scholarly journals Noninterventional Open-Label Trial Investigating the Efficacy and Safety of Ectoine Containing Nasal Spray in Comparison with Beclomethasone Nasal Spray in Patients with Allergic Rhinitis

2014 ◽  
Vol 2014 ◽  
pp. 1-12 ◽  
Author(s):  
Uwe Sonnemann ◽  
Marcus Möller ◽  
Andreas Bilstein
Keyword(s):  
Quality Of Life ◽  
Allergic Rhinitis ◽  
Nasal Spray ◽  
Efficacy And Safety ◽  
Open Label ◽  
Equivalence Test ◽  
Nasal Symptoms ◽  
Open Label Trial ◽  
Design And Methods

Objectives. The current study aimed to compare the efficacy and safety of a classical anti-inflammatory beclomethasone nasal spray in comparison to a physic-chemical stabilizing ectoine containing nasal spray in the treatment of allergic rhinitis. Design and Methods. This was a noninterventional, open-label, observational trial investigating the effects of beclomethasone or ectoine nasal spray on nasal symptoms and quality of life. Over a period of 14 days, patients were asked to daily document their symptoms. Efficacy and tolerability were assessed by both physicians and patients. Results. Both treatments resulted in a significant decrease of TNSS values. An equivalence test could not confirm the noninferiority of ectoine treatment in comparison with beclomethasone treatment. Although clear symptom reduction was achieved with the ectoine products, the efficacy judgment showed possible advantages for the beclomethasone group. Importantly, tolerability results were comparably good in both groups, and a very low number of adverse events supported this observation. Both treatments resulted in a clear improvement in the quality of life as assessed by a questionnaire answered at the beginning and at the end of the trial. Conclusion. Taken together, it was shown that allergic rhinitis can be safely and successfully treated with beclomethasone and also efficacy and safety were shown for ectoine nasal spray.

scholarly journals Efficacy and safety of two Ayurvedic dosage forms for Allergic rhinitis: Study protocol for an open-label randomized controlled trial

2019 ◽  
Author(s):  
JM Dahanayake ◽  
Pathirage Kamal Perera ◽  
P Galappaththy ◽  
D Samaranayake
Keyword(s):  
Quality Of Life ◽  
Allergic Rhinitis ◽  
Controlled Trial ◽  
Dosage Forms ◽  
Efficacy And Safety ◽  
Open Label ◽  
Randomized Controlled ◽  
Nasal Symptoms ◽  
Freeze Dried

Abstract Background: Allergic rhinitis (AR) is an immune response of the nasal mucosa to airborne allergens and involves nasal congestion, watery nasal discharge, itching of the nose and sneezing. The symptoms of allergic rhinitis may significantly affect a patient’s quality of life and can be associated with conditions such as fatigue, headache, cognitive impairment and sleep disturbances. Various complementary and alternative medicine treatments have been used for this condition in clinical practice. The Ayurveda system of medicine is the most common complementary medicine system practiced in Sri Lanka. The aim of this study is to examine the efficacy and safety of a decoction used in traditional Ayurveda for allergic rhinitis and it’s ready to use freeze dried formulation in comparison to an antihistamine over a period of 4 weeks on relief of symptoms in allergic rhinitis. Study design: This is a three arm, open label, non-inferiority, randomized controlled clinical trial enrolling patients with AR. Tamalakyadi decoction containing 12 ingredients (TMD12), used in traditional Ayurveda and its freeze dried formulation are the test products. The efficacy and safety of the two Ayurvedic dosage forms will be tested against the antihistamine loratidine Patients with symptoms of AR will be allocated randomly into the 3 arms after a 1 week run-in period and the medications will be given orally for 28 days. Total Nasal symptom Score (TNSS) of the patients will be used as the primary efficacy endpoint. TNSS will be recorded and compared between the 3 arms prior to visit 1, at the end of 28 days, end of the and second months of follow up. Symptom scores of daytime nasal symptoms, night time nasal symptoms, non-nasal symptoms and Health Related Quality of Life questionnaire are used as secondary end points. Discussion: This clinical trial will be able to provide evidence based scientific data on Ayurvedic dosage form, TMD12 and the freeze-dried formulation in the treatment of allergic rhinitis. This trial is expected to develop capacity to scientifically evaluate various Ayurvedic treatments that are claimed to have efficacy in treatment of various disease conditions. Trial registration:ISRCTN18149439 (06 May 2019) Keywords: Allergic rhinitis, Ayurvedic dosage forms, Tamalakyadi decoctions, Randomized controlled trial

scholarly journals Efficacy and safety of two Ayurvedic dosage forms for allergic rhinitis: Study protocol for an open-label randomized controlled trial

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Jeevani Maheshika Dahanayake ◽  
Pathirage Kamal Perera ◽  
Priyadarshani Galappaththy ◽  
Dulani Samaranayake
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Allergic Rhinitis ◽  
Dosage Forms ◽  
Efficacy And Safety ◽  
Open Label ◽  
Randomized Controlled ◽  
Nasal Symptoms ◽  
Freeze Dried

Abstract Background Allergic rhinitis (AR) is an immune response of the nasal mucosa to airborne allergens and involves nasal congestion, watery nasal discharge, itching of the nose, and sneezing. The symptoms of allergic rhinitis may significantly affect a patient’s quality of life and can be associated with conditions such as fatigue, headache, cognitive impairment, and sleep disturbances. Various complementary and alternative medicine treatments have been used for this condition in clinical practice. The Ayurveda system of medicine is the most common complementary medicine system practiced in Sri Lanka. The aim of this study is to examine the efficacy and safety of a decoction used in traditional Ayurveda for allergic rhinitis and its ready- to-use freeze dried formulation in comparison to an antihistamine over a period of 4 weeks on relief of symptoms in allergic rhinitis. Study design This is a three-arm, open-label, non-inferiority, randomized controlled clinical trial enrolling patients with AR. Tamalakyadi decoction containing 12 ingredients (TMD12), used in traditional Ayurveda and its freeze-dried formulation are the test products. The efficacy and safety of the two Ayurvedic dosage forms will be tested against the antihistamine loratadine. Patients with symptoms of AR will be allocated randomly into the three arms after a 1-week run-in period and the medications will be given orally for 28 days. Total Nasal symptom Score (TNSS) of the patients will be used as the primary efficacy endpoint. TNSS will be recorded and compared between the three arms prior to visit 1, at the end of 28 days, and end of the first and second months of follow-up. Symptom scores of daytime nasal symptoms, night time nasal symptoms, non-nasal symptoms and health-related quality of life questionnaire are used as secondary end points. Discussion This clinical trial will be able to provide evidence-based scientific data on Ayurvedic dosage form, TMD12, and the freeze-dried formulation in the treatment of allergic rhinitis. This trial is expected to develop capacity to scientifically evaluate various Ayurvedic treatments that are claimed to have efficacy in treatment of various disease conditions. Trial registration ISRCTN18149439 (6 May 2019).

scholarly journals Efficacy and safety of two Ayurvedic dosage forms for Allergic rhinitis: Study protocol for an open-label randomized controlled trial

2019 ◽  
Author(s):  
JM Dahanayake ◽  
Pathirage Kamal Perera ◽  
P Galappaththy ◽  
D Samaranayake
Keyword(s):  
Quality Of Life ◽  
Allergic Rhinitis ◽  
Controlled Trial ◽  
Dosage Forms ◽  
Efficacy And Safety ◽  
Open Label ◽  
Randomized Controlled ◽  
Nasal Symptoms ◽  
Freeze Dried

Abstract Background: Allergic rhinitis (AR) is an immune response of the nasal mucosa to airborne allergens and involves nasal congestion, watery nasal discharge, itching of the nose and sneezing. The symptoms of allergic rhinitis may significantly affect a patient’s quality of life and can be associated with conditions such as fatigue, headache, cognitive impairment and sleep disturbances. Various complementary and alternative medicine treatments have been used for this condition in clinical practice. The Ayurveda system of medicine is the most common complementary medicine system practiced in Sri Lanka. The aim of this study is to examine the efficacy and safety of a decoction used in traditional Ayurveda for allergic rhinitis and it’s ready to use freeze dried formulation in comparison to an antihistamine over a period of 4 weeks on relief of symptoms in allergic rhinitis. Study design: This is a three arm, open label, non-inferiority, randomized controlled clinical trial enrolling patients with AR. Tamalakyadi decoction containing 12 ingredients (TMD12), used in traditional Ayurveda and its freeze dried formulation are the test products. The efficacy and safety of the two Ayurvedic dosage forms will be tested against the antihistamine loratidine Patients with symptoms of AR will be allocated randomly into the 3 arms after a 1 week run-in period and the medications will be given orally for 28 days. Total Nasal symptom Score (TNSS) of the patients will be used as the primary efficacy endpoint. TNSS will be recorded and compared between the 3 arms prior to visit 1, at the end of 28 days, end of the and second months of follow up. Symptom scores of daytime nasal symptoms, night time nasal symptoms, non-nasal symptoms and Health Related Quality of Life questionnaire are used as secondary end points. Discussion: This clinical trial will be able to provide evidence based scientific data on Ayurvedic dosage form, TMD12 and the freeze-dried formulation in the treatment of allergic rhinitis. This trial is expected to develop capacity to scientifically evaluate various Ayurvedic treatments that are claimed to have efficacy in treatment of various disease conditions. Trial registration:ISRCTN18149439 (06 May 2019) Keywords: Allergic rhinitis, Ayurvedic dosage forms, Tamalakyadi decoctions, Randomized controlled trial

scholarly journals Efficacy and safety of two Ayurvedic dosage forms for Allergic rhinitis: Study protocol for an open-label randomized controlled trial

2019 ◽  
Author(s):  
JM Dahanayake ◽  
Pathirage Kamal Perera ◽  
P Galappaththy ◽  
D Samaranayake
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Allergic Rhinitis ◽  
Dosage Forms ◽  
Open Label ◽  
Randomized Controlled ◽  
Nasal Symptoms ◽  
Freeze Dried

Abstract Background Allergic rhinitis (AR) is an immune response of the nasal mucosa to airborne allergens and involves nasal congestion, watery nasal discharge, itching of the nose and sneezing. The symptoms of allergic rhinitis may significantly affect a patient’s quality of life and can be associated with conditions such as fatigue, headache, cognitive impairment and sleep disturbances. Various complementary and alternative medicine treatments have been used for this condition in clinical practice. The Ayurveda system of medicine is the most common complementary medicine system in Sri Lanka. The aim of this study is to find out whether the use of two preparations (decoction and its freeze dried powder) over a period of 4 weeks is able to cure the symptoms of allergic rhinitis. Study design This is a three arm open label non-inferiority randomized controlled clinical trial in patients with AR. The study duration is 28 days oral administration of the two Ayurvedic dosage forms (Decoction and freeze dried) and the antihistamine loratidine into the 3 arms allocated randomly. After a 1 week run-in period, eligible subjects are randomly assigned to the TMD12 decoction group, TMD12 freeze dried group and the antihistamine group. Total Nasal symptom Score (TNSS) of the patients are used as the primary efficacy outcome. TNSS is recorded and compared in all 3 arms prior to visit 1, at the end of 28 days, end of the first month of follow up and second month of follow up. Symptom scores of daytime nasal symptoms, night time nasal symptoms, non-nasal symptoms and Health Related Quality of Life questionnaire are used as secondary end points. Discussion This clinical trial will be able to provide supportive evidence based scientific data on classical Ayurvedic dosage forms and the new dosage forms developed as freeze dried powder in the treatment of allergic rhinitis. Also by this trial, it is expected to develop capacity to scientifically evaluate Ayurvedic treatments that may help patients having conditions such as allergic rhinitis.

scholarly journals Assessment of quality of life measured by rhinoconjuctivits quality of life questionnaire in patients of allergic rhinitis treated with commonly used oral antihistaminics

2019 ◽  
Vol 8 (8) ◽  
pp. 1830
Author(s):  
Ganesh S. Pentewar ◽  
Ranjit J. Wagh
Keyword(s):  
Quality Of Life ◽  
Allergic Rhinitis ◽  
Symptom Score ◽  
Life Questionnaire ◽  
Open Label ◽  
Treatment Groups ◽  
Quality Of Life Questionnaire ◽  
Nasal Symptoms ◽  
The Impact

Background: Nasal and non-nasal symptoms in allergic rhinitis (AR) can be assessed by measuring health related quality of life (HRQOL). Present study was to assess the impact of use of antihistaminic in AR which will affect the work productivity, sleep, frequent visits to health care professional and expenditure on medicines. For this evaluation, Rhinoconjuctivits Quality Of Life Questionnaire (RQLQ) has been used.Methods: In this study 52 patients with AR were randomized in an open-label, 4-arm, parallel group, single center study. Questionnaire information was obtained about allergy-related RQLQ. Subjects received either Tablet Cetirizine 5 mg, Levocetirizine 5 mg, Loratidine 5 mg or Fexofenadine 120 mg. Changes from baseline until the end of study visit (1 week following) were evaluated by RQLQ.Results: When compared between treatment groups using one-way ANOVA it was observed that there is no variation in RQLQ overall Score in all the four treatment groups and there is no difference from treatment to treatment. Overall RQLQ score was reduced maximum in Levocetirizine group. Individual symptoms of RQLQ that is sleep score, non-hay fever, practical problem, nasal symptom score, Eye symptom Score, activities Score, and emotion score were also improved in the Levocetirizine group.Conclusions: Patients of all four study groups showed an improved perception of their HRQL according to the RQLQ. Significant improvements are reported in nasal symptoms, daily activities, sleep and psychological impact. Our results provide support for an AR and its impact on quality of life. Our recommendation stipulating that levocetirizine is superior to rest drug group for the treatment of AR with safety and tolerability.

scholarly journals Efficacy of Bimin decoction for patients with perennial allergic rhinitis: an open-label non-inferiority randomized controlled trial

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Jingyi Zhao ◽  
Xinyu Yan ◽  
Jianqing Gai ◽  
Jinshuai Han ◽  
Hong Zhang ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomized Controlled Trial ◽  
Allergic Rhinitis ◽  
Nasal Spray ◽  
Controlled Trial ◽  
Control Group ◽  
Nasal Resistance ◽  
Open Label ◽  
Randomized Controlled

Abstract Background Allergic rhinitis (AR) is a common allergic disease. It affects people worldwide and traditional Chinese medicine is becoming popular among AR patients because it has a definite clinical effect and there are few adverse reactions. Lung qi deficiency and cold syndrome (LQDCS) is a frequent type of AR, and the Chinese herbal medicine bimin decoction (BMD) is prescribed for it. This study compared the clinical efficacy of BMD for AR patients with LQDCS to the conventional medicine loratadine and fluticasone nasal spray. Methods The study was an open-label non-inferiority randomized controlled trial. A total of 108 AR patients with LQDCS aged 19 to 60 were randomly allocated in a 1:1 ratio to the BMD group or the control group by the central computer system in Beijing Hospital of Traditional Chinese Medicine from January 2017 to April 2018. In total, 98 participants completed the study (BMD group n = 51 and control group n = 47). Patients in the BMD group received BMD while those in the control group received fluticasone nasal spray and loratadine tablets for 4 weeks. The primary outcome was the change in the Total Nasal Symptom Score (TNSS) between the baseline and the end of treatment. Changes in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ), nasal resistance, and acoustic rhinometry parameters were secondary outcomes. All side effects due to the treatments were recorded. Results After the 4-week treatment, the total TNSS was significantly reduced in both groups compared to the baseline (P <  0.05). No significant between-groups differences were observed for changes in TNSS scores [− 0.298 (95% confidence interval −0.640 to 0.140)], which was within the defined non-inferiority margin. RQLQ in both groups decreased significantly (P <  0.001) from baseline, though a more obvious reduction was observed for the BMD group (P <  0.001). There were no significant differences in nasal resistance, nasal volume, or nasal minimum cross-sectional area between groups after treatment (P > 0.05). Conclusions These findings indicate that BMD helps relieve the symptoms of perennial AR and improves rhinitis-related quality of life. Our study indicates that BMD is non-inferior to loratadine tablets and fluticasone nasal spray for AR patients with LQDCS. Trial registration Chinese Clinical Trial Registry, ChiCTR-INR-16010063. Registered on 2 December 2016.

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