the study is intended to test the effect of Nigella sativa nasal oil drops on selected outcomes among patients with chronic rhinosinusitis using prospective clinical trial design. To achieve the aim of the current trial the following research hypotheses are postulated: H1. The total severity of symptoms mean scores of patients with CRS who will use Nigella sativa nasal oil drops will be different from the total severity of symptoms mean scores of a control group.
H2. The total sleep quality mean scores of patients with CRS who will use Nigella sativa nasal oil drops will be different from the total sleep quality mean scores of a control group.
H3. The total patient satisfaction mean scores of patients with CRS who will use Nigella sativa nasal oil drops will be different from the total patient satisfaction mean scores of a control group.

Start Date07 Aug 2022

Sponsor / Collaborator

Cairo University

IRCT201201025069N5 / CompletedNot ApplicableIIT

Efficacy of Nigella Sativa and Fish Oil in Vitiligo

Start Date22 Jun 2011

Sponsor / Collaborator-

100 Clinical Results associated with Nigella sativa nasal oil drops(Cairo University)

100 Translational Medicine associated with Nigella sativa nasal oil drops(Cairo University)

100 Patents (Medical) associated with Nigella sativa nasal oil drops(Cairo University)

109

Literatures (Medical) associated with Nigella sativa nasal oil drops(Cairo University)

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

01 Apr 2024·Health Science Reports

The efficacy and safety of Nigella sativa in the management of osteoarthritis: A systematic review

Article

Author: Fazlollahi, Asra ; Noordoost, Mahdi ; Safiri, Saeid ; Marandi, Hanieh ; Kolahi, Ali-Asghar ; Mousavi, Seyed Ehsan ; Sullman, Mark J M ; Nejadghaderi, Seyed Aria ; Karamzad, Nahid ; Noori, Maryam ; Rahmani, Shayan

AbstractBackground and AimsOsteoarthritis (OA) is one of the most common debilitating diseases among the aging population. Nigella sativa is one potential treatment for OA. Here, we sought to evaluate the efficacy and safety of Nigella sativa for treating patients with OA.MethodsPubMed, Scopus, Embase, and Web of Science were searched up to October 20, 2022. The primary outcome was changes in the pain score after receiving Nigella sativa or control agents based on the results of randomized controlled trials (RCTs). The secondary outcome was set as the frequency of adverse events reported during the follow‐up period.ResultsSix RCTs involving a total of 370 patients with knee OA were included in the present systematic review. Among the four screened studies, the topical administration of Nigella sativa oil was found to be more effective than the placebo in relieving pain in three trials. Additionally, the oral use of Nigella sativa oil was assessed in two trials, and an improvement in pain score relative to placebo was documented in only one of the studies. Also, the trial that evaluated the effectiveness of Nigella sativa oral capsules did not demonstrate any difference in pain reduction between the intervention and placebo groups. Overall, either topical or oral administration of Nigella sativa was well tolerated, and no serious adverse events were reported.ConclusionNigella sativa is generally safe, but conflicting findings from low‐quality studies hinder the ability to make clinical recommendations for or against treating OA. Robust trials are needed for informed decisions.

News (Medical) associated with Nigella sativa nasal oil drops(Cairo University)

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

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