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Chewable cough tablets with improved palatability: A comparative phase II clinical trial.
Khan, M, Rehman, H, Naveed, S, Zaidi, SF, Ayaz, S, Owais, A, Usmanghani, K
Pakistan journal of pharmaceutical sciences. 2019;(1(Supplementary)):339-343
Abstract
Cough is the common disease condition which affects patients of every age. Numerous OTC medications available in community pharmacies however no antiviral treatment and even antibiotics has been shown to be effective without pre-existing lung infection. The treatment approach of medicinal herbs has been recognized for many decades and even longer for the treatment and prevention of cough. The aim of this study was to evaluate the safety and efficacy of Mukalbion poly herbal chewable tablets for the treatment of cough with improved palatability against a marketed brand (Poly herbal). For the formulation development of test group, the herbs were supplied by the Procurement department of Herbion Pakistan Pvt. Ltd. Althea officinalis (roots), Hedera helix (leaves) and Sisymbrium irio (seeds) were used for the manufacturing of Mukalbion (poly herbal, test group) chewable tablet. The comparative control clinical trial was carried out during a time frame of 07 months with sample size of 70 patients as per epidemiological software for sample size and each group contained 35 (±5) patients. Chewable tablets were administered and evaluated for effectiveness after 15 days of treatment. The data were collected by the patients through clinical trial questionnaire. The validated quality of life questionnaire (LCQ) was also used for assessment. The results were analyzed by applying paired sample T test by using IBM SPSS version 20.00. The p value was <0.005 at 95% confidence interval for cough variables including cough bouts, viscosity of sputum, chest congestion, sore throat and shortness of breath. The LCQ cough scale score was higher in test group as compared to control group. The test group also showed well tolerated in term of palatability. None of the patient claimed any of the side effects and no compliance were observed against the marketed brand.
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2.
Antitussive effect of a fixed combination of Justicia adhatoda, Echinacea purpurea and Eleutherococcus senticosus extracts in patients with acute upper respiratory tract infection: A comparative, randomized, double-blind, placebo-controlled study.
Barth, A, Hovhannisyan, A, Jamalyan, K, Narimanyan, M
Phytomedicine : international journal of phytotherapy and phytopharmacology. 2015;(13):1195-200
Abstract
BACKGROUND Kan Jang® oral solution (KJ) is a fixed combination of aqueous ethanolic extracts of Justicia adhatoda L. leaf, Echinacea purpurea (L.) Moench root, and Eleutherococcus senticosus (Rupr. & Maxim.) Harms root. It is approved in Scandinavia as an herbal medicinal product for respiratory tract infection treatment. PURPOSE The present clinical trial aimed to compare the antitussive effect of KJ with placebo (PL) and bromhexine (BH) among patients of 18-65 years old with non-complicated upper respiratory infections (URI; i.e., common cold). STUDY DESIGN We performed a parallel-group, randomized, double-blinded, placebo-controlled trial in in 177 patients with acute URI over a 5 day period. METHODS We investigated the antitussive effects of a KJ (30 ml/day; 762 mg genuine extracts with standardized contents of 0.2 mg/ml vasicine, 0.8 mg/ml chicoric acid, and 0.03 mg/ml eleutherosides B and E), bromhexine hydrochloride (24 mg/30 ml/day) and PL on cough and blood markers. The primary outcome was cough relief, which was assessed as the change of cough frequency from baseline (cough index). Secondary outcomes were safety with regards to reported adverse events (AEs) and hematological data. RESULTS Both KJ and BH relieved cough more effectively than placebo. On the third and fourth days of treatment, we observed faster improvement in the group receiving KJ compared to in the groups receiving BH (100%) or PL (100%), indicating a slightly shorter recovery time in the KJ group. KJ showed a good tolerability and safety profile. CONCLUSION KJ exerted significant antitussive effects in URI. The present data further support the therapeutic use of KJ in upper respiratory tract infections.
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3.
Multisite comparison of mucociliary and cough clearance measures using standardized methods.
Bennett, WD, Laube, BL, Corcoran, T, Zeman, K, Sharpless, G, Thomas, K, Wu, J, Mogayzel, PJ, Pilewski, J, Donaldson, S
Journal of aerosol medicine and pulmonary drug delivery. 2013;(3):157-64
Abstract
BACKGROUND A standardized protocol for measuring mucociliary (MCC) and cough clearance (CC) was developed and tested at the University of North Carolina at Chapel Hill, NC (UNC), Johns Hopkins University (JHU), and the University of Pittsburgh (Pitt). METHODS A total of 50 healthy nonsmoking adults with normal lung function were studied at the three sites: 30 [21 males/9 females (21M/9F)] at UNC, 10 (6M/4F) at JHU, and 10 (4M/6F) at Pitt. Subjects inhaled an aerosol of (99m)technetium sulfur colloid in 0.9% saline (mass median aerodynamic diameter=5.4 μm) under controlled breathing conditions (500 mL/sec, 30 breaths/min) by following a metronome and flow signal from a commercial dosimeter. Following inhalation, subjects sat in front of a gamma camera as sequential lung images were acquired for 60 min. Subjects then coughed 60 times, and images were acquired after each set of 20 coughs, i.e., at 70, 80, and 90 min. Subjects returned to the laboratory approximately 24 hr later for a final image of residual lung activity. Initial aerosol distribution was measured as a central/peripheral (C/P) ratio of activity. MCC/CC was expressed as the area under the retention versus time curve over 90 min (AUC90). RESULTS A multivariate analysis of clearance versus time with site and C/P as covariates showed no significant site-specific differences. Interestingly, MCC/CC was greater in females (n=19) versus males (n=31), with AUC90=0.84 ± 0.11 and 0.90±0.07, respectively (p=0.03), for the combined data set from all sites (not significant for any given site). There were no gender differences for either C/P ratio or 24-hr clearance. CONCLUSIONS This standardized protocol may prove beneficial in multicenter trials for testing new therapies that are designed to improve MCC/CC.
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4.
Suitability of ivy extract for the treatment of paediatric cough.
Schmidt, M, Thomsen, M, Schmidt, U
Phytotherapy research : PTR. 2012;(12):1942-7
Abstract
Two galenical formulations of an ivy herbal extract, syrup and cough drops, were tested for their efficacy and safety in the paediatric treatment of cough and bronchitis in two independent open, non-interventional studies with identical design. Two-hundred and sixty-eight children aged 0-12 yr were treated with one of the two preparations for up to 14 days. The effects on cough-related symptoms were addressed on a verbal rating scale. At the end of the study the major symptoms rhinitis, cough and viscous mucus, were found to be only mildly expressed or absent in 93, 94.2 and 97.7% of cases. The global effect was rated as 'good' or 'very good' in 96.5% of cases. Tolerability and compliance were found 'good' to 'very good' in 99% (syrup) and 100% (drops) of patients on completion of the study. A subgroup analysis according to four different age and dosing groups did not reveal differences in treatment response. Safety was confirmed and corresponded to literature findings. Five adverse events classified as mild and non-serious were reported (1.9%). In conclusion, ivy leaf extract in the form of syrup and of cough drops was confirmed as an effective and safe treatment of cough in children.
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5.
[Treatment of acute bronchitis in children and adolescents. Non-interventional postmarketing surveillance study confirms the benefit and safety of a syrup made of extracts from thyme and ivy leaves].
Marzian, O
MMW Fortschritte der Medizin. 2007;(27-28 Suppl):69-74
Abstract
OBJECTIVE For the investigation of the benefits and tolerability of a syrup made of extracts from thyme and ivy (Bronchipret Saft) in children and adolescents (ages: 2-17 years) with acute bronchitis and productive cough, a non-interventional postmarketing surveillance study was carried out. METHODS Prerequisites for participation in the surveillance study were productive cough for a maximum of two days, at least ten coughing fits per day prior to the initiation of treatment (estimation of the parents or adolescent) and a Bronchitis Severity Score (BSS) of at least five points. The primary outcome measure was the change in the clinical symptoms based on the BSS. Treatment was carried out using age-appropriate dosages prescribed by the doctor on a case-by-case basis in accordance with the summary of product characteristics. Documentation of the course of treatment for the surveillance study was to be taken on treatment days 0, 4 and 10. RESULTS For the descriptive, statistical evaluation of the surveillance study, the data from 1234 children and adolescents (623 boys and 611 girls) in the age groups < 2 years (N = 12), 2-5 years (N = 372), 6-11 years (N = 438) and 12-17 years (N = 412) were available. The correspondence of the dosages to the age-specific recommendations of the valid summary of product characteristics varied from 81.7% to 93.9% in the different age groups. The average BSS value decreased from 8.8 points to 4.8 on treatment day 4 and to 1.3 points after about ten days of treatment. Compared to that of the initial examination, the number of documented coughing fits had decreased on the average by 18.7 (81.3%) on day 10. The responder rates of the various age groups were 92.0% to 96.5%. The tolerability was rated as very good to good by the physicians in 96.5% of the cases. Two female patients had temporary, not serious adverse drug reactions (stomache ache, mild nausea). CONCLUSION Acute bronchitis with productive cough in (young) children and adolescents can be treated safely and effectively with the thyme and ivy syrup. A ten-day treatment using age-appropriate dosages led to a clear improvement in the symptoms or cure with very good tolerability.
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6.
How does lobeline injected intravenously produce a cough?
Raj, H, Bakshi, GS, Tiwari, RR, Anand, A, Paintal, AS
Respiratory physiology & neurobiology. 2005;(1):79-90
Abstract
In order to examine, whether the lobeline-induced cough is a true reflex or a voluntary effort to get rid of its irritating sensations in the upper respiratory tract, we systematically studied the cough response to lobeline, of subjects who were unable to make conscious discriminations i.e. were either comatose (n=4) or anaesthetized (n=5). 8 microg/kg lobeline injected into the right atrium of one and 29 microg/kg intravenously (i.v.) into another evenly and spontaneously breathing comatose subject produced a cough after 4s and 12s, respectively. Cough was repeatable and showed a dose response relationship i.e., its latency decreasing and its duration/intensity increasing with the dose. In a third subject, capable only of weak spontaneous respiration, a relatively high dose injected into the right atrium (44 microg/kg) generated a pronounced cough-like respiratory movement superimposed on the artificial ventilation and also during the apnoea after disconnecting the pump. No respiratory response was evoked in a fourth subject who had no evidence of brainstem reflexes. In five normals, cough was elicited with a mean dose of 35+/-5 microg/kg i.v. (latency 14+/-2 s; duration 10+/-3 s). After thiopental anaesthesia, injecting 41+/-7 microg/kg produced a cough within 13+/-2 s that lasted for 12+/-2 s. It may be noted that neither the later dose nor the latency or duration of cough that it produced were significantly different from the pre anaesthesia values (P>0.05). These two sets of results show unequivocally that the lobeline-induced cough is evoked reflexly; its magnitude in the conscious state could vary by subjective influences. We discuss the likelihood of its origin from juxtapulmonary capillary receptors.
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7.
Inhaled nedocromil sodium for persistent cough in children.
Chan, PW, Debruyne, JA
The Medical journal of Malaysia. 2001;(4):408-13
Abstract
The efficacy of inhaled nedocromil sodium (NS) for children with a persistent cough was studied. Children aged 4-12 years with a persistent cough for >1 month were recruited and entered a 2-week baseline period during which an asthma diary was kept. Children with a cough score of >20 received inhaled NS via a spacer, 4mg qid for 2 weeks followed by 4mg bd for another 4 weeks. Twenty-two (42%) of 52 children recruited fulfilled treatment criteria. Four children were withdrawn from the study (2 developed wheezing and 2 were not compliant). The baseline cough score (29.1 +/- 13.6) improved after 2 weeks of treatment (15.2 +/- 9.3, p < 0.01) and improvement was sustained after 6 weeks (14.2 +/- 13.0, p = 0.01). Parents and patients had a more favourable perception of its efficacy compared to physicians (72% vs 50%, p = 0.01) Inhaled NS may be considered for treatment of persistent cough in children.
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8.
Inhaled isotonic alkaline versus saline solution and radioaerosol clearance in chronic cough.
Haidl, P, Schönhofer, B, Siemon, K, Köhler, D
The European respiratory journal. 2000;(6):1102-8
Abstract
The aim of the present study was to test the influence of inhaled isotonic Ems salt (brine from the spa of Bad Ems, Germany) compared to isotonic saline on radioaerosol clearance (RC) in patients with chronic cough. Ems salt is an alkaline solution (pH 8.0-9.0) containing largely bicarbonate ions rather than the chloride ions present in isotonic saline (pH 6.4). RC was assessed with a radioaerosol technique using technetium-99m albumin in supine patients. After a 30-min baseline measurement of RC according to a single blind and randomized design, patients inhaled Ems salt (n=22, 20-77 yrs) or isotonic saline (n=21, 34-72 yrs) via a jet nebulizer (Pari Boy) for 10 min and were scanned for an additional 30 min. There was no difference between the two groups before intervention in terms of deposition pattern, lung function and baseline RC rate. After inhalation of Ems salt, the RC rate (1/tau) improved significantly from 0.15+/-0.14 (mean+/-SD) to 0.53+/-0.70 L.h(-1) (p<0.005); no change was found after isotonic saline (0.13+/-0.13 to 0.08+/-0.09 L.h(-1), NS). Voluntary coughs performed after 60 min had no effect on the RC rate. However, in the Ems salt group, significantly more patients reported an inhalation induced cough. Compared to the Ems salt patients, who did not cough during and after inhalation, the RC rate in the cough group was enhanced significantly (0.10+/-0.12 versus 0.73+/-0.83, p=0.017), this effect being seen more frequently in females (p=0.003). It is concluded that Ems salt improves radioaerosol clearance significantly in patients with chronic cough. The underlying mechanism, regarding whether induced cough, increased water content in the mucus or enhanced ciliary beat frequency is the leading cause of Ems salt action, remains unclear.