This study was carried out to examine the incidence of diabetes and the factors associated with this in a cohort of South Indian women 5 years after they were examined for gestational diabetes (GDM). Women (N = 630) whose GDM status was determined (Carpenter-Coustan criteria; GDM: N = 41) delivered live babies without major anomalies at the Holdsworth Memorial Hospital, Mysore. Of these, 526 women (GDM: N = 35) available for follow-up after 5 years underwent a 2-h oral glucose tolerance test and detailed anthropometry. Diabetes was determined using WHO criteria, and Metabolic Syndrome using IDF criteria recommended for south Asian women. The incidence of diabetes (37% versus 2%) and Metabolic Syndrome (60% versus 26%) was considerably higher in women with previous GDM compared to non-GDM women. GDM women who developed diabetes had lower gestational insulin area-under-the-curve (P = 0.05). They had larger waist-to-hip ratio, skinfolds, body mass index, and lower 30-min insulin increment at follow-up than other GDM women. In all, history of diabetes in first-degree relatives was independently associated with higher incidence of diabetes (P < 0.001). Our findings suggest high diabetes and cardiovascular risks in women with previous GDM. Follow-up of these women after delivery would provide opportunities to modify adverse lifestyle factors.

Aims/hypothesis The association between lower birthweight and metabolic syndrome may result from fetal undernutrition (fetal programming hypothesis) and/or genes causing both low birthweight and insulin resistance (fetal insulin hypothesis). We studied associations between the birthweight of parents and metabolic syndrome in the offspring. Methods We identified men and women (aged 35-68 years), who had been born in Holdsworth Memorial Hospital, Mysore, India. We also identified the offspring (20-46 years) of these men and women. In total, 283 offspring of 193 mothers and 223 offspring of 144 fathers were studied. Investigations included anthropometry, oral glucose tolerance, plasma insulin and lipid concentrations and blood pressure. The metabolic syndrome was defined using WHO criteria.Results Among the offspring, lower birthweight was associated with an increased risk of glucose intolerance (impaired glucose tolerance, impaired fasting glucose or type 2 diabetes) and higher cholesterol and triacylglycerol concentrations (p<0.05 for all adjusted for sex and age). Most outcomes in the offspring, including most individual components of the metabolic syndrome, were unrelated to parental birthweight. However, both maternal and paternal birthweight were inversely related to offspring metabolic syndrome (odds ratio [OR] 0.36 [95% CI: 0.13-1.01] per kg, p=0.053 for mother-offspring pairs; OR 0.26 [0.07-0.93], p=0.04 for father-offspring pairs, adjusted for offspring age, sex, BMI and socioeconomic status). Maternal birthweight was inversely related to offspring systolic blood pressure (β=−2.5 mmHg [−5.00 to 0.03] per kg maternal birthweight; p=0.052). Conclusions/interpretation Factors in both parents may influence the risk of metabolic syndrome in their offspring. There are several possible explanations, but the findings are consistent with the fetal insulin (genetic) hypothesis.

Introduction Despite several ongoing efforts in biomedicine and traditional medicine, there are no drugs or vaccines for coronavirus disease 2019 (COVID-19) as of May 2020; Kabasura Kudineer (KSK), a polyherbal formulation from India’s Siddha system of medicine, has been traditionally used for clinical presentations similar to that of COVID-19. We explored the efficacy of KSK in reducing viral load and preventing the disease progression in asymptomatic, COVID-19 cases. Methods A prospective, single-center, open-labeled, randomized, controlled trial was conducted in a COVID Care Centre in Chennai, India. We recruited reverse-transcription polymerase chain reaction (RT-PCR)-confirmed COVID-19 of 18 to 55 years of age, without clinical symptoms and co-morbidities. They were randomized (1:1 ratio) to KSK (60 mL twice daily for 7 days) or standard of care (7 days supplementation of vitamin C 60,000 IU morning daily and zinc 100 mg evening daily) groups. The primary outcomes were reduction in the SARS-CoV-2 load [as measured by cyclic threshold (CT) value of RT-PCR], prevention of progression of asymptomatic to symptomatic state, and changes in the immunity markers including interleukins (IL-6, IL-10, IL-2), interferon gamma (IFNγ), and tumor necrosis factor (TNF α). Siddha clinical assessment and the occurrence of adverse effects were documented as secondary outcomes. Paired t-test was used in statistical analysis. Results Viral load in terms of the CT value (RdRp: 95% CI = 1.89 to 5.74) declined significantly on the seventh day in the KSK group and that of the control group, more pronounced in the study group. None progressed to the symptomatic state. There was no significant difference in the biochemical parameters. We did not observe any changes in the Siddha-based clinical examination and adverse events in both groups. Conclusion KSK significantly reduced SARS-CoV-2 viral load among asymptomatic COVID-19 cases and did not record any adverse effect, indicating the use of KSK in the strategy against COVID-19. Larger, multi-centric trials can strengthen the current findings. Trial registration Clinical Trial Registry of India CTRI2020/05/025215. Registered on 16 May 2020

Objectives The primary objectives of this study are to determine efficacy of Siddha medicine, Kabasura kudineer in reduction of SARS-CoV-2 viral load and reducing the onset of symptoms in asymptomatic COVID-19 when compared to Vitamin C and Zinc (CZ) supplementation. In addition, the trial will examine the changes in the immunological markers of the Siddha medicine against control. The secondary objectives of the trial are to evaluate the safety of the Siddha medicine and to document clinical profile of asymptomatic COVID-19 as per principles of Siddha system of Medicine. Trial design A single centre, open-label, parallel group (1:1 allocation ratio), exploratory randomized controlled trial. Participants Cases admitted at non-hospital settings designated as COVID Care Centre and managed by the State Government Stanley Medical College, Chennai, Tamil Nadu, India will be recruited. Eligible participants will be those tested positive for COVID-19 by Reverse Transcriptase Polymerase Chain reaction (RT-PCR) aged 18 to 55 years without any symptoms and co-morbidities like diabetes mellitus, hypertension and bronchial asthma. Those pregnant or lactating, with severe respiratory disease, already participating in COVID trials and with severe illness like malignancy will be excluded. Intervention and comparator Adopting traditional methods, decoction of Kabasura kudineer will be prepared by boiling 5g of KSK powder in 240 ml water and reduced to one-fourth (60ml) and filtered. The KSK group will receive a dose of 60ml decoction, orally in the morning and evening after food for 14 days. The control group will receive Vitamin C (60000 IU) and Zinc tablets (100mg) orally in the morning and evening respectively for 14 days. Main outcomes The primary outcomes are the reduction in the SARS-CoV-2 load [as measured by cyclic threshold (CT) value of RT-PCR] from the baseline to that of seventh day of the treatment, prevention of progression of asymptomatic to symptomatic state (clinical symptoms like fever, cough and breathlessness) and changes in the immunity markers [Interleukins (IL) 6, IL10, IL2, Interferon gamma (IFNγ) and Tumor Necrosis Factor (TNF) alpha]. Clinical assessment of COVID-19 as per standard Siddha system of medicine principles and the occurrence of adverse effects will be documented as secondary outcomes. Randomisation The assignment to the study or control group will be allocated in equal numbers through randomization using random number generation in Microsoft Excel by a statistician who is not involved in the trial. The allocation scheme will be made by an independent statistician using a sealed envelope. The participants will be allocated immediately after the eligibility assessment and informed consent procedures. Blinding (masking) This study is unblinded. The investigators will be blinded to data analysis, which will be carried out by a statistician who is not involved in the trial. Numbers to be randomised (sample size) Sample size could not be calculated, as there is no prior trial on KSK. This trial will be a pilot trial. Hence, we intend to recruit 60 participants in total using a 1:1 allocation ratio, with 30 participants randomised into each arm. Trial status Protocol version 2.0 dated 16th May 2020. Recruitment is completed. The trial started recruitment on the 25th May 2020. We anticipate study including data analysis will finish on November 2020. We also stated that protocol was submitted before the end of data collection Trial registration The study protocol was registered with clinical trial registry of India (CTRI) with CTRI/2020/05/025215 on 16 May 2020. Full protocol The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file 2).

Background: Henoch Schonlein purpura (HSP) is the most common systemic vasculitis in children. It is an immunoglobulin A (IgA) mediated systemic small-vessel vasculitis, with IgA deposition in vessel walls leading to symptoms involving the skin, joints, intestines, and kidneys. The objective of present study was to identify and describe the clinical profile, pattern of joint involvement, histopathological features, treatment modalities and complications of Henoch Schonlein purpura.Methods: 52 children less than 12 years diagnosed to have Henoch Schonlein Purpura according to the European League against Rheumatism criteria were included in the study. All patients were subjected to detailed history taking and thorough examination. The clinical features, investigations, management and complications of the disease were studied. Descriptive statistics was used to analyse the results.Results: The common clinical features were palpable purpura (100%) followed by arthritis (66%) and abdominal pain (50%). Renal manifestations were in the form of hematuria in 12% of the patients. Skin biopsy was done in 25 patients of which 19 had findings suggestive of Henoch Schonlein purpura. Steroids were used in 42% of patients. The severity of illness was associated with lower mean age, arthritis, leg edema and stool occult blood.Conclusions: The clinical features of Henoch Schonlein purpura in the population were different from the previously published studies. Renal involvement was less common. The short-term outcome of the patients were satisfactory.