Anti-protozoal Effect of Steroid Hormone 20-hydroxyecdysone

NCT04827537 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: 2019121819
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Giardia Lamblia Infection

Outcome Measures

Primary Outcomes (1)

• Anti-protozoal effect of steroid hormone 20-hydroxyecdysone

  Detection of Anti-protozoal effect of steroid hormone 20-hydroxyecdysone

  up to 24 months

Study Arms (3)

20-hydroxyecdysone group

EXPERIMENTAL

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

metronidazole group

ACTIVE COMPARATOR

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

placebo group

PLACEBO COMPARATOR

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

Interventions

20-hydroxyecdysone Oral DRUG

100 mg (one pill) x two times a day orally, 10 consecutive days

Also known as: ecdysterone

20-hydroxyecdysone group

Metronidazole Oral DRUG

500 mg (one pill) x two times a day orally, 10 consecutive days

Also known as: Metronidazole

metronidazole group

Placebo Oral DRUG

100 mg (one pill) x two times a day orally, 10 consecutive days

Also known as: shugar pills

placebo group

Eligibility Criteria

• Age: 18 Years - 27 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \- a presence of giardia lamblia in stool samples of partisipants

You may not qualify if:

• 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.

Sponsors & Collaborators

• Research Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan: lead

Study Sites (1)

Research institute of epidemiology, microbiology and infectious diseases

Tashkent, Uchtepa, 100133, Uzbekistan

Location

MeSH Terms

Conditions

Giardiasis

Interventions

Ecdysterone; Metronidazole

Condition Hierarchy (Ancestors)

Intestinal Diseases, Parasitic; Parasitic Diseases; Infections; Protozoan Infections; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Ecdysteroids; Cholestenones; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Insect Hormones; Invertebrate Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Abdurakhim Toychiev, PhD

  research institute of epidemiology, microbiology and infectious diseases

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: March 30, 2021
• First Posted: April 1, 2021
• Study Start: January 1, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 4, 2025

Record last verified: 2025-04

Locations

UZ (1)