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临床试验/NCT06290219
NCT06290219尚未招募3 期

The Effect of Platelet-rich Plasma and Hyaluronic Acid Nasal Injection in the Treatment of Traumatic Olfactory Dysfunction

Taichung Veterans General Hospital1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年3月20日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
尚未招募
入组人数
80
试验地点
1
主要终点
phenyl ethyl alcohol odor detection threshold test

研究概览

简要总结

The purpose of this study is to explore the efficacy of injecting high-concentration platelet plasma combined with hyaluronic acid into the nasal olfactory mucosa in the treatment of traumatic anosmia.

详细描述

Causes of olfactory impairment include sinus diseases, post-viral olfactory dysfunction, neurological diseases, and post-traumatic lesions of the olfactory nerve. Since the outbreak of the COVID-19 in 2019, there has been a significant increase in the number of patients suffering from olfactory disorders, and the duration of loss of smell and taste varies. According to follow-up studies, nearly 46% of those patients still have symptoms of olfactory impairment one year after diagnosis, and nearly 7% have even completely lost their ability to smell. In recent years, injecting platelet-rich plasma into the nasal cavity has been a new method to improve the sense of smell. The effects of platelet-rich plasma can reduce chronic inflammation and cell-related damage and promote regeneration of olfactory tissue, while hyaluronic acid can promote the release of growth factors from platelets.

The purpose of this study is to explore the efficacy of injecting high-concentration platelet plasma combined with hyaluronic acid into the nasal olfactory mucosa in the treatment of traumatic anosmia. A total of 80 patients with olfactory dysfunction were collected from otolaryngology, head and neck outpatient clinics. Selection criteria are 18 years of age or older, and loss of olfactory function for more than 6 months after head trauma. Exclusion criteria are pregnant or lactating women, patients with compromised immune function, patients with acute or chronic sinus infection, patients with nasal polyps, patients with a history of sinonasal cancer, and patients with low platelets or hemophilia and other blood and blood cell-related diseases.

This study will establish experimental groups and control groups according to random distribution. Subjects in both groups received zinc tablets and olfactory training for 12 weeks. The experimental group additionally received an injection of platelet-rich plasma combined with hyaluronic acid. After treatment, patients return to the clinic to track the olfactory condition.

Before treatment, the subjects evaluated their olfactory function using a Visual Analogue Scale (VAS) and performed the phenyl ethyl alcohol odor detection threshold test and the traditional Chinese version of the University of Pennsylvania Olfactory Identification Test. In the experimental group, 10cc of blood will be drawn from the subjects in the experimental group, the drawn blood will be centrifuged, the centrifuge tube will be inverted 20 times to mix the plasma and hyaluronic acid, and finally 5cc of the plasma mixed with hyaluronic acid will be drawn out using an empty syringe. The project investigator injects plasma mixed with hyaluronic acid into the nasal septum and the medial side of the middle turbinate of the patient's nasal cavity under a nasal endoscope. The two groups will undergo the same olfactory tests three months later to compare the changes in olfactory function of the two groups of patients before and after treatment to explore the efficacy of injecting high-concentration platelet plasma combined with hyaluronic acid into the nasal olfactory mucosa to treat traumatic anosmia.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 years of age or older, and loss of olfactory function for more than 6 months after head trauma

排除标准

  • pregnant or lactating women, patients with compromised immune function, patients with acute or chronic sinus infection, patients with nasal polyps, patients with a history of sinonasal cancer, and patients with low platelets or hemophilia and other blood and blood cell-related diseases

研究组 & 干预措施

platelet-rich plasma combined with hyaluronic acid nasal injection

Experimental

a nasal injection of platelet-rich plasma combined with hyaluronic acid at the first day of the treatment. At the same time, one tablet of zinc gluconate (10mg) three times a day for 12 weeks and traditional olfactory training with 4 separate bottles of phenyl ethyl alcohol, lemon, eucalyptus, and clove oil. Patients were told to sniff each odorant for 10 seconds, twice a day for 12 weeks.

干预措施: platelet-rich plasma combined with hyaluronic acid (Combination Product)

platelet-rich plasma combined with hyaluronic acid nasal injection

Experimental

a nasal injection of platelet-rich plasma combined with hyaluronic acid at the first day of the treatment. At the same time, one tablet of zinc gluconate (10mg) three times a day for 12 weeks and traditional olfactory training with 4 separate bottles of phenyl ethyl alcohol, lemon, eucalyptus, and clove oil. Patients were told to sniff each odorant for 10 seconds, twice a day for 12 weeks.

干预措施: Zinc Gluconate 10 MG Oral Tablet (Drug)

platelet-rich plasma combined with hyaluronic acid nasal injection

Experimental

a nasal injection of platelet-rich plasma combined with hyaluronic acid at the first day of the treatment. At the same time, one tablet of zinc gluconate (10mg) three times a day for 12 weeks and traditional olfactory training with 4 separate bottles of phenyl ethyl alcohol, lemon, eucalyptus, and clove oil. Patients were told to sniff each odorant for 10 seconds, twice a day for 12 weeks.

干预措施: 4 bottles of phenyl ethyl alcohol, lemon, eucalyptus, and clove oil (Device)

Control

Active Comparator

one tablet of zinc gluconate (10mg) three times a day for 12 weeks and traditional olfactory training with 4 separate bottles of phenyl ethyl alcohol, lemon, eucalyptus, and clove. Patients were told to sniff each odorant for 10 seconds, twice a day for 12 weeks.

干预措施: Zinc Gluconate 10 MG Oral Tablet (Drug)

Control

Active Comparator

one tablet of zinc gluconate (10mg) three times a day for 12 weeks and traditional olfactory training with 4 separate bottles of phenyl ethyl alcohol, lemon, eucalyptus, and clove. Patients were told to sniff each odorant for 10 seconds, twice a day for 12 weeks.

干预措施: 4 bottles of phenyl ethyl alcohol, lemon, eucalyptus, and clove oil (Device)

结局指标

主要结局

phenyl ethyl alcohol odor detection threshold test

时间窗: up to 12 weeks

The phenyl ethyl alcohol (PEA) odor detection threshold test uses a rose-like PEA odorant to assess a patient's odor detection threshold.

traditional Chinese version of University of Pennsylvania Smell Identification Test (TC-UPSIT)

时间窗: up to 12 weeks

TC-UPSIT is the traditional Chinese version of the University of Pennsylvania Smell Identification Test. It is a modified version of the North American version, with 8 unfamiliar odorants replaced by other odorants.29 The TC-UPSIT consists of 40 tests as it follows the North American version of the University of Pennsylvania Smell Identification Test. In each test, the brown strip at the bottom of the test page consists of microcapsules of an odorant, which is released by scratching the strip using a pencil tip. The patient sniffs the released odorant and selects a response from 4 odor descriptor options that are used to identify the odorant. The TC-UPSIT score is the number of correct responses among the 40 tests taken.

次要结局

  • Visual Analogue Scale(up to 12 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rong-San Jiang

Professor

Taichung Veterans General Hospital

研究点 (1)

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