key: cord-1048016-hs7ewa72 authors: Kumar, A.; Prasad, G.; Srivastav, S.; Gautam, V. K.; Sharma, N. title: Efficacy and Safety of Guduchi Ghan Vati in the Management of Asymptomatic COVID-19 infection: An Open Label Feasibility Study date: 2020-09-23 journal: nan DOI: 10.1101/2020.09.20.20198515 sha: 9813dc0ed1670eabe4afaea3d6c3b0ff28bdac40 doc_id: 1048016 cord_uid: hs7ewa72 Background: Guduchi Ghan Vati (aqueous extract of Tinospora cordifolia) is an essential herbal plant in Indian traditional medicine (Ayurveda) that is well documented as an immunomodulator and antimicrobial agent. A recent in silico study found the therapeutic efficacy of Guduchi against SARS-CoV-2. Based on available evidence, we conducted a feasibility study of the safety and efficacy of Guduchi Ghan Vati in asymptomatic patients with covid-19. Patients and methods: An open label, feasibility trial was conducted on 46 patients in the hospital setting. A single-arm study with no control group and blinding was executed in Jodhpur, Rajasthan, India. All patients orally received 2 tablets (1000 mg) twice daily for 2 weeks. Clinical parameters were collected at baseline, day 3, day 7 and day 14. Patients were continuously monitored for side effects and adverse reactions during the study period. . Results: Out of 46 asymptomatic patients included in the study, 40 completed the 14-day follow-up period. None developed any Covid-19 symptoms after admission to the hospital. On day 3 post-treatment, viral clearance was reported in 16 (32.5%) patients. By the end of D-7, 38 (95%) patients had viral load disappearance. Follow-up at D-14 showed that all participants tested negative. Conclusion: In adult patients with asymptomatic Covid-19, Gudhuchi Ghan Vati could be effective. Randomized controlled trials with larger sample sizes in patients with Covid-19 are urgently needed to confirm the definite benefit with Ayurveda. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a constantly evolving threat with over 25.8 million active cases and over 859 K deaths worldwide. 1 Almost 80% of Covid-19 confirmed patients suffer from mild to moderate symptoms and recover on their own. Among these large proportion of low-risk Covid-19 cases, asymptomatic patients are merging higher. Asymptomatic patients appear with no clinical symptoms but are contagious. 2 The emergence of asymptomatic patients poses a significant challenge to the prevention and treatment of the epidemic. Most clinical drugs and supportive therapies are focused on severe patients, whereas treatment options for asymptomatic to mild symptoms remain unclear. Asymptomatic to symptomatic cases may evolve to the most severe disease form without treatment indications. Standard guidelines suggest isolation for asymptomatic cases to control the spread of virus. 3 There have not been any treatment options that reduce the viral load or preventive options that reduce the risk of developing severe conditions. Various medicinal plants in Ayurveda (Indian Traditional Medicine) 4 have been valued as immunomodulators, 5,6 antiviral 7,8 and antimicrobials. [9] [10] [11] [12] These properties have been scientifically investigated previously with promising results. Among them, Tinospora Cordifolia (Guduchi/ Giloy), 13 showed the feasible efficacy of Guduchi against coronavirus in general and SARS-CoV-2 specifically. The reported efficacy of favipiravir, lopinavir/ritonavir and remdesivir was found to be either similar or inferior to the natural component from Guduchi. A previous retrospective study 21 also found that Guduchi Ghan Vati was effective in viral clearance and reducing hospital stay compared to standard care. Therefore, based on the available preliminary evidence, the first prospective feasibility study was undertaken. We aimed to investigate the safety of Guduchi Ghan Vati in asymptomatic patients with Covid-19 and to establish an initial impression of its efficacy. . CC-BY-NC-ND 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. (which was not certified by peer review) preprint The copyright holder for this this version posted September 23, 2020. . https://doi.org/10.1101/2020.09.20.20198515 doi: medRxiv preprint In urgent response to the accelerating outbreak of Covid-19 in India, the present study was conducted at Covid Care Centre, Jodhpur, Rajasthan, India, as a nonrandomized, single arm trial. The study was approved by the Institutional Review Board, who independently This study enrolled 46 patients who were admitted between May 1, 2020 and May 31, 2020 in the government of Rajasthan designated the Covid-19 treatment centre. There was no placebo used, and the drug was not masked. Eligible patients were given study details and provided an information sheet on Ayurveda medicine along with trial information. Written informed consent was obtained from each participant. Participants were free to withdraw from the study willingly at any stage. All patients were managed with WHO and ICMR clinical practice guidelines for Covid-19. Teams of laboratory technicians who performed clinical measurements were unaware of treatment information. Guduchi Ghana is a unique Ayuvedic classical preparation prepared from aqueous extracts of Tinospora cordifolia stem. For the purpose of the present study, the Va i (tablet) form was prepared in the Pharmacy, University College of Ayurveda, Jodhour, India following the standard procedure. Guduchi Ghan Vati was orally administered 2 tablets (1000 mg) twice daily for 2 weeks. The primary end point was virologic clearance at day 7 post-treatment. Secondary outcomes were clinical follow-up (day 14) (body temperature, clinical symptoms, hospital stay and complications) and the occurrence of any side effects. Outcome measures were collected at baseline, day 3, day 7 and day 14. In addition to SARS-CoV-2 testing, patients were assessed for vital signs and laboratory tests at hospital admission and follow-up at day 14. Records of Guduchi administration, side effects and adverse events were reviewed daily to ensure patient safety. This study was taken as a pilot study for asymptomatic patients only. Assuming a 50% efficacy of Guduchi Ghan Vati in reducing the viral load at day 7, an 85% power, a type I error rate of 5%, and 20% dropouts, we calculated that a total of 46 Covid-19 patients would be required for the analysis (Fleiss with CC). Of 92 screened Covid-confirmed patients, 46 asymptomatic patients were included in the study, and 40 completed the 14-day follow-up. The total dropout rate was 13.04%), and all 14 days of drug compliance was 100%. The median participant age was 31 years, and 80% were male. None of the patients had pre-existing conditions. Table 1 . CC-BY-NC-ND 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. (which was not certified by peer review) preprint The copyright holder for this this version posted September 23, 2020. . https://doi.org/10.1101/2020.09.20.20198515 doi: medRxiv preprint Major limitations of the study should be considered. First, properly designed controlled trials are urgently required to confirm the benefits of Ayurveda treatment. Second, without any preexisting symptoms or medical conditions, in the healthy asymptomatic Covid-19 confirmed case, the role of Ayurveda intervention needs to be evaluated with caution. Finally, background therapies, including support interventions previously taken by participants, were not protocolled. Since the early outbreak, prophylactic support therapies (herbal supplements, Ayurveda, Homeopathy) have been recommended by the Government of India and are widely used by people. . CC-BY-NC-ND 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. (which was not certified by peer review) preprint The copyright holder for this this version posted September 23, 2020. . https://doi.org/10.1101/2020.09.20.20198515 doi: medRxiv preprint World Health Organization. Covid-19. 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