Efficacy and Safety of High-Concentration 35 kDa Hyaluronan Gel for Chronic Nasopharyngitis (HA35)
A Prospective, Single-Arm, Open-Label Pilot Clinical Study to Evaluate Efficacy and Safety of Topical 10% 35 kDa Hyaluronan (HA35) Gel for Ultra-Rapid Relief of Skin Pruritus
調査の概要
状態
詳細な説明
This prospective, single-center, single-arm, open-label pilot clinical study is designed to investigate the efficacy and safety of a 13.6% high-concentration 35 kDa hyaluronan (HA35) nasopharyngeal care gel for the management of chronic rhinitis and chronic pharyngitis.
Participants meeting all eligibility criteria will receive the HA35 gel via nasopharyngeal administration, one unit per nostril, twice daily (morning and evening) for 10 consecutive days.
Symptom assessments will be performed at baseline, 30 minutes after the first administration, 1, 2, and 3 hours after the first morning dose, and on day 10. Assessments include numeric rating scales (NRS) for nasopharyngeal discomfort, posterior pharyngeal discomfort and cough, nasal airflow obstruction, overall rhinitis and pharyngitis symptom severity, and subjective mental clarity.
Safety evaluations will monitor all adverse events, local tolerability, and any unexpected reactions throughout the study period.
This study involves a non-invasive, non-pharmacological non-drug intervention with minimal risk to participants. All procedures will be conducted in accordance with the Declaration of Helsinki, and written informed consent will be obtained from all subjects prior to enrollment.
研究の種類
入学 (推定)
段階
- 適用できない
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Age 18-80 years, male or female
- Clinically diagnosed with chronic rhinitis and chronic pharyngitis for ≥3 months
- Baseline nasopharyngeal discomfort NRS score ≥4 points
- Baseline posterior pharyngeal discomfort NRS score ≥4 points
- Voluntary participation and signed written informed consent
- Ability to complete symptom assessment independently
Exclusion Criteria:
- Acute upper respiratory tract infection within 2 weeks
- Use of antihistamines, intranasal corticosteroids, decongestants, or other nasal medications within 2 weeks prior to screening
- History of nasal/sinus surgery within 6 months
- Known hypersensitivity to hyaluronan or any gel ingredients
- Pregnant or lactating women
- Severe systemic diseases or malignant tumors
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：HA35 Nasopharyngeal Care Gel Intervention Group
Participants will receive 13.6% high-concentration 35 kDa hyaluronan (HA35) nasopharyngeal care gel, administered via the nasopharyngeal route, one unit per nostril, twice daily (morning and evening) for 10 consecutive days.
The intervention is non-pharmacological and designed to evaluate efficacy and safety in subjects with chronic rhinitis and chronic pharyngitis.
|
A topical, non-pharmacological nasopharyngeal care gel containing 13.6% high-concentration 35 kDa hyaluronan.
It is designed to support mucosal hydration and reduce inflammation in the nasopharynx.
Administration is via direct nasopharyngeal application, twice daily for 10 consecutive days.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Posterior Pharyngeal Discomfort and Cough NRS Score (0-10)
時間枠：Baseline to 30 minutes after first administration
|
Change in posterior pharyngeal discomfort and associated cough intensity, measured using a 0-10 Numeric Rating Scale (NRS), where 0 = no discomfort/cough and 10 = worst imaginable discomfort/cough.
|
Baseline to 30 minutes after first administration
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- HA35202601
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。