Trial · NCT07899515
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Total Nasal Symptom Score (TNSS) | Baseline, Day 7 (±1 day), and Day 14 (±1 day) | The Total Nasal Symptom Score (TNSS) was used to assess four nasal symptoms: nasal congestion, rhinorrhea, nasal itching, and sneezing. Each symptom was rated on a 4-point scale from 0 to 3, with 0 indicating no symptoms and 3 indicating severe symptoms. The four item scores were summed to obtain a total score ranging from 0 to 12, with higher scores indicating greater symptom severity. |
| Secondary | Nasal Sign Score (inferior turbinate swelling score) | baseline, Day 7 (±1 day), and Day 14 (±1 day) | Nasal signs were assessed by examination of the nasal cavity, with the degree of inferior turbinate swelling rated on a 4-point scale from 0 to 3 according to the prespecified study criteria. A score of 0 indicated no swelling, whereas higher scores represented progressively greater inferior turbinate swelling. |
| Secondary | Traditional Chinese Medicine syndrome score for Fei-deficiency and cold syndrome | Baseline, Day 7 (±1 day), and Day 14 (±1 day) | The TCM syndrome score was assessed using the prespecified quantitative scale for Fei-deficiency and cold syndrome. The four principal symptoms-nasal congestion, rhinorrhea, nasal itching, and sneezing-were rated as 0, 2, 4, or 6 according to severity. Secondary symptoms and nasal signs were scored according to the prespecified study criteria. Individual item scores were summed to obtain the total TCM syndrome score, with higher scores indicating greater syndrome severity. |
| Secondary | Visual Analogue Scale (VAS) for nasal symptoms | Baseline and daily during the 14-day treatment period (Day 1 to Day 14) | The Visual Analogue Scale (VAS) was used to assess the daily severity of nasal symptoms. Participants rated their symptom severity on a 0-10 cm continuous scale, where 0 indicated no symptoms and 10 indicated the most severe symptoms imaginable. VAS assessments included four major nasal symptoms: nasal congestion, rhinorrhea, nasal itching, and sneezing. Participants completed the baseline assessment and recorded symptom scores daily after initiation of study medication for 14 consecutive days. Higher scores indicated greater symptom severity. |
| Secondary | Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score | Baseline, Day 7 (±1 day), and Day 14 (±1 day) | The 28-item Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) was used to assess the impact of allergic rhinitis on health-related quality of life. The questionnaire covers seven domains: activity limitations, sleep problems, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional function. Each item is rated from 0 (not troubled) to 6 (extremely troubled). Overall and domain scores were calculated according to the questionnaire scoring method, with higher scores indicating greater impairment in quality of life. |
| Secondary | Total Non-Nasal Symptom Score (TNNSS) | Baseline, Day 7 (±1 day), and Day 14 (±1 day) | The Total Non-Nasal Symptom Score (TNNSS) was used to assess associated symptoms, including postnasal drip, tearing, ocular itching, nasal or palatal itching, and headache. Each symptom was rated as absent (0) or present (1), and the individual scores were summed to obtain the total score. Higher scores indicated greater severity of associated symptoms. |
| Other | Number of Participants With Clinically Significant Laboratory Abnormalities | Baseline and Day 14 (±1 day) | Laboratory safety assessments include hematology (red blood cell count, white blood cell count, neutrophil percentage, lymphocyte percentage, platelet count, and hemoglobin), serum biochemistry (ALT, AST, serum creatinine, and blood urea nitrogen), and urinalysis (urine protein, glucose, ketones, occult blood, white blood cell count, and red blood cell count). Findings will be categorized as normal, abnormal without clinical significance, abnormal with clinical significance, or not tested. At each assessment, participants with at least one clinically significant laboratory abnormality will be counted once, regardless of the number of abnormal parameters. |
| Other | Number of Participants With Clinically Significant ECG Abnormalities | baseline and Day 14 (±1 day) | Electrocardiogram (ECG) examinations will include assessment of heart rate, corrected QT (QTc) interval, and other ECG findings. Results will be classified as normal or abnormal, and abnormal findings will be evaluated for clinical significance by the investigator. The number of participants with at least one clinically significant ECG abnormality will be reported at each assessment time point. |
| Other | Systolic Blood Pressure | baseline, Day 7 (±1 day), and Day 14 (±1 day) | Systolic blood pressure will be measured in millimeters of mercury (mmHg) and recorded at each scheduled assessment. |
| Other | Diastolic Blood Pressure | Baseline, Day 7 (±1 day), and Day 14 (±1 day) | Diastolic blood pressure will be measured in millimeters of mercury (mmHg) and recorded at each scheduled assessment. |
| Other | Heart Rate | Baseline, Day 7 (±1 day), and Day 14 (±1 day) | Heart rate will be measured in beats per minute (bpm) and recorded at each scheduled assessment. |
| Other | Respiratory Rate | Baseline, Day 7 (±1 day), and Day 14 (±1 day) | Respiratory rate will be measured in breaths per minute and recorded at each scheduled assessment. |
| Other | Body Temperature | Baseline, Day 7 (±1 day), and Day 14 (±1 day) | Body temperature will be measured in degrees Celsius (°C) and recorded at each scheduled assessment. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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