The Efficacy of Nigella Sativa in Children With House Dust Mite-Induced Respiratory Allergy Receiving Immunotherapy

NCT05450289 | Unknown

• 1 other identifier: CRP/2022/VI/001
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

An experimental study aims to investigate the efficacy of Nigella Sativa in children with house dust mite (HDM)-induced respiratory allergy receiving immunotherapy. This study observes symptom, medication, combine symptom-medication score, quality of life (QoL), skin prick test, IL-4, TGF-β, IL-10, IgG4 specific HDM, IgE Specific HDM, and IFN-γ as the outcome. This study will be done on 40 subjects (20 subjects in control group and 20 subjects in experimental group), in children diagnosed with house dust mite-induced respiratory allergy such as allergic rhinoconjunctivitis and/or asthma, with an age of 2 to 17 years old, receiving allergen specific immunotherapy, not having an autoimmune disease, malignancy, nor chronic respiratory infection at the beginning of study, and has an approval from their parents. In control group, subjects will receive allergen specific immunotherapy and standard pharmacotherapy for underlying diagnose. In experimental group, subjects will receive nigella sativa oil for 14 weeks, allergen specific immunotherapy, and standard pharmacotherapy for underlying diagnose. All subjects will observe for 14 weeks during build up phase of immunotherapy. They will be monitored regularly, since this study starts, at each week, and at the end of this study. The symptom, medication, and combine symptom-medication score will be calculated at every session of monitoring. Quality of life (QoL), skin prick test, IL-4, TGF-β, IL-10, IgG4 specific HDM, IgE Specific HDM, and IFN-γ will be collected at the beginning and the end of this study.

Conditions

House Dust Mite Allergy

Outcome Measures

Primary Outcomes (3)

• The change of Symptom score

  The change from baseline Symptom Score at 14 weeks. The symptom score (SS) is divided in three domain symptoms which are nasal symptoms (Itchy nose, sneezing, runny nose, and blocked nose), conjunctival symptoms (itchy/red eyes and watery eyes), and lung symptoms (cough, wheeze, shortness of breath, and chest tightness). Each of the symptoms is scored from 0 to 3, considering the severity of each value. The final SS would be the sum of all individual symptom scores divided by the number of symptoms, being the range of SS from 0 to 3. The score is: 0 = no symptoms (or signs); 1 = mild symptoms (sign/ symptom clearly present, but minimal awareness; easily tolerated); 2 = moderate symptoms (definite awareness of sign/symptom that is bothersome but tolerable); 3 = severe symptoms (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping).

  At the beginning of the study (1st week) and at the end of the study (14th week)

• The change of Medication score

  The change from baseline Medication Score at 14 weeks. The medication score (MS) is divided in two domain with range of value from 0 to 3, first for allergic rhinoconjunctivitis medication, 0 = no use of medication, 1=use of oral and/or topical H1A, 2=use of intranasal corticosteroids with/without H1A; 3=use of oral corticosteroid with/without intranasal corticosteroids, with/without H1A. Second for lung/asthma medication, the score is 0=no use of medication, 0.5= SABA, 1=low-dose ICS, alternative: LTRA, 1.5=low dose ICS + LABA or medium dose ICS, 2=medium dose ICS+LABA, 2.5=high dose ICS+LABA, 3=high dose ICS+LABA+systemic corticosteroid

  At the beginning of the study (1st week) and at the end of the study (14th week)

• The change of Combination symptom-medication score

  The change from baseline Combination Symptom-Medication Score at 14 weeks. The Combination symptom-medication score (CSMS) is the sum of SS (range 0-3) and MS (range 0-3). Therefore, the values of CSMS are in the range of 0-6.

  At the beginning of the study (1st week) and at the end of the study (14th week)

Secondary Outcomes (8)

• Pediatric Quality of Life Inventory (PedsQL)

  At the beginning of the study (1st week), at the middle of study (8th week), and at the end of the study (14th week)

• Skin prick test

  At the beginning of the study(1st week) and at the end of the study (14th week)

• IL-4

  At the beginning of the study(1st week) and at the end of the study (14th week)

• TGF-β

  At the beginning of the study(1st week) and at the end of the study (14th week)

• IL-10

  At the beginning of the study(1st week) and at the end of the study (14th week)

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Control group will receive allergen specific immunotherapy and standard pharmacotherapy

Drug: Allergen Specific Immunotherapy; Drug: Standard pharmacotherapy

Experimental Group

EXPERIMENTAL

Experimental group will receive allergen specific immunotherapy, standard pharmacotherapy, and nigella sativa oil

Drug: Nigella Sativa Oil; Drug: Allergen Specific Immunotherapy; Drug: Standard pharmacotherapy

Interventions

Nigella Sativa Oil DRUG

In this study, we use nigella sativa oil (NSO), which are packed in capsule. One capsule contained 550 mg of nigella sativa oil.

Also known as: Habbatussauda Oil MADINAH

Experimental Group

Allergen Specific Immunotherapy DRUG

In this study, we use the house dust mite allergen immunotherapy (Teaching Industry Allergen by Dr. Soetomo Hospital-Airlangga University, Surabaya, Indonesia) used was an extract of Dermatophagoides pteronyssinus via subcutaneous injection.

Control Group; Experimental Group

Standard pharmacotherapy DRUG

Standard pharmacotherapy as indicated based on patient's symptoms i.e none, antihistamine, corticosteroids, bronchodilators, etc.

Control Group; Experimental Group

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Diagnosed with house dust mite-induced respiratory allergy such as allergic rhinoconjunctivitis, and/or asthma,
• Receiving allergen specific immunotherapy
• Parents want to follow the study by signing the informed consent

You may not qualify if:

• Autoimmune disease
• Malignancy
• Chronic respiratory infection
• Anatomical abnormalities of respiratory tract

Sponsors & Collaborators

• Universitas Airlangga: lead

Related Publications (14)

• Gabet S, Ranciere F, Just J, de Blic J, Lezmi G, Amat F, Seta N, Momas I. Asthma and allergic rhinitis risk depends on house dust mite specific IgE levels in PARIS birth cohort children. World Allergy Organ J. 2019 Oct 4;12(9):100057. doi: 10.1016/j.waojou.2019.100057. eCollection 2019 Sep.

  PMID: 31641405 BACKGROUND

• Soegiarto G, Abdullah MS, Damayanti LA, Suseno A, Effendi C. The prevalence of allergic diseases in school children of metropolitan city in Indonesia shows a similar pattern to that of developed countries. Asia Pac Allergy. 2019 Apr 20;9(2):e17. doi: 10.5415/apallergy.2019.9.e17. eCollection 2019 Apr.

  PMID: 31089459 BACKGROUND

• Calderon MA, Kleine-Tebbe J, Linneberg A, De Blay F, Hernandez Fernandez de Rojas D, Virchow JC, Demoly P. House Dust Mite Respiratory Allergy: An Overview of Current Therapeutic Strategies. J Allergy Clin Immunol Pract. 2015 Nov-Dec;3(6):843-55. doi: 10.1016/j.jaip.2015.06.019. Epub 2015 Sep 3.

  PMID: 26342746 BACKGROUND

• 4. Pfaar O, Bachert C, Bufe A, Buhl R, Ebner C, Eng P, et al. Guideline on allergen-specific immunotherapy in IgE-mediated allergic diseases. Allergologie. 2015;38(9):431-70.

  BACKGROUND

• Qiu J, Grine K. Complementary and Alternative Treatment for Allergic Conditions. Prim Care. 2016 Sep;43(3):519-26. doi: 10.1016/j.pop.2016.04.012.

  PMID: 27545740 BACKGROUND

• Ahmad A, Husain A, Mujeeb M, Khan SA, Najmi AK, Siddique NA, Damanhouri ZA, Anwar F. A review on therapeutic potential of Nigella sativa: A miracle herb. Asian Pac J Trop Biomed. 2013 May;3(5):337-52. doi: 10.1016/S2221-1691(13)60075-1.

  PMID: 23646296 BACKGROUND

• Salem ML. Immunomodulatory and therapeutic properties of the Nigella sativa L. seed. Int Immunopharmacol. 2005 Dec;5(13-14):1749-70. doi: 10.1016/j.intimp.2005.06.008. Epub 2005 Jul 1.

  PMID: 16275613 BACKGROUND

• Kabir Y, Akasaka-Hashimoto Y, Kubota K, Komai M. Volatile compounds of black cumin (Nigella sativa L.) seeds cultivated in Bangladesh and India. Heliyon. 2020 Oct 27;6(10):e05343. doi: 10.1016/j.heliyon.2020.e05343. eCollection 2020 Oct.

  PMID: 33163654 BACKGROUND

• Barlianto W, Wulandari D, Chusniyah M, Chandra Kusuma HMS, Prawiro SR. Improvement of th17/treg balance and asthma control test score by nigella sativa supplementation in asthmatic children: A new approach to managing asthma. Turkish J Immunol. 2018;6(1):1-7.

  BACKGROUND

• Kalus U, Pruss A, Bystron J, Jurecka M, Smekalova A, Lichius JJ, Kiesewetter H. Effect of Nigella sativa (black seed) on subjective feeling in patients with allergic diseases. Phytother Res. 2003 Dec;17(10):1209-14. doi: 10.1002/ptr.1356.

  PMID: 14669258 BACKGROUND

• Abbas AK, Lichtman andrew H, Pillai S. Basic Immunology : Fungtion and Disorders of the Immune System,. 2007.

  BACKGROUND

• Pfaar O, Demoly P, Gerth van Wijk R, Bonini S, Bousquet J, Canonica GW, Durham SR, Jacobsen L, Malling HJ, Mosges R, Papadopoulos NG, Rak S, Rodriguez del Rio P, Valovirta E, Wahn U, Calderon MA; European Academy of Allergy and Clinical Immunology. Recommendations for the standardization of clinical outcomes used in allergen immunotherapy trials for allergic rhinoconjunctivitis: an EAACI Position Paper. Allergy. 2014 Jul;69(7):854-67. doi: 10.1111/all.12383. Epub 2014 Apr 25.

  PMID: 24761804 BACKGROUND

• Caballero R, Grau A, Javaloyes G, Del Pozo S, Leon MA, Romero M, Casanovas M. Combination of Allergic Asthma Symptom and Medication Scores in Allergen Immunotherapy Trials: A Proposal. Int Arch Allergy Immunol. 2021;182(7):571-573. doi: 10.1159/000513543. Epub 2021 Jan 26. No abstract available.

  PMID: 33498057 BACKGROUND

• Canonica GW, Baena-Cagnani CE, Bousquet J, Bousquet PJ, Lockey RF, Malling HJ, Passalacqua G, Potter P, Valovirta E. Recommendations for standardization of clinical trials with Allergen Specific Immunotherapy for respiratory allergy. A statement of a World Allergy Organization (WAO) taskforce. Allergy. 2007 Mar;62(3):317-24. doi: 10.1111/j.1398-9995.2006.01312.x.

  PMID: 17298350 BACKGROUND

MeSH Terms

Conditions

Dust Mite Allergy

Interventions

Nigella sativa oil

Condition Hierarchy (Ancestors)

Rhinitis, Allergic, Perennial; Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Ida Bagus Ramajaya Sutawan, MD

  Universitas Airlangga

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ida Bagus Ramajaya Sutawan, MD

CONTACT

+62811392440; ramasutawan@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fellowship Training of Allergy Immunology Division, Department of Child Health Airlangga University, Principal Investigator

Study Record Dates

• First Submitted: June 18, 2022
• First Posted: July 8, 2022
• Study Start: August 1, 2022
• Primary Completion: March 1, 2023
• Study Completion: May 1, 2023
• Last Updated: July 8, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 6 months after publication
• Access Criteria: The data will be shared by email sent by the primary investigator