Assessment of safety and adverse drug reactions of COVID vaccination in the South Indian population: An observational prospective cross-sectional study.

Background: COVID vaccination is now offering a way to transit out of this phase of the pandemic. Two vaccines were approved by the Central Drugs Standard Control Organization (CDSCO) in India: Covishield and Covaxin. However, the vaccines are known to have Adverse Drug Reactions (ADRs) like fever, body pains, headache, pain, and swelling at the injection site. Aim: To assess the Safety of ADRs with Covid Vaccination in the South Indian Population. Method: This prospective, multi-centric study was carried out for six months (February 2021-July 2021). Subjects vaccinated against COVID were enrolled in the study. Informed consent was taken from the study participants, and required data (age, gender, type of vaccine, and ADRs) was collected through telephonic interviews. The data were analyzed by using the Chi-square test. Results: A total of 3032 participants were enrolled in the study. The prevalence of ADRs is highly observed after the 2nd dose (51%) of COVID vaccination. ADRs were mainly experienced by females (55%) than males (45%). The incidence of fever and body pains was high in Covishield after dose one and Covaxin after dose 2. The pain at the injection site was high in Covaxin after dose 2. The WHO assessment scale and Naranjo's scale shows that ADRs are higher likely than probable. Conclusion: We concluded that frequent ADRs that occurred with Covaxin and Covishield were fever, body pains, weakness, headache, and pain at the injection site. All the ADRs were mild and manageable with Paracetamol. So, the vaccines are safe to administer.

Evaluation of one-year effectiveness of clobazam as an add-on therapy to anticonvulsant monotherapy in participants with epilepsy having uncontrolled seizure episodes: An Indian experience.

OBJECTIVES: To prospectively study the effectiveness and safety of clobazam as an add-on therapy in patients with epilepsy whose seizures are not adequately controlled with antiseizure medicine (ASM) monotherapy. METHODS: We conducted a prospective, observational study at 28 neurology outpatient clinics in India from June 2017 to October 2019. Consecutive patients with epilepsy (older than 3 years) with inadequate seizure control with ASM monotherapy were initiated on clobazam. Patients were followed up at 1, 3, 6, 9, and 12 months. Seizure control and adverse events were assessed through personal interviews and seizure diaries. RESULTS: Out of 475 eligible patients, data of 429 patients (men: 65.5%) were evaluated (46 excluded due to protocol deviations). The median age was 25 (range, 3-80 years) years and the median duration of epilepsy was 3 (0.1-30) years. The majority of patients had focal epilepsy (55.0%) and genetic generalized epilepsy (40.1%). The one-year follow-up was completed by 380 (88.5%) patients. At one-year follow-up, 317 (83.4%; N = 380) patients in the study remained seizure free. These 317 patients who were seizure free at 12 months comprised 73.9% of the evaluable population (N = 429). In 98.8% of patients, the primary reason for adding clobazam was inadequate control of seizures with treatment. During one-year follow-up, a total of 113 (22.6%) patients experienced at least one adverse event which included 103 (20.6%) patients who experienced 386 episodes of seizures. CONCLUSION: The study provides preliminary evidence that clobazam is effective and well-tolerated as add-on therapy for a period of one year among patients with epilepsy inadequately stabilized with monotherapy. TRIAL REGISTRATION NUMBER: CTRI/2017/12/010906.

Salacia reticulata improves serum lipid profiles and glycemic control in patients with prediabetes and mild to moderate hyperlipidemia: a double-blind, placebo-controlled, randomized trial.

The present randomized, double-blind, placebo-controlled study evaluated the efficacy and safety of Salacia reticulata leaves and root bark extracts in 29 patients with prediabetes and mild to moderate hyperlipidemia. Patients received either Salacia extracts (500 mg/day) or placebo along with therapeutic lifestyle changes for a period of 6 weeks. Efficacy was evaluated in terms of change in lipid profile and glycemic levels. The safety and tolerability was evaluated by a physical examination and clinical laboratory evaluations. Improvements in lipid profiles and glycemic levels were observed in Salacia extract-treated groups when compared to placebo at week 6. A statistical significant reduction was observed in low-density lipoprotein cholesterol and fasting blood sugar (FBS) levels at week 3 and 6 when treated with root bark extract. The leaves extract-treated group showed statistically significant reduction in FBS levels at week 6 only. No adverse events occurred and all safety parameters were within normal ranges during the study. This study revealed that treatment with S. reticulata was safe and well-tolerated and may be beneficial in the management of prediabetes and mild to moderate hyperlipidemia.

A randomized double blind placebo controlled clinical evaluation of extract of Andrographis paniculata (KalmCold) in patients with uncomplicated upper respiratory tract infection.

A randomized, double blind placebo controlled clinical study was conducted to evaluate the efficacy of KalmCold, an extract of Andrographis paniculata, in patients with uncomplicated upper respiratory tract infection (URTI). The assessment involved quantification of symptom scores by Visual Analogue Scale. Nine self evaluated symptoms of cough, expectoration, nasal discharge, headache, fever, sore throat, earache, malaise/fatigue and sleep disturbance were scored. A total of 223 patients of both sexes were randomized in two groups which received either KalmCold (200 mg/day) or placebo in a double blind manner. In both the treatments, mean scores of all symptoms showed a decreasing trend from day 1 to day 3 but from day 3 to day 5 most of the symptoms in placebo treated group either remained unchanged (cough, headache and earache) or got aggravated (sore throat and sleep disturbance) whereas in KalmCold treated group all symptoms showed a decreasing trend. Within groups, mean scores of symptoms in both the groups decreased significantly (p < or = 0.05) from day 1 to day 3 and day 5 while from day 3 to day 5 all symptoms except expectoration in placebo group did not improve significantly whereas in KalmCold treated group all symptoms improved significantly (p < or = 0.05) except earache. Comparing mean between both groups, all symptoms at day 1 and day 3 were found to be the same while at day 5 all symptoms except earache in KalmCold treated group improved significantly (p < or = 0.05) than placebo group. Similarly, within groups, overall scores of all symptoms in both the groups decreased significantly (p < or = 0.05) from day 1 to day 3 and day 5 while from day 3 to day 5 placebo group did not improve significantly whereas KalmCold treated group showed significant improvement (p < or = 0.05). On between groups analysis, KalmCold group showed significant reduction (p < or = 0.05) in overall symptom scores as compared to placebo group. In both placebo and KalmCold treated groups, there were only a few minor adverse effects with no significant difference in occurrence (Z = 0.63; p > 0.05). The comparison of overall efficacy of KalmCold over placebo was found to be significant (p < or = 0.05) and it was 2.1 times (52.7%) higher than placebo. The findings of this study revealed that KalmCold was effective in reducing symptoms of upper respiratory tract infection.

Safety evaluation of BacoMind in healthy volunteers: a phase I study.

BacoMind is an enriched phytochemical composition of Bacopa monniera (B. monniera), a common medicinal plant used in the traditional systems of medicine as a memory-enhancing agent. BacoMind was standardized with reference to bioactive compounds and was evaluated for short-term safety and tolerability in healthy adult volunteers. The study plan employed randomized, open label, dose escalation design. Each of 23 participants were orally given one single capsule of BacoMind daily for 30 days, i.e., 300 mg for first 15 days and 450 mg for next 15 days. Detailed examination of clinical, hematological, biochemical and electrocardiographic parameters done in pre and post-treatment periods did not indicate any untoward effects in any of the treated volunteers. Mild adverse events related to gastrointestinal system were observed in the trial, which subsided spontaneously. BacoMind was found to meet the safety criteria at the dose administered for the given duration of trial period in healthy adult volunteers.

Screening of selected Indian medicinal plants for acetylcholinesterase inhibitory activity.

Seventy-six plant extracts including methanolic and successive water extracts from 37 Indian medicinal plants were investigated for acetylcholinesterase (AChE) inhibitory activity (in vitro). Results indicated that methanolic extracts to be more active than water extracts. The potent AChE inhibiting methanolic plant extracts included Withania somnifera (root), Semecarpus anacardium (stem bark), Embelia ribes (Root), Tinospora cordifolia (stem), Ficus religiosa (stem bark) and Nardostachys jatamansi (rhizome). The IC(50) values obtained for these extracts were 33.38, 16.74, 23.04, 38.36, 73.69 and 47.21mug/ml, respectively. These results partly substantiate the traditional use of these herbs for improvement of cognition.

Multicenter clinical trials on a novel polyherbal formulation in allergic rhinitis.

Allergic rhinitis is the most frequently occurring immunological disorder. It affects men, women and children and represents significant cost in terms of suffering and loss of productivity. Allergy is termed as an excessive reaction to an environmental allergen. Pollen, mold, dust, mite and animal allergens that contact the nasal or eye lining cause sneezing, nasal congestion and itchy, watery, swollen, red eyes. Although a broad spectrum of therapeutic options is available, the treatment of allergic rhinitis appears to be far from satisfactory. A novel polyherbal formulation (PF; Aller-7/NR-A2) comprising seven medicinal herbal extracts was assessed in a multicenter clinical trial involving 545 patients (321 males and 224 females) aged 18-59 years for 12 weeks to evaluate its clinical efficacy in patients suffering from allergic rhinitis. A total of 171 patients participated in double-blind, randomized, placebo-controlled studies in three centers, while 374 patients were included in the open-label studies in 11 centers. The three major symptoms (sneezing, rhinorrhea and nasal congestion) of allergic rhinitis were significantly reduced. Significant improvement was also observed in absolute eosinophil count, mucociliary clearance time, peak expiratory flow rate and peak nasal flow rate. No serious adverse events that warranted cessation of treatment were observed. Minor adverse effects were noted in both the treatment and placebo groups. Thus, this study demonstrates that Aller-7/NR-A2 is well tolerated and efficacious in patients with allergic rhinitis.

Microbial contamination of donor eyes.

A total number of 1,516 donor eyes received from various sources during the years 1973-1985 were subjected to the isolation of bacterial contamination. The bacterial cultures taken from the pretreatment eyeball showed culture growth in 366 (24.1%) eyes. Of the 366 positive cultures, 331 (21.8%) were bacterial and 35 (2.3%) were fungal. Amongst the bacterial the major contamination was by staphylococcus aureus and albus and pseudomonas aeruginosa. Gentamicin was found to be the most sensitive antibiotic against a wider group of organisms, the next being chloramphenicol. Thus, treatment of a cadaver eye with a solution of normal saline containing 0.1-0.5 mg/ml of gentamicin is recommended before and after the donor eye is enucleated.