Traditional Antipyretics from the text of Usada Wariga Dalem as an Ayurveda knowledge

Text Usada Wariga Dalem is one of Usada in Bali as a national cultural heritage which contains the knowledge system of traditional Balinese treatment which includes symptoms of disease, names of diseases, medicinal facilities, how to mix, and how to treat. One of the symptoms contained in the text of Usada Wariga Dalem usada is fever. Handling of fever can be done by using medicinal plants as contained in the text of Usada Wariga Dalem. Treatment with medicinal herbs is still one of the options for Balinese people in treating diseases. Traditional medicinal herbs for fever are often used as alternative and complementary medicines. This research examined what included fever in the text of Usada Wariga Dalem, what were the ingredients of fever medicine in the text of Usada Wariga Dalem and how the medicine could be a complementary and alternative medicine for the Balinese people. This research used a descriptive qualitative research method. literature study and ethnography method. The data needed in this study were collected using a library study, observation, and in-depth interviews. The data is sourced from the Usada Wariga Dalem lontar text, which was collected at the Lontar Study Center, Faculty of Cultural Sciences, Udayana University. The traditional medicine for fever contained in the Usada Wariga Dalem text can be used for complementary and alternative medicine. This traditional treatment using medicinal ingredients from processed plants, has been proven to reduce the patient's fever.

Allied Health and Complementary Therapy Usage in Australian Women With Chronic Pelvic Pain: a Cross-Sectional Study

Background Chronic pelvic pain (CPP) causes non-cyclical pelvic pain, period pain, fatigue and other painful symptoms. Current medical and surgical management strategies are often not sufficient to manage these symptoms and may lead to uptake of other therapies. Aims To determine the prevalence of allied health (AH) and complementary therapy (CM) use, the cost burden of these therapies and explore predictive factors for using allied health or complementary medicines.Materials and Methods An online cross-sectional questionnaire using the WERF EndoCost tool was undertaken between February to April 2017. People were eligible to participate in the survey if they were aged 18-45, living in Australia and had chronic pelvic pain. Results From 409 responses, 340/409 (83%) of respondents reported a diagnosis of endometriosis. One hundred and five (30%) women with self-reported endometriosis, and thirteen (18%) women with other forms of CPP saw at least one AH or CM practitioner in the previous two months, with physiotherapists and acupuncturists the most common. Women who accessed CM or AH services spent an average of $480.32 AUD in the previous two months. A positive correlation was found between education and number of AH or CM therapies accessed in the past two months (p<0.001) and between income level and number of therapists (p=0.028).Conclusions Women with CPP commonly access AH and CM therapies, with a high out of pocket cost. The high cost and associations with income and education levels may warrant a change to policy to improve equitable access to these services.

Natural Products for the Prevention and Control of the COVID-19 Pandemic: Sustainable Bioresources

Background: The world has been unprecedentedly hit by a global pandemic which broke the record of deadly pandemics that faced humanity ever since its existence. Even kids are well-versed in the terminologies and basics of the SARS-CoV-2 virus and COVID-19 now. The vaccination program has been successfully launched in various countries, given that the huge global population of concern is still far behind to be vaccinated. Furthermore, the scarcity of any potential drug against the COVID-19-causing virus forces scientists and clinicians to search for alternative and complementary medicines on a war-footing basis.Aims and Objectives: The present review aims to cover and analyze the etiology and epidemiology of COVID-19, the role of intestinal microbiota and pro-inflammatory markers, and most importantly, the natural products to combat this deadly SARS-CoV-2 virus.Methods: A primary literature search was conducted through PubMed and Google Scholar using relevant keywords. Natural products were searched from January 2020 to November 2020. No timeline limit has been imposed on the search for the biological sources of those phytochemicals. Interactive mapping has been done to analyze the multi-modal and multi-target sources.Results and Discussion: The intestinal microbiota and the pro-inflammatory markers that can serve the prognosis, diagnosis, and treatment of COVID-19 were discussed. The literature search resulted in yielding 70 phytochemicals and ten polyherbal formulations which were scientifically analyzed against the SARS-CoV-2 virus and its targets and found significant. Retrospective analyses led to provide information about 165 biological sources that can also be screened if not done earlier.Conclusion: The interactive analysis mapping of biological sources with phytochemicals and targets as well as that of phytochemical class with phytochemicals and COVID-19 targets yielded insights into the multitarget and multimodal evidence-based complementary medicines.

Compliance to GMP guidelines for Herbal Manufacturers in East Africa: A Position Paper

With the global increase in the use of traditional and complementary remedies for the prevention and treatment of illness, the quality and safety of these medicines have become a significant concern for all regulatory authorities. Herbal medicines are the most commonly used form of traditional and complementary medicines in the world and the efficacy and safety of herbal medicines, like conventional medicines, largely depends on their quality from planting to harvesting, preprocessing and final processing. Due to the inherent complexity of herbal medicines, often containing an array of active compounds, the primary processing of herbal medicines has a direct influence on their quality. Quality concerns are the reason why the medicines regulatory agencies insist that manufacturers of medicines strictly follow Good Manufacturing Practices since it is an essential tool to prevent instances of contamination, mix-ups, deviations, failures and errors. However, a strict application of GMP requirements is expensive and would drive the prices of the manufactured products up. As a result, a maturity level grading of facilities is proposed as a way of justifying the costs incurred for manufacturers desiring to reach a broader market and investing in continuous improvement. 36 Good Manufacturing Practice (GMP) inspection reports of local herbal manufacturers conducted by National Drug Authority were analyzed to establish the type and extent of deficiencies to GMP requirements for local herbal manufacturers in Uganda. The different GMP chapters and related sub-parameters constituted the variables used for the analysis of conformity to requirements. The primary outcome variable was the conclusion regarding compliance or noncompliance of the inspected local herbal manufacturing facility. GMP parameters that were frequently defaulted by local herbal manufacturers and the corresponding frequencies were identified. The Pearson Chi-square test was applied independently on each category to find the association that existed between conformity and the questions in each category. Only 22% (8) of the 30 inspected facilities were found to comply with GMP requirements, as per National Drug Authority (NDA) guidelines; while the majority of the facilities, 28 (78%), were found not to comply. Of the facilities inspected, 25 were undergoing GMP inspection for the first time. A total of 1,236 deficiency observations were made in the 36 inspection reports reviewed for the study. The mean for all deficiencies was 34.3, and the standard deviation was 15.829. 91.5% of the facilities did not have mechanisms for a record of market complaints; 80.9% did not meet documentation requirements; 78.9% did not have quality control measures in place, and 65.7% did not meet stores requirements. By encouraging a culture of self/voluntary improvement through the introduction of listing of manufacturers based on a maturity level grading, the National Drug Authority will improve the Herbal Medicines sector as per the mandate of improving the herbal medicine industry. Also, increased sensitization of all relevant stakeholders regarding the requirements for GMP should be intensified.

IMMU-25. SYNERGY BETWEEN TMZ AND INDIVIDUALIZED MULTIMODAL IMMUNOTHERAPY TO IMPROVE OS OF IDH1 WILD TYPE MGMT PROMOTOR UNMETHYLATED GBM PATIENTS

The prognosis of IDH1 wild type MGMT promotor unmethylated (MGMT-p-UM) GBM patients remains poor. Addition of TMZ to radiotherapy shifted the median OS from 11.8 to 12.6 months (Stupp, Lancet Oncol 2019). We retrospectively analysed the value of individualized multimodal immunotherapy (IMI) to improve OS in these patients. Adults with first event of IDH1wt GBM and documented status of MGMT-p-UM, and treated with IMI in the period June 2015 till July 2020, were selected. IMI consisted of 1/ immunogenic cell death (ICD) therapy (NDV injections + modulated electrohyperthermia), 2/ active specific immunotherapy with autologous mature dendritic cells loaded with tumor lysate or ICD therapy-induced serum-derived antigenic extracellular microvesicles and apoptotic bodies (IO-Vac® is an approved advanced therapy medicinal product since 27/05/2015), 3/ modulatory immunotherapy adapted to the patient, and 4/ complementary medicines. Twenty-eight patients (11f, 17m) had a median age of 48y (range 18-69) and a KPI of 90 (50-100). Extent of resection was complete (11), &lt; complete (9) or not documented (8). Seven patients were treated with surgery/radio(chemo)therapy and subsequent IMI (Group-1); 21 patients were treated with radiochemotherapy followed by maintenance TMZ + ICD therapy, followed by DC vaccines (Group-2). Both groups received further maintenance ICD therapy. Age, KPI and extent of resection were not different amongst both groups. PFS was not assessed because of challenges about pseudoprogression. The median OS of group-1 patients was 11m (2y OS: 0%). Surprisingly the median OS of group-2 patients was 18m with 2y OS of 17% (CI95%: +31, -15), which was significantly (Log-rank: p = 0.027) different from group-1. The data suggest that addition of IMI after local therapy on its own has no relevant effect on OS in IDH1 wild type MGMT-p-UM GBM patients, similar to maintenance TMZ. However, the combination of both TMZ + IMI significantly improves median OS.

Recent drug regulatory affair and CTD module progress review for submission of pharmaceuticals product

Regulatory Affairs (RA), also known as government affairs, is a relatively new profession that arose from governments' desire to protect public health by regulating the safety and efficacy of products such as pharmaceuticals, medical devices, pesticides, veterinary medicines, cosmetics, agrochemicals, and complementary medicines. Pharmaceutical regulatory affairs is concerned with the registration of pharmaceutical goods. All regulatory elements and guidelines connected to product filing are summarized in this evaluation. This study covers the whole CTD and eCTD submission process, as well as the modules that go with it. It also focuses on the key regulatory bodies across the world. Various roles of DRA departments, drug regulatory affairs professionals, the importance of drug affairs in pharmacy curriculum, emerging trends affecting regulatory strategy, regulatory affairs in product management, clinical trials, R&D and the drug approval process in the US, EU, and ROW market trends are discussed.

COVID-19 and Other Prevalent Diseases in Africa: A Pragmatic Approach

The aim of this paper is to propose that the development and legitimization of African knowledge and validation systems on a pragmatic basis, is an efficient and effective means of responding to a myriad of health problems plaguing Africans, particularly the COVID-19 pandemic. Whenever there is a novel disease outbreak, the norm is to wait for the development of scientifically proven vaccines for its treatment. However, the scientific validation of drugs is a rigorous and lengthy process, thereby inappropriate for dealing with health emergencies like the COVID-19 outbreak. The alarming rapidity with which the novel COVID-19 pandemic rages globally and decimates humanity has brought to the fore the need for Africa to look inwards in search of viable and efficient alternative approaches to the pandemic. In this paper, I examine pragmatism as a theoretical framework and relate it to proposed African epistemic and validation frameworks with a particular reference to homegrown orthodox and alternative/complementary medicines. I argue that the validation and approval of any knowledge claim based on pragmatism is a more expeditious mode of attending to COVID-19 and other prevalent diseases in Africa. The application of knowledge that brings practical success in dealing with health challenges in Africa without necessarily following rigid and lengthy scientific validation procedures will go a long way toward improving human conditions and well-being. I conclude that pragmatic considerations should ultimately inform local approval to homegrown African medicines for use in Africa.

Development of a nursing assessment form for patients with diabetes mellitus in a hospital: A research and development study

Background: People with Diabetes Mellitus (DM) tend to seek herbal medicine or complementary drugs in their treatments. But, unfortunately, the existing nursing assessment forms have not prepared the format for the use of complementary medicine. Objective: This study aimed to develop a nursing assessment form in patients with DM based on the Chronic Care Model (CCM) approach. Methods: This study employed a Research and Development study design, which consists of ten stages. The nursing assessment form was developed based on CCM theory and integrated complementary medicines into the assessment form. A content validity test was done by four experts and calculated using Aiken's V formula. Face validity among 12 nurses through Focus Group Discussions (FGDs) was also employed to test the quality of the nursing assessment form based on three aspects: functionality, efficiency, and usability. In addition, nine nurses were included for pilot testing of the form. Data were analyzed using descriptive analysis. Results: The nursing assessment form demonstrated a good content validity, with Aiken's V value of 0.94. The form was categorized based on four components of CCM: self-management support, decision support, social activities, and clinical information. Additionally, all nurses could fill the form properly. Conclusion: The nursing assessment form is valid. It can be used for nurses to assess patients with DM based on the CCM with an additional component to evaluate the use of complementary medicine. Funding: This research received financial support from Politeknik Kesehatan Kemenkes Surabaya, Indonesia, through a superior applied research program.

Action Mechanisms of Antirheumatic Herbal Medicines

Rheumatoid arthritis (RA) is a chronic inflammatory and debilitating joint disorder that causes severe impairment and reduces the quality of life. The available synthetic medicines used as standard therapy for RA have numerous side effects that can compromise their therapeutic outcomes. Thus, the demand for alternative and complementary medicines is increasing. A search of English articles in PubMed, Scopus, Google Scholar, and Web of Science databases was carried out on probable mechanisms of action of herbs with the antirheumatic property. Herbal medicines stated in folk medicine face acceptance concerns by the medical community because of the lack of scientific documents regarding their physio-pharmacological mechanisms. This chapter aims to review the possible antirheumatic effects of various herbs, including Rosmarinus officinalis L., Curcuma longa, and Crocus sativus, their related mechanisms, and preclinical applications, in order to recall the therapeutic properties of herbal medicine. However, more clinical trials are required to confirm the safety and efficacy of these antirheumatic herbal medicines.

The Phytochemical and Pharmacological Properties of Persicaria odorata: A Review

World Health Organization (WHO) reported that 88% of its member or 61 countries acknowledge the use of traditional and complementary medicines. Persicaria odorata is being used as traditional herbs to treat fever, nausea and promoting hair growth. Besides, it is used as an anti-inflammatory agent in Vietnam to relieve swelling and treat wounds, sores, and ulcers. This review aims to evaluate the phytochemical and pharmacological status of P. odorata. P. odorata is a plant with a high content of phenols and flavonoids. Among the essential chemical constituents in the P. odorata are methyl gallate, (+)-catechin, eupatoriochromene, n-dodecanal, polygonumins A, α-humulene and anthraquinone. P. odorata also exerts many pharmacological effects such as antioxidant, anti-inflammatory, antibacterial and anticancer effects. The commonly used part of P. odorata for extraction are leaves followed by the aerial part, rhizomes and stems. Nevertheless, more studies are needed to identify the efficacy and toxicity of P. odorata. New drugs could be developed from the active compounds of P. odorata in the future.