Ashwagandha (Withania somnifera) and Shunthi (Zingiber officinale) in mild and moderate COVID-19: An open-label randomized controlled exploratory trial.

BACKGROUND: Ayurveda interventions have been used for prophylaxis and care during the COVID-19 pandemic in India and have shown promising results in promoting early clinical recovery from COVID-19. OBJECTIVE: To assess the efficacy and safety of Ashwagandha [Withania somnifera (L.) Dunal] tablet and Shunthi (Zingiber officinale Roscoe) capsule in mild and moderate COVID-19 compared to conventional standard care. METHODS: A randomized controlled exploratory trial was conducted at a designated COVID-19 care center in India with 60 participants having mild or moderate COVID-19. Ashwagandha, two tablets (250 mg each), and Shunthi, two capsules (500 mg each) twice daily for 15 days, were given orally to the participants in the Ayurveda group (AG) and the control group (CG) received conventional standard care. The outcome measures included clinical recovery rate, the proportion of participants with negative RT-PCR assay for COVID-19 on day 7 and day 15, mean time to attain clinical recovery, change in pro-inflammatory markers, serum IgG for COVID-19, HRCT chest findings, disease progression and incidence of adverse events (AE). RESULTS: A total of 60 participants were enrolled, and the data of 48 participants (AG = 25 and CG = 23) were considered for the statistical analysis. The mean time for clinical recovery was reduced by almost 50 % in the AG (6.9 days) compared to CG (13.0 days) (p < 0.001). The proportion of participants who attained viral clearance in AG was 76.0 % compared to 60.8 % in the CG (RR= 1.24, 95 % CI: 0.841, 1.851, p-value = 0.270). Changes in the pro-inflammatory markers, serum IgG for COVID-19, and HRCT chest findings were comparable in both groups, and no AE or disease progression was reported. CONCLUSIONS: The Ayurveda interventions, Ashwagandha and Shunthi, can effectively reduce the duration of clinical recovery and improve time for viral clearance in mild and moderate COVID-19. These interventions were observed to be safe and well-tolerated during the duration of the trial. TRIAL REGISTRATION: Clinical Trial Registry of India - CTRI/2020/08/027224.

Disease Characteristics, Care-Seeking Behavior, and Outcomes Associated With the Use of AYUSH-64 in COVID-19 Patients in Home Isolation in India: A Community-Based Cross-Sectional Analysis.

Background: During the second wave of the COVID-19 pandemic in India, the Ministry of Ayush conducted a community study to provide therapeutic care to patients with asymptomatic, mild, and moderate COVID-19 in home isolation based on the empirical evidence generated on the efficacy of AYUSH-64 in COVID-19. Objective: To document disease characteristics, care-seeking behavior, and outcomes in patients with asymptomatic, mild, or moderate COVID-19 in home isolation who used AYUSH-64 for COVID-19. Methods: Cross-sectional analysis of the data generated through a community study conducted in India from 08 May to 31 August 2021 was performed to study the disease characteristics, care-seeking behavior during home isolation, clinical outcomes, adverse events, and the association between various risk factors and clinical recovery during the study period. The data were collected through semi-structured questionnaires, available in electronic data collection format at the baseline, 7, 14, and 21 days. A logistic regression was performed to explore the relationship between relevant variables and clinical recovery. Results: Data from 64,642 participants were analyzed for baseline assessment, and final analysis was done for 49,770 participants. The mean age of the enrolled participants was 38.8 ± 11.7 years, and 8.4% had co-morbidities. AYUSH-64 was utilized as an add-on to the standard care by 58.3% of participants. Comparable clinical outcomes were observed in participants utilizing AYUSH-64 either as a standalone or as an add-on to standard care, in terms of clinical recovery, disease progression, the requirement for oxygen supplementation, hospitalization, ICU admission, and need for ventilator support. Younger age, having no co-morbidities or substance abuse, and having been vaccinated were associated with early clinical recovery than those who were older and not vaccinated. Conclusions: The study findings suggest that AYUSH-64 use, either standalone or as an adjunct to standard care, in asymptomatic, mild, or moderate COVID-19 is associated with good clinical outcomes. Ayush services and interventions can be effectively integrated into the mainstream public health architecture to serve public health goals.

AYUSH-64 as an adjunct to standard care in mild to moderate COVID-19: An open-label randomized controlled trial in Chandigarh, India.

OBJECTIVE: To determine the therapeutic efficacy and safety of AYUSH-64 as an add-on to standard care in mild to moderate COVID-19. DESIGN SETTING, AND INTERVENTIONS: This open-label randomized controlled parallel-group trial was conducted at a designated COVID care centre in India in 80 patients diagnosed with mild to moderate COVID-19 and randomized into two groups. Participants in the AYUSH-64 add-on group (AG) received AYUSH-64 two tablets (500 mg each) three times a day for 30 days along with standard conventional care. The control group (CG) received standard care alone. MAIN OUTCOME MEASURES: Proportion of participants who attained clinical recovery on day 7, 15, 23 and 30, proportion of participants with negative RT-PCR assay for COVID-19 at each weekly time point, change in pro-inflammatory markers, metabolic functions, HRCT chest (CO-RADS category) and incidence of Adverse Drug Reaction (ADR)/Adverse Event (AE). RESULTS: Out of 80 participants, 74 (37 in each group) contributed to the final analysis. Significant difference was observed in clinical recovery in the AG (p < 0.001 ) compared to CG. Mean duration for clinical recovery in AG (5.8 ± 2.67 days) was significantly less compared to CG (10.0 ± 4.06 days). Significant improvement in HRCT chest was observed in AG (p = 0.031) unlike in CG (p = 0.210). No ADR/SAE was observed or reported in AG. CONCLUSIONS: AYUSH-64 as adjunct to standard care is safe and effective in hastening clinical recovery in mild to moderate COVID-19. The efficacy may be further validated by larger multi-center double-blind trials.

AYUSH 64, a polyherbal Ayurvedic formulation in Influenza-like illness - Results of a pilot study.

BACKGROUND: Influenza-like Illness (ILI) refers to a wide range of viral infections with an important cause of morbidity and mortality worldwide. The global incidence of ILI is estimated at 5-10% in adults and 20-30% in children. In India influenza accounts for 20-42% of monthly acute medical illness hospitalizations during the peak rainy season. AYUSH-64, a poly-herbal drug, is in practice for 40 years for various clinical conditions like fevers, microfilaremia, and inflammatory conditions. OBJECTIVE: A pilot study was conducted to evaluate the safety and efficacy of Ayurvedic formulation, AYUSH-64 in clinically diagnosed ILI for accelerating the recovery. MATERIAL AND METHODS: A prospective, open-label, nonrandomized, single group, single-center pilot clinical study with pre-test and post-test design was conducted at Raja Ramdeo Anandilal Podar Central Ayurveda Research Institute for Cancer, Mumbai, an institute of Central Council for Research in Ayurvedic Sciences (CCRAS) between June 2018 and July 2019. A total of 38 participants of clinically diagnosed ILI (18-65 years) were studied with an one-week intervention of 'AYUSH 64' in a dose of 3 gm/day and three weeks post-treatment observation period. Assessment of parameters viz. improvement in the symptoms of ILI, frequency of usage of acetaminophen, antihistaminic and cough syrup, hematology, liver function and kidney function tests along with incidence of secondary complications, and time to return to a normal routine was done. RESULTS: One-week intervention of AYUSH 64 helped to recover from ILI symptoms with reduced frequency of usage of acetaminophen and antihistaminic. The intervention was safe on hematology and biochemical parameters. No serious adverse effects were observed during the study. CONCLUSION: AYUSH 64 along-with standard care in ILI is safe and efficacious and this may be used in other viral infections with pyrexia as add-on to standard care for early recovery and better outcome.

A pilot clinical study of an add-on Ayurvedic formulation containing Tinospora cordifolia and Piper longum in mild to moderate COVID-19.

BACKGROUND: After declaration of COVID- 19 as pandemic by WHO, countries adopted several measures to contain the spread as well as test and treat the patients. Further, as no effective management protocols to address this pandemic were available, a need was felt to explore the integration of modern and traditional medicines to treat COVID- 19 cases. OBJECTIVE: To undertake a study with Ayurveda formulation as add on to existing standard of care (SOC) and to compare the outcomes in terms of patient acceptability, the time to clinical recovery, hospital stay as well as any signs of drug-herb interaction between the Ayurveda formulation and the SOC. MATERIAL AND METHODS: An exploratory nonrandomized prospective study has been undertaken for comparing the outcomes of traditional Ayurvedic classical formulation of Tinospora cordifolia (Guduchi) and Piper longum (Pippali) as an add on to standard of care (SOC) using modern medicine with SOC alone. This has been done in mild and moderate COVID- 19 cases, at a tertiary care integrative Medicine hospital in the National Capital Region, Gurgaon, India. The outcomes have been evaluated in terms of the duration of hospital stay, the time to clinical recovery, safety and non- interference/interaction of Ayurvedic and Further, long term impact of COVID- 19 treatment has been evaluated using quality of life questionnaire after 3 months of discharge. RESULTS: Findings of present study reveals that the Ayurveda add-on formulation of T. cordifolia (Guduchi) and P. longum (Pippali) has reduced the length of hospital stay and improve the recovery time. General feeling of wellbeing and activity levels were better in the 3 month follow-up post discharge in the Ayurveda add-on group. CONCLUSION: Addition of Ayurveda formulation has reduced the time of recovery and duration of hospital stay. However, this formulation needs further investigated to provide more information on effective and safe herbal add-on to SOC for better outcomes to treatment of COVID-19 disease.

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.

Mobile App-Reported Use of Traditional Medicine for Maintenance of Health in India During the COVID-19 Pandemic: Cross-sectional Questionnaire Study.

BACKGROUND: India follows a pluralistic system for strategic and focused health care delivery in which traditional systems of medicine such as Ayurveda, yoga and naturopathy, Unani, Siddha, Sowa Rigpa, and homoeopathy (AYUSH) coexist with contemporary medicine, and this system functions under the Ministry of AYUSH (MoA). The MoA developed a mobile app, called AYUSH Sanjivani, to document the trends of the use of AYUSH-based traditional and holistic measures by the public across India. Analysis of the data generated through this app can help monitor the extent of the use of AYUSH measures for maintenance of health during the COVID-19 pandemic and aid effective health promotion and communication efforts focused on targeted health care delivery during the pandemic. OBJECTIVE: The purpose of the study was to determine the extent of use of AYUSH measures by the public in India for maintenance of health during the COVID-19 pandemic as reported through the AYUSH Sanjivani mobile app. METHODS: Cross-sectional analysis of the data generated through the Ayush Sanjivani app from May 4 to July 31, 2020, was performed to study the pattern and extent of the use of AYUSH-based measures by the Indian population. The responses of the respondents in terms of demographic profile, use pattern, and benefits obtained; the association between the use of AYUSH-based measures and symptomatic status; and the association between the duration of use of AYUSH-based measures and the outcome of COVID-19 testing were evaluated based on bivariate and multivariate logistic regression analysis. RESULTS: Data from 723,459 respondents were used for the analysis, among whom 616,295 (85.2%) reported that they had been using AYUSH measures for maintenance of health during the COVID-19 pandemic. Among these 616,295 users, 553,801 (89.8%) either strongly or moderately agreed to have benefitted from AYUSH measures. Ayurveda and homeopathic measures and interventions were the most preferred by the respondents across India. Among the 359,785 AYUSH users who described their overall improvement in general health, 144,927 (40.3%) rated it as good, 30,848 (8.6%) as moderate, and 133,046 (40.3%) as slight. Respondents who had been using AYUSH measures for less than 30 days were more likely to be COVID-19-positive among those who were tested (odds ratio 1.52, 95% CI 1.44-1.60). The odds of nonusers of AYUSH measures being symptomatic if they tested positive were greater than those of AYUSH users (odds ratio 4.01, 95% CI 3.61-4.59). CONCLUSIONS: The findings of this cross-sectional analysis assert that a large proportion of the representative population practiced AYUSH measures across different geographic locations of the country during the COVID-19 pandemic and benefitted considerably in terms of general well-being, with a possible impact on their quality of life and specific domains of health.

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.

Swasthya Assessment Scale (SAS)-Ayurveda based health assessment tool-insights on its development and validation.

Introduction: Ayurveda has a unique way of understanding the body, health, and diseases. Various determinants, including biological, ecological, medical, psychological, sociocultural, spiritual, and metaphysical factors, which depend on each other, have their role in determining health in Ayurveda. Currently, no validated health assessment scale, based on the principles of Ayurveda is available. This article, for the first time, reports the development, validation, and reliability testing of the Swasthya assessment scale - a health assessment tool developed in Ayurveda. Materials and methods: A thorough literature search and expert consultations were done to draft the items encompassing the concept of health in Ayurveda. A group of experts assessed the content validity of the drafted items. Cognitive de-briefing and pretesting were performed to modify the language and the content again. Reliability testing was done with an inter-observer agreement in a sample of 183 individuals. Results: The content validity index for items and the scale-level content validity index (S-CVI) were calculated. S-CVI for scale was excellent, with 85% agreement. The S-CVI/universal agreement was 0.45, and S-CVI/Average was 0.95. In inter-rater reliability, the percentage agreement was 73.7%. Pearson correlation coefficient was 0.808 showing a strong correlation. Conclusion: Following appropriate validation, the scale can be widely used in clinical practice to assess the patient's health status, guide the treatment plans, and monitor the progress of the health. It can also be used as a sensitive tool in the research of Ayurveda to assess the changes in patients brought about by Ayurveda interventions.

Evaluation of the Modified Naranjo Criteria for Assessing Causal Attribution of Clinical Outcome to Homeopathic Intervention as Presented in Case Reports.

OBJECTIVES: The objective of this study was to establish the reliability and content validity of the "Modified Naranjo Criteria for Homeopathy-Causal Attribution Inventory" as a tool for attributing a causal relationship between the homeopathic intervention and outcome in clinical case reports. METHODS: Purposive sampling was adopted for the selection of information-rich case reports using pre-defined criteria. Eligible case reports had to fulfil a minimum of nine items of the CARE Clinical Case Reporting Guideline checklist and a minimum of three of the homeopathic HOM-CASE CARE extension items. The Modified Naranjo Criteria for Homeopathy Inventory consists of 10 domains. Inter-rater agreement in the scoring of these domains was determined by calculating the percentage agreement and kappa (κ) values. A κ greater than 0.4, indicating fair agreement between raters, in conjunction with the absence of concerns regarding the face validity, was taken to indicate the validity of a given domain. Each domain was assessed by four raters for the selected case reports. RESULTS: Sixty case reports met the inclusion criteria. Inter-rater agreement/concordance per domain was "perfect" for domains 1 (100%, κ = 1.00) and 2 (100%, κ = 1.00); "almost perfect" for domain 8 (97.5%, κ = 0.86); "substantial" for domains 3 (96.7%, κ = 0.80) and 5 (91.1%, κ = 0.70); "moderate" for domains 4 (83.3%, κ = 0.60), 7 (67.8%, κ = 0.46) and 9 (99.2%, κ = 0.50); and "fair" for domain 10 (56.1%, κ = 0.38). For domains 6A (46.7%, κ = 0.03) and 6B (50.3%, κ = 0.18), there was "slight agreement" only. Thus, the validity of the Modified Naranjo Criteria for Homeopathy tool was established for each of its domains, except for the two that pertain to direction of cure (domains 6A and 6B). CONCLUSION: The MO: dified NAR: anjo C: riteria for H: omeopathy-Causal Attribution Inventory was identified as a valid tool for assessing the likelihood of a causal relationship between a homeopathic intervention and clinical outcome. Improved wordings for several criteria have been proposed for the assessment tool, under the new acronym "MONARCH". Further assessment of two MONARCH domains is required.

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.

Impact of Yoga on Periodontal Disease and Stress Management.

BACKGROUND: Yoga is considered to be one of the most important, effective, and valuable tools available for man to overcome various physical and psychological problems. Stress contributes significantly to the pathogenesis of periodontal diseases; hence, it becomes important to reduce the level of stress for prevention and management of diseases. AIMS AND OBJECTIVES: The present study was aimed: (1) To understand and analyze the possibilities of employing yogic practices in the treatment of periodontal disease along with conventional dental therapy, (2) to understand the effect of stress on periodontal treatment outcome, (3) to evaluate the efficacy of yoga in the management of periodontal disease with reference to stress. MATERIALS AND METHODS: An outpatient department-based parallel group randomized study was performed with standard treatment for periodontal disease yoga therapy as Group II and only standard treatment as Group I. Periodontal health status was recorded using indices of modified plaque index (PI), bleeding on probing (BOP), probing depth, and clinical attachment loss (CAL). The Cohen's perceived stress questionnaire was also used to determine stress severity. The yogic intervention consists of lectures and practical sessions on asanas, pranayama, kriyas, and meditation. RESULTS: Repeated measure analysis of variance revealed a significant difference (P < 0.001) in all the outcome variables with respect to time in both groups. It was observed that mean PI score reduced by 1.35 in Group II as compared to 0.54 in Group I, mean probing pocket depth reduced by 1.60 in Group II as compared to only 0.68 in Group I, and mean CAL score reduced by 1.60 in Group II as compared to 0.68 in Group I. Similarly, Cohen's perceived stress scale score also reduced by 18.76 points in Group II as compared to only 2.58 points in Group I, BOP also shows better improvement in Group II with a reduction of 0.68 as compared to reduction of only 0.08 in Group I. The results obtained ascertained the role of yoga in stress reduction in periodontal disease. CONCLUSION: Although yoga does not play a direct role in improving periodontal disease, it accelerates the treatment outcomes by combating the stress which is a major factor affecting the treatment of periodontal disease.

Analysis of repeated measurement data in the clinical trials.

Statistics is an integral part of Clinical Trials. Elements of statistics span Clinical Trial design, data monitoring, analyses and reporting. A solid understanding of statistical concepts by clinicians improves the comprehension and the resulting quality of Clinical Trials. In biomedical research it has been seen that researcher frequently use t-test and ANOVA to compare means between the groups of interest irrespective of the nature of the data. In Clinical Trials we record the data on the patients more than two times. In such a situation using the standard ANOVA procedures is not appropriate as it does not consider dependencies between observations within subjects in the analysis. To deal with such types of study data Repeated Measure ANOVA should be used. In this article the application of One-way Repeated Measure ANOVA has been demonstrated by using the software SPSS (Statistical Package for Social Sciences) Version 15.0 on the data collected at four time points 0 day, 15(th) day, 30(th) day, and 45(th) day of multicentre clinical trial conducted on Pandu Roga (~Iron Deficiency Anemia) with an Ayurvedic formulation Dhatrilauha.