scholarly journals Evaluation of Comparative Dermal Toxicity and Efficacy of Aargwadhadi Oil and Aargwadhadi Ointment

2021 ◽  
pp. 264-273
Author(s):  
Premadevi Kalmegh ◽  
Bharat Rathi ◽  
Renu Rathi ◽  
Poonam Madan
Keyword(s):  
Analytical Study ◽  
Skin Diseases ◽  
Herbal Medicines ◽  
Control Group ◽  
Toxicity Profile ◽  
Efficacy And Safety ◽  
Dermal Toxicity ◽  
Pharmaceutical Development ◽  
Experimental Group ◽  
Topical Applications

Introduction: Skin diseases are among the most common of all health illness in recent years, In Ayurveda, management of skin diseases includes internal and external administration. External administration includes various topical applications However, herbal medicines are not completely safe from adverse effects and develop irritation, rashes, redness and burning sensation on the skin as observed in recent researches.“Hence there is a requirement of a safe drug which should be economical & affordable for all. Hence present study is undertaken to study dermal toxicity profile Aargwadhadi oil and Aargwadhadi ointment in an experimental animal and make available safe and efficient drug to the human being. Aim and Objective: Pharmaceutical development, standardization and evaluation of acute, sub-acute dermal toxicity and efficacy of a Aargwadhadi oil and Aargwadhadi ointment and compare efficacy and safety of Aargwadhadi oil and Aargwadhadi ointment. Materials and Methods: Aargwadhadioil and Aargwadhadi Ointment will be prepared as per classical reference and it will be converted into ointment form. Analytical study for standardization of Aargwadhadi oil and Aargwadhadi ointment will be done.  Evaluation of Acute and sub-acute dermal toxicity study in experimental animals of both dosage forms as well, efficacy study of Aargwadhadi oil and Aargwadhadi ointment on animal model of vitiligo will be done. Observations and Results: Observation will be done on the basis of assessment criteria evaluation of control group and experimental group will be noted. Results will be drawn on the basis of observations and applying suitable tests. It will be noted and presented in form of table, charts, graphs etc. Conclusion: Conclusion of the study will be drawn accordingly from the recorded observations, analysis of data.

scholarly journals Efficacy and safety of a monodisperse solid-in-oil-in-water emulsion in transcatheter arterial chemoembolization in a rabbit VX2 tumor model

2019 ◽  
Author(s):  
Daisuke Yasui ◽  
Aya Yamane ◽  
Hiroshi Itoh ◽  
Masayuki Kobayashi ◽  
Shin-ichiro Kumita
Keyword(s):  
Adverse Events ◽  
Transcatheter Arterial Chemoembolization ◽  
Iodine Concentration ◽  
Control Group ◽  
Efficacy And Safety ◽  
Water Emulsion ◽  
Left Liver Lobe ◽  
Vx2 Tumor ◽  
Experimental Group ◽  
Arterial Chemoembolization

AbstractTranscatheter arterial chemoembolization (TACE) is a standard treatment for unresectable hepatocellular carcinoma; however, it does not always result in tumor control. Nevertheless, treatment outcome can be improved with monodisperse emulsions of anticancer agents. In this study, the efficacy and safety of a monodisperse miriplatin-Lipiodol emulsion were evaluated in Japanese white rabbits. VX2 tumor was implanted into the left liver lobe of each rabbit. The animals were divided into control and experimental groups (of five animals each) and respectively administered a conventional miriplatin suspension or the emulsion via the left hepatic artery. Computed tomography (CT) was performed before, immediately after, and two days following TACE. All rabbits were sacrificed two days after the procedure. Each tumor was removed and cut in half for assessment of iodine concentration in one half by mass spectroscopy and evaluation of Lipiodol accumulation and adverse events in the other half. Mean Hounsfield unit (HU) values were measured using plain CT images taken before and after TACE. Iodine concentration was higher in the experimental group [1100 (750–1500) ppm] than in the control group [840 (660–1800) ppm]. Additionally, the HU value for the experimental group was higher than that for the control group immediately after [199.6 (134.0– 301.7) vs. 165.3 (131.4–280.5)] and two days after [114.2 (56.1–229.8) vs. 58.3 (42.9–132.5)] TACE. Cholecystitis was observed in one rabbit in the control group. Ischemic bile duct injury was not observed in any group. The results show that Lipiodol accumulation and retention in VX2 tumor may be improved by using a monodisperse emulsion. Moreover, no significant adverse events are associated with the use of the emulsion.

scholarly journals Efficacy and Safety of Socheongryong-Tang Among Atopic Dermatitis Patients With Respiratory Disorders: A Double-Blinded, Randomized, Placebo-Controlled Clinical Trial

2020 ◽  
Vol 11 ◽  
Author(s):  
Ju Hyun Lee ◽  
Eun Heui Jo ◽  
Jee Youn Jung ◽  
Young-Eun Kim ◽  
Mi-Ju Son ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Atopic Dermatitis ◽  
Safety Evaluation ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Efficacy And Safety ◽  
Inflammatory Skin Disease ◽  
Double Blinded ◽  
Study Participants ◽  
Experimental Group

Atopic dermatitis is a chronic inflammatory skin disease that affects the growth and development of children. The prevalence of atopic dermatitis has been continually increasing, and this has also been accompanied by rising socioeconomic costs. Interest has been growing in alternative medicine as a means of alleviating the burden of atopic dermatitis. This was a single-center, double-blinded, randomized, placebo-controlled investigator-led clinical trial including 60 atopic dermatitis patients. The participants were classified into an experimental group (30 persons) and a control group (30 persons), who were administered, respectively, socheongryong-tang or a placebo for 4 weeks. After 4 weeks of treatment, the participants visited the trial center again and assess their efficacy and safety. The researchers performed statistical comparisons of the changes in the SCORAD Index, amount and frequency of ointment use, and height and weight to assess the efficacy. To assess the safety, diagnostic tests and vital sign checks were performed at each visit, and the presence or absence of adverse events was observed. As a result, the frequency and the amount of steroid ointment application in both groups increased, but the experimental group showed less tendency (p = 0.081). Results of analyzing the children in the experimental group in relation to growth showed a significantly greater height growth than the control group (p < 0.05). In addition, all study participants did not show any remarkable abnormal signs in the safety evaluation. In conclusion, compared to the control group, the experimental group, who took socheongryong-tang showed a tendency to be less dependent on steroid ointment and statistically significant increase in height.

Clinical efficacy and safety of silver nanoparticlebased disinfectant combined with piperacillin sodium and sulbactam sodium in the treatment of lower respiratory tract infection

2020 ◽  
Vol 10 (5) ◽  
pp. 756-761
Author(s):  
Xiaofei Li ◽  
Lina Sheng ◽  
Juncai Tu ◽  
Lianqing Lou
Keyword(s):  
Tract Infection ◽  
Respiratory Tract ◽  
Silver Nanoparticle ◽  
Lower Respiratory Tract ◽  
Respiratory Tract Infections ◽  
Control Group ◽  
Efficacy And Safety ◽  
Lower Respiratory Tract Infections ◽  
Tract Infections ◽  
Experimental Group

This study evaluated the clinical efficacy and safety of piperacillin sulbactam in the treatment of lower respiratory tract infections, as well as the efficacy of silver nanoparticle-based disinfectant in equipment disinfection to reduce exogenous infection. From May 2018 to November 2018, 100 patients that had been diagnosed with a lower respiratory tract infection and hospitalized were divided into an experimental group and a control group. The experimental group was given piperacillin/sulbactam, and the control group was given mezlocillin/sulbactam, where 5.0 g was added to 100 mL of normal saline and administered via intravenous drip twice a day over a treatment course of 14 days. The cure rate of the experimental and control groups were 65.22% and 56.52% respectively. The efficacy rate was 91.30% and 91.30% respectively, with no significant difference between the two groups (P > 0.05). The results indicated that piperacillin/sulbactam is a safe, effective treatment for lower respiratory tract infections in elderly patients, the equipment was sterilized with silver nanoparticle-based disinfectant to reduce the incidence of adverse reactions and exogenous infections.

Efficacy and safety of PEGylated recombinant human granulocyte stimulating factor in the prevention of neutropenia during concurrent chemoradiotherapy.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e18018-e18018
Author(s):  
Dongling Zou ◽  
Qi Zhou ◽  
Mingfang Guo
Keyword(s):  
Cervical Cancer ◽  
Concurrent Chemoradiotherapy ◽  
Measurement Data ◽  
Test Group ◽  
Control Group ◽  
Fisher Exact Test ◽  
Combination Regimen ◽  
Efficacy And Safety ◽  
Grade 3 ◽  
Experimental Group

e18018 Background: This randomized controlled prospective study aims to explore the efficacy and safety of using PEG-rhG-CSF to prevent neutropenia during concurrent chemoradiotherapy of paclitaxel and cisplatin (TP) regimen for cervical cancer. Methods: Patients who met the eligibility criteria were divided into two groups according to the randomized principle of 2:1: the experimental group (patients used 6 mg PEG-rhG-CSF prophylactically after chemotherapy) and the control group (patients did not use PEG-rhG-CSF for prevention and were given 5 ug / kg rhG-CSF when ANC < 1✕109). TP combination regimen was used for concurrent chemotherapy, specifically as follows: paclitaxel 150mg / m2 (day 1), cisplatin 35mg / m2 (day 1-2), repeated every three weeks. The PTV dose was 45 Gy in 1.8 Gy daily fractions, with five fractions per week. SPSS 25.0 software was used for statistical analysis of the data, t-test was used for measurement data, and χ2 test Fisher exact test was used for enumeration data. P < 0.05 was considered statistically significant. Results: As of September 2019, 30 patients were enrolled into this study, including 18 in the experimental group and 12 in the control group. One of the 18 patients in the test group (5.6%) had a Grade 3/4 neutropenia. Ten of the 12 patients in the control group (83.3%) developed Grade 3/4 neutropenia. The incidence of Grade 3/4 neutropenia in the two groups was statistically significant (P < 0.001, Table 1). The incidence of FN was 5.6% in the experimental group and 8.3% in the control group (P = 1.000). The incidence of delayed chemotherapy course was 11.1% in the experimental group and 58.3% in the control group (P = 0.013). The incidence of delayed chemotherapy course in the two groups was statistically significant (Table 1). As shown in Figure 4, the experimental group had a completion time of radiotherapy for 46.7 days, while the control group had 49.0 days (P = 0.278). Conclusions: Although the results of bone marrow function and overall survival are still to be obtained, it can be initially seen from the intermediate-term data that the use of PEG-rhG-CSF primary prevention reduced the granulocytopenia and the delay of the chemotherapy course during the concurrent chemoradiotherapy TP regimen for cervical cancer, which has the value of further completing this study. [Table: see text]

scholarly journals Anerning Granule for Community Acquired Pneumonia: Protocol for Randomized, Double-Blind, Single-Dummy, Parallel Control of Placebo, Multicenter Clinical Trial

2021 ◽  
Author(s):  
Menghua Sun ◽  
Jian Lyu ◽  
Yi-li Zhang ◽  
Xu Wei ◽  
Li-dan Zhang ◽  
...  
Keyword(s):  
Adverse Events ◽  
Community Acquired Pneumonia ◽  
Clinical Treatment ◽  
Secondary Outcome ◽  
Control Group ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Ceftriaxone Sodium ◽  
Parallel Control ◽  
Experimental Group

Abstract Background: Community acquired pneumonia (CAP) in children is one of the common clinical diseases and infectious diseases threatening the health of the population. CAP has complicated causes, closely related to region, season, age, and primary disease. It is the most common cause of children being hospitalized and the first cause of death for children under 5 years old. At present, the clinical treatment is mainly antibiotics, but abuse and non-standard combination of antibiotics have led to increasing antibiotic resistance. Anerning Granules have the functions of clearing away heat and removing wind, reducing phlegm and relieving cough, and improving cough symptoms and lung signs. Thus, this study aims to evaluate the efficacy and safety of Anerning Granules (AEN) in the treatment of community-acquired pneumonia in children, and to explore whether AEN can reduce the use of antibiotics and have a good effect on the clinical treatment of CAP.Methods and analysis: this study, a randomized, double-blind, single-dummy, parallel control of placebo, multicenter clinical study will be established in 7 hospitals in the same period. A total of 216 patients with community-acquired pneumonia will be randomly allocated at a ratio of 2:1 to two groups: experimental group, control group. The experimental group receives Anerning Granules plus ceftriaxone sodium; the control group receives AEN placebo plus ceftriaxone sodium. Each group will be treated for ten days, and a stage effect evaluation will be conducted on the sixth day. The primary outcome is the end of antibiotics in frequency (DDDs) and effective rate. Secondary outcome measures of effectiveness are the full fever time, sore throat onset time, and safety assessment. Outcomes will be assessed at baseline and after treatment. In addition, adverse events will be monitored throughout the trial process and must be traced to be resolved.Discussion: This study protocol will provide the research data regarding the efficacy and safety of AEN for the treatment of community-acquired pneumonia in children. The first aim is to determine whether Anerning Granules can reduce the use of antibiotics; the second aim is to evaluate the effectiveness of Anerning Granules combined with ceftriaxone sodium in the treatment of children with community-acquired pneumonia. The third aim is to observe the safety of clinical application of Anerning Granules. The results of this study will improve the rational use of drugs, especially the rational application of antibiotics. It will also enable safety evaluation from laboratory indices of adverse events, which will provide reliable evidence for clinical treatment.Trial registration: Clinicaltrials.gov identifier: NCT03675178, registered on 16 September 2018.

scholarly journals Evolution of Needling: Preliminary Results of Microinvasive Antiglaucoma Reoperation

2021 ◽  
Vol 18 (1) ◽  
pp. 36-45
Author(s):  
I. B. Alekseev ◽  
A. K. Aylarova ◽  
G. Sh. Arzhimatova ◽  
A. V. Dobroserdov ◽  
A. I. Samoylenko
Keyword(s):  
Surgical Treatment ◽  
Clinical Case ◽  
Ultrasound Biomicroscopy ◽  
Main Group ◽  
Control Group ◽  
Ophthalmological Examination ◽  
Efficacy And Safety ◽  
Internal Fistula ◽  
Dynamic Observation ◽  
Experimental Group

Purpose: to assess the efficacy and safety of needling performed by the new scleroconjunctival dissector according to our specific technique.Patients and methods. The study included 60 patients diagnosed with operated subcompensated or decompensated glaucoma. Thirty patients underwent microinvasive reoperation with the help of a sclero-conjunctival dissector. The control group consisted of 30 patients; they underwent repeated sinustrabeculectomy with iridectomy. A standard ophthalmological examination and ultrasound biomicroscopy were performed before the operation and in dynamics (after 1, 3, 6, 9 months).Results: 76.7 % of the experimental group had IOP less than or equal to 15 mm Hg six months after microinvasive reoperation. In the control group, the same mark was 70 %. Hyphema occurred in 23.3 % of the main group, it was stopped by conservative treatment. 10 % of patient developed choroid detachment, it did not require surgical treatment. Hyphema was formed in 36.7 % in the control group and choroid detachment — in 53.3 % of patients. The complications were more manifested and required surgical treatment in the control group. According to the data of ultrasound biomicroscopy, the acoustic density in the control group steadily increased, while the height of the filtration bleb first increased and then decreased. This may indicate significant tissue induration, probably as a result of fibrosis after an operating injury. The intrascleral «lake» height does not differ between the groups when comparing dynamic observations, and the volume of the intrascleral cavity is significantly greater in the main group than in the control group (p < 0.0001) at admission and during dynamic observation. The text of the article describes a clinical case of a patient who underwent microinvasive reoperation.Conclusion. When there are indications for re-surgery, an adequate and thorough diagnosis of the preservation of the surgically created outflow tract, namely gonioscopy and ultrasound biomicroscopy, is important. In patients with intact internal fistula and without pronounced fibrosis of the intrascleral drainage pathways, it is possible to carry out microinvasive reoperation according to our technique using a scleroconjunctival dissector, this allows to reduce the risk of postoperative complications and achieve hypotensive efficacy comparable to repeated filtering surgery.

Characteristics of COVID-19 and possibilities of early causal therapy. Results of favipiravir use in clinical practice

2020 ◽  
Vol 18 (3) ◽  
pp. 30-40
Author(s):  
L.A. Balykova ◽  
◽  
A.V. Govorov ◽  
A.O. Vasilyev ◽  
E.N. Simakina ◽  
...  
Keyword(s):  
Adverse Events ◽  
Clinical Improvement ◽  
Standard Therapy ◽  
Control Group ◽  
Efficacy And Safety ◽  
Virus Elimination ◽  
Good Safety Profile ◽  
Causal Therapy ◽  
Lung Condition ◽  
Experimental Group

This paper provides the results of a study evaluating the efficacy and safety of etiotropic therapy in patients hospitalized with SARS-CoV-2 infection. Objective. Тo evaluate the efficacy and safety of favipiravir (Areplivir) in patients with coronavirus disease 2019 (COVID-19) and compare it with recommended standard therapy. Patients and methods. Two hundred men and women aged between 18 and 80 years with COVID-19 were randomized into this study. The experimental group included patients who received favipiravir, whereas the control group comprised patients who received causal therapy in accordance with the latest version of the temporary methodical recommendations of the Ministry of Health of Russia ‘Prevention, diagnosis, and treatment of coronavirus infection (COVID-19).’ The efficacy and safety of therapy were evaluated by assessing clinical improvement using the WHO Ordinal Scale for Clinical Improvement, clinical and laboratory parameters, findings of chest computed tomography (CT), and elimination of SARS-CoV-2. We also analyzed the frequency and type of adverse events, need for invasive and non-invasive ventilation, and death rates. Results. Our analysis has demonstrated significant benefits of favipiravir over standard therapy in terms of the time to clinical improvement (in the experimental group it was 4 days shorter on average), time to recovery, frequency of recovery after 10 days (44% of patients from the experimental group and 10% of patients from the control group had no clinical signs of the disease at this time-point), and frequency of virus elimination by day 10 of therapy. Treatment with favipiravir was associated with a significant improvement in the lung condition (according to CT), normalization of laboratory parameters, and saturation level. Favipiravir has demonstrated a good safety profile similar to that of standard therapy. There was no difference in the frequency of adverse events between the experimental and control groups. Conclusion. The use of favipiravir for the treatment of SARS-CoV-2 infection reduced the time to clinical improvement by 4 days on average compared to standard therapy, ensured improvement of the lung condition (according to CT scans), and facilitated virus elimination in more than 90% of patients, thereby promoting faster recovery. Favipiravir had a good safety profile and was well tolerated by patients. This treatment regimen was shown to be effective, sufficient, and clinically reasonable to achieve good outcomes. Timely initiation of therapy with favipiravir (Areplivir) improves disease prognosis and reduces the global socioeconomic burden of the current pandemic. Key words: COVID-19, Areplivir, coronavirus, causal therapy, favipiravir

scholarly journals Efficacy and Safety of Mecobalamin Combined with Prokinetic Agents in the Treatment of Diabetic Gastroparesis: A Meta-Analysis

2021 ◽  
Author(s):  
Jia Yao ◽  
Bo Peng ◽  
Xiayu Gong ◽  
Xiaoyan Shi ◽  
Simin Fan ◽  
...  
Keyword(s):  
Recurrence Rate ◽  
Adverse Reactions ◽  
Meta Analysis ◽  
Diabetic Gastroparesis ◽  
Control Group ◽  
Efficacy Rate ◽  
Efficacy And Safety ◽  
Prokinetic Drugs ◽  
Prokinetic Agents ◽  
Experimental Group

Background: The aim of the present study was to systematically review the efficacy and safety of mecobalamin combined with prokinetic agents in diabetic gastroparesis (DGP). Methods: A variety of databases were searched from inception to Nov 2, 2018. RCTs of mecobalamin combined with prokinetic agents group (experimental group) versus prokinetic agents only group (control group) in DGP were included. RevMan 5.3 and Stata 12.0 were used to perform the meta-analysis. Finally, 24 RCTs with 1,878 patients were included. Results: The total efficacy rate was significantly higher in the experimental group (mecobalamin combined with prokinetic drugs) compared with the control group (prokinetic drugs alone) (P<0.001), and the improvement was observed regardless of the administration route. Furthermore, the treatment group exhibited a significantly improved gastric emption rate (P<0.001), motilin (P<0.001) and recurrence rate (P<0.001), and there was no statistical difference in the incidence of adverse reactions between two groups (P=0.49). Conclusion: Mecobalamin combined with prokinetic agents can significantly improve total efficacy rate and gastric emptying rate, decrease serum motilin and the recurrence rate without increasing adverse reactions in DGP. Thus, mecobalamin may can be used as a new therapeutic option for DGP.

scholarly journals Clinical efficacy of acupoint application of Chinese herbal medicine to prevent acute exacerbation of stable chronic obstructive pulmonary disease: A study protocol for a randomized placebo-controlled trial

2019 ◽  
Author(s):  
Zhang Chuantao ◽  
Yang Hongjing ◽  
Gan Wenfan ◽  
Xie Xiaohong ◽  
Gao Peiyang ◽  
...  
Keyword(s):  
Chronic Obstructive Pulmonary Disease ◽  
Clinical Trial ◽  
Acute Exacerbation ◽  
Controlled Trial ◽  
Control Group ◽  
Chronic Obstructive ◽  
Efficacy And Safety ◽  
Obstructive Pulmonary Disease ◽  
Chinese Herbal ◽  
Experimental Group

Abstract Background: Chronic obstructive pulmonary disease (COPD) is a major public health problem that severely affects the quality of life of patients and may even endanger their lives. The key to prevent the progression of COPD is active treatment during the stable phase that prevents and reduces acute exacerbation of COPD. Although modern medicine has achieved significant results in relieving the clinical manifestations of COPD, it is difficult to prevent its progression and acute exacerbation entirely. As one of the classic aspects of acupuncture and moxibustion therapy, acupoint application of Chinese herbal medicine (CHM) can improve the clinical efficacy of Western medicine in treating COPD. To date, however,there is no high-quality clinical trial to assess the effectiveness of CHM acupoint application directly in preventing acute exacerbation of stable COPD.Thus, we designed this randomized placebo-controlled clinical trial to evaluate the long-term efficacy and safety of CHM acupoint application in preventing the acute exacerbation of stable COPD.Methods: The study is a randomized, double-blind, placebo-controlled trial, in which 200 stable COPD patients will be randomly and equally divided into the experimental group or control group. Both groups will undergo standard Western medicine treatment; however, the patients in the experimental group will be also treated with CHM acupoint application, while the control group will be given placebo acupoint application. The duration of the treatment will be 1 month and a follow-up for 11 months. The primary outcome will be the number of acute exacerbation episodes of COPD, and the secondary outcomes will include the lung function, St George's Respiratory Questionnaire, COPD Assessment Test, and 6-Minute Walk Test. A safety assessment will also be performed during the trial.Discussion: The aim of this study is to evaluate the efficacy and safety of CHM acupoint application in preventing acute exacerbation of stable COPD. Our study will provide sound evidence to support the evidence-based medicine of CHM acupoint application as an additional measure in the prevention of acute exacerbation of stable COPD.

scholarly journals Efficacy and Safety of Tirofiban in Thrombolytic Therapy for Ischemic Stroke

2019 ◽  
Vol 4 (1) ◽  
Author(s):  
Ruixian Wang ◽  
Lishun Yang ◽  
Jianhui Zhang ◽  
Qingping Yao ◽  
Zihuan Zhang
Keyword(s):  
Ischemic Stroke ◽  
Thrombolytic Therapy ◽  
Platelet Glycoprotein ◽  
Control Group ◽  
Therapeutic Effects ◽  
Efficacy And Safety ◽  
Improvement Rate ◽  
Stroke Thrombolysis ◽  
Experimental Group ◽  
Receptor Inhibitor

Objective: To evaluate the efficacy and safety of tirofiban hydrochloride in the treatment of ischemic stroke with thrombolytic therapy. Method: Two hundred patients with acute ischemic stroke thrombolysis were randomly divided into the experimental group and the control group. The experimental group was given tirofiban with the addition of rtpa in the control group and the therapeutic effects of the two groups were compared. Results: In comparison with the control group, the NIHSS improvement rate was 98% in the experimental group within 14 days. The platelet aggregation rate and efficacy in the experimental group were significantly reduced than the control group (P < 0.01). The major adverse reaction in the two groups was hemorrhage with an incidence rate of 3%. Conclusion: Tirofiban hydrochloride is a highly effective and selective platelet glycoprotein IIb/IIIa receptor inhibitor, which is safe and effective in combination with heparin and aspirin.

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