The Efficacy of Traditional Chinese Medicine in Olfactory Dysfunction: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 278
- 试验地点
- 1
- 主要终点
- Olfactory function test result
研究概览
简要总结
Studies have demonstrated that patients with olfactory dysfunction could improve the olfactory function after olfactory training. But the efficacy of Traditional Chinese Medicine is unknown.The purpose of this study is to evaluate its efficacy in olfactory dysfunction.
详细描述
A recent meta-analysis found significant positive effects of olfactory training on the individual subcomponents of odor threshold, discrimination, identification, and the composite TDI score. In addition to the evidenced improvement in olfactory function after olfactory training, this form of treatment carries very little risk of adverse effects, is cheap, and can be administered by the patient. For these collective reasons, olfactory training is an attractive treatment modality. Chinese experts consensus on diagnosis and treatment of olfactory dysfunction in 2017 shown that some evidences proved that Traditional Chinese Medicine treatment would benefit olfactory dysfunction but the evidences is not adequate. Until now, the efficacy of Traditional Chinese Medicine is controversial. This study investigate the efficacy and the safety of Traditional Chinese Medicine and olfactory training as a treatment for patients with olfactory dysfunction.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of Olfactory dysfunction;
- •18 ≤ age ≤ 55 years old;
- •No active infection, such as uncontrolled pneumonia;
- •Women with reproductive potential and sexually active men agree to use acceptable and effective contraceptive methods.
排除标准
- •Refuse to sign informed consent;
- •With other diseases that affect the result, such as severe hepatic and renal dysfunction and the investigators believes will interfere with the treatment;
- •Pregnant or lactating women;
- •Without personal freedom and independent civil capacity;
- •Enrolled in other intervention clinical trials;
- •Autoimmune diseases;
- •Other situations that the investigators think are not suitable for the trial.
研究组 & 干预措施
Traditional Chinese Medicine with olfactory training
Traditional Chinese Medicine therapy:
Oral Traditional Chinese Medicine CU Xiu Tang once a day for at least 3 months
Olfactory training:
repeat and deliberate sniffing of a set of odorants for 20 seconds each at least twice a day for at least 3 months
干预措施: Traditional Chinese Medicine CU Xiu Tang (Drug)
Traditional Chinese Medicine with olfactory training
Traditional Chinese Medicine therapy:
Oral Traditional Chinese Medicine CU Xiu Tang once a day for at least 3 months
Olfactory training:
repeat and deliberate sniffing of a set of odorants for 20 seconds each at least twice a day for at least 3 months
干预措施: Olfactory Training (Other)
Olfactory training
repeat and deliberate sniffing of a set of odorants for 20 seconds each at least twice a day for at least 3 months
干预措施: Olfactory Training (Other)
结局指标
主要结局
Olfactory function test result
时间窗: 3 months
Olfactory tests combination of odor threshold (T), odor discrimination (D), and odor identification (I). The minimum values is 0, the maximum values of odor threshold (T), discrimination (D), and identification (I) is 16, the sum of the scores is TDI, which is between 0 to 48, the higher scores mean a better outcome.
次要结局
- Odor threshold (T), Odor Discrimination (D), Odor Identification (I)(3 months)
- the Visual Analogue Scale(VAS) of Olfactory Function(3 months)