The cases of COVID-19 are still increasing day-by-day worldwide, even after a year of its first occurrence in Wuhan city of China. The spreading of SARS-CoV-2 infection is very fast and different from other SARS-CoV infections possibly due to structural differences in S proteins. The patients with severe diseases may die due to acute respiratory distress syndrome (ARDS) caused by systemic inflammatory reactions due to the excessive release of pro-inflammatory cytokines and chemokines by the immune effector cells. In India too, it is spreading very rapidly, although the case fatality rate is below 1.50% (https://www.statista.com), which is markedly less than in other countries, despite the dense population and minimal health infrastructure in rural areas. This may be due to the routine use of many immunomodulator medicinal plants and traditional AYUSH formulations by the Indian people. This communication reviews the AYUSH recommended formulations and their ingredients, routinely used medicinal plants and formulations by Indian population as well as other promising Indian medicinal plants, which can be tested against COVID-19. Special emphasis is placed on Indian medicinal plants reported for antiviral, immunomodulatory and anti-allergic/anti-inflammatory activities and they are categorized for prioritization in research on the basis of earlier reports. The traditional AYUSH medicines currently under clinical trials against COVID-19 are also discussed as well as furtherance of pre-clinical and clinical testing of the potential traditional medicines against COVID-19 and SARS-CoV-2. The results of the clinical studies on AYUSH drugs will guide the policymakers from the AYUSH systems of medicines to maneuver their policies for public health, provide information to the global scientific community and could form a platform for collaborative studies at national and global levels. It is thereby suggested that promising AYUSH formulations and Indian medicinal plants must be investigated on a priority basis to solve the current crisis.

Moringa oleifera Lam. (family; Moringaceae), commonly known as drumstick, have been used for centuries as a part of the Ayurvedic system for several diseases without having any scientific data. Demineralized water was used to prepare aqueous extract by maceration for 24 h and complete metabolic profiling was performed using GC-MS and HPLC. Hypoglycemic properties of extract have been tested on carbohydrate digesting enzyme activity, yeast cell uptake, muscle glucose uptake, and intestinal glucose absorption. Type 2 diabetes was induced by feeding high-fat diet (HFD) for 8 weeks and a single injection of streptozotocin (STZ, 45 mg/kg body weight, intraperitoneally) was used for the induction of type 1 diabetes. Aqueous extract of M. oleifera leaf was given orally at a dose of 100 mg/kg to STZ-induced rats and 200 mg/kg in HFD mice for 3 weeks after diabetes induction. Aqueous extract remarkably inhibited the activity of α-amylase and α-glucosidase and it displayed improved antioxidant capacity, glucose tolerance and rate of glucose uptake in yeast cell. In STZ-induced diabetic rats, it produces a maximum fall up to 47.86% in acute effect whereas, in chronic effect, it was 44.5% as compared to control. The fasting blood glucose, lipid profile, liver marker enzyme level were significantly (p < 0.05) restored in both HFD and STZ experimental model. Multivariate principal component analysis on polar and lipophilic metabolites revealed clear distinctions in the metabolite pattern in extract and in blood after its oral administration. Thus, the aqueous extract can be used as phytopharmaceuticals for the management of diabetes by using as adjuvants or alone.

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BGR-34 is a polyherbal formulation frequently used to combat diabetes around the globe especially in Asian countries. It provides an attractive treatment option to prediabetics, diabetics, and in metabolic disorders by controlling the altered blood glucose level. The lack of phytopharmacological studies on BGR-34 prompted as to reveal the compounds responsible for the antidiabetic and free-radical scavenging activity of BGR-34. An attempt was made to assess in vitro α-amylase and α-glucosidase enzyme inhibition of BGR-34 along with its free-radical scavenging potential via DPPH scavenging activity. Further, HPTLC profiling and quantitative analysis of berberine and palmatine in BGR-34 were carried out. Thereafter, the TLC-bioautographic-MS analysis was performed to identify the compounds responsible for antidiabetic and antioxidant activities in BGR-34. The results had shown a significant and dose-dependent inhibition potential of BGR-34 against in vitro α-amylase and α-glucosidase enzymatic reactions along with significant inhibition in DPPH free-radical scavenging activity. The HPTLC profiling and quantitative validation studies showed the presence of berberine and palmatine 44.926 ± 0.2907 and 10.507 ± 0.154 μg/g, respectively. The TLC-MS bioautography revealed a total of four DPPH-active, two α-amylase-active, and nine α-glucosidase-active compounds in BGR-34. It was observed from the study that BGR-34 possesses verities of bioactive compounds, which are reasonable not only for its antidiabetic effect but also for its antioxidant activity.

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World Health Organization (WHO) has defined herbal medicines as finished labeled medicinal product that contain an active ingredient, aerial, or underground parts of the plant or other plant material or combinations. According to a report of WHO, about 80% of the world population is reported to rely on traditional medicine for their primary health care needs. Even in the developed countries, complementary or alternative medicine is gaining popularity. A report of a global survey on national policy on traditional medicine and regulation of herbal medicines indicated that about 50 countries including China, Japan, and Germany already have their national policy and laws on regulations of traditional medicines. Herbal drugs possess a long history of its use and better patient tolerance. These are cheaper and easily available in countries like India due to rich agro culture conditions. However, reckless utilization of resources threatens the sustainability of several plant species. Traditional medicines are governed by the Drugs and Cosmetics Act of 1940 and the Drugs and Cosmetics Rules of 1945. In 1959, the Government of India amended the Drugs and Cosmetics Act to include drugs that are derived from traditional Indian medicine. In 1993, the guidelines for the safety and efficacy of herbal medicines developed by an expert committee directed that the procedures laid down by the office of the Drug Controller General of India for allopathic drugs should be followed for all traditional and herbal products to enter into clinical trials for any therapeutic condition. However, there are certain loop holes in the clinical trials of herbal drugs as the lack of stringent bylaws and regulations. Hence, a deep insight of important challenges and major regulatory guidelines for clinical trial of herbal drugs and botanicals is discussed in the present communication. There is lack of scientific evidence to evaluate safety and efficacy of herbal drugs. The quality of the trial drug has to be tested for batch-to-batch uniformity of the active constituents. It is very difficult to have active and control groups with identical color, smell and taste of the herbal drug, which cannot be imitated while manufacturing a placebo. These challenges can be reduced or overcome by applying most recent methodologies and guidelines for clinical trials. Since the quality control of herbal medicines is complicated and difficult, relevant and appropriate requirements should be established for the assessment of safety and efficacy for different categorized herbal medicines to reduce cost and expenditure. And, efforts should be made for the integration of traditional medicine into national healthcare systems. Different challenges and regulatory guidelines discussed for the clinical trial of herbal drugs will be useful for various industries for considering it before going ahead for clinical trial of their product.

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