Safety and efficacy of a Siddha Medicine fixed regimen for the treatment of asymptomatic and mild COVID-19 patients.

Background: The Coronavirus disease 2019 (COVID-19) pandemic caused by the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) is a massive threat to public health worldwide. Siddha system of medicine is one of the traditional medicines of South India. The recommended formulations in Siddha Sasthric Medicines- Fixed Regimen (SSM-FiRe) are Amukkura tablets, Kaba Sura Kudineer (KSK) for asymptomatic COVID-19 positive (RT-PCR) patients, and Athimathuram tablets, Adathodai Manappagu syrup, Thippili Rasayanam, Brahmananda Bairavam tablet, and Notchi Kudineer for mild symptomatic patients. The core objective of the trial was to document the efficacy of SSM-FiRe in the prevention of asymptomatic and mild COVID-19 disease progression to the next level of severity, reduce the severity of symptoms and revert to RT-PCR Negative. Methods: An exploratory, prospective, open-labeled, single-arm, non-randomized trial was designed as per GCP guidelines to assess the efficacy of SSM-FiRe. Sixty RT-PCR positive participants who were asymptomatic or with mild COVID-19 symptoms were recruited for the study at the Siddha COVID Care Centre, Vyasarpadi, Chennai from June to August 2020. Nasal and oropharyngeal swab tests were performed on the 0, 7th, and 14th days. All participants were treated with SSM - FiRe regimen. All the participants were also assessed based on Siddha Yakkkaiyin Ilakkanam, which included Clinical symptoms and vitals. Laboratory investigations such as Haemogram, Liver Function Test, Renal Function Test, HbA1C, Electrolytes, Inflammatory markers, Cardiac profile, Immunoglobulins, and anti-SARS-CoV-2 antibody tests were performed. Results: 83% of COVID-19 patients turned RT-PCR negative on the 7th day and in most of the cases, symptoms were reduced within the first 5 days of admission. The RT-PCR cycle threshold (ct) value increased significantly (<0.001) after treatment and all the participants were RT-PCR negative, except one, who was positive even after 14 days. Anti-SARS-CoV-2 antibodies developed significantly (p-value - 0.006). LFT, RFT, CBC, Total proteins, and electrolytes continued to be in the normal range after treatment, indicating the safety of the intervention. Conclusion: Asymptomatic and mild COVID-19 disease can be well managed by SSM - FiRe treatment, Further studies could be taken up to strengthen the findings.

A comparison of hepatoprotective activity of Bacoside to Silymarin treatment against a combined Isoniazid and Rifampin-induced hepatotoxicity in female Wistar rats.

The liver is an important organ that plays a vital role in homeostasis maintenance and regulation. Any liver damage or injury caused by drugs or chemicals is called hepatotoxicity. Isoniazid and rifampin are drugs used separately to treat tuberculosis but have unique side effects and potential hepatotoxicity. The metabolism of isoniazid (INH) and rifampin (RIF) takes place in liver hence hepatotoxicity is the main cause of their continuous use. Bacoside was obtained from the plant Bacopa monnieri, a dammarene type triterpenoid saponin, found distributed throughout India. Bacoside has been used as a nerve tonic, a free radical scavenger, and antioxidant. It is known that the combined INH-RIF induced hepatotoxicity can be antagonized by maintaining hepatocyte membrane integrity in rats. Silymarin, an herbal drug, and its component silybin were reported to work as lipid peroxidation inhibitors and antioxidants which scavenge free radicals. Due to minimal toxicity and no adverse drug interactions, Silymarin is used to treat various medically confirmed hepatic disorders. The aim of this study was to evaluate the beneficial effect of Bacoside against INH- and RIF-induced toxicity in livers of Wistar albino rats. Four experimental groups of rats were used to study four parameters; bodyweight, liver enzyme markers, liver antioxidant, and liver histopathology. INH- and RIF-treated rats showed abnormalities in liver markers which were normalized by Bacoside and that seems similar to the normal control and Silymarin-treated groups. Thus, the current study demonstrated the hepatoprotective effect of Bacoside against INH- and RIF-induced toxicity in Wistar albino rats.

Intestinal parasitic infestations and anemia among urban female school children in Kancheepuram district, Tamil Nadu.

INTRODUCTION: In India, intestinal parasitic infection and anemia remain the most important cause of morbidity especially among the adolescent school children due to lack of awareness of personal hygiene practices, leading to intestinal parasite infections which could in turn lead to anemia. AIM: This study was conducted with the aim to find out the prevalence of intestinal parasitic infection and anemia among adolescent female school children in an urban area of Tamil Nadu. MATERIALS AND METHOD: This descriptive cross-sectional study was done among adolescent female school children in Anakaputhur area of Kancheepuram district. Three schools were selected randomly from a total of eight schools in the study area. Universal sampling was applied in each school, and a total of 250 willing children participated in the study. Early morning stool specimen was collected for microscopic examination and hemoglobin estimation was done. A pretested structured questionnaire was used to collect relevant data which were analyzed using SPSS version 22. RESULTS: The prevalence of intestinal parasitic infection was found to be 36% with Entamoeba histolytica being the commonly isolated organism (23.2%) followed by Giardia intestinalis (5.2%), Hookworm (4.4%), and Ascaris lumbricoides (3.2%). The prevalence of anemia among them was found to be 84.8% with mild, moderate, and severe anemia being 12.8%, 46.8%, and 25.2%, respectively. Statistically significant association was found between intestinal parasitic infection and open field defecation, inadequate hand washing practices, and anemia. CONCLUSION: The study reveals high prevalence of anemia and intestinal parasitic infection among female school children. Preventive measures such as periodic deworming and health education about nutritional balanced diet, iron supplements, and personal hygiene practices have to be given to both the parents and their children to prevent and reduce disease burden.

Adolescent Community Reinforcement Approach implementation and treatment outcomes for youth with opioid problem use.

BACKGROUND: This paper compares adolescents with primary opioid problem use (OPU) to those with primary marijuana or alcohol problem use (MAPU) who received up to six months of Adolescent Community Reinforcement Approach (A-CRA), an empirically supported treatment. METHODS: Intake clinical characteristics, treatment implementation measures, and clinical outcomes of two substance problem groups (OPU and MAPU) were compared using data from 1712 adolescents receiving A-CRA treatment. Data were collected at intake and 3, 6, and 12 months post-intake. RESULTS: At intake, adolescents in the OPU group were more likely than those in the MAPU group to be Caucasian, older, female, and not attending school; report greater substance and mental health problems; and engage in social and health risk behaviors. There was statistical equivalence between groups in rates of A-CRA treatment initiation, engagement, retention, and satisfaction. Both groups decreased significantly on most substance use outcomes, with the OPU group showing greater improvement; however, the OPU group had more severe problems at intake and continued to report higher frequency of opioid use and more days of emotional problems and residential treatment over 12 months. CONCLUSIONS: The feasibility and acceptability of A-CRA for OPUs was demonstrated. Despite significantly greater improvement by the OPU group, they did not improve to the level of the MAPU group over 12 months, suggesting that they may benefit from A-CRA continuing care up to 12 months, medication to address opioid withdrawal and craving, and the inclusion of opioid-focused A-CRA procedures.

Antiulcer activity of Andrographis paniculata (Burm.f.) wall. against cysteamine-induced duodenal ulcer in rats.

Antiulcer activity of Andrographis paniculata was evaluated by cysteamine induced duodenal ulcer model in rats. Male albino Wistar rats were pre-administered with 200 mg/kg body wt. of hydroalcoholic extact of Andrographis paniculata (HAEAP) orally, for 30 days prior to i.p. administration of 420 mg/kg body wt. of cysteamine as a single dose. Rats preadministered with 30 mg/kg body wt. of ranitidine served as standard drug. Ulcer index, thiobarbituric acid reactive substances, mucin, glutathione peroxidase and myeloperoxidase activities, reduced glutathione/oxidized glutathione (GSH/GSSG) ratio, glycoproteins and membrane bound enzyme activities were measured in duodenum of experimental animals. The ulcer score and myeloperoxidase activity were significantly minimized in rats treated with HAEAP. Mucin content was found to be preserved in rats treated with the extract. GSH/GSSG ratio and glutathione peroxidase activities were found to be maintained by the HAEAP. Level of lipid peroxidation products was found to be significantly low in HAEAP treated rats compared to ulcer control rats. The basolateral and brush border membrane bound enzyme activities which were depleted significantly in ulcer control rats were found to be maintained in rats pre-treated with the extract. The ulcer preventing effect was comparable to that of ranitidine treated rats. Level of glycoproteins was also found to be preserved in rats treated with the extract. The normal rats treated with the HAEAP did not show any abnormal alterations in the parameters studied. Histopathological observations also showed the ulcer preventing effect of the HAEAP. It is suggested that the ulcer preventing effect may be due to its mucin preserving and antioxidant nature.

Hepatoprotective action of ethanolic extracts of Melia azedarach Linn. and Piper longum Linn and their combination on CCl4 induced hepatotoxicity in rats.

A comparison of analysis in evaluating the hepatoprotective action of ethanolic extract of M. azedarach (MAE) and P. longum (PLE) with their combination biherbal extract (BHE) against carbon tetrachloride (CCl4) induced hepatic damage is reported in albino rats. There was a marked elevation of serum marker enzyme levels in CCl4 treated rats, which were restored towards normalization in the drug (MAE and/or PLE:50 mg/kg body weight po, once daily for 14 days) treated animals. The biochemical parameters like total protein, total bilirubin, total cholesterol, triglycerides, and urea were also restored towards normal levels. The combined BHE showed more significant reduction of the enzymes than MAE or PLE against CCl4 induced hepatotoxicity. The results strongly indicate that BHE has more potent hepatoprotective action than MAE or PLE individually against CCl4 induced hepatic damage in rats. Among these extracts, BHE showed similar hepatoprotective action to silymarin, which was the positive control in this study.

The added risk of opioid problem use among treatment-seeking youth with marijuana and/or alcohol problem use.

OBJECTIVES: To determine the added risk of opioid problem use (OPU) in youth with marijuana/alcohol problem use (MAPU). METHODS: A total of 475 youth (ages 14-21 years) with OPU + MAPU were compared to a weighted sample of 475 youth with MAPU only (i.e. no OPU) before and after propensity score matching on gender, age, race, level of care and weekly use of marijuana/alcohol. Youth were recruited from 88 drug treatment sites participating in eight Center for Substance Abuse Treatment-funded grants. At treatment intake, participants were administered the Global Appraisal of Individual Need to elicit information on demographic, social, substance, mental health, human immunodeficiency virus (HIV), physical and legal characteristics. Odds ratios with confidence intervals were calculated. RESULTS: The added risk of OPU among MAPU youth was associated with greater comorbidity; higher rates of psychiatric symptoms and trauma/victimization; greater needle use and sex-related HIV risk behaviours; and greater physical distress. The OPU + MAPU group was less likely to be African American or other race and more likely to be aged 15-17 years, Caucasian; report weekly drug use at home and among peers; engage in illegal behaviors and be confined longer; have greater substance abuse severity and polydrug use; and use mental health and substance abuse treatment services. CONCLUSIONS: These findings expand upon the existing literature and highlight the substantial incremental risk of OPU on multiple comorbid areas among treatment-seeking youth. Further evaluation is needed to assess their outcomes following standard drug treatment and to evaluate specialized interventions for this subgroup of severely impaired youth.

Clinical characteristics of treatment-seeking adolescents with opioid versus cannabis/alcohol use disorders.

OBJECTIVES: To assess the clinical characteristics of adolescents with DSM-IV opioid use disorder (OUD) and compare them to adolescents with cannabis/alcohol use disorders. METHOD: 94 adolescents (ages 14-18 years) with a current OUD and 74 adolescents with a current non-OUD cannabis/alcohol use disorders were recruited from admissions, predominantly residential, to a substance abuse treatment program in Baltimore, ML. Participants were assessed cross-sectionally using standardized interviews and self-reports. Chi-square, t-tests and ANCOVA (adjusting for age, gender and treatment setting, race and residence) were performed to determine group differences on demographic, substance use, psychiatric and HIV-risk behaviors; logistic regression analyses, both unadjusted and adjusted for the above five factors were conducted to assess the strength of associations. RESULTS: The OUD group was more likely to be Caucasian, to have dropped out of school and to live in the suburbs (trend). They also had greater substance use severity with higher proportion of current sedative and multiple substance use disorders (SUD). There were generally no differences in rates of criminal behaviors. Both groups had high rates of current psychiatric disorders (83% vs. 78%, n.s.) but the OUD adolescents reported higher depressive symptoms, mostly in the moderate range. Injection drug use (IDU) and needle sharing was almost exclusive to the OUD group, while both groups reported similar high rates of risky sexual behaviors. CONCLUSIONS: While there were similarities between the two groups, OUD adolescents evidenced greater impairment in academic, substance use, depressive symptom and IDU-related HIV-risk areas. Findings suggest poorer long-term prognosis and highlight the need for specialized interventions for treatment-seeking OUD adolescents.