House Dust Mite Allergy Clinical Trial
Official title:
The Efficacy of Nigella Sativa in Children With House Dust Mite-Induced Respiratory Allergy Receiving Immunotherapy
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.
Status | Not yet recruiting |
Enrollment | 40 |
Est. completion date | May 2023 |
Est. primary completion date | March 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 2 Years to 17 Years |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - Autoimmune disease - Malignancy - Chronic respiratory infection - Anatomical abnormalities of respiratory tract |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Universitas Airlangga |
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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. Review. — View Citation
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* Note: There are 14 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
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Primary | 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 (de?nite 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) | |
Primary | 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) | |
Primary | 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 | Pediatric Quality of Life Inventory (PedsQL) | The measured Quality of Life (QoL) outcomes using Pediatric Quality of Life Inventory (PedsQL). The items of PedsQL are grouped together on the actual questionnaire into four Scales (Physical Functioning, Emotional Functioning, Social Functioning, and School Functioning). Items are reversed scored and linearly transformed to a 0-100 scale. To reverse score, transform the 0-4 scale items to 0-100 as follows: 0=100, 1=75, 2=50, 3=25, 4=0. Higher scores indicate better HRQOL (Health-Related Quality of Life) | At the beginning of the study (1st week), at the middle of study (8th week), and at the end of the study (14th week) | |
Secondary | Skin prick test | Skin prick test will be done using the house dust mite allergen (Teaching Industry Allergen by Dr.Soetomo Hospital-Airlangga University, Surabaya, Indonesia) used was an extract of Dermatophagoides pteronyssinus. | At the beginning of the study(1st week) and at the end of the study (14th week) | |
Secondary | IL-4 | Examination for IL-4 using an enzyme-linked immunosorbent assay/ELISA, will be done by taking 3-5 ml of blood sample at the beginning and the end of the study | At the beginning of the study(1st week) and at the end of the study (14th week) | |
Secondary | TGF-ß | Examination for TGF-ß using an enzyme-linked immunosorbent assay/ELISA, will be done by taking 3-5 ml of blood sample at the beginning and the end of the study | At the beginning of the study(1st week) and at the end of the study (14th week) | |
Secondary | IL-10 | Examination for IL-10 using an enzyme-linked immunosorbent assay/ELISA, will be done by taking 3-5 ml of blood sample at the beginning and the end of the study | At the beginning of the study(1st week) and at the end of the study (14th week) | |
Secondary | IgG4 specific HDM | Examination for IgG4 specific HDM using an enzyme-linked immunosorbent assay/ELISA, will be done by taking 3-5 ml of blood sample at the beginning and the end of the study | At the beginning of the study(1st week) and at the end of the study (14th week) | |
Secondary | IFN-? | Examination for IFN-? using an enzyme-linked immunosorbent assay/ELISA, will be done by taking 3-5 ml of blood sample at the beginning and the end of the study | At the beginning of the study(1st week) and at the end of the study (14th week) | |
Secondary | IgE Specific HDM | Examination for IgE specific HDM using an enzyme-linked immunosorbent assay/ELISA, will be done by taking 3-5 ml of blood sample at the beginning and the end of the study. | At the beginning of the study(1st week) and at the end of the study (14th week) |
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