group drugs, antihistamines, or inhaled drugs such as intranasal steroids as they affect the cross-sectional area of the nasal cavity for 1 week before the start of the project (6) Have a body mass index (BMI) of 18-35 kg/m2 and normal vital signs (7) Volunteers were welcome to participate in research projects.
Exclusion criteria
Exclusion criteria: (1) People who take anticoagulant drugs (anticoagulant) (2) People who take antiplatelet drugs (antiplatelet aggregation) (3) There is a history of severe side effects from Loratadine. (4) Allergy to major fragile drugs (5) High fever with temperature between 39.5 to 40.5 degrees (6) Severe Urticaria and Anaphylaxis (7) Nose septum perforated or has undergone nasal surgery (8) The subject was immunocompromised or a serious chronic patient such as AIDS. (9)Macrolide antimicrobials such as erythromycin and clarithromycin were used. Alternatively, Imidazole antifungal drugs such as ketoconazole, itraconazole, fluconazole, or HIV protease inhibitors, as well as other drugs that inhibit the activity of the CYP450 enzyme such as cimetidine, metronidazole, zafirlukast, SSRIs, etc. (10) Use medications that prolong the ECG QT interval, such as Calcium Channel Blockers (e.g., bepridil, verapamil), Tricyclic antidepressants, cisapride, quinidine, etc. (11) Have a history of congenital diseases such as tuberculosis, rhinitis, kidney disease, heart disease, liver disease, epilepsy, severe asthma, high blood pressure (12) Pregnant or breastfeeding In the case of screening, it was found that female volunteers of childbearing age wishing to participate in the research project were not pregnant or in the planning stage. In the case of symptoms suggesting a predisposition to pregnancy, the trial recommends that participants perform a self-confirmed urine pregnancy test prior to enrolling in the trial. And recommend periodic inspections throughout the duration of participating in the project to protect the safety of the volunteers. (13) Currently participating in another research project (14) Prednisolone was taken 1 week prior to study participation. (15) Volunteers who cannot read or write
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total nasal symptom scores (TNSS) at 0, 3, 6 weeks patient self-assessment model | — |
Secondary
| Measure | Time frame |
|---|---|
| Minimal Cross-sectional Area (MCA) at 0, 3, 6 weeks Acoustic rhinometry | — |
Countries
Thailand
Contacts
Public ContactArunporn Itharat
Faculty of Medicine, Thammasat University
Outcome results
None listed