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Anti-cancer Potentiality of Saffron Against Hepatocellular Carcinoma

Anti Cancer Potential of Saffron in Hepatocellular Carcinoma

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06464380
Enrollment
40
Registered
2024-06-18
Start date
2024-10-30
Completion date
2025-10-01
Last updated
2024-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma

Keywords

Saffron

Brief 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.

Interventions

DIETARY_SUPPLEMENTSaffranal

HCC patients will receive 50 mg safranal regimen in dose of once per day for six months.

DIETARY_SUPPLEMENTPlacebo

HCC patients will receive Placebo in dose of once per day for six months.

Sponsors

Mohamed, Ahmed A., M.D.
CollaboratorINDIV
Amr Amin College of Medicine, University of Sharjah, Sharjah 27272, UAE.
CollaboratorUNKNOWN
Ahmed Cordie Endemic Medicine department, Cairo University Hospitals.
CollaboratorUNKNOWN
Nouran Mohamed Endemic Medicine department, Cairo University Hospitals.
CollaboratorUNKNOWN
Gamal Esmat Faculty of Biotechnology, Misr University for Science and Technology, Giza, Egypt.
CollaboratorUNKNOWN
Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

Single blinded

Intervention model description

randomized clinical trial

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
overall survivalthree monthsoverall survival in patients presented with end-stage hepatocellular carcinoma.

Secondary

MeasureTime frameDescription
treatment responsethree monthsresponse to treatment through impact on the underlying liver status

Countries

Egypt

Contacts

Primary ContactAmal A. Elkholy
amal.elkhouly@pharma.asu.edu.eg01060355448

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026