Prevalence and factors associated with utilization of ayurvedic drugs during COVID-19. A community-based cross-sectional study.

Background: COVID-19 pandemic emerged as a major public health emergency. Ayurvedic medicines are not generally considered as conventional medicine. Hence, we aimed to assess the prevalence of utilization of Ayurveda as prophylaxis for COVID-19 during the pandemic, factors associated with utilization, and willingness to use Ayurvedic medicines in future prospects. Methods: This cross-sectional analytical study was conducted in urban Bengaluru, India from April to May 2022. The sample size of the study was 427. Systematic random sampling was done and data were collected using a validated semi-structured questionnaire. Results: The mean (SD) age of the participants was 38.9 (±14.08) years. The proportion of utilization of ayurvedic medicines was 22.5% (n = 96, 95% CI 18.6-26.7) and social class was significantly associated with non-utilization (p = 0.042). Among the utilizers, 66% of them used Ayurvedic medicines for prevention/post-COVID ailments. More than half (55%, 95% CI 49.7-59.4) of the individuals were willing to use Ayurvedic medicines in the future and level of education was associated with unwillingness (p=0.010). Conclusion: Nearly three-fourth of the participants were not utilized Ayurvedic medicines during COVID-19 pandemic. Strengthening ayurvedic services and improving awareness may increase the utilization in the community. An integrated health system approach at the policy level is pivotal in mainstreaming Ayurvedic medicines.

An Insight of Clinical Evidence of Ayurveda Interventions in the Management of COVID-19 Patients.

BACKGROUND: Coronavirus disease 2019 (COVID-19) was caused by the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) and patients with COVID-19 may be treated with traditional medicine like Ayurveda alone or in combination with standard allopathic treatment, as Ayurveda is one of the oldest traditional medicinal systems followed by millions around the world. METHODS: The literature was searched in databases such as LitCOVID, Google Scholar, Science Direct, EBSCO, Scopus, Web of Science, EMBASE, and reference lists to identify articles relevant to the use of Ayurvedic medicines in the management of COVID-19. RESULTS: Several clinical studies have determined the efficacy of Ayurvedic medicines and formulations in the management of patients with COVID-19. CONCLUSION: The Ayurvedic medicines and formulations with antiviral, antioxidant, anti-inflammatory, and immunomodulatory properties could be used along with standard allopathic medicines to assist in the earlier detection of virus, speedy recovery of patients with COVID-19, faster discharge from hospitals, and the prevention of further deterioration.

Development and validation of a rapid high-performance thin-layer chromatographic method for quantification of gallic acid, cinnamic acid, piperine, eugenol, and glycyrrhizin in Divya-Swasari-Vati, an ayurvedic medicine for respiratory ailments.

Divya-Swasari-Vati is a calcium containing polyherbal ayurvedic medicine prescribed for the lung-related ailments observed in the current pandemic of Severe Acute Respiratory Syndrome Coronavirus 2 infections. The formulation is a unique quintessential blend of nine herbs cited in Ayurvedic texts for chronic cough and lung infection. Analytical standardization of herbal medicines is the pressing need of the hour to ascertain the quality compliance. This persuaded us to develop a simple, rapid, and selective high-performance thin-layer chromatographic method for Divya-Swasari-Vati quality standardization. The developed method was validated for the quantification of marker components, gallic acid, cinnamic acid, piperine, eugenol and glycyrrhizin, against reference standards in five different batches of Divya-Swasari-Vati. The analytes were identified by visualization at 254 nm, and by matching their retention factor with authentic standards. The developed method was validated as per the guidelines recommended by the International Council for Harmonization for parameters like, linearity, limit of detection, limit of quantification, accuracy, and precision. Therefore, the developed novel high-performance thin-layer chromatographic process could be employed for rapid standardization of Divya-Swasari-Vati and other related herbal formulation, which would aid in quality manufacturing and product development.

Assessment of essential and non-essential elements in selected traditional medicines from India, Ghana and China.

Traditional medicine (TM) also known as folk medicine consists of medical knowledge systems that were developed over generations in various countries before the era of modern medicine. Over the last few years, there has been a shift in universal trend from modern medicine to TM because it is believed that these medicines are non-toxic to humans, have little to no side-effects, are readily available and affordable. The purpose of this study was to investigate the essential and non-essential elemental concentrations of ayurvedic medicines (AM), Ghanaian traditional medicines (GTM) and Chinese traditional medicines (CTM). The results indicate that the mean elemental concentrations in TM varied greatly. The mean concentrations of copper and mercury in AM, GTM and CTM ranged from 4 to 45 mg/kg and 0.01 to 2 mg/kg, respectively. Multivariate statistical analyses applied to recognise inter-element associations indicated that at 0.05 significant level, there was a positive correlation between elements suggesting they may have originated from the same source. The study concludes by highlighting the need for monitoring of the elemental concentrations in commonly consumed traditional medicines regularly to detect contamination in these medicines since the occurrence of metals in these medicines above or below legally permissible limits can be harmful to consumers.

Radionuclide concentrations in medicinal florae and committed effective dose through Ayurvedic medicines.

Purpose: Ayurveda is one of the oldest systems of medicines in the world being practiced widely in the Indian subcontinent for more than 3000 years, and still remains as one of the important traditional health care systems. The Ayurvedic drugs are derived primarily from various parts of the plants, like root, leaf, flower, fruit or plant as a whole. Plants uptake minerals and other nutrients from the soil through their root system. Along with other minerals radionuclides present in the growing media also reach to the plant parts following the same pathway. Realizing the probable health hazards via the intake of Ayurvedic drugs, it is important to assess the concentration of natural radionuclides in commonly used medicinal plants.Materials and methods: NaI(Tl) scintillator-based gamma-ray spectrometry has been used to determine the activity concentrations of primordial radionuclides (226Ra, 232Th and 40K) in the most commonly used medicinal plant parts as ingredients of Ayurvedic medicines in India.Results and discussion: The average specific activity (Bqkg-1) of 226Ra, 232Th and 40K was found to be 43 ± 18, 36 ± 15[Formula: see text] and 230 ± 46, respectively. The estimated annual committed effective doses due to the intake of common Ayurvedic medicines at prescribed dosage was found to be 39 ± 16 µSv y-1,[Formula: see text] which is quite low as compared with the radiation dose limit of 1 mSvy-1 from all natural sources, reported by the International Commission on Radiological Protection (ICRP-60).Conclusions: It is found categorically that intake of Ayurvedic medicines at normal dosage poses no radiological hazard to the individual. Present results are significant in the wake of myths that many hazardous materials including radioisotopes are present at higher levels. Obtained results also serve as a reference information for the distribution of radionuclides in medicinal plant species.

Untargeted metabolomics reveals alterations in metabolites of lipid metabolism and immune pathways in the serum of rats after long-term oral administration of Amalaki rasayana.

Amalaki rasayana, a traditional preparation, is widely used by Ayurvedic physicians for the treatment of inflammatory conditions, cardiovascular diseases, and cancer. Metabolic alterations induced by Amalaki rasayana intervention are unknown. We investigated the modulations in serum metabolomic profiles in Wistar rats following long-term oral administration of Amalaki rasayana. Global metabolic profiling was performed of the serum of rats administered with either Amalaki rasayana (AR) or ghee + honey (GH) for 18 months and control animals which were left untreated. Amalaki rasayana components were confirmed from AR extract using HR-LCMS analysis. Significant reductions in prostaglandin J2, 11-dehydrothromboxane B2, and higher levels of reduced glutathione and glycitein metabolites were observed in the serum of AR administered rats compared to the control groups. Eleven different metabolites classified as phospholipids, glycerophospholipids, glucoside derivatives, organic acids, and glycosphingolipid were exclusively observed in the AR administered rats. Pathway analysis suggests that altered metabolites in AR administered rats are those associated with different biochemical pathways of arachidonic acid metabolism, fatty acid metabolism, leukotriene metabolism, G-protein mediated events, phospholipid metabolism, and the immune system. Targeted metabolomics confirmed the presence of gallic acid, ellagic acid, and arachidonic acid components in the AR extract. The known activities of these components can be correlated with the altered metabolic profile following long-term AR administration. AR also activates IGF1R-Akt-Foxo3 signaling axis in heart tissues of rats administered with AR. Our study identifies AR components that induce alterations in lipid metabolism and immune pathways in animals which consume AR for an extended period.

Lead Poisoning Due to Herbal Medications.

Many herbal products are harmless or possess minimal toxicity, whereas, some contain toxic ingredients that may not be identified due to lack of quality control or not listed on the label. Over the years, several case reports and studies have documented that herbal medications may contain ingredients that are toxic. Several studies have documented that some herbal medications contained high concentrations of heavy metals, such as lead, mercury, and arsenic. Publications of such case reports and studies have repeatedly reminded us that we have failed in our legal and civic duties of educating users of herbal medications and general population about the grave concerns posed by the herbal medications and their associated toxicities.

Comparative analysis of speciation and bioaccessibility of arsenic in rice grains and complementary medicines.

In many countries, rice grains and complementary medicines are important sources of arsenic (As) consumption. The objective of this study was to compare the speciation and bioaccessibility of As in selected rice grains and complementary medicines. A number of rice grain samples, and a range of herbal and ayurvedic medicines were analyzed for total As, speciation of As using sequential fractionation and extended x-ray absorption fine structure (EXAFS) techniques, and bioaccessibility of As using an in vitro extraction test. The daily intake of As through the uptake of these As sources was compared with the safety guidelines for As. The results demonstrated higher levels of As in ayurvedic medicines compared to herbal medicines and rice grains. The sequential fractionation showed the dominance of organic-bound As species in rice grains and herbal medicines, however, inorganic-bound As species dominated the ayurvedic medicines. This implies that As is derived from plant uptake in herbal medicines and rice grains, and from inorganic mineral input in ayurvedic medicines. Arsenic bioaccessibility was higher in ayurvedic than herbal medicines and rice grains, suggesting that inorganic As added as a mineral therapeutic input is more bioaccessible than organic As species derived from plant uptake. This study also showed a positive relationship between soluble As fractions and bioaccessibility indicating that solubility is an important factor controlling bioaccessibility. The daily intake values for As as estimated by total As content are likely to exceed the safe threshold level in rice grains that are enriched with As.

Ayurvedic medicine in Mauritius: Profile of Ayurvedic outlet, use, sale, distribution, regulation and importation.

ETHNOPHARMACOLOGICAL RELEVANCE: Ayurvedic medicine (AM) is a legalised alternative traditional medical system in the multicultural tropical island of Mauritius. A panoply of Ayurvedic specialised shops/centres involved in the provision of Ayurvedic services hereafter termed as 'outlets' operates in different regions of the island and is extensively exploited by a significant number of Mauritians. Nonetheless, there is currently no study geared towards studying the status of AM and profile of Ayurvedic outlets in Mauritius and there is undoubtedly a dearth of standardized regulatory framework governing the practice of AM in Mauritius. The present study attempts to study the profile of Ayurvedic outlets, sale, distribution, regulation and importation of AM in Mauritius. AIM OF STUDY: To evaluate the characteristics profile of Ayurvedic shops/clinics/pharmacies/centres, to document common Ayurvedic products used in the treatment and management of diseases, and to analyse existing regulatory control of AM in Mauritius. MATERIAL AND METHODS: Ayurvedic outlets were identified using a random approach. Once permission granted, outlets were visited where face-to-face interviews with Ayurvedic practitioners/directors/dispensers were undertaken using a semi-structured questionnaire. The characteristics of the outlets with respect to the type of business registration, procurement and dispensing of products, registration and qualification of personnels employed amongst others were studied. The International Classification of Diseases (ICD) 10 was used to classify common AM dispensed to patients. Additionally, information was sought from local authorities pertaining to existing legislation governing the importation and regulation of AM in Mauritius. RESULTS: A total of 16 Ayurvedic outlets ('pharmacies' (n=3), clinics (n=2), shops (n=5) and centres (n=6)) was surveyed. Six outlets dispensed AM strictly on prescription only after consultation with an onsite full-time employed registered Ayurvedic practitioner. Seven outlets offered AM both on prescription and over-the-counter where consultation was not mandatory. The remaining three outlets, where no Ayurvedic practitioner was employed, did not offer consultation at any time and dispensed the medicines over-the-counter most of the time. There is currently no such legal framework that acknowledges the existence of an Ayurvedic pharmacy in Mauritius and no trained Ayurvedic pharmacist was recruited in any of the outlets. It was also found that no specific requirements were in place to establish an Ayurvedic outlet in Mauritius. A wide variety of Ayurvedic formulated and single herb products were recorded to be in use against common diseases. Ayurvedic products were imported from India (n=10), purchased from local suppliers (n=6) or locally manufactured (n=1). The Traditional Medicine Board under the aegis of the pharmacy board is a regulatory body which requires Ayurvedic practitioners to be registered so as to practice AM in Mauritius. Additionally, the government has an Ayurvedic committee, under the aegis of the Pharmacy board in the Ministry of Health and Quality of Life to monitor the importation of AM. However, no legal framework has been enacted to regulate the sale of AM under prescription or under the supervision of an Ayurvedic practitioner. CONCLUSION: The current regulatory framework is such that the sale/use/distribution of AM is not strictly controlled unlike its importation. This has led to a certain form of unregulated practice in the private sector whereby the dispensing and sale of AM are being done over-the-counter without professional recommendations. It is recommended that authorities need to regulate the Ayurvedic medical system in Mauritius by amending stringent laws to ensure safety of patients.

Speciation and bioavailability of lead in complementary medicines.

Complementary medicines have associated risks which include toxic heavy metal(loid) and pesticide contamination. The objective of this study was to examine the speciation and bioavailability of lead (Pb) in selected complementary medicines. Six herbal and six ayurvedic medicines were analysed for: (i) total heavy metal(loid) contents including arsenic (As), cadmium (Cd), Pb and mercury (Hg); (ii) speciation of Pb using sequential fractionation and extended x-ray absorption fine structure (EXAFS) techniques; and (iii) bioavailability of Pb using a physiologically-based in vitro extraction test (PBET). The daily intake of Pb through the uptake of these medicines was compared with the safety guidelines for Pb. The results indicated that generally ayurvedic medicines contained higher levels of heavy metal(loid)s than herbal medicines with the amount of Pb much higher than the other metal(loid)s. Sequential fractionation indicated that while organic-bound Pb species dominated the herbal medicines, inorganic-bound Pb species dominated the ayurvedic medicines. EXAFS data indicated the presence of various Pb species in ayurvedic medicines. This implies that Pb is derived from plant uptake and inorganic mineral input in herbal and ayurvedic medicines, respectively. Bioavailability of Pb was higher in ayurvedic than herbal medicines, indicating that Pb added as a mineral therapeutic input is more bioavailable than that derived from plant uptake. There was a positive relationship between soluble Pb fraction and bioavailability indicating that solubility is an important factor controlling bioavailability. The daily intake values for Pb as estimated by total and bioavailable metal(loid) contents are likely to exceed the safe threshold level in certain ayurvedic medicines. This research demonstrated that Pb toxicity is likely to result from the regular intake of these medicines which requires further investigation.

Assembling cyavanaprash, Ayurveda's best-selling medicine.

The paper discusses the many forms and representations of cyavanaprash, Ayurveda's best-selling medicine, already mentioned in Caraka's Compendium (c. 200 CE). The medicine's compositions, applications, and meanings, change over time and from locality to locality. Cyavanaprash is, for example, a patriotic formula, a booster of the immune system, a modern geriatric drug, and one of the elements in canonical Ayurvedic treatments. In the beginning of the 19th century cyavanaprash was a patriotic formula for fortifying Indian bodies and the nascent Indian nation. Nowadays the medicine is a Fast Moving Consumer Good (FMCG) and a money maker for Dabur India Ltd., the world largest Ayurvedic manufacturer. Instead of vitalising the nation its consumption now promises to make urban middle class consumers effectively modern. Branding and modern science must make Dabur Chyawanprash attractive in the eyes of these consumers. Ayurveda and cyavanaprash are also part of a global counter culture marked by neo-Orientalism and Ayurvedic medicines as facilitators of spirituality. The marketing of cyavanaprash by India's largest Ayurvedic manufacturer is used as a case study for discussing the proliferation of Ayurvedic brands and its critics. The imaging of Ayurvedic brands such as Dabur Chyawanprash threatens to obscure the fact that Ayurveda represents a unique way of looking upon health, disease and the human body. The proliferation of brands also makes Ayurvedic medicines more expensive and puts pressure on the natural environment as the main supplier of Ayurvedic ingredients.

Ayurvedic medicine offers a good alternative to glucosamine and celecoxib in the treatment of symptomatic knee osteoarthritis: a randomized, double-blind, controlled equivalence drug trial.

OBJECTIVE: To demonstrate clinical equivalence between two standardized Ayurveda (India) formulations (SGCG and SGC), glucosamine and celecoxib (NSAID). METHODS: Ayurvedic formulations (extracts of Tinospora cordifolia, Zingiber officinale, Emblica officinalis, Boswellia serrata), glucosamine sulphate (2 g daily) and celecoxib (200 mg daily) were evaluated in a randomized, double-blind, parallel-efficacy, four-arm, multicentre equivalence drug trial of 24 weeks duration. A total of 440 eligible patients suffering from symptomatic knee OA were enrolled and monitored as per protocol. Primary efficacy variables were active body weight-bearing pain (visual analogue scale) and modified WOMAC pain and functional difficulty Likert score (for knee and hip); the corresponding a priori equivalence ranges were ±1.5 cm, ±2.5 and ±8.5. RESULTS: Differences between the intervention arms for mean changes in primary efficacy variables were within the equivalence range by intent-to-treat and per protocol analysis. Twenty-six patients showed asymptomatic increased serum glutamic pyruvic transaminase (SGPT) with otherwise normal liver function; seven patients (Ayurvedic intervention) were withdrawn and SGPT normalized after stopping the drug. Other adverse events were mild and did not differ by intervention. Overall, 28% of patients withdrew from the study. CONCLUSION: In this 6-month controlled study of knee OA, Ayurvedic formulations (especially SGCG) significantly reduced knee pain and improved knee function and were equivalent to glucosamine and celecoxib. The unexpected SGPT rise requires further safety assessment. TRIAL REGISTRATION: Clinical Drug Trial Registry-India, www.ctri.nic.in, CTRI/2008/091/000063.

Toxicological studies of "Chondrokola Rosh", an Ayurvedic preparation on liver function tests of rats.

Chondrokola Rosh (CKR) is a traditional metallic Ayurvedic preparation widely used by the rural and ethnic people of Bangladesh in dysuria. It is a preparation of various roasted metals (Hg and Cu), non-metal (sulphur and Mica) and medicinal herbs. Considering the controversy over the risk of toxic heavy metals in Ayurvedic herbo-mineral preparations, toxicological parameters on liver functions were investigated. A single dose of 100mg/kg body weight of the preparation was administered orally to the rats of both sexes for ninety days. In this evaluation a statistically significant (p<0.001) increase of serum albumin levels in male (17%) and female (15%) rat groups were observed. On the other hand, the plasma bilirubin level was decreased 50% and 28% respectively in both rats groups. But no remarkable differences were observed in plasma protein, sGPT, sGOT and ALP activities from their corresponding control values. This study showed that CKR had no remarkable toxic effect on liver of the animals despite the presence of traces of transformed heavy metals.

Efficacy and safety of Ayurvedic medicines: Recommending equivalence trial design and proposing safety index.

Ayurvedic drugs have begun to be evaluated in controlled clinical trials. The trials, often placebo controlled, are usually designed to demonstrate superiority. Though the results have been usually reported as encouraging, statistical significance has been elusive. In this melee to show efficacy, several positive results related to safety and other purported advantages with Ayurvedic drugs, including improved quality of life, easy drug availability and less cost, get drowned. Though safety is the prime concern, efficacy ultimately matters in trials. Excellent safety profile offset modest efficacy, especially for long-term management of chronic difficult to treat disorders. There is a trade-off between efficacy and safety but we have no means to put them together in a mathematical evaluation to judge the overall performance of a drug. However, we need more suitable modern science methods/techniques to unravel the true therapeutic role of Ayurvedic drugs. We propose "equivalence trials" using modern medicine benchmark as a comparator and a "safety/tolerability index" on this perspective. We believe that several Ayurvedic drugs are capable of demonstrating equal efficacy but superior safety. Our concept may also be applicable for pragmatic trials that are more suitable for Ayurvedic therapy.