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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03869788
Other study ID # PEOFCSP
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date September 1, 2019
Est. completion date March 1, 2022

Study information

Verified date March 2019
Source Assiut University
Contact samah M Ahmad, demonstrator
Phone 00201025180292
Email samahahmad0411@gmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

WHO considers foodborne trematodes as neglected tropical diseases. Fascioliasis is the most widely distributed trematode reported from over 81 countries around the world it imposes its highest burden in developing countries


Description:

liver flukes are disease affecting herbivorous animals and caused by Fasciola hepatica and Fasciola gigantica In Egypt, donkeys and camels as well, are hosts for Fasciola gigantica. Fascioliasis also affects man . number of humans infected with Fasciola spp. has been estimated at 2.6 million . Globally, fascioliasis due to both fluke species is conservatively thought to cause production losses of over US$3 billion per annum .

These infection sources include foods, water and combinations of both. Ingestion of freshwater wild plants is the main source, with watercress and secondarily other vegetables involved. . Drinking of contaminated water, beverages and juices, ingestion of dishes and soups and washing of vegetables, fruits, tubercles and kitchen utensils with contaminated water are increasingly involved .

. Two clinical stages are recognized in humam fascioliasis: An acute stage coincides with the larval migration and worm maturation in the hepatic tissue, and a chronic stage coincides with the persistence of Fasciola worms in the bile ducts

- the acute phase of fascioliasis is characterized by fever, abdominal pain, hepatosplenomegaly, gastrointestinal disturbances, skin rashes, high leukocyte count, eosinophilia, anemia, and elevated erythrocyte sedimentation rate (ESR); abnormal liver function tests have also been reported .

- The latent phase is characterized by nonspecific symptoms, including vague gastrointestinal disturbances, and intermittent eosinophilia.

- The chronic phase is characterized by regular and constant biliary obstruction; symptoms include biliary colic pain, intermittent jaundice, eosinophilia, and right upper-quadrant abdominal tenderness. However, the percentage of asymptomatic infections is high .

Triclabendazole (TCBZ) is a benzimidazole derivative and is the current drug of choice for treating fascioliasis. What sets TCBZ aside from the other available fasciolicides is its ability to target flukes from as early as 3 days old right through to the fully mature stages ,. Due to the high prevalence of TCBZ resistance (TCBZ-R), effective management of drug resistance is now critical for sustainable livestock production Wich highlights the importance of plant essential oils as novel anti-parasitic agents; Some plant oils have immunomodulatory effects that could modify host- parasite immunobiology In addition, the safety and use of plant essential oils in drug resistant cases are considered the most advantages.

Allium sativum commonly called garlic belongs to the family Alliaceae. It has been used for centuries to fight infections as an antioxidant ,antibacterial, antiviral, antifungal , anti-parasitic , antihypertensive , anthelmintic, and anti- diabetic agent .

Lately, the anthelmintic effect of garlic has been a matter of interest of researchers .

It's Potentially Active Chemical Constituents are :

- Sulfur compounds: aliin, allicin, ajoene, allylpropyl disulfide, diallyl trisulfide, s- allylcysteine, vinyldithiines, S-allylmercaptocystein, and others .

- Enzymes: allinase, peroxidases, myrosinase, and others .

- Amino acids and their glycosides: arginine and others .

- Selenium, germanium, tellurium and other trace minerals . Cloves (Syzygium aromaticum) Are the dried flower buds of an aromatic tree that is used as a spice. It mainly contains volatile oil, i.e. eugenol 81.1%, caryophyllin, tannins and gum.Clove oil has been used as analgesic, antibacterial, anticonvulsant, anticoagulant, antifungal, anti-inflammatory, antioxidant, antiseptic, antitumor, antiviral, disinfectant, immune stimulant as well as insecticidal .

Nanotechnology has a wide range of action in sciences like medicine, electronics, food and agriculture. Its application has strengthen systems to control diseases in animals, water disinfection, safety in systems of food supply, energy conversion, plague localization technology, advances in fast detection of morphological changes in the physicochemical properties of food, increment in nutrient value, quality control, food security, development of novel products and packing design .

It is the current trend in research field, using small size of materials with wide range of application . In nanotechnology there is treatment of atom, molecules or compounds to produce nanoparticle with different properties .The size and structure of nanoparticle is similar to most biological molecules, therefore nano particle can be useful for in research .

There are many types of nanoparticles: organic, inorganic, nanocrystals, nanotubes, polymeric structures such as dendrimers, etc. They are used primarily in research and drug delivery systems .

In that research garlic and cloves will be used in vitro to detect their fasciolicidal effects on adult Worm obtained from locally slaughtered animals .


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date March 1, 2022
Est. primary completion date March 1, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 16 Years to 85 Years
Eligibility Inclusion Criteria:

- vague gastrointestinal disturbances.

- intermittent eosinophilia.

- biliary obstruction.

- biliary colic pain.

- intermittent jaundice.

- right upper-quadrant abdominal tenderness.

Exclusion Criteria:

- no exclusion Criteria

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Egypt Assiut University Hospital Assiut

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

Nahed HA, Hoda AT, Yomna IM. Effects of garlic on albino mice experimentally infected with Schistosoma mansoni: a parasitological and ultrastructural study. Trop Biomed. 2009 Apr;26(1):40-50. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Number of human cases whose stool examination positive for fasciola eggs . Stool analysis will be done to detect eggs of fasciola worm by direct smear and concentration techniques .
to patients complaining of vague gastrointestinal disturbances, and biliary colic pain, intermittent jaundice and right upper quadrant abdominal tenderness .
One year
See also
  Status Clinical Trial Phase
Not yet recruiting NCT06367361 - One and Two Doses of Oxfendazole Versus a Schedule of Two Doses of Triclabendazole in Chronic Fascioliasis Phase 2
Recruiting NCT04230148 - Study of Safety, Tolerability and Clinical Outcomes of Egaten in Fascioliasis Patients (6 Years of Age or Older). Phase 4