Efficacy and Safety of Polyherbal formulation as an add-on to the standard of care in mild to moderate COVID-19: A randomized, double-blind, placebo-controlled trial

ObjectiveTo assess the efficacy and safety of polyherbal formulation (designated as IP) in comparison to placebo as add on to the standard of care (SoC) among patients with mild to moderate novel corona virus disease 2019 (COVID-19) MethodsLaboratory proved patients of mild to moderate COVID-19 disease were randomized to either placebo or IP as an add-on to SoC. Using quantitative reverse transcription-polymerase chain reaction (qRTPCR), we assessed the effect on viral load (VL). Change in immunological parameters such as blood lymphocyte subset, serum immunoglobulin was determined. The clinical improvement was assessed using a numerical rating scale (NRS) and WHO ordinal scale. Patients were followed for 30 days after randomization. ResultsIn total, 72 patients were randomized to either placebo (n=33) and IP (n=39). Fifty-two patients (n=21 in placebo and n=31 in IP arm) had qRT-PCR on day 0 and day 4. There was significant reduction in VL in IP arm (from 662081 copies/mL on day 0 to 48963 copies/mL on day 4; p=0.002)) but not in the placebo arm (from 385670 copies/mL on day 0 to 66845 copies/mL on day 4, p=0.106). Change in the NRS score and WHO ordinal scale score was significant in both treatment arms. However, the difference between the two groups was statistically significant in favour of drug group. The increase in Th1 response was significant in the IP arm (p=0.023) but not in the placebo arm (p=0.098), thus implying immunomodulatory activity in the drug. No safety concerns were observed in any of the trial participants. ConclusionThis study finds that polyherbal formulation reduces viral load and contributes to immunomodulation and improvement in clinical conditions when used as add-on to the standard care in patients with mild to moderate COVID-19 without any side effects. These findings need to be further confirmed in a large, prospective, randomized study.

Development and application of RAPD-SCAR marker for identification of Phyllanthus emblica LINN.

Correct genotype identification of medicinal plant material remains important for botanical drug industry. Limitations of chemical and morphological approaches for authentication have generated need for newer methods in quality control of botanicals. The present study was carried out to develop DNA based marker for identification of Phyllanthus emblica LINN. A putative marker (1.1 kb) specific for P. emblica was identified by Random Amplified Polymorphic DNA (RAPD) technique. Sequence Characterized Amplified Region (SCAR) marker was developed from the RAPD amplicon. The SCAR marker was found useful for identification of P. emblica in its commercial samples and Triphalachurna, a multi-component Ayurvedic formulation.

Classification of human population based on HLA gene polymorphism and the concept of Prakriti in Ayurveda.

BACKGROUND: Correlating phenotypes with genotypes remains the major postgenomic challenge. Attempts to correlate phenotype characteristics associated with ethnicity, geographical divisions, or diseases to genotypes have had limited success. This means that current approaches for identifying phenotypes associated with haplotypes may be inadequate. OBJECTIVES: We hypothesize that a human phenome based on Ayurveda could provide an appropriate approach. Specifically, there could be a genetic basis for the three major constitutions (Prakriti) described in Ayurveda. The Prakriti classification is based on differences in physical, physiological, and psychologics characteristics and is independent of racial, ethnic, or geographical considerations. It may provide an appropriate means of classifying phenotypes to be considered collectively for genotyping. DESIGN: As a pilot study to test the hypothesis, we evaluated 76 subjects both for their Prakriti and human leucocyte antigen (HLA) DRB1 types. The genomic DNA was extracted using a standard protocol. Subsequently, HLA DRB1 typing was done by low-resolution polymerase chain reaction sequence specific primers and oligonucleotide probes. RESULTS: We observed a reasonable correlation between HLA type and Prakriti type. The complete absence of the HLA DRB1*02 allele in the Vata type and of HLA DRB1*13 in the Kapha type are significant, with X2 = 4.715 and p < 0.05. HLA DRB1*10 had higher allele frequency in the Kapha type than in the Pitta and Vata types. CONCLUSION: Ayurveda classifies the whole human population in three major constitutions as Vata, Pitta, Kapha and their possible combinations. Their homologous relation to human genetic structure needs to be studied for validation. If validated, our hypothesis would have far reaching implications for pharmacogenomics, modern genetics, human health, and Ayurveda.