Anti-protozoal Effect of Steroid Hormone 20-hydroxyecdysone
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Anti-protozoal effect of steroid hormone 20-hydroxyecdysone
研究概览
简要总结
20-hydroxyecdysone is an ecdysteroid hormone found in invertebrates and plants. 20-hydroxyecdysone exhibits a broad range of biological properties in various in vitro and in vivo models, including anabolic, antioxidant, anti-inflammatory, immunomodulatory, anti-obesity and antidiabetic activities, in addition to acting as neuroprotective and hepatoprotective agent. Ecdysteroids are widely used by athletes as dietary supplements to increase strength and muscle mass during resistance training, to reduce fatigue and to ease recovery. Mhashilkar AS et al. (2016) were revealed anti-parasitic activity of 20-hydroxyecdysone against the human filarial parasites. According to recent searches in academic databases and medical search engines (Google, www.google.com; PubMed, www.ncbi.nlm.nih.gov/pubmed; and Medline, www.medline.com), no studies have been conducted to assess the anti-protozoal activity of 20-hydroxyecdysone.
The aim of the study is to assess anti-protozoal activity of 20-hydroxyecdysone in water sports athletes with giardiasis.
详细描述
The randomized, double-blinded, placebo-controlled clinical study will be conducted by the Uzbek State University of Physical Education and Sport, Institute of the Chemistry of Plant Substances named acad. S. Yu. Yunusov and Republican Specialized Scientific and Practical Medical Center of Epidemiology, Microbiology, Infectious and Parasitic Diseases, Tashkent, Uzbekistan
Both informed and written consents will be obtained from the participants.
Study participants will be included about 200 athletes aged 18 to 27 years with giardiasis. All the participants will be residents of Uzbekistan.
Diagnosis of giardiasis will be based on the results of parasitological examination. Inclusion criteria:presence of giardia intestinalis in the stool samples of participant.
The exclusion criteria: chronic and acute infectious diseases, endocrine diseases, congenital diseases, allergic dermatitis, bronchial asthma, allergic rhinitis and/or conjunctivitis, other skin disorders, history of using vitamin D supplements within three months ago, or use of any medication influencing endocrine parameters.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 27 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •a presence of giardia lamblia in stool samples of partisipants
排除标准
- •chronic and acute infectious diseases,
- •endocrine diseases, congenital diseases,
- •allergic dermatitis,
- •bronchial asthma,
- •allergic rhinitis and/or conjunctivitis,
- •other skin disorders,
- •history of using vitamin D supplements within three months ago, or use of any medication influencing endocrine parameters.
研究组 & 干预措施
20-hydroxyecdysone group
water sports athletes with Giardia infection will receive 20-hydroxyecdysone (100 mg (one pill) x two times a day orally), 10 consecutive days
干预措施: 20-hydroxyecdysone Oral (Drug)
metronidazole group
water sports athletes with Giardia infection will receive metronidazole, 500 mg (one pill) x two times a day orally, 10 consecutive days
, and placebo preparations, respectively
干预措施: Metronidazole Oral (Drug)
placebo group
water sports athletes with Giardia infection will receive placebo preparation, 100 mg (one pill) x two times a day orally, 10 consecutive days
干预措施: Placebo Oral (Drug)
结局指标
主要结局
Anti-protozoal effect of steroid hormone 20-hydroxyecdysone
时间窗: up to 24 months
Detection of Anti-protozoal effect of steroid hormone 20-hydroxyecdysone
次要结局
未报告次要终点
研究者
Svetlana Osipova, MD, PhD, DS
Dr.
Research Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan