Development and standardisation of Laghu Sudarshan Churna – An Ayurvedic polyherbal formulation

106-112Laghu Sudarshan Churna, LSC is an Ayurvedic polyherbal formulation employed for different types of jvaras (fevers). The present study was undertaken to prepare its standardised formulation and to standardise the finished product using quality control procedures mentioned in Ayurvedic Pharmacopoeia of India (API). For this, four batches of the finished products were prepared on a laboratory scale and performed the pharmacognostical parameters (macroscopic, microscopic and powder drug analysis); thin layer chromatography; quantitative physicochemical evaluation including loss on drying, total ash, acid-insoluble ash, alcohol & water soluble extractive values, and pH; & measuring the level of aflatoxins, microbial load, heavy metals and pesticide residues of the finished product. This study is the foremost effort to develop the standardised formulation along with the evaluation parameters for LSC. Thus, obtained results would be beneficial and will act as the reference for the standardisation of LSC

Ayurveda in Knee Osteoarthritis—Secondary Analyses of a Randomized Controlled Trial

Background: Ayurveda is widely practiced in South Asia in the treatment of osteoarthritis (OA). The aim of these secondary data analyses were to identify the most relevant variables for treatment response and group differences between Ayurvedic therapy compared to conventional therapy in knee OA patients. Methods: A total of 151 patients (Ayurveda n = 77, conventional care n = 74) were analyzed according to the intention-to-treat principle in a randomized controlled trial. Different statistical approaches including generalized linear models, a radial basis function (RBF) network, exhausted CHAID, classification and regression trees (CART), and C5.0 with adaptive boosting were applied. Results: The RBF network implicated that the therapy arm and the baseline values of the WOMAC Index subscales might be the most important variables for the significant between-group differences of the WOMAC Index from baseline to 12 weeks in favor of Ayurveda. The intake of nutritional supplements in the Ayurveda group did not seem to be a significant factor in changes in the WOMAC Index. Ayurveda patients with functional limitations > 60 points and pain > 25 points at baseline showed the greatest improvements in the WOMAC Index from baseline to 12 weeks (mean value 107.8 +/- 27.4). A C5.0 model with nine predictors had a predictive accuracy of 89.4% for a change in the WOMAC Index after 12 weeks > 10. With adaptive boosting, the accuracy rose to 98%. Conclusions: These secondary analyses suggested that therapeutic effects cannot be explained by the therapies themselves alone, although they were the most important factors in the applied models

Clinical Aspect of Diseases of Cornea in Ayurveda

Introduction: There are total seventy sixocular diseases described in Sushruta Samhita and 94 diseases in Astanga Sangrah & Astanga Hridya. This concept of classification of ocular disorders is well buttressed by classifying the disease as Sandhigata (Diseases affecting junctional areas of eye), Vartamagata (Diseases of eyelids), Shuklagata (Diseases of Sclera plus Conjunctiva), Krishnagata (Diseases of Cornea), Sarvagata (Diseases affecting all parts of Eye), Drishtigata (Diseases of Lens). Material and Methods: Extensive literary review of various text of Ayurveda in order to carve out a possible comparison of Ayurvedic Corneal Ophthalmological disorders with modern counterpart. Aims: To establish clinical correlation between diseases of Krishna mandala to disease of the cornea. Discussion: Classifications of corneal diseases in classical Ayurvedic texts are sequential and progressive in nature viz. one condition progress to the next corresponding stage. Acharya Sushruta described 4 types of diseases of cornea while Vagbhatta has enumerated 5 types. A conscious endeavor is made to correlate the Ayurvedic and modern corneal disorders in a complimentary manner. Conclusion: The congruent behavior of corneal disorders of Ayurved and modern is justified by the clinical symptomology, progression of the disease, prognostic reasons and relevant intervention. The integrated disease approach, treatment application and predicting prognosis will suffice the resultant outcome of the disease in a more favorable perspective which will herald a better approach in managing preventable corneal blindness.Â

Autoimmune Pancreatitis: A Report from India

Context Autoimmune pancreatitis is characterized by immune-mediated inflammation, prominent lymphocytic infiltration and fibrosis of pancreas. It accounts for 4.6-6% of chronic pancreatitis but only a few cases from India have been reported. Objective Evaluation of cases of autoimmune pancreatitis diagnosed between July 2006 and June 2009. Design Retrospective analysis of the clinical records of all patients diagnosed as autoimmune pancreatitis between July 2006 and June 2009. Setting Tertiary care centre, northern India. Main outcome measure Clinical records of all patients with autoimmune pancreatitis were analyzed with respect to their initial diagnosis and treatment, imaging, cytology, serology, presence of other organ involvement and response to treatment. Results The 5 cases of autoimmune pancreatitis included 4 men and one woman ranging in age from 48 to 60 years. The interval between initial consultation and diagnosis ranged from 3 months to 7 years. Symptoms included obstructive jaundice (5/5), abdominal pain (3/5) and weight loss (3/5). In 3 cases a presumptive diagnosis of a pancreatic mass with a biliary stricture was made and, in one patient, the diagnosis of primary sclerosing cholangitis was considered. These four patients had received a biliary stent and it was only on follow-up and review of the repeat CT scan that a diagnosis of autoimmune pancreatitis was suggested. In one patient, a diagnosis of autoimmune pancreatitis was considered in the first instance. Radiologically, all 5 patients showed a bulky pancreas with loss of lobulations. Conclusion In this report from India, we highlight the need for a high index of suspicion in diagnosing autoimmune pancreatitis because it responds dramatically to steroids.Image: Pancreatic acinar cell cluster with lymphocytes and plasma cells in the background

Reliability of ayurvedic diagnosis for knee osteoarthritis patients: a nested diagnostic study within a randomized controlled trial

Background: Ayurveda is a traditional Indian system of medicine. The customized Ayurvedic approach consists of a combination of several diagnostic procedures and subsequent individualized therapeutic interventions. Evaluation of inter-rater reliability (IRR) of Ayurvedic diagnoses has rarely been performed. The aim of this study was to evaluate IRR of Ayurvedic diagnosis for patients with knee osteoarthritis. Methods: A diagnostic reliability study of 30 patients and 4 Ayurvedic experts was nested in a randomized controlled trial. Patients were diagnosed in a sequential order by all experts utilizing a semistructured patient history form. A nominal group technique as consensus procedure was performed to reach agreement on the items to be diagnosed. An IRR analysis using Fleiss' and Cohen's kappa statistics was performed to determine a chance-corrected measure of agreement among raters. Results: One hundred and twenty different ratings and 30 consensus ratings were performed and analyzed. While high percentages of agreement for main diagnostic entities and the final Ayurveda diagnosis (95% consensus agreement on main diagnosis) could be observed, this was not reflected in the corresponding kappa values, which largely yielded fair-to-poor inter-rater agreement kappas for central diagnostic aspects such as prakriti and agni (κ values between 0 and 0.4). Notably, agreement on disease-related entities was better than that on constitutional entities. Conclusions: This is the first diagnostic study embedded in a clinical trial on patients with knee osteoarthritis utilizing a multimodality whole systems approach. Results showed a contrast between the high agreement of the consented final diagnosis and disagreement on certain diagnostic details. Future diagnostic studies should have larger sample sizes and a methodology more tailored to the specificities of traditional whole systems of medicine. Equal emphasis will need to be placed on all core diagnostic components of Ayurveda, both constitutional and disease specific, using detailed structured history taking forms

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ABSTRACT Context Autoimmune pancreatitis is characterized by immune-mediated inflammation, prominent lymphocytic infiltration and fibrosis of pancreas. It accounts for 4.6-6% of chronic pancreatitis but only a few cases from India have been reported

Ayurveda in Knee Osteoarthritis—Secondary Analyses of a Randomized Controlled Trial

Background: Ayurveda is widely practiced in South Asia in the treatment of osteoarthritis (OA). The aim of these secondary data analyses were to identify the most relevant variables for treatment response and group differences between Ayurvedic therapy compared to conventional therapy in knee OA patients. Methods: A total of 151 patients (Ayurveda n = 77, conventional care n = 74) were analyzed according to the intention-to-treat principle in a randomized controlled trial. Different statistical approaches including generalized linear models, a radial basis function (RBF) network, exhausted CHAID, classification and regression trees (CART), and C5.0 with adaptive boosting were applied. Results: The RBF network implicated that the therapy arm and the baseline values of the WOMAC Index subscales might be the most important variables for the significant between-group differences of the WOMAC Index from baseline to 12 weeks in favor of Ayurveda. The intake of nutritional supplements in the Ayurveda group did not seem to be a significant factor in changes in the WOMAC Index. Ayurveda patients with functional limitations > 60 points and pain > 25 points at baseline showed the greatest improvements in the WOMAC Index from baseline to 12 weeks (mean value 107.8 ± 27.4). A C5.0 model with nine predictors had a predictive accuracy of 89.4% for a change in the WOMAC Index after 12 weeks > 10. With adaptive boosting, the accuracy rose to 98%. Conclusions: These secondary analyses suggested that therapeutic effects cannot be explained by the therapies themselves alone, although they were the most important factors in the applied models. Keywords: Ayurveda; traditional Indian medicine; knee osteoarthritis; complementary medicine; integrative medicin

Efficacy and safety of Guduchighan Vati in asymptomatic and mild to moderate cases of COVID-19: A randomized controlled pilot study

Background: Currently, there is no approved treatment for the management of COVID-19 pandemic. Drug repurposing of existing medications could be a possible way to find out a novel therapeutic entity to combat the COVID-19. Objectives: To determine the clinical effectiveness and safety profile of an Ayurveda Intervention (Guduchighan Vati) in asymptomatic and mild to moderate cases of COVID-19. Methods: This was an open-label randomized controlled pilot study with a sample size of 30 participants (15 in each arm). The participants were asymptomatic or mild to moderate cases of COVID-19. Guduchighan Vati 500 mg twice daily for 10 days was administered in the intervention group as standalone therapy and Hydroxychloroquine in the control group. Outcome measures: Time to negative RT-PCR for COVID-19, proportion of participants turned RT-PCR negative for COVID-19 at 5th and 10th day, duration to achieve complete clinical recovery, improvement in laboratory parameters and incidence of Adverse Drug Reaction/Adverse Event. The data was compared within group using paired sample t-test/ Wilcoxon signed rank test and between group using independent sample t-test/Mann-Whitney test. The results of RT-PCR test was compared between group using chi-square test. Results: 93.3% participants turned RT-PCR negative for COVID-19 in the intervention group, as compared to 66.6% participants in control group till 10th day of the study period. However, the results are statistically insignificant (p = 0.068) which might be attributed to smaller sample size. All the symptomatic patients in the intervention group were clinically recovered at 5th day whereas 14 out of 15 recovered in the control group. No symptoms were observed at 10th day in both the groups. No adverse drug reaction/serious adverse event were observed during the study period. Conclusion: Guduchighan Vati is a safe and effective treatment for asymptomatic and mild cases of COVID-19 and it lowers the time to RT-PCR negative status without any adverse drug reaction/adverse event

AYUSH-64 as add-on to standard care in asymptomatic and mild cases of COVID-19: A randomized controlled trial

Background: The evidence on the efficacy and safety of Ayurveda interventions as add-on to the standard conventional care for COVID-19 is limited. This study was planned to explore the potential of AYUSH-64 as add-on to conventional care in improving the clinical recovery and negative RT-PCR conversion in asymptomatic and mild COVID-19 cases. Materials and Methods: An open-label randomized controlled study was conducted at Government Medical College, Nagpur, Maharashtra, India with a sample size of 60 participants. In this study, asymptomatic or mild COVID-19 patients were randomized and allocated into intervention and control group in 1:1 ratio. AYUSH-64 two capsules (500 mg each) were administered thrice daily, after food with water for 30 days along with standard care in the intervention group, while the control group received only standard care. The effect of the interventions was assessed in terms of negative RT-PCR for COVID-19, clinical cure rate and inflammatory cytokines. Outcome measures: Primary outcome was the time to attain negative RT-PCR for COVID-19 and proportion of participants turned RT-PCR negative for COVID-19 at 7th, 15th, 22nd and 30th day respectively in the intervention group compared to the control group. Secondary outcomes were the proportion of participants who attained clinical recovery at 7th, 15th, 22nd, and 30thday; improvement in laboratory parameters on the 30th day (as compared to baseline) and incidence of Adverse Drug Reactions/Adverse Events (ADRs/AEs). The data was compared within group using paired sample t-test/ Wilcoxon signed rank test and between group using independent sample t-test/Mann-Whitney test. Results: Statistically significant difference was not observed in the proportion of participants who turned RT-PCR negative during each of the follow-ups (p=0.134) and both groups demonstrated comparable efficacy. The clinical recovery rate in terms of time taken for complete cure of symptoms in the symptomatic participants was 60% and 37% on day 15 (p=0.098) and 100% and 85.2% on day 30 (p=0.112), in the intervention and control group respectively which is numerically a better clinical outcome in the intervention group. The improvement in the inflammatory markers such as IL-6, TNF-α and D-dimer was statistically significant in the intervention group (p<0.05). None of the participants developed any complications nor were any significant ADR/AE observed in both the groups. Conclusion: In patients with asymptomatic and mild COVID-19, AYUSH-64 as add-on to standard conventional care, contributed to improving the duration for attaining complete clinical cure and demonstrated potential in reducing the levels of pro-inflammatory markers in the body