Effects of Black Seed supplementation on management outcome of partially controlled asthma
| ISRCTN | ISRCTN48853858 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN48853858 |
| Secondary identifying numbers | KFU-LEC-130. date 11/7/2009 |
- Submission date
- 26/08/2009
- Registration date
- 10/11/2009
- Last edited
- 06/02/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Abdullah Omer Bamousa
Scientific
Scientific
College of Medicine
King Faisal University
PO Box 2114
Dammam
31451
Saudi Arabia
Study information
| Study design | Interventional single-centre double-blind randomised placebo-controlled clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Effects of Nigella sativa supplementation on airway resistance and inflammatory mediators in patients with partly controlled asthma |
| Study objectives | Treatment supplementation with whole black seeds (Nigella sativa) in asthmatic patients has benificial effects on signs and symptoms, lung function tests and inflammatory markers in the serum, sputum and breath. |
| Ethics approval(s) | Local Committee of Biomedical Ethics at King Faisal University, 11/07/2009, ref: KFU-LEC-130 |
| Health condition(s) or problem(s) studied | Asthma (partly controlled) |
| Intervention | 1. Group 1 (n = 30) will be given a placebo and serve as the control group 2. Group 2 (n = 30) will be given 500 mg of Nigella sativa 3. Group 3 (n = 30) will be given 1 g Nigella sativa 4. Group 4 (n = 30) will be given 2 g Nigella sativa Nigella sativa will be given in the form of 500 mg powder capsules (Bio Extracts, Sri Lanka). A single capsule in the morning for group 2 and in divided doses (morning and evening) for groups 3 and 4. The control group will be given capsules similar to those given to the test group but filled with a placebo. The patients will be assigned to the control and test groups' randomly, by using table of random numbers. The ongoing conventional treatment of the patients will not be interrupted or modified. The study subjects will be evaluated four times during the course of the study; at the time of recruitment (baseline) and monthly thereafter for 3 months. |
| Intervention type | Supplement |
| Primary outcome measure | The following assessments will be made during all the four visits to determine the effect of treatment with Nigella: 1. Anthropometric measurements including weight (measured using a digital Holtain electronic scale [150 ± 0.1 kg]) and height (measured with a Holtain stadiometer to the nearest millimetre). These measurements will be used for interpretation of lung function tests. 2. Clinical assessment, performed by pulmonologists in the research team at King Fahad Hospital of the University in Al-Khobar. It will be carried out according to the criteria adopted by the Global Initiative for Asthma (GINA 2008) to determine level of control of the patients. The asthma control test questionnaire will be filled for every patient. The type of medication used will also be recorded and any modifications needed will be noted and recorded. 3. Lung function tests: Peak expiratory flow (PEF), Forced Expiratory Volume in First second (FEV1) and forced vital capacity (FVC) will be measured during each visit for the sake of evaluating control. FEV1 and FVC will be measured using Vitalograph Pneumotrac® model 6800. Wright peak flow meter will be used for measurement of PEF. In addition, another independent indicator of asthma control; variability in airflow limitation will be evaluated. For this sake a hand held portable Peak Expiratory Flow meter will be given to every patient in the study. The patients will be asked to measure their PEF twice every day. This will be preceded by careful explanation of the procedure to the patients. These measurements will be performed during the week preceding the start of the trial to establish baseline data and will be repeated during the week preceding every visit. The patients will be reminded in due time. PEF is measured first thing in the morning before treatment is taken, when values are often close to their lowest and last thing at night. PEF variability will be evaluated by obtaining the difference between the maximum and minimum over the week and dividing this by the mean value over that week. FEV1, forced expiratory volume during the mid-part of vital capacity (FEF25-75%) and FVC will be measured on the day of each of the four visits. 4. Exhaled Nitric Oxide (FeNO) levels will be measured at all the visits by using Niox Mino® (Aerocrine AB, Sweden). The results will be managed by software Niox Mino Data Manager®. 5. Immune cells and inflammatory mediators: Total and differential count of the white blood cells will be done for all patients in all the four visits including the recruitment visit. Th1 and Th2 counts will also be performed. In addition eosinophil count will be done in a sample of induced sputum. Interleukins 4, 5, 8, 10, 13 and Tumour Necrosis Factor (TNF) will be measured in blood and sputum. Leukotrienes, LTB4, LTC4, LTD4 and LTE4 will also be measured in blood as well as in the induced sputum. T helper-1 (Th1) and T helper-2 (Th2) will be evaluated by flow cytometry. The leukotrienes and interleukins and other cytokines will be done by Enzyme Linked Immunosorbent Assay (ELISA) with Quantikines kits purchased from RD systems using the original method described by Yalo and Berson. Sputum induction will be performed using a method previously described. In brief, the procedure will be started 10 minutes after the administration of 400 µg of inhaled salbutamol. Hypertonic saline (3%) will be inhaled using a nebuliser for 15 minute or until enough sputum is obtained for analysis. The procedure will be terminated if there is a decrease in FEV1 20% in relation to the baseline value occurs. Saline nebulisation will be performed using a Fisoneb ultrasonic nebulizer (Fisons, Pickering, Ontario, Canada), with an output rate of 0.87 mL/min and particles presenting a median aerodynamic mass diameter of 5.58 µm. During the inhalation period, FEV1 will be measured every three minutes to ensure the safety of the test. Sputum samples will be processed and analysed within two hours. An induced sputum sample appropriate for analysis will be defined as that containing expectorated material with cellular viability greater than 50% and contamination by oropharyngeal squamous cells lower than 20%, as well as being of a quantity sufficient for differential counts of 400 cells. The standard protocol presented by Lacy and colleagues will be used (Lacy et al 2005). In the induced sputum specimen collected the following will be measured: 5.1. Total and differential white cell count 5.2. IgE 5.3. Interleukins 4, 5, 8, 10, 13 and TNF-alpha 5.4. Leukotriens LTB4, LTC4, LTD4 and LTE4 5.5. Eosinophil cationic protein 5.6. Eotaxin All related information and results for each patient will be recorded in a separate proforma for regular follow up and quick reference. |
| Secondary outcome measures | No secondary outcome measures |
| Overall study start date | 01/10/2009 |
| Completion date | 30/09/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 60 Years |
| Sex | Both |
| Target number of participants | 120 |
| Key inclusion criteria | 1. Established diagnosis of partly controlled asthma 2. Aged 18 - 60 years old, either sex 3. Willingness to participate in the study |
| Key exclusion criteria | 1. Patients whose compliance is less than 90% 2. Patients having chronic diseases (heart, liver or kidney disease, diabetes) 3. Patients on long-term oral steroids, leukotriene modifiers, anti-cholinergics, theophylline and cromones |
| Date of first enrolment | 01/10/2009 |
| Date of final enrolment | 30/09/2011 |
Locations
Countries of recruitment
- Saudi Arabia
Study participating centre
King Faisal University
Dammam
31451
Saudi Arabia
31451
Saudi Arabia
Sponsor information
King Faisal University (Saudi Arabia)
University/education
University/education
PO Box 1982
Dammam
31451
Saudi Arabia
| Website | http://www.kfu.edu.sa |
|---|---|
"ROR" |
https://ror.org/00dn43547 |
Funders
Funder type
University/education
King Faisal University (Saudi Arabia)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/01/2017 | Yes | No |
Editorial Notes
06/02/2017: Publication reference added.
