Anti-protozoal Effect of Steroid Hormone 20-hydroxyecdysone
Primary Purpose
Giardia Lamblia Infection
Status
Active
Phase
Phase 2
Locations
Uzbekistan
Study Type
Interventional
Intervention
20-hydroxyecdysone Oral
Metronidazole Oral
Placebo Oral
Sponsored by
About this trial
This is an interventional treatment trial for Giardia Lamblia Infection
Eligibility Criteria
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.
Sites / Locations
- Research institute of epidemiology, microbiology and infectious diseases
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
20-hydroxyecdysone group
metronidazole group
placebo group
Arm Description
water sports athletes with Giardia infection will receive 20-hydroxyecdysone (100 mg (one pill) x two times a day orally), 10 consecutive days
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
water sports athletes with Giardia infection will receive placebo preparation, 100 mg (one pill) x two times a day orally, 10 consecutive days
Outcomes
Primary Outcome Measures
Anti-protozoal effect of steroid hormone 20-hydroxyecdysone
Detection of Anti-protozoal effect of steroid hormone 20-hydroxyecdysone
Secondary Outcome Measures
Full Information
NCT ID
NCT04827537
First Posted
March 30, 2021
Last Updated
April 7, 2022
Sponsor
Research Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan
1. Study Identification
Unique Protocol Identification Number
NCT04827537
Brief Title
Anti-protozoal Effect of Steroid Hormone 20-hydroxyecdysone
Official Title
Anti-protozoal Effect of Steroid Hormone 20-hydroxyecdysone
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
December 31, 2027 (Anticipated)
Study Completion Date
December 31, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Research Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Giardia Lamblia Infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
20-hydroxyecdysone group
Arm Type
Experimental
Arm Description
water sports athletes with Giardia infection will receive 20-hydroxyecdysone (100 mg (one pill) x two times a day orally), 10 consecutive days
Arm Title
metronidazole group
Arm Type
Active Comparator
Arm Description
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
Arm Title
placebo group
Arm Type
Placebo Comparator
Arm Description
water sports athletes with Giardia infection will receive placebo preparation, 100 mg (one pill) x two times a day orally, 10 consecutive days
Intervention Type
Drug
Intervention Name(s)
20-hydroxyecdysone Oral
Other Intervention Name(s)
ecdysterone
Intervention Description
100 mg (one pill) x two times a day orally, 10 consecutive days
Intervention Type
Drug
Intervention Name(s)
Metronidazole Oral
Other Intervention Name(s)
Metronidazole
Intervention Description
500 mg (one pill) x two times a day orally, 10 consecutive days
Intervention Type
Drug
Intervention Name(s)
Placebo Oral
Other Intervention Name(s)
shugar pills
Intervention Description
100 mg (one pill) x two times a day orally, 10 consecutive days
Primary Outcome Measure Information:
Title
Anti-protozoal effect of steroid hormone 20-hydroxyecdysone
Description
Detection of Anti-protozoal effect of steroid hormone 20-hydroxyecdysone
Time Frame
up to 24 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
27 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abdurakhim Toychiev, PhD
Organizational Affiliation
research institute of epidemiology, microbiology and infectious diseases
Official's Role
Study Chair
Facility Information:
Facility Name
Research institute of epidemiology, microbiology and infectious diseases
City
Tashkent
State/Province
Uchtepa
ZIP/Postal Code
100133
Country
Uzbekistan
12. IPD Sharing Statement
Learn more about this trial
Anti-protozoal Effect of Steroid Hormone 20-hydroxyecdysone
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