Chemoprofiling and medicinal potential of underutilized leaves of Cyperus scariosus.

Agro-waste is the outcome of the under-utilization of bioresources and a lack of knowledge to re-use this waste in proper ways or a circular economy approach. In the Indian medicinal system, the root of Cyperus scariosus (CS) is used at a large scale due to their vital medicinal properties. Unfortunately, the aerial part of CS is treated as agro-waste and is an under-utilized bioresource. Due to a lack of knowledge, CS is treated as a weed. This present study is the first ever attempt to explore CS leaves as medicinally and a nutrient rich source. To determine the food and nutritional values of the neglected part of Cyperus scariosus R.Br. (CS), i.e. CS leaves, phytochemicals and metal ions of CS were quantified by newly developed HPLC and ICPOES-based methods. The content of the phytochemicals observed in HPLC analysis for caffeic acid, catechin, epicatechin, trans-p-coumaric acid, and trans-ferulic acid was 10.51, 276.15, 279.09, 70.53, and 36.83 µg/g, respectively. In GC-MS/MS analysis, fatty acids including linolenic acid, phytol, palmitic acid, etc. were identified. In ICPOES analysis, the significant content of Na, K, Ca, Cu, Fe, Mg, Mn, and Zn was observed. The TPC and TFC of the CS leaves was 17.933 mg GAE eq./g and 130.767 mg QCE eq./g along with an IC50 value of 2.78 mg/mL in the DPPH assay and better antacid activity was measured than the standard (CaCO3). The methanolic extract of CS leaves showed anti-microbial activity against Staphylococcus aureus (15 ± 2 mm), Pseudomonas aeruginosa (12 ± 2 mm) and Escherichia coli (10 ± 2 mm). In silico studies confirmed the in vitro results obtained from the antioxidant, antiacid, and anti-microbial studies. In addition, in silico studies revealed the anti-cancerous and anti-inflammatory potential of the CS leaves. This study, thus, demonstrated the medicinal significance of the under-utilized part of CS and the conversion of agro-waste into mankind activity as a pharmaceutical potent material. Consequently, the present study highlighted that CS leaves have medicinal importance with good nutritional utility and have a large potential in the pharmaceutical industry along with improving bio-valorization and the environment.

Effect of Ayurveda intervention in the integrated management of essential hypertension- a retrospective observational study.

BACKGROUND: A study titled 'Integration of AYUSH (Ayurveda) with National Programme for Prevention and Control of Cancer, Diabetes, Cardiovascular Diseases and Stroke (NPCDCS)' implemented in India in three districts of three states, namely Bhilwara (Rajasthan), Gaya (Bihar), and Surendranagar (Gujarat) since 2015 for the management of various non-communicable diseases (NCDs) through integrated approach. OBJECTIVE(S): To evaluate the effect of Ayurveda medication, lifestyle modification, and Yoga in integration with standard care for the management of essential hypertension. MATERIAL AND METHODS: A retrospective analysis of the demographic and clinical records available from NPCDCS-AYUSH Integration Project was done. The data of participants with Essential Hypertension (EHTN), aged between 30 and 60 years, who had completed six months integrated management as per the treatment protocol of the NPCDCS-AYUSH Integration project between July 2018 and March 2019 were taken and distributed in two groups based on their intervention. Those advised for lifestyle modification and Yoga in addition to standard care with any of the five medicines/combinations i.e. Amlodipine or Atenolol or Amlodipine + Atenolol or Losartan or Telmisartan were assigned Group I and those who were given Ayurveda medication, lifestyle modification and Yoga in addition to standard care were assigned to Group II. The change in blood pressure was analysed and dose reduction/discontinuation of conventional medications was also observed. RESULTS: Data of 1938 participants who had completed treatment under the NPCDCS program was analysed. At the 6th month, systolic and diastolic blood pressure was significantly reduced (P < 0.01) in all categories of Group I and Group II from baseline. Further, the dose of conventional medicine was reduced in 33.1% of participants of Group I and in 30.4% participants of Group II when compared to 0 day while conventional medicines were discontinued in 15.1% of Group I and 36.7% of Group II participants. CONCLUSION: Ayurveda medication along with lifestyle management and Yoga effectively controls systolic and diastolic blood pressure and further helps in reducing/discontinuation of dose of conventional medicines in EHTN participants.

Safety and efficacy of Ayurvedic interventions and Yoga on long term effects of COVID-19: A structured summary of a study protocol for a randomized controlled trial.

OBJECTIVES: Primary Objective • To assess the efficacy of Ayurveda interventions and Yoga in rehabilitation of COVID-19 cases suffering with long term effects of COVID 19 as compared to WHO Rehabilitation Self-Management after COVID-19- Related Illness. Secondary Objective • To assess the safety of Ayurvedic interventions in cases suffering with long term effects of COVID 19 TRIAL DESIGN: Multi-centric, randomized, controlled, parallel group, open-label, exploratory study. The study duration is 9 months and the intervention period is 90 days from the day of enrolment of the participant. PARTICIPANTS: Patients of either sex between 18 to 60 years, ambulatory, willing to participate, with history (not more than 4 weeks) of positive RT-PCR for COVID-19 or IgM antibodies positivity for SARS CoV-2, but having negative RT-PCR for COVID-19 at the time of screening will be considered eligible for enrolment in the study. Critically ill patients with ARDS (acute respiratory distress syndrome), requiring invasive respiratory support in the intensive care unit, known case of any malignancy, immune-compromised state (e.g. HIV), diabetes mellitus, active pulmonary tuberculosis, past history of any chronic respiratory disease, motor neuron disease, multiple sclerosis, stroke, impaired cognition, atrial fibrillation, acute coronary syndrome, myocardial infarction, severe arrhythmia, concurrent serious hepatic disease or renal disease, pregnant or lactating women, patients on immunosuppressive medications, history of hypersensitivity to the trial drugs or their ingredients, depressive illness (before COVID-19), diagnosed psychotic illnesses, substance dependence or alcoholism will be excluded. The trial will be conducted at two medical colleges in Maharashtra, India. INTERVENTION AND COMPARATOR: Intervention Arm (Group-I): Ayurveda interventions including Agastya Haritaki six gram and Ashwagandha tablet 500 mg twice daily orally after meals with warm water and two sessions of yoga (morning 30 minutes and evening 15 minutes) daily for 90 days, as per the post-COVID-19 care protocol provided in National Clinical Management Protocol based on Ayurveda and Yoga for management of COVID-19 published by Ministry of AYUSH, Government of India. Comparator Arm (Group-II): WHO Rehabilitation Self-Management after COVID-19 related illness for 90 days. The trial drugs are being procured from a GMP certified pharmaceutical company. MAIN OUTCOMES: Primary Outcome: Change in respiratory function to be assessed by San Diego shortness of breath Questionnaire, 6-minutes walk test and pulmonary function test. SECONDARY OUTCOMES: Change in High-resolution Computed Tomography (HRCT) Chest Change in Fatigue score assessed by Modified Fatigue Impact Scale Change in Anxiety score assessed by Hospital Anxiety and Depression Scale Score Change in Sleep Quality assessed by Pittsburgh Sleep Quality Index Change in the quality of life assessed by COV19-QoL scale Safety of the interventions will be assessed by comparing hematological and biochemical investigations before and after the intervention period and Adverse Event/ Adverse drug reaction TIMELINES FOR OUTCOME ASSESSMENT: Subjective parameters and clinical assessment will be assessed at baseline, 15th day, 30th day, 60th day and 90th day. Laboratory parameters (CBC, LFT, KFT, HbA1c, Hs-CRP, D-dimer), Pulmonary function test and HRCT Chest will be done at baseline and after completion of study period i.e. 90th day. RANDOMISATION: Statistical package for Social Sciences (SPSS) version 15.0 is used to generate the random number sequences. The participants will be randomized to two study groups in the ratio of 1:1. BLINDING (MASKING): The study is open-label design. However, the outcome assessor will be kept blinded regarding the study group allocation of the participants. NUMBERS TO BE RANDOMISED (SAMPLE SIZE) SAMPLE SIZE: The sample size for the study is calculated assuming improvement in 6-minutes walk test by 40 meter in Group I and a change of 10 meter in Group II with a standard deviation of 50 meter based on the results of the previous studies, with 95% Confidence Level (α = 0.05) and 80% power and expecting a dropout rate of 20%. The number of participants to be enrolled in the study should be approximately 55 in each group. Hence, a total of 110 participants will be enrolled in the trial at each study site. TRIAL STATUS: Participants' recruitment started on 1st May 2021. Anticipated end of recruitment is August 2021. Protocol number: CCRAS-01 Protocol version number: 1.1, 13th January 2021. TRIAL REGISTRATION: The trial is prospectively registered with the Clinical Trial Registry of India (CTRI) on 03rd March 2021 [ CTRI/2021/03/031686 ]. FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Journal website (Additional file 1). This communication serves as a summary of the key elements of the full protocol.

Dhatri Lauha in the management of iron deficiency anemia: A prospective open-label single-arm multi-center trial.

Background: The burden of iron-deficiency anemia (IDA) remains persistently high in India due to the poor tolerability of oral iron supplementation. Therefore, more focus is required to explore traditional medicine for safe and effective options for managing IDA. Aim: To assess the clinical safety and efficacy of Dhatri Lauha in patients with IDA. Materials and methods: An open-label, prospective, single-arm, multi-center trial was conducted at 12 centers with a sample size of 40 participants per study site. Patients with IDA aged 18-60 years with hemoglobin levels in the range of 6-10gm/dl, mean corpuscular volume (MCV) <80 fl, mean corpuscular hemoglobin concentration (MCHC) <34 µg/dl, serum ferritin <30 µg/dl and serum iron <50 µg/dl were included in the study. Dhatri Lauha 500 mg capsule was administered twice daily with lukewarm water after meals for 45 days. The primary outcome measure was the change in hemoglobin (Hb%) level from baseline to day 45. Secondary outcome measures included the change in MCV, MCHC, serum iron and ferritin levels, incidence of adverse events, and change in safety parameters (liver and kidney function tests). The mean (statistical) change in outcome measures from baseline to day 45 was compared using a paired sample t-test. Results: Out of 458 participants enrolled in the study, 400 contributed to the final analysis. A significant difference was observed in the outcome parameters such as Hb%, MCV, MCHC, serum ferritin, and serum iron levels (P < 0.001) after 45 days of treatment. Mean Hb% changed from 8.46 ± 1.14 g/dl at baseline to 9.18 ± 1.61 g/dl on day 45 (P < 0.001). LFT and KFT were within the normal limits after the study period. No participant withdrew from the study due to adverse events. Conclusions: Dhatri Lauha is a safe intervention and can be expected to improve hemoglobin levels, red blood cell parameters, and iron stores in patients with IDA. Future RCTs with a larger sample size, standard care as control and a longer follow-up may produce more accurate and reliable results.

AYUSH-64 as an 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 an add-on to the standard conventional care for coronavirus disease-2019 (COVID-19) is limited. AIM AND OBJECTIVE: This study was planned to explore the potential of AYUSH-64 as an add-on to conventional care in improving the clinical recovery and negative reverse transcription-polymerase chain reaction (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 groups (CG) in a 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 (IG), while the CG received only standard care. The primary outcome was the proportion of participants who turned RT-PCR negative for COVID-19 at 7th, 15th, 22nd and 30th days. Secondary outcomes were the proportion of participants who attained clinical recovery at 7th, 15th, 22nd and 30th days, change in laboratory parameters on the 30th day and incidence of adverse drug reactions/adverse events. The data were 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 in terms of complete relief in 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 CG, respectively. The improvement in the inflammatory markers such as interleukin (IL)-6, tumor necrosis factor-α (TNF-α), and D-dimer was statistically significant (P < 0.05) in the IG, whereas in the CG, it was statistically significant for D-dimer only. None of the participants developed any complications nor were any significant ADR/AE observed in the groups. CONCLUSIONS: In patients with asymptomatic and mild COVID-19, AYUSH-64, as add-on to standard conventional care, contributed to improved clinical recovery and demonstrated potential in reducing the levels of pro-inflammatory markers such as IL-6 and TNF-α. Further, both the groups demonstrated comparable efficacy regarding negative RT-PCR for COVID-19.

Effect of Ayurveda intervention, lifestyle modification and Yoga in prediabetic and type 2 diabetes under the National Programme for Prevention and Control of Cancer, Diabetes, Cardiovascular Diseases and Stroke (NPCDCS)-AYUSH integration project.

BACKGROUND: Type 2 diabetes is a lifestyle-related disorder that affects around 422 million individuals in India. Integration of AYUSH (Ayurveda) with the National Programme for Prevention and Control of Cancer, Diabetes, Cardiovascular Diseases and Stroke (NPCDCS) was conceived on pilot basis at Gaya, Bihar, to provide integrative treatment for non-communicable disease patients and to manage the burden of non-communicable diseases in India. OBJECTIVES: The objective of this study was to analyze the effect of Ayurveda intervention, lifestyle modification and Yoga in the management of type 2 diabetes under NPCDCS-AYUSH integration project. MATERIALS AND METHODS: A multi-centric, open-labeled, prospective, comparative clinical study was conducted at 17 community health centers and 1 district hospital. Population over 30 years of age was screened and prediabetic or type 2 diabetic individuals were enrolled in two cohorts, i.e., pre-diabetic (Cohort A) and type 2 diabetic (Cohort B). Each cohort was further divided into two groups: Group A1 was advised for lifestyle modification and Yoga and group A2 was given Ayurveda medication in addition to lifestyle modification and Yoga. Similarly, group B1 was advised for lifestyle modification and Yoga along with allopathic medication and group B2 was given Ayurveda medication, i.e., Mamajjaka, Amalaki and Guduchi powder in addition to lifestyle modification and Yoga along with allopathic medication. Treatment was given for 6 months. Data were analyzed through paired t-test. RESULTS: A significant reduction was observed in fasting blood sugar level in groups A2 and B2 (P = 0.001) and also in the postprandial blood sugar level in Groups A2 and B2 (P = 0.001). Further, improvement in subjective symptoms such as polyuria, polydipsia, polyphagia, blurred vision and weakness was found in all the groups, while non-healing ulcer does not show any improvement. CONCLUSION: The study reveals that Ayurveda intervention, i.e., Mamajjaka Churna (1 g), Amalaki Churna (3 g) and Guduchi Churna (3 g) two times a day effectively controls blood sugar level in pre-diabetic and type 2 diabetic patients and improves the disease management with lifestyle modification and Yogasana as well as with allopathic treatment.