Anti-protozoal Effect of Steroid Hormone 20-hydroxyecdysone

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Giardia Lamblia Infection
• Intervention / Treatment: Drug: 20-hydroxyecdysone Oral; Drug: Metronidazole Oral; Drug: Placebo Oral

Detailed Description

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.

Measurement of anthropometric indices Demographic data will be obtained in the survey included age, gender, and body mass index (BMI) calculated as weight (kg)/height2 (m2).

Blood Sample Collection and Storage Five milliliters of peripheral venous blood sample will be taken (after 8-12 hours of fasting) from each participant and will be collected into HumaTube Serum Gel - C/A for ELISA. Serum will be appropriately obtained and stored at -20°C maximum of 30 days. All blood samples will be collected before and after therapy.

200 water sports athletes with Giardia infection will be randomized from 1 to 3 groups to receive 20-hydroxyecdysone, metronidazole and placebo preparations, respectively

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Uzbekistan
  • Uchtepa
    • Tashkent, Uchtepa, Uzbekistan, 100133
      • Research institute of epidemiology, microbiology and infectious diseases

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 23 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

- a presence of giardia lamblia in stool samples of partisipants

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: 20-hydroxyecdysone Oral; 100 mg (one pill) x two times a day orally, 10 consecutive days; Other Names: ecdysterone
Active Comparator: 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	Drug: Metronidazole Oral; 500 mg (one pill) x two times a day orally, 10 consecutive days; Other Names: Metronidazole
Placebo Comparator: 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	Drug: Placebo Oral; 100 mg (one pill) x two times a day orally, 10 consecutive days; Other Names: shugar pills

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anti-protozoal effect of steroid hormone 20-hydroxyecdysone	Detection of Anti-protozoal effect of steroid hormone 20-hydroxyecdysone	up to 24 months

Collaborators and Investigators

• Sponsor: Research Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan
• Investigators: Study Chair: Abdurakhim Toychiev, PhD, Research institute of epidemiology, microbiology and infectious diseases

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: March 30, 2021
• First Submitted That Met QC Criteria: March 30, 2021
• First Posted (Actual): April 1, 2021

Study Record Updates

• Last Update Posted (Actual): April 4, 2025
• Last Update Submitted That Met QC Criteria: April 1, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Intestinal Diseases; Infections; Digestive System Diseases; Gastrointestinal Diseases; Protozoan Infections; Parasitic Diseases; Intestinal Diseases, Parasitic; Giardiasis; Anti-Bacterial Agents; Anti-Infective Agents; Antiprotozoal Agents; Antiparasitic Agents; Metronidazole
• Other Study ID Numbers: 2019121819

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No