• Title/Summary/Keyword: medical formulation

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A Randomized single blind controlled clinical trial on safety and efficacy of a Unani formulation (Itrifal-e-Sagheer) in dyslipidemia

  • Alam, Sazid;Alam, MD Anzar;Quamri, MA;Sofi, Ghulamuddin;Khan, Mohd. Qudratullah;Ansari, Shabnam
    • CELLMED
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    • v.10 no.1
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    • pp.8.1-8.7
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    • 2020
  • Aim:'Itrifal-e-Sagheer', a compound Unani formulation has been indicated in disease conditions simulating dyslipidemia. The present study was done to substantiate the efficacy of 'Itrifal-e-Sagheer' in dyslipidemia on scientific parameters. Materials and methods: A randomized, single blind, controlled, clinical trial was carried out on 30 patients of dyslipidemia who were randomly allocated into test (n = 15) or control (n = 15) groups. The test drug, Itrifal-e-Sagheer and control drug, Abana® were given to respective group for 45 days along with lifestyle modification. Results: The test drug significantly alleviated the symptoms of subjective parameters (palpitation, breathlessness and weight gain) (p<0.05). There was statistically significant reduction in lipid profile of the patients in test group (p<0.05) than control drug treatment. Conclusion: The study evidenced that Itrifal-e-Sagheer is potentially effective and safe in the treatment of dyslipidemia. However, a multicentric study with robust study design is required to generalize the results.

Different Clinical Courses for Poisoning with WHO Hazard Class Ia Organophosphates EPN, Phosphamidon, and Terbufos in Humans (WHO 분류 1 등급 EPN, Phosphamidone, Terbufos 유기인계 중독환자의 임상 양상)

  • Mun, Jong Gu;Moon, Jeong Mi;Lee, Mi Jin;Chun, Byeong Jo
    • Journal of The Korean Society of Clinical Toxicology
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    • v.16 no.1
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    • pp.1-8
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    • 2018
  • Purpose: Extremely hazardous pesticides are classified as World Health Organization (WHO) hazard class Ia. However, data describing the clinical course of WHO class Ia OP (organophosphate) poisonings in humans are very scarce. Here, we compare the clinical features of patients who ingested hazard class Ia OPs. Methods: This retrospective observational case study included 75 patients with a history of ingesting ethyl p-nitrophenol thio-benzene phosphonate (EPN), phosphamidon, or terbufos. The patients were divided according to the chemical formulation of the ingested OP. Data regarding mortality and the development of complications were collected and compared among groups. Results: There were no differences in the baseline characteristics and severity scores at presentation between the three groups. No fatalities were observed in the terbufos group. The fatality rates in the EPN and phosphamidon groups were 11.8% and 28.6%, respectively. Patients poisoned with EPN developed respiratory failure later than those poisoned with phosphamidon and also tended to require longer mechanical ventilatory support than phosphamidon patients. The main cause of death was pneumonia in the EPN group and hypotensive shock in the phosphamidon group. Death occurred later in the EPN group than in the phosphamidon group. Conclusion: Even though all three drugs are classified as WHO class Ia OPs (extremely hazardous pesticides), their clinical courses and the related causes of death in humans varied. Their treatment protocols and predicted outcomes should therefore also be different based on the chemical formulation of the OP.

Triticum aestivum (Wheatgrass) formulation: An alternate treatment for the patients with Thalassemia

  • Desai, TR;Solanki, JK;Buch, Pankaj;Goyal, RK
    • Advances in Traditional Medicine
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    • v.7 no.5
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    • pp.466-476
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    • 2008
  • We have developed the tablet formulation of Triticum aestivum (wheatgrass) and investigated clinically, its effects in patients suffering from b-thalassemia (major) at K. T. Children Hospital, Civil Hospital, Rajkot. The tablets (wheatgrass powder 250 mg.) were given 3 times in a day for 9 months. Blood samples were collected at the start, after 6 months and 9 months and analyzed for various biochemical and hematological parameters. Treatment with wheatgrass formulation for 9 months produced significant decrease in hemoglobin, total RBC, eosinophil and reticulocyte counts. The mean corpuscular volume (MCV) and mean corpuscular hemoglobin concentration (MCHC) were significantly increased was significantly increased. The serum ferritin was also significantly decreased. There was no influence on serum magnesium, serum iron and Thiobarbituric acid reacting substances (TBARS). Our data indicate that treatment with wheatgrass on patients with $\beta$-thalassemia (major) may have beneficial effects in the form of a decrease in ineffective erythropoiesis, stimulation of hemoglobin synthesis in RBC, decrease in iron load and decrease in eosinophil count.

The Innovative Medical Devices Using Big Data and Artificial Intelligence: Focusing on the cases of Korea, the United States, and Europe (빅데이터 및 인공지능을 이용한 혁신의료기기 발전 방향: 한국, 미국, 유럽의 사례중심)

  • Yun Hee Song;Gyu Ha Ryu
    • Journal of Biomedical Engineering Research
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    • v.44 no.4
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    • pp.264-274
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    • 2023
  • Purpose: The objective is to extract insights that can contribute to the formulation of harmonized international policies and support measures for innovative medical devices and management systems. This study aims to propose effective strategies for future medical device innovation and healthcare delivery. Results: It investigates technological advancements, regulatory approval systems, insurance policies, and successful commercialization cases in South Korea, the United States, and the European Union. In 2018, the FDA implemented insurance coverage for Software as a Medical Device (SaMD) and recognized insurance coverage for Digital Therapeutics (DTx). Germany is a country that ensures permanent reimbursement for healthcare applications since 2020, making it the first country to provide legal health insurance coverage for fostering a digital ecosystem. Conclusion: The findings of this research highlight the importance of cultivating a supportive regulatory and environmental framework to facilitate the adoption of innovative medical devices. Continuous support for research and development (R&D) efforts by companies, along with the validation of clinical effectiveness, is crucial.

Convenient Preparation of Tumor-specific Immunoliposomes Containing Doxorubicin

  • Nam, Sang-Min;Cho, Jang-Eun;Son, Byoung-Soo;Park, Yong-Serk
    • BMB Reports
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    • v.31 no.1
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    • pp.95-100
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    • 1998
  • Two innovative methods to prepare target-sensitive immunoliposomes containing doxorubicin by coupling monoclonal antibodies (mAb DH2, SH1) specific to cancer cell surface antigens ($G_{M3}$, $Le^X$) have been developed and are described here. Firstly, liposomes containing N-glutaryl phosphatidylethanolamine (NGPE) were prepared, followed by the encapsulation of doxorubicin, DH2 or SH1 antibodies were conjugated to NGPE in the liposomes (direct coupling). Secondly, liposomes were prepared with NGPE/mAb conjugates by the detergent dialysis method (conjugate insertion), and then doxorubicin was encapsulated by proton gradient. The immunoliposomes prepared by both methods were able to specifically bind to the surface of the tumor cells - B16BL6 mouse melanoma cells. The efficiencies of doxorubicin-entrapping into liposomes prepared by direct coupling and conjugate insertion was about 98% and 25%, respectively. These types of liposomal formulation are sensitive to target cells, which can be useful for various clinical applications.

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Analysis of Herbal combination frequence on Clicical Herbal formulation (임상한의사 처방의 약물 배합 빈도 분석)

  • Cha, Woong-Seok;Lee, Tae-Hyung;Lee, Byung-Wook
    • Herbal Formula Science
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    • v.19 no.2
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    • pp.1-10
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    • 2011
  • Objectives : Since its enactment in 1987, the 56 standard prescriptions covered by insurance have remained unchanged from its original version. In this study, we tried to discover most frequently used herbal combinations by analyzing prescriptions used in actual clinical settings. Methods : We have built Structured Query Language to analyze herbal combination and progressed this analysis through analyzing the frequencies of medicinal herb combinations in medical prescription slips. Results : We have found out that traditional Korean medical doctors use about 13 herbs in a prescriptions and usually use 253 kinds of herb. And We have found out the most frequently used herbal combination. Conclusions : In this study, We can suggest new method to decide what do we need on insurance prescriptions.

Effect of Gongjindan, a Polyherbal Formula on the Pharmacokinetics Profiles of Sorafenib in Male SD Rats (1) - Single Oral Combination Treatment of Sorafenib 50mg/kg with Gongjindan 100mg/kg within 5min -

  • Kim, SeungMo;Lee, Chang Hyeong;Park, Soo Jin;Kang, Su Jin;Song, Chang Hyun;Han, Chang Hyun;Ku, Sae Kwang;Lee, Young Joon
    • Journal of Society of Preventive Korean Medicine
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    • v.18 no.2
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    • pp.89-100
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    • 2014
  • Objective : The co-administration effects of Gongjindan (GJD) on the pharmacokinetics (PK) of sorafenib were observed as a process of the comprehensive and integrative medicine. Methods : After sorafenib treatment, GJD was administered within 5 min. The plasma were collected at 30min before administration, 30min, 1, 2, 3, 4, 6, 8 and 24hrs after end of GJD treatment, and plasma concentrations of sorafenib were analyzed using LC-MS/MS methods. PK parameters of sorafenib ($T_{max}$, $C_{max}$, AUC, $t_{1/2}$ and $MRT_{inf}$) were analysis as compared with sorafenib single administered rats. Results : The absorption of sorafenib were significantly increased at 30min, 1, 6 and 6hrs after co-administration with GJD as compared with sorafenib single treated rats. Accordingly, the $AUC_{0-t}$ (47.20%) of sorafenib was significantly increased but $t_{1/2}$ (-30.63%) and $MRT_{inf}$ (-34.11%) in co-administered rats were non-significantly decreased. These findings are considered as direct evidences that GJD increased the oral bioavailability of sorafenib through increase of the absorption, when they co-administered within 5min. Conclusion : Based on the results, co-administration of GJD increased the oral bioavailability of sorafenib through increase of the gastrointestinal absorption. It is considered that the more detail pharmacokinetic studies should be tested to conclude the effects of GJD on the pharmacokinetics of sorafenib, when they were co-administered, like the effects after co-administration with reasonable intervals considering the $T_{max}$ of sorafenib (about 3.5hr-intervals) and after repeated co-administrations.Hence, concomitant uses of GJD with sorafenib may require close monitoring for potential drug interactions.

The Effects of Herbal Formula (KH-204) on the Penile Erection and Corpus Cavernosum of Spontaneous Hypertensive Male Rats (본태성 고혈압 수컷 흰쥐에서 복합생약제제 (KH-204)가 음경발기 및 음경해면체 조직에 미치는 효과)

  • Sohn, Dong-Wan;Yoon, Byung-Il;Kim, Sung-Dae;Lee, Eun-Jeong;Kim, Hee-Seok;Hwang, Sung-Wan;Hwang, Sung-Yeoun;Kim, Du-Bae;Kim, Hyun-Woo;Cho, Yong-Hyun;Kim, Sae-Woong
    • Korean Journal of Pharmacognosy
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    • v.38 no.3 s.150
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    • pp.239-244
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    • 2007
  • The herbal formulation (KH-204) mainly consisted of the fruits of Lycium chinense, Cornus officinalis, Rubus coreanus, Cuscuta chinensis and Schizandra chinensis. We investigated the effects of this herbal formulation on the penile erection and corpus cavernosum of spontaneous hypertensive male Rats (SHR). We used male SHR aged 16 weeks as a model of hypertension. The treatment groups received once a day oral doses KH-204 100 and 300 mg/kg per day for 4 weeks. Distilled water was administered in the control group. To investigate the penile erection, intracavernosal pressure (ICP) and mean arterial pressure (MAP) were recorded in all groups. We analyzed the distribution of NOS by immunohistochemical staining and the expression of nNOS, eNOS concentration in the isolated corpus cavernosum by western blotting. In the control group, ICP/MAP ratio was $14.9{\pm}1.4%$ after pelvic nerve stimulation. ICP/MAP ratio was markedly increased in the treatment group with KH-204 100, 300 mg/kg, compared with control group. Immunohistochemical staining for NOS showed that eNOS and nNOS was stained as brown color. Compared with the control group, NOS activities of KH-204 100, 300 mg/kg were increased significantly. Also the penile expression levels of nNOS, eNOS in KH-204 100, 300 mg/kg treatment group were more increased significantly than control group by western blotting. This study showed that KH-204 enhances the penile erection and the level of eNOS and nNOS expression of penile corpus cavernosum of male SHR.

Laser-assisted Delivery of a Combined Antioxidant Formulation Enhances the Clinical Efficacy of Fractional Microneedle Radiofrequency Treatment: A Pilot Study

  • Kim, Jihee;Kim, Soo Min;Jung, Bok Ki;Oh, Sang Ho;Kim, Young-Koo;Lee, Ju Hee
    • Medical Lasers
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    • v.10 no.3
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    • pp.161-169
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    • 2021
  • Background and Objectives Fractional microneedle radiofrequency systems are popular options to increase elasticity in aging skin. Laser-assisted drug delivery is a promising method for the epidermal injection of topically applied drugs and cosmetic ingredients. This study assesses the safety and efficacy of topical delivery of L-ascorbic acid, vitamin E, and ferulic acid after fractional microneedle radiofrequency treatment for reducing photodamage. Materials and Methods In this prospective, single-center, split-face, controlled pilot study, six women (mean age, 48.0 years; range, 35-57 years; Fitzpatrick skin types III and IV) exhibiting mild to moderate photodamage, underwent a single session of fractional microneedle radiofrequency treatment. The patients were instructed to apply the antioxidant formulation to only one side of the face. Patients were evaluated 3 days, 7 days, and 4 weeks thereafter, using three-dimensional imaging and ultrasound. Ex vivo, the full-thickness human skin was used for molecular and histological evaluation. Statistical analysis was achieved by applying t-tests, Mann-Whitney U tests, and one-way analyses of variance. Results Compared to the untreated side, the antioxidant-treated side exhibited a significant increase in dermal thickness (10.32% vs. 17.54%, p < 0.05), but not in skin elasticity (4.76% vs. 4.69%, p > 0.05). The difference in erythema between the sides was statistically not significant (p > 0.05). In the ex vivo model, expression of FGF2 in the skin was significantly increased after application of the antioxidant formulation, as compared to results obtained subsequent to fractional microneedle radiofrequency treatment only (p < 0.01). Conclusion This study demonstrates that for the treatment of photodamaged skin, laser-assisted delivery of the antioxidant formulation is a safe and effective adjuvant modality following fractional microneedle radiofrequency.

Induction of Forkhead Class box O3a and apoptosis by a standardized ginsenoside formulation, KG-135, is potentiated by autophagy blockade in A549 human lung cancer cells

  • Yao, Chih-Jung;Chow, Jyh-Ming;Chuang, Shuang-En;Chang, Chia-Lun;Yan, Ming-De;Lee, Hsin-Lun;Lai, I-Chun;Lin, Pei-Chun;Lai, Gi-Ming
    • Journal of Ginseng Research
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    • v.41 no.3
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    • pp.247-256
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    • 2017
  • Background: KG-135, a standardized formulation enriched with Rk1, Rg3, and Rg5 ginsenosides, has been shown to inhibit various types of cancer cells; however, the underlying mechanisms are not fully understood. In this study, we explored its effects in A549 human lung cancer cells to investigate the induction of Forkhead Class box O3a (FOXO3a) and autophagy. Methods: Cell viability was determined by sulforhodamine B staining. Apoptosis and cell cycle distribution were analyzed using flow cytometry. The changes of protein levels were determined using Western blot analysis. Autophagy induction was monitored by the formation of acidic vesicular organelles stained with acridine orange. Results: KG-135 effectively arrested the cells in G1 phase with limited apoptosis. Accordingly, a decrease of cyclin-dependent kinase-4, cyclin-dependent kinase-6, cyclin D1, and phospho-retinoblastoma protein, and an increase of p27 and p18 proteins were observed. Intriguingly, KG-135 increased the tumor suppressor FOXO3a and induced the accumulation of autophagy hallmark LC3-II and acidic vesicular organelles without an increase of the upstream marker Beclin-1. Unconventionally, the autophagy adaptor protein p62 (sequestosome 1) was increased rather than decreased. Blockade of autophagy by hydroxychloroquine dramatically potentiated KG-135-induced FOXO3a and its downstream (FasL) ligand accompanied by the cleavage of caspase-8. Meanwhile, the decrease of Bcl-2 and survivin, as well as the cleavage of caspase-9, were also drastically enhanced, resulting in massive apoptosis. Conclusion: Besides arresting the cells in G1 phase, KG-135 increased FOXO3a and induced an unconventional autophagy in A549 cells. Both the KG-135-activated extrinsic FOXO3a/FasL/caspase-8 and intrinsic caspase-9 apoptotic pathways were potentiated by blockade of autophagy. Combination of KG-135 and autophagy inhibitor may be a novel strategy as an integrative treatment for cancers.