Surgical resection and liver transplantation are the primary curative treatments for hepatocellular carcinoma (HCC). However, many patients are ineligible for these treatments due to advanced disease, social factors, or limited availability of liver donors. Therefore, for patients with unresectable HCC, locoregional therapies like transarterial radioembolization (TARE with Y90) are considered the next best non-operative option, especially when the cancer remains confined to the liver. Despite the use of these liver-directed therapies, relapse rates and mortality remain high, underscoring the need for new predictive biomarkers and therapeutic targets, including immune modulation.
The rationale behind NP-101 (TQ formula) stems from its immune modulatory properties as a potent drug derived from a natural substance, black seed or Nigella Sativa. Previous studies have demonstrated its immune modulation and anti-cancer effects, showing promise in preclinical models of HCC. In a randomized phase 2 study conducted in Covid patients, NP-101 exhibited safety and significantly increased T effector cells (CD4+ and CD8+ T lymphocytes), resulting in accelerated recovery. The immune modulation effect of NP-101, observed in the Covid study, and its potential to enhance CD4+ and CD8+ T effector lymphocytes can potentially modify the immune microenvironment and improve outcomes in locally advanced HCC patients undergoing Y90 treatment.
This study will investigate the safety, efficacy and maximum tolerated dose of NP-101 in patients with unresectable hepatocellular carcinoma.
The dosing scheme for NP-101 in this study will follow a Bayesian Optimal Interval design. Based on the target dose-limiting toxicity (DLT) rate of 30% and assuming a 3+3 design, three subjects will be sequentially enrolled at each of the 3 dose levels (beginning with 3g) until at least one DLT occurs.
If no DLTs occur, dosing will be escalated to the next dose level for the next three enrolled subjects. At either of the two dose levels, if 1 DLT occurs, three more subjects will be enrolled at that dose level. If no DLTs occur in these subjects, three more subjects will be enrolled at the next highest dose level. Dosing escalation will be stopped if two or more total DLTs occur at any dose level. The maximum tolerated dose (MTD) will be one dose level below the dose level at which two or more DLTs occurred.

Start Date01 Apr 2025

Sponsor / Collaborator

University of Florida

[+2]

IRCT20190215042716N8

/ SuspendedPhase 2/3IIT

Investigating the effect of topical application of Nigella Sativa oil on the prevention of bedsores in hospitalized patients in Ispecial care unit Martyr Dr.Labafi Nejad Superspeciality Teaching Hospital in Tehran

Start Date20 Jan 2025

Sponsor / Collaborator

Islamic Azad University

NCT06030141

/ CompletedNot ApplicableIIT

Investigation of the Effect of Nigella Sativa Oil and Sesame Oil in Preventing Phlebitis

Phlebitis is an inflammatory reaction of the venous system and surrounding tissues that may be associated with mechanical, chemical or infectious microorganisms; It is the most common complication of intravenous injection. Symptoms of phlebitis; local pain, swelling, warmth, erythema, tenderness; prominent redness and palpable firmness and purulent discharge along the vascular access.
Phlebitis is the most important peripheral intravenous catheter-related complication and is seen in 0.1%- 63.3% of patients with peripheral intravenous catheters. Intravenous amiodarone is an important treatment for arrhythmias. However, peripheral infusion causes direct irritation of the vessel walls. Intravenous amiodarone is one of the most widely used antiarrhythmics for the treatment of atrial fibrillation with rapid ventricular response.
However, peripheral infusion of amiodarone usually causes pain during the infusion followed by phlebitis. Peripheral intravenous infusion of amiodarone associated with phlebitis is common in clinical practice, with an incidence of 5% to 65%.
Herbal treatment is a popular method in recent years In recent studies to prevent phlebitis, it has been determined that topical application of sesame oil and black cumin oil is effective in preventing phlebitis.
Sesame oil has antioxidant, anti-inflammatory and antibacterial properties and contains several lignans such as sesamin and sesaminol that inhibit inflammation, including interleukin 8 and endothelin 1. The therapeutic properties of black seed oil are due to the presence of phenolic compounds, especially thymoquinone. The anti-inflammatory mechanism of action of black seed oil occurs by inhibiting cyclo-oxygenase and 5-lipoxygenase pathways and preventing the production of thromboxane B2 and leukotriene B4.
There is no study in the literature comparing the effects of sesame oil and black cumin oil to prevent phlebitis.

Start Date15 Nov 2023

Sponsor / Collaborator-

100 Clinical Results associated with Nigella Sativa(Novatek Pharmaceuticals)

100 Translational Medicine associated with Nigella Sativa(Novatek Pharmaceuticals)

100 Patents (Medical) associated with Nigella Sativa(Novatek Pharmaceuticals)

113

Literatures (Medical) associated with Nigella Sativa(Novatek Pharmaceuticals)

01 Apr 2025·Behavioural Brain Research

Nigella sativa oil modulates neurobehavioral and neurochemical alterations in alcohol-exposed rats: An in vivo and in silico study

Article

Author: Rafi, Sidra ; Homberg, Judith R ; Haleem, Darakhshan Jabeen ; Asrar, Beenish ; Hassam, Muhammad ; Ullah, Ikram

BACKGROUNDChronic alcohol (ethanol) drinking changes central serotonin and dopamine levels, and thereby the functioning of brain circuits that support cognition and anxiety. Previously, it has been proven that Nigella sativa oil (NSO) improves cognition and reduces anxiety by regulating the neurotransmission but the underlying mechanisms are unknown.METHODSTo address the knowledge gap, an in vivo experiment was done to investigate effects of NSO on behavior and neurotransmission in ethanol drinking Wistar male rats. Specifically, control, NSO treated, ethanol and ethanol + NSO treated groups were tested for changes in anxiety-like behavior, locomotor activity and learning and memory using the elevated plus-maze test (EPM) and light and dark (L&D) box test; open field test (OFT) and Morris water maze (MWM) test, respectively. Brain neurotransmitter concentrations were determined using HPLC-EC. To validate the in vivo findings, we assessed in silico the docking between NSO compounds and proteins using auto dock vina.KEY FINDINGSEthanol and NSO reduced weight in the ethanol and ethanol + NSO groups. Food intake, fluid consumption, calorie intake, and growth were similarly affected by ethanol and NSO. In the in behavioral tests, ethanol drinking rats spent less time in the open arms of the EPM and had fewer entries compared to controls, while ethanol + NSO group also showed reduced entries. Similar patterns were observed in the OFT. No differences were found in the L&D box test. In the memory tests, ethanol + NSO treatment increased latency in short-term memory, while ethanol consumption increased latency in retention. Neurochemical analysis revealed that ethanol + NSO treatment increased serotonin levels in the PFC and hippocampus while reducing dopamine levels in the PFC compared to all groups, and in the hippocampus compared to control and NSO groups. The in silico experiment revealed that NSO has nine main active compounds. By molecular docking, we found that all nine compounds showed good binding affinity with our target proteins but the best docking values were obtained with thymoquinone and dithymoquinone. The binding affinity estimations identified the superior binding affinity and efficiency of dithymoquinone over all nine NSO compounds for serotonin, dopamine receptors and MAO-enzymes.CONCLUSIONS AND SIGNIFICANCENSO partially modulated ethanol induced neurobehavioral and neurochemical alterations, improving serotonin levels but not fully reversing behavioral deficits. Further studies are needed to explore its protective potential.

09 Aug 2024·Medicine

A randomized, double-blind, placebo-controlled study to evaluate the benefits of a standardized Nigella sativa oil containing 5% thymoquinone in reducing the symptoms of seasonal allergy

Article

Author: Mundkur, Lakshmi ; Majeed, Anju ; Murali, Avinash ; Gudimallam, Satish ; Siddegowda, Chikkalingaiah ; Parameswarappa, Avinash Kadasiddappa ; Chandrashekar, Harshith ; Majeed, Shaheen

Background:Allergic rhinitis (AR) or seasonal allergy characterized by sneezing, nasal congestion, nasal itching, and nasal discharge, triggered by immune reactions to environmental allergens. Present day customers also monitor the personal improvements in the area of Evidence-Based natural medicines/supplementsMethods:A randomized, double-blind, placebo-controlled study was conducted on 65 participants aged 18 to 60 years having 2 or more allergic symptoms like sneezing, rhinorrhoea, nasal obstruction, and nasal itching for a cumulative period greater than 1 hour per day. The study participants received a capsule of NSO (250 mg) with 2.5 mg piperine (BioPerine) as a bioavailability enhancer or a placebo, twice a day, after food for 15 days. The primary objectives were evaluated by mean change in Total Nasal Symptom Score and the duration of AR symptoms per day from baseline to Day 15. Secondary endpoints were changes in Total Ocular Symptoms Score, AR symptom frequency and severity, serum Immunoglobulin E levels, and Patient Global Impression of Change scale. Adverse events were monitored throughout the study.Results:Sixty-five patients were enrolled and all of them completed the study, N = 33 in NSO and N = 32 in placebo. A significant reduction in Total Nasal Symptom Score and Total Ocular Symptoms Score was observed in the NSO group compared to the placebo, highlighting the potential of NSO in alleviating AR symptoms. The episodes of AR symptoms per day and the frequency of symptoms in 24 hours reduced significantly in 15 days in both groups, but the extent of improvement was significantly higher in NSO compared to placebo. Improvement in Patient Global Impression of Change was also significantly better in NSO compared to the placebo. Serum Immunoglobulin E levels decreased in NSO but were not significantly different from placebo. No clinically significant changes were observed in vital signs, liver and renal function, lipid profile, hematology, fasting blood sugar, or urine analysis at the end of the study.Conclusion:The result of the study demonstrates that NSO 250 mg with 2.5 mg piperine is an effective and well-tolerated supplement for the management of AR symptoms.

01 Jul 2024·Heliyon

Manuka combinations with nigella sativa and hydroxyurea in treating iron overload of pediatric β-thalassemia major, randomized clinical trial

Article

Author: Elberry, Ahmed A ; Hussein, Raghda R S ; Abdelhalim, Shaimaa M ; Meabed, Mohamed Hussein ; Gamaleldin, Mohamed M ; Mahmoud Hussein, Ahmed F ; Abraham, Ivo L

Backgroundβ-thalassemia major is microcytic hypochromic anemia disorder inherited from parents, resulting from a mutation in the β-globin locus. As a result, a quantitative defective hemoglobin synthesis and relative excess in α-globin is occurred. As such, frequent blood transfusion is required, that leads to iron overload. Iron overload results in several pathological complications, including cell death, tissue injury, organ dysfunction, and liver fibrosis. The present study examined the effectiveness of nigella Sativa and manuka honey combination or manuka honey alone to the conventional therapy (Deferasirox + blood transfusion) used for preventing and managing iron overload in pediatric β-thalassemia major patients.MethodsOne hundred sixty-five patients participated in this randomized, double-blind, standard therapy-controlled, parallel-design multisite trial. The patients were randomly allocated into three groups, receiving either 500 mg nigella sativa oil combined with manuka honey lozenge (344 mg) daily or manuka honey alone plus the conventional therapy for ten treatment months. Ferritin level, serum iron, transferrin saturation, total iron binding capacity, alanine transaminase, and aspartate transaminase were determined at baseline and month 10.ResultsEventually, serum ferritin and iron were decreased significantly in the nigella sativa + manuka honey group as compared with the control group. Other clinical parameters were significantly impacted. The level of alanine transaminase and aspartate transaminase were significantly decreased in the nigella sativa plus manuka honey group compared with the control group.ConclusionResults showed that nigella sativa plus manuka honey was more effective than manuka alone or the conventional treatment alone in managing iron overload of β-thalassemia major patients.

News (Medical) associated with Nigella Sativa(Novatek Pharmaceuticals)

28 Nov 2022

·www.biospace.com

Therapeutic Solutions International Granted Broad Patent on Treatment of Neurodegenerative Conditions

Phase III Adult Stem Cell Company Covers Ability of its COVID-19 Nutraceutical to Repair Injured Brain Cells and Stimulate Endogenous Brain Stem Cells ELK CITY, Idaho--(BUSINESS WIRE)-- Therapeutic Solutions International (TSOI) announced today issuance of United States Patent # 11,504,4101 which in its broadest claim covers: “A method of protecting from damage and/or of regenerating a neurological tissue, comprising administration of: (a) pterostilbene, and/or blueberry, and/or an extract thereof; (b) green tea and/or an extract thereof; (c) Nigella sativa and/or an extract thereof; and (d) broccoli and/or an extract thereof.” Dependent patent claims cover various mechanisms of neural protection and regeneration, as well as treatment of different pathologies which cause neural deterioration. The Company views the issuance of these claims in an extremely positive manner because they not only cover the composition of matter of its commercially available immune modulatory nutraceutical QuadraMune®, but they also cover individual ingredients that comprise QuadraMune®. “If one searches pterostilbene, nigella sativa, sulforaphane, or EGCG, you can see that these ingredients are already used for a variety of nutraceutical applications. The fact that we have an issued patent covering their use for brain regeneration both alone and together, positions the Company strongly in this crowded space,” said Dr. James Veltmeyer, Chief Medical Officer of the Company, and co-inventor on the patent. “We are in a very rare and unique situation in that after we filed the patent, numerous independent academic institutes have confirmed the biological properties of these ingredients that we covered in the patent and now have been granted to us for conceptualizing them before anyone else.” There are many examples of the science behind QuadraMune® being confirmed by independent groups. One example was the work of Johns Hopkins University which showed COVID-19 virus inhibition by one of the ingredients in QuadraMune® after the Company filing its patents2. This is the third patent issued surrounding QuadraMune® and its ingredients. The first covered therapeutic immune modulation and inhibition of the immune suppressive enzyme indolamine 2,3 deoxygenase (#11,229,6743), and the second patent covered the prevention and treatment of COVID-19 (#11,266,7074). “As a Company, our main mission is to hyper-accelerate scientific and corporate progress which is essential for delivering life-saving medicine to patients who have no other options. Whether it is successful treatment of epilepsy5, Emergency INDs for treatment of COVID-196, or treatment of cancer patients with ValloVax7, we are happy for the support our efforts are receiving,” said Timothy Dixon, President, and CEO of the Company and co-inventor. “The granting of these broad claims in our recently issued patent provides strong support for the scientific innovation of our work and we believe will accelerate our commercial and patient success.” About Therapeutic Solutions International, Inc. Therapeutic Solutions International is focused on immune modulation for the treatment of several specific diseases. The Company's corporate website is . 1 Neuroprotection and neuroregeneration by pterostilbene and compositions thereof 2 John Hopkin’s University Publishes Efficacy of QuadraMune™ Ingredient Sulforaphane at Inhibiting Coronavirus in Laboratory Studies 3 Nutraceuticals for suppressing indolamine 2,3 deoxygenase 4 Nutraceuticals for the prevention, inhibition, and treatment of SARS-CoV-2 and associated COVID-19 5 Therapeutic Solutions International Announces Successful Treatment of Epilepsy in Animal Model and Complete Cessation of Seizures in Treatment Resistant Patient 6 Therapeutic Solutions International Granted Emergency IND by FDA for Expanded Patient Access to JadiCell™ Universal Donor Stem Cell for COVID-19 ARDS Outside of Ongoing Phase III Clinical Trial 7 Therapeutic Solutions International Spin-Off Res Nova Bio Collaborates with Veltmeyer MD Inc. to Provide Breast Cancer Patients Access to Novel Cancer Immunotherapy

ImmunotherapyPhase 3

100 Deals associated with Nigella Sativa(Novatek Pharmaceuticals)

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Indication	Highest Phase	Country/Location	Organization	Date
COVID-19	Phase 2	United States	Novatek Pharmaceuticals, Inc.	08 Jun 2021
Unresectable Hepatocellular Carcinoma	Phase 1	United States	Novatek Pharmaceuticals, Inc.	01 Apr 2025
Unresectable Hepatocellular Carcinoma	Phase 1	United States	University of Florida	01 Apr 2025
Gastro-Enteropancreatic Neuroendocrine Tumor	Phase 1	United States	Novatek Pharmaceuticals, Inc.	15 Dec 2022
Neuroendocrine Carcinoma	Phase 1	United States	Novatek Pharmaceuticals, Inc.	15 Dec 2022

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04914377 (BOSS, CTgov)	Phase 2	COVID-19	55	TQ Formula/Tab (Active Drug)	(bsvgdmjent) = pdxmbmlylb yfdzvrhiop (abjbhaywoz, peacxbrhzo - woqynzdons) View more	-	14 Aug 2024
				TQ Formula/Tab (Placebo)	(bsvgdmjent) = vjbjlekgpm yfdzvrhiop (abjbhaywoz, pvlcsoazdj - tbnchvtuwb) View more

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