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Trial Title:
Anti-cancer Potentiality of Saffron Against Hepatocellular Carcinoma
NCT ID:
NCT06464380
Condition:
Hepatocellular Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Conditions: Keywords:
Saffron
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
randomized clinical trial
Primary purpose:
Treatment
Masking:
Single (Participant)
Masking description:
Single blinded
Intervention:
Intervention type:
Dietary Supplement
Intervention name:
Saffranal
Description:
HCC patients will receive 50 mg safranal regimen in dose of once per day for six months.
Arm group label:
safranal Group
Intervention type:
Dietary Supplement
Intervention name:
Placebo
Description:
HCC patients will receive Placebo in dose of once per day for six months.
Arm group label:
Control Group
Summary:
Saffron has recently gained considerable interest for its capacity to interfere with
cancer at initiation and promotion stages as well as for cancer treatment. Although
saffron and its constituents have been shown to have antitumorigenic and proapoptotic
activities in different cancer cell lines.
The aim of the current investigation is to identify the anti-cancer potentiality of
saffron on hepatocellular carcinoma patients.
Detailed description:
Hepatocellular carcinoma (HCC) is the fifth most common cancer and the third leading
cause of cancer mortality in the world. Chronic infection with hepatitis B and C is the
major risk factors for HCC worldwide. Other factors that contribute to the formation of
HCC include exposure to environmental carcinogens, iron overload, fatty liver disease,
and alcohol abuse.
there has been a sustained rise in its incidence in both developing and developed
countries. Despite the growing therapeutic options for patients with cancer, their
efficacy is time-limited and non-curative. Hence to overcome these drawbacks, an
incessant screening for superior and safer drugs has been ongoing for numerous decades,
resulting in the detection of anti-cancer properties of several phytochemicals.
Chemoprevention using readily available natural substances from vegetables, fruits, herbs
and spices is one of the significantly important approaches for cancer prevention in the
present era. Among the spices, saffron has generated interest because pharmacological
experiments have established numerous beneficial properties including radical scavenging,
anti-mutagenic and immuno-modulating effects.
Saffron is a naturally derived plant product from the dried stigma of the Crocus sativus
flower (family Iridaceae) that may have biologically useful properties. In fact, saffron
extract and its biologically active compounds, including crocin, crocetin, carotene, and
safranal, have been shown both in vitro and in vivo to possess antioxidant, anticancer,
anti-inflammatory, and memory-improving properties. Saffron is also used in folk medicine
as an antispasmodic, antidepressant, and aphrodisiac. Furthermore, it is one of the most
commonly used species around the world for flavouring and colouring foods.
Saffron has recently gained considerable interest for its capacity to interfere with
cancer at initiation and promotion stages as well as for cancer treatment. Although
saffron and its constituents have been shown to have antitumorigenic and proapoptotic
activities in different cancer cell lines.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Adult male and female patients above 18 years
- Patients with end-stage HCC not candidate for curative, loco regional treatment and
/or systemic chemotherapy
- Patients with available baseline laboratory parameters and contrast- enhancing
images after given written consent for research participation.
Exclusion Criteria:
- Patients who are candidate for curative and/or loco-regional or combination
treatment for HCC
- Patients with concomitant malignancies other than HCC
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Amal A. Elkholy
Address:
City:
Al 'Abbāsīyah
Zip:
123456
Country:
Egypt
Contact:
Last name:
Amal A. Elkholy
Phone:
01060355448
Email:
amal.elkhouly@pharma.asu.edu.eg
Facility:
Name:
Dermatology Clinic of National Hepatology and Tropical Medicine Research Institute
Address:
City:
Cairo
Zip:
123456
Country:
Egypt
Start date:
October 30, 2024
Completion date:
October 1, 2025
Lead sponsor:
Agency:
Ain Shams University
Agency class:
Other
Collaborator:
Agency:
Mohamed, Ahmed A., M.D.
Agency class:
Other
Collaborator:
Agency:
Amr Amin College of Medicine, University of Sharjah, Sharjah 27272, UAE.
Agency class:
Other
Collaborator:
Agency:
Ahmed Cordie Endemic Medicine department, Cairo University Hospitals.
Agency class:
Other
Collaborator:
Agency:
Nouran Mohamed Endemic Medicine department, Cairo University Hospitals.
Agency class:
Other
Collaborator:
Agency:
Gamal Esmat Faculty of Biotechnology, Misr University for Science and Technology, Giza, Egypt.
Agency class:
Other
Source:
Ain Shams University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06464380
