Anti-protozoal Effect of Steroid Hormone 20-hydroxyecdysone
NCT ID: NCT04827537
Last Updated: 2025-04-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
PHASE2/PHASE3
200 participants
INTERVENTIONAL
2021-01-01
2027-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The aim of the study is to assess anti-protozoal activity of 20-hydroxyecdysone in water sports athletes with giardiasis.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Impact of Anti-Giardia and Antihelmintic Treatment on Infant Growth in Bangladesh
NCT00607074
Treatment of Clonorchiasis in Guangxi With Albendazole, Tribendimidine, and Praziquantel
NCT07074444
Compassionate Use of Triclabendazole for the Treatment of Parasites (Prior to FDA Approval; Expanded Access Program)
NCT01931085
Sm-TSP-2 Schistosomiasis Vaccine in Healthy Ugandan Adults
NCT03910972
Arachidonic Acid Treatment Against Schistosomiasis Infection in Children
NCT02144389
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
20-hydroxyecdysone Oral
100 mg (one pill) x two times a day orally, 10 consecutive days
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
Metronidazole Oral
500 mg (one pill) x two times a day orally, 10 consecutive days
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
Placebo Oral
100 mg (one pill) x two times a day orally, 10 consecutive days
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
20-hydroxyecdysone Oral
100 mg (one pill) x two times a day orally, 10 consecutive days
Metronidazole Oral
500 mg (one pill) x two times a day orally, 10 consecutive days
Placebo Oral
100 mg (one pill) x two times a day orally, 10 consecutive days
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* 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.
18 Years
27 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Research Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Svetlana Osipova, MD, PhD, DS
Dr.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Abdurakhim Toychiev, PhD
Role: STUDY_CHAIR
research institute of epidemiology, microbiology and infectious diseases
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Research institute of epidemiology, microbiology and infectious diseases
Tashkent, Uchtepa, Uzbekistan
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2019121819
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.