Final statistical report of AyuBreth clinical study:
Introduction
A clinical study on the bronchodilator effect of Ayubreth®, a proprietary herbal formulation, based on Ayurvedic principles was carried out.
The incidence of Asthma, Allergic bronchitis, Respiratory Tract disorders such as COPD, ILD and several viral diseases has been increasing. This could be attributed to air pollution, lifestyle and other causes, leading to conditions like breathlessness, cough and cold. Acute management of breathlessness, with fast onset of action, mostly relies on Bronchodilators like salbutamol and Tiotropium (modern medicine). These medicines are generally administered as (mouth) “inhalers”, as they are considered to be easy – safer – faster – convenient to carry and use. In chronic conditions, like asthma, often patients turn to Ayurvedic medicines. All herbal products available for the management of respiratory tract disorders are in the form of Tablet, Capsule, Syrup – which are metabolised in the liver, and hence take longer time to respond and need higher doses.
Ayubreth® was designed as a fast acting, safe herbal formulation to be used to increase the comfort in breathing in patients suffering from shortness of breath due to various respiratory conditions like – Asthma, Bronchitis, Breathlessness, Upper Respiratory Tract problems etc. Ultimately, it is expected to increase the oxygen saturation of blood.
The study was initiated with the following objectives:
- To study the effectiveness of AyuBreth by evaluating the comfort of breathing in breathlessness due to various respiratory tract disorders
- To assess the extent of bronchodilatory effect of Ayubreth within a short time (10 min).
In Ayurveda, the concept of respiratory diseases and breathlessness is deeply rooted in the understanding of the doshas (Vata, Pitta, and Kapha) and the balance between them. Prana Vayu, one of the five subtypes of Vata, controls respiratory functions, an imbalance in which, can result in respiratory distress. Besides Dosha imbalance the accumulation of ama, or toxins, in the body is often associated with respiratory ailments. Accumulation of Ama can lead to clogging of the respiratory channels, leading to breathlessness. Asthma (Swasa Roga), Bronchitis (Tamaka Shwasa), Allergic Rhinitis (Vataja Pratishyaya), Upper respiratory tract problems like sneezing, nasal congestion, and breathlessness are most common Respiratory ailments according to Ayurveda. In Asthma, due to airway inflammation and bronchoconstriction, it results in breathlessness, wheezing, and coughing. Ingredients in AyuBreth® like Camphor, Ajwain, Mint, Licorice etc. are expected to reduce inflammation and improve bronchodilation, helping to alleviate above mentioned symptoms.
In modern system of medicine antibiotics, anti-histamines, bronchodilators, cough expectorants etc are commonly used for the management of chronic bronchitis. Recent experiences in the COVID pandemic have highlighted the importance of development of therapeutic measures for bronchodilation and improvement of Oxygen saturation with a short duration of action and adequate safety to avoid complications with repeated use. Ayubreth® addresses this very component with an aim to give the patient a fighting chance by comforting breathing and hence maintaining oxygenation status.
Description of Clinical study:
This study was an interventional, open label, prospective clinical trial to evaluate the effectiveness of Ayubreth®, a fast acting and safe, proprietary herbal formulation to be used to increase the comfort in breathing in patients suffering from shortness of breath due to various respiratory conditions. The bronchodilatory effect of the spray was also evaluated at a fixed time point of 10 min after administration.
The patients who participated in the study were administered with a single spray/puff of Ayubreth ®. The respiratory parameters were assessed before and 10 min. after administration of Ayubreth®, using a spirometer (RMS Helios 401). The Primary outcome measure was the comfort from breathlessness. The secondary outcome measure was % change in predicted values of FEV1, FVC and PEF.
Results:
A total of 113 subjects who visited Dr. Jivraj Mehta Hospital, Ahmedabad, with complaints of breathlessness or dyspnea were considered for this study. The study was considered complete and further recruitment stopped when 100 (82.65%) completed the study. The patients who were found to have taken other bronchodilators or did not complete the second reading within stipulated time were not included in the final study.
Majority of the patients (44%) in this study were found to be more than 60 years of age, followed by those in the age group 46-60 years (37%). Majority of included patients were male (67%).
The respiratory function of an overwhelming majority of the patients included in this study, as determined using the Spirometer was found to compromised. The no of patients with a % predicted value of FEV1 <80% was found to be 74. The no of patients with a low % predicted value (<80%) of FVC and PEF was even more at 90 and 91 respectively. This would be expected, considering that their approach to the hospital was as a result of respiratory difficulties. The possible causes of respiratory dysfunction was varied – Asthma, Bronchitis, Breathlessness, Upper Respiratory Tract problems etc. The mean % predicted values of all the patients before treatment were as follows –
FEV1: 60.57 ± 23.40, FVC: 56.36 ± 20.19, PEFR: 46.47 ± 23.07.
Effect of therapy on primary outcome:
There was a significant improvement in all the parameters mentioned above (p<0.05)
FEV1 – There was a significant improvement in the FEV1 of all patients (64.22 ± 20.57, p<0.05), when measured 10 min after administration of a single puff of Ayubreth®. This indicates a positive change in % predicted FEV1 by 6.28%. The improvement in males (% change = 7.59 vs 3.62) was found to be slightly more than that of females, however this difference was not statistically significant.
FVC – There was a similar trend in the FVC of all patients (62.50 ± 22.59, p<0.05), when measured 10 min after administration of a single puff of Ayubreth®. The improvement in % predicted FVC was even better than that in FEV1, at 11.37%.
PEFR – The improvement in the Peak exploratory flow rate of all patients (51.33 ± 24.00, p<0.05) was the highest among the respiratory function parameters assessed, with a % change of 15.30 %. Like FEV1, the improvement in males (% change = 16.35 vs 13.17) was found to be slightly more than that of females, though not statistically significant.
Overall, this study clearly indicates a statistically significant improvement in the respiratory functions assessed 10 min after administration of a single puff of Ayubreth®. The reported comfort in breathing also improved in most of patients. There was no report of any untoward effects as a result of the use of Ayubreth® in this study. The impact of this preparation on respiratory function in the long term, needs to be evaluated.
Registration details of Clinical Trial with CTRI:
CTRI Registration Ayulink Dr Prerak Shah_001