Efficacy and Safety of a Combination of Cinnarizine and Dimenhydrinate in the Treatment of Vertigo

2018 ◽  
Vol 3 (01) ◽  
Author(s):  
Dr. Mayuresh Kiran ◽  
Mr. Lalit Pawaskar
Keyword(s):  
Clinical Study ◽  
Adverse Events ◽  
Calcium Antagonists ◽  
Safety Assessment ◽  
Channel Blocker ◽  
Medical Condition ◽  
Age Group ◽  
Efficacy And Safety ◽  
Efficacy Assessment ◽  
Antihistaminic Drug

Introduction and Background: Vertigo is a medical condition where a person feels as he/ she or the objects around them are moving when they are stable and not moving. Antihistamines, Calcium antagonists, histamine analogs (eg, betahistine derivatives), diuretics, neuroleptics as well as other psychotherapeutic drugs, corticosteroids agents and hemorheologics can be used for the treatment of Vertigo. Combination of Cinnarizine which is a selective calcium-channel blocker and Dimenhydrinate which is an H 1 antihistaminic drug can be used in combination for the treatment of vertigo. This clinical study was conducted to evaluate the efficacy and safety of combination of Cinnarizine 20 mg and Dimenhydrinate 40 mg in patients of vertigo of age group 18 to 65 years. Methodology: Out of total 216 patients, 168 completed the study. Efficacy assessment was made by analysing the reduction in vertigo symptom score (VSS). Safety assessment was made by analysing the adverse events experienced by the patient or observed by the investigator during trial. Results: Reduction in VSS from 7.277 (baseline) to 3.975 (day 3) and 0.987 (day 5). At visit 2 and visit 3 there was reduction of 45.373 % and 86.426 % in mean VSS score. Conclusion: A combination of Cinnarizine 20 mg and Dimenhydrinate 40 mg is safe and efficacious in the treatment of vertigo.

scholarly journals A Multi-centered Study to Evaluate the Efficacy and Safety of Amitriptyline and Mecobalamine in the Management of Neuropathic Pain

2019 ◽  
Vol 4 (01) ◽  
Author(s):  
Dr. Mayuresh Dilip Kiran ◽  
Shaheen Naseem Sheikh ◽  
Lalit Jeeevan Pawaskar
Keyword(s):  
Neuropathic Pain ◽  
Adverse Events ◽  
Risk Reduction ◽  
Safety Assessment ◽  
Moderate Intensity ◽  
Efficacy And Safety ◽  
Vas Score ◽  
Efficacy Assessment ◽  
The Central Nervous System ◽  
Patients Experience

Introduction: Neuropathic Pain (NP) is known as ‘nerve pain’- is a type of chronic pain that occurs when nerve in the central nervous system becomes damage or injured. An FDC of Amitriptyline a neuroanalgesia and Mecobalamine (Vitamin B12) a damage nerve rejuvenator have an important role in management of NP. Methodology: Of 786 registered, 666 patients completed the study. Efficacy assessment was made by reduction in mean VAS score and ≥50% reduction in NP was calculated at conclusion visit and used to determine the corresponding NNT which was calculated by using risk reduction. Safety assessment was made by inspecting the adverse events during trial. Results: Reduction in mean VAS score was from 7.3 (baseline) to 5.6 (day 30) and 3.9 (day 45). Nearly all the patients had experience ≥50% reduction in NP and NNT score of 1.21 which was calculated by using risk reduction parameter at conclusion visit. Overall 236 patients experience adverse events and were of mild to moderate intensity, sedation and drowsiness being dominantly seen. Conclusion: A combination of Amitriptyline and Mecobalamine was efficacious, safe and well-tolerated in management of Neuropathic pain (NP).

Safety and Efficacy of a Combination of Chloramphenicol, Polymyxin-B and Dexamethasone in Ocular Infection with Inflammation

2018 ◽  
Vol 3 (01) ◽  
Author(s):  
Dr. Mayuresh Dilip Kiran ◽  
Shaheen Naseem Sheikh, Lalit Jeevan Pawaskar
Keyword(s):  
Adverse Events ◽  
Analogue Scale ◽  
Safety Assessment ◽  
Polymyxin B ◽  
Fixed Dose ◽  
Ocular Infection ◽  
Vas Score ◽  
Efficacy Assessment ◽  
Dose Combination ◽  
Ocular Discharge

Introduction: Ocular infection with inflammation is very common in developing countries like India. Multi-drug therapy is used in the treatment of Ocular infection with inflammation. We studied the safety as well as efficacy of one such combination anti-bacterial (Chloramphenicol and Polymyxin -B) and corticosteroid (Dexamethasone) in the treatment of Ocular infection with inflammation especially mild keratitis and conjunctivitis. Methodology: Out of 151 patients, 117 were completed the study. Efficacy assessment was made by reduction in Visual Analogue Scale (VAS) Score of Ocular hypermia, Ocular discharge, Keratitis and Conjunctivitis related to Ocular infection with inflammation. Safety assessment was made by inspecting the adverse events during the study. Results: Reduction in mean VAS score was analysed from 4.47 (baseline) to 2.76 (day 3) to 0.55 (day 5) of ocular hypermia, from 3.42 (baseline) to 2.03 (day 3) to 0.24 (day 5) of ocular discharge, 3.57 (baseline) to 1.89 (day 3) to 0.21 (day 5) of keratitis and from 3.84 (baseline) to 2.10 (day 3) to 0.20 (day 5) of conjunctivitis. Majority of patients had more than 90% reduction in their VAS score at conclusion visit in all the parameters. 8.54% of adverse events of mild intensity was observed. Conclusion: A fixed dose combination of Chloramphenicol, Polymyxin-B and Dexamethasone of is safe and effective in the treatment of Ocular infection with inflammation.

IMPACT study: A phase II-III clinical study with the immunomodulator MGN1703 in patients with advanced colorectal carcincoma.

2012 ◽  
Vol 30 (4_suppl) ◽  
pp. 633-633 ◽  
Author(s):  
Marina Tschaika ◽  
Hans-Joachim Schmoll ◽  
Jorge Riera-Knorrenschild ◽  
Dieter Nitsche ◽  
Jorg Trojan ◽  
...  
Keyword(s):  
Clinical Study ◽  
Adverse Events ◽  
Disease Control ◽  
Phase Ii ◽  
Impact Study ◽  
Efficacy And Safety ◽  
First Line ◽  
First Line Therapy ◽  
Line Therapy ◽  
The Impact

633 Background: The synthetic DNA-based immunomodulator MGN1703 acts as an agonist of toll-like receptor 9. Based on promising data from a phase I study in patients with metastatic solid tumors including those with CRC, a phase II-III study was initiated in patients with advanced CRC having disease control after first-line therapy. The objective of the study is to assess efficacy and safety of the MGN1703 treatment in comparison to placebo. Methods: The IMPACT study is designed as a randomized double-blind placebo-controlled phase II-III study, which is conducted in patients with advanced CRC showing disease control after first-line therapy with standard chemotherapy regimen. The treatment is administered subcutaneously twice weekly in a ratio 2:1 (60 mg MGN1703 or placebo). The study is conducted in Germany, Austria, France, UK, Czech Republic and Russia, and 129 patients will be recruited into the study. The efficacy and safety of the study treatment will be evaluated based on extensive immunological tests, radiological assessment, safety laboratory results and assessments of the quality of life. The study treatment will be continued until tumor progression, intolerable toxicity, exclusion criteria or withdrawal of consent. Results: The majority of adverse events were assessed as not drug-related by the investigator. The remaining AEs include mild night sweat (not assessable), mild fever (at three occasions, possible related), and mild arthralgia (certain related) in one patient each. Three SAE have been reported so far of which one was assessed as probably drug-related – atypical pneumonia. Only in single patients local reactions such as mild redness and swelling at injection site were reported. No laboratory or clinical signs of autoimmunity or dose-limiting toxicities were reported, so far. Conclusions: With these preliminary safety results of the ongoing clinical study in patients with advanced CRC it could be shown that ttreatment with MGN1703 at the dosage of 60 mg is well tolerated and safe. Reported adverse events assessed as possibly drug-related belong to expected study drug reactions known for immune modulating drugs. These events were not accompanied by any signs of autoimmunity.

scholarly journals Efficacy and safety of local lysozyme treatment in patients with oral mucositis after chemotherapy and radiotherapy

2019 ◽  
Vol 69 (4) ◽  
pp. 695-704
Author(s):  
Dzenana Eminagić ◽  
Aida Lokvančić ◽  
Berisa Hasanbegović ◽  
Alma Mekić-Abazović ◽  
Asmir Avdičević ◽  
...  
Keyword(s):  
Clinical Study ◽  
Adverse Events ◽  
Pain Intensity ◽  
Oral Mucositis ◽  
Solid Food ◽  
Efficacy And Safety ◽  
Chemotherapy Group ◽  
Radiotherapy Group ◽  
Group Reduction ◽  
Liquid Foods

Abstract This observational clinical study was composed of two substudies: a non-comparative one (n = 166), testing only lysozyme-based compounds (LBCs), and a comparative substudy (n = 275), testing both LBCs and bicarbonate-based local compounds (BBCs) on the healing of oral mucositis during radio- or chemotherapy. The density of ulcerations has decreased significantly after the treatment with lysozyme in both substudies. The density of ulcerations in the radiotherapy group was lower in patients treated with LBCs compared to patients treated with BBCs (p < 0.001). In the chemotherapy group, reduction of ulceration density was similar with both LBCs and BBCs. The LBCs reduced pain intensity during the intake of solid food and speech more than BBCs in both patient cohorts (p < 0.05). In the radiotherapy cohort, pain intensity when consuming liquid foods was reduced more with LBCs than with BBCs (p < 0.05). No adverse events were recorded. This study demonstrates the advantages of treating oral mucositis during radiotherapy or chemo-therapy with LBCs.

scholarly journals Mini-Review Discussing the Reliability and Efficiency of COVID-19 Vaccines

Diagnostics ◽  
2021 ◽  
Vol 11 (4) ◽  
pp. 579
Author(s):  
Bogdan Doroftei ◽  
Alin Ciobica ◽  
Ovidiu-Dumitru Ilie ◽  
Radu Maftei ◽  
Ciprian Ilea
Keyword(s):  
Side Effects ◽  
Severe Acute Respiratory Syndrome ◽  
Adverse Events ◽  
Adverse Reactions ◽  
Age Group ◽  
Efficacy And Safety ◽  
Short Time ◽  
Dose Dependent ◽  
Severe Adverse Reactions ◽  
Age And Sex

Severe Acute Respiratory Syndrome Coronavirus 2 is a novel strain of human beta-coronavirus that has produced over two million deaths and affected one hundred million individuals worldwide. As all the proposed drugs proved to be unstable, inducing side effects, the need to develop a vaccine crystallized in a short time. As a result, we searched the databases for articles in which the authors reported the efficacy and safety of the use of several vaccines vaccines by sex, age group, and frequency of adverse reactions. We identified a total of 19 relevant articles that were discussed throughout this manuscript. We concluded that from all eleven vaccines, three had an efficacy >90% (Pfizer–BioNTech (~95%), Moderna (~94%), and Sputnik V (~92%)) except for Oxford–AstraZeneca (~81%). However, Moderna, Sputnik V, and Oxford–AstraZeneca also alleviate severe adverse reactions, whereas in Pfizer–BioNTech this was not revealed. The remaining five (Convidicea (AD5-nCOV); Johnson & Johnson (Ad26.COV2.S); Sinopharm (BBIBP-CorV); Covaxin (BBV152), and Sinovac (CoronaVac)) were discussed based on their immunogenicity, and safety reported by the recipients since only phases 1 and 2 were conducted without clear evidence published regarding their efficacy. CoviVac and EpiVacCorona have just been approved, which is why no published article could be found. All adverse events reported following the administration of one of the four vaccines ranged from mild to moderate; limited exceptions in which the patients either developed severe forms or died, because most effects were dose-dependent. It can be concluded that aforementioned vaccines are efficient and safe, regardless of age and sex, being well-tolerated by the recipients.

scholarly journals Potential Usefulness of the Kampo MedicineYokukansan, ContainingUncariaHook, for Paediatric Emotional and Behavioural Disorders: A Case Series

2013 ◽  
Vol 2013 ◽  
pp. 1-4 ◽  
Author(s):  
Yoshiyuki Tanaka ◽  
Takeshi Sakiyama
Keyword(s):  
Clinical Study ◽  
Adverse Events ◽  
Clinical Efficacy ◽  
Case Series ◽  
Outpatient Clinics ◽  
Efficacy And Safety ◽  
Behavioural Disorders ◽  
Double Blind ◽  
Randomized Clinical Study ◽  
Pharmacologic Treatments

Background. Paediatric emotional and behavioural disorders (EBD) are relatively common diseases. Although nonpharmacologic and pharmacologic treatments are utilized in these cases, it is sometimes difficult to manage the symptoms of EBD. Historically,Uncariahook has been used for treating nighttime crying and convulsions in children. Recent clinical studies have demonstrated that the Kampo medicineYokukansan(YKS), which containsUncariahook, is efficacious for behaviour disorders in Alzheimer’s disease patients. Herein, we investigated the clinical efficacy and safety of YKS in a series of cases with paediatric EBD.Patients and Methods. We retrospectively reviewed all paediatric patients who sought Japanese Kampo therapy at our outpatient clinics between April 1, 2012, and April 30, 2013; we selected patients who were diagnosed with paediatric EBD and were treated with YKS.Results. After screening all candidates, 3 patients were eligible for this analysis. Their average age was 11.6 years (range 10–13 years). All 3 patients responded very well to YKS within 1 month. No drug-related adverse events were observed during the course of YKS treatment.Conclusion.Yokukansanmay be efficacious for paediatric EBD. We believe these results warrant further evaluation of the clinical efficacy and safety ofYokukansanfor paediatric EBD in a carefully designed, double-blind, randomized clinical study.

scholarly journals A randomized, double-blind, comparative study for efficacy assessment of two hyaluronic acid nasolabial fillers

2018 ◽  
Vol 3 (2) ◽  
Author(s):  
Saman Ahmad Nasrollahi ◽  
Mansour Nassiri Kashani ◽  
Taraneh Yazdanparast ◽  
Setareh Ameri ◽  
Alireza Firooz
Keyword(s):  
Hyaluronic Acid ◽  
Safety Assessment ◽  
Clinical Signs ◽  
P Value ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Efficacy Assessment ◽  
Spss Software ◽  
Nasolabial Folds ◽  
Better Than

<p class="Default">Hyaluronic acid fillers are considered safe for use in cosmetics as described in the safety assessment. This study was aimed to assess and compare the efficacy and safety of two hyaluronic acid (HA) fillers on mild nasolabial folds. Ten women aged 30-50 years with mild nasolabial folds participated for injection of A and B gels into right or left nasolabial folds. The volume and surface of nasolabial folds were measured by CSI software and the density and thickness of dermis assessed by skin ultrasonography before and 2, 12, and 24 weeks after injection. The data were analyzed using SPSS software version 20, and p-value &lt;0.05 were considered as significant. Global assessment showed over 50% improvement in patients injected with both gel A and B. At 2 weeks after injecting gel A the volume and surface of wrinkles decreased significantly. In the side injected with gel B, this reduction was significant at 2 and 12 weeks after injection. In addition, 24 weeks after injection of both gels the dermis echo-density increased and the dermis thickness decreased.  This study indicated the significant positive filling effect of both HA fillers in decreasing the clinical signs of wrinkles at nasolabial folds. Comparing both fillers, there were not any statistically significant differences in any of measurements, but the persistence of gel B to improve the wrinkle appearance was slightly better than gel A. </p>

Almotriptan is an Effective and Well-Tolerated Treatment for Migraine Pain: Results of A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Cephalalgia ◽  
2002 ◽  
Vol 22 (6) ◽  
pp. 453-461 ◽  
Author(s):  
AJ Dowson ◽  
H Massiou ◽  
JM Laínez ◽  
X Cabarrocas
Keyword(s):  
Adverse Events ◽  
Standard Treatment ◽  
Controlled Clinical Trial ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Migraine Pain ◽  
Significant Difference ◽  
Severe Intensity ◽  
Efficacy Assessment ◽  
Better Than

Almotriptan is a novel and specific serotonin 5-HT1B/1D agonist for the acute treatment of migraine. This randomized, single-dose, double-blind, multicentre, study assessed the efficacy and safety of oral almotriptan (12.5 mg and 25 mg) in patients with migraine, and compared it with the standard treatment (sumatriptan 100 mg) and placebo. A total of 668 patients treated one migraine attack of moderate or severe intensity with study medication. The primary efficacy assessment was migraine pain relief, improvement from severe or moderate pain to mild or no pain, at 2 h after treatment. Response rates, stratified for variation in baseline pain levels, for both almotriptan doses were equivalent to sumatriptan and significantly better than placebo. Other efficacy assessments confirmed the equivalence of the almotriptan groups with the sumatriptan group. Almotriptan 12.5 mg was as well tolerated as placebo ( P = 0.493) and significantly better tolerated than sumatriptan ( P < 0.001), in terms of the overall incidence of adverse events. There was no statistically significant difference in the incidence of adverse events between almotriptan 25 mg and sumatriptan 100 mg ( P = 0.376). The results from this large clinical study indicate that the new, specific 5-HT1B/1D agonist, almotriptan, is an effective and well-tolerated treatment for migraine pain.

scholarly journals Safety assessment of a new anti-tuberculosis drug in silico and with the participation of healthy volunteers

2022 ◽  
pp. 42-47
Author(s):  
A. Yu. Savchenko ◽  
G. V. Ramenskaya ◽  
V. G. Kukes ◽  
M. S. Burenkov ◽  
B. V. Shilov
Keyword(s):  
Clinical Study ◽  
Adverse Events ◽  
Healthy Volunteers ◽  
In Silico ◽  
Safety Assessment ◽  
Study Drug ◽  
Open Label ◽  
Good Tolerability ◽  
Carcinogenic Effect ◽  
Clinical Safety

Relevance. In connection with the increase in the number of cases of multidrug-resistant tuberculosis (MDR-TB), the search for new anti-tuberculosis drugs (ATD) is necessary. The assessment of its effect on the human body outside the aspect of the therapeutic effect is one of the main directions in the development of anti-TB drugs.Aim. Evaluation of the possible toxicity of thiosonide, a new domestic anti-TB drug, combining a consistent study of this side of the drug using a bioinformatics approach and an analysis of the results of a clinical safety study.Methods. The bioinformatic assessment was carried out using web services and models to predict the toxicity of thiosonide. The safety assessment in relation to healthy volunteers was carried out as part of a clinical study according to the protocol: «An open-label study of the pharmacokinetics, safety and tolerability of the drug thiozonide, capsule 100 mg with a single dose of increasing doses by various groups of healthy volunteers.» (2013, Permit No. 187 to conduct a clinical trial dated March 22, 2013, issued by the Ministry of Health of the Russian Federation).Results. Potential unwanted targets were identified, the predicted activity value for which was greater than 7. The results obtained indicate the likelihood of the effect of thiosonide on these protein targets and, possibly, the ability of the latter to cause side effects associated with changes in the activity of these molecules. The cytotoxic and carcinogenic effect of thiosonide is not predicted. During a clinical study, the drug thiosonide showed good tolerance and safety, since the identified adverse events did not show a definite or reliable relationship with the study drug. The resolution of all adverse events was complete, and dose escalation did not affect the number, severity of AEs and association with the study drug.Conclusion. The safety analysis of thiosonide demonstrated its good tolerability both during in silico assessment and in a study with the participation of healthy volunteers.

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