Journal of Pharmacopuncture (대한약침학회지)

KOREAN PHARMACOPUNCTURE INSTITUTE (대한약침학회)
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The Effect of Glasthma Syrup in Asthma: a study protocol for a triple-blind randomized controlled trial

  • Derakhshan, Ali Reza (School of Persian and Complementary Medicine, Mashhad University of Medical Sciences) ;
  • Saeidinejat, Shahin (Social Determinants of Health Research Center, Health School, Mashhad University of Medical Sciences) ;
  • Khadem-Rezaiyan, Majid (Department of Community Medicine and Public Health, Faculty of Medicine, Mashhad University of Medical Sciences) ;
  • Asnaashari, Amir-Mohammad-Hashem (Lung Disease Research Center, Faculty of Medicine, Mashhad University of Medical Sciences) ;
  • Mirsadraee, Majid (Department of Internal Medicine, Faculty of Medicine, Islamic Azad University-Mashhad Branch) ;
  • Salari, Roshanak (School of Persian and Complementary Medicine, Mashhad University of Medical Sciences) ;
  • Jabbari-Azad, Farahzad (Department of Immunology and Allergy, Head of Allergy Research Center, Ghaem Hospital, Mashhad University of Medical Sciences) ;
  • Jalali, Shima (Student Research Committee, Mashhad University of Medical Sciences) ;
  • Jalali, Shabnam (Student Research Committee, Mashhad University of Medical Sciences)
  • Received : 2022.01.24
  • Accepted : 2022.07.28
  • Published : 2022.09.30
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Abstract

Objectives: Asthma is a chronic disease, and the demand for herbal medicines in this field has increased in recent years. The new findings highlight the role of the gut-lung axis in the pathophysiology of asthma. Hence, this study will evaluate the safety and efficacy of Glasthma syrup, an herbal formula based on Persian medicine, in improving asthma and regulating intestinal permeability. The formula consists of five herbal ingredients that have anti-inflammatory effects on the respiratory tract, also known as gut tonics. Methods: The study will be conducted as a placebo-controlled, triple-blind, randomized trial. It will consist of a 4-week intervention followed by a 4-week follow-up period. The target sample size is 20 patients with moderate asthma aged 18 to 60 years. Eligible participants will be randomly assigned to either the experimental group or the control group in equal numbers. Patients in the experimental group will take Glasthma syrup (7.5 mL, twice a day), while patients in the control group will take a matching placebo. Both groups will receive a 4-week combination of a long-acting beta2 agonist and a leukotriene modulator as standard of care. Inhaled corticosteroids can be used as rescue medication as needed. Results: The primary outcomes are asthma symptom scale, lung function, and intestinal permeability. Secondary outcomes include quality of life, symptom recurrence rates, and blood tests. A safety assessment will also be conducted during the trial. Conclusion: In this trial, the effects of Glasthma syrup in patients with moderate asthma will be examined. The study will also assess the effects of the formulation on the gut-lung axis by simultaneously monitoring the gut permeability index, asthma symptoms, and lung function.

Keywords

Acknowledgement

The researchers are particularly grateful to the staff in the hematology, biochemistry and spirometry labs for their help in getting the job done. This study is a part of PhD thesis of Dr. Shahin Saeidinejat and supported by Mashhad University of Sciences.

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