BackgroundEvidence is lacking for multi-ingredient herbal supplements claiming therapeutic effect in sexual dysfunction in men. We examined the safety and efficacy of VigRX Plus (VXP) – a proprietary polyherbal preparation for improving male sexual function, in a double blind, randomized placebo-controlled, parallel groups, multi-centre study.Methods78 men aged 25–50 years of age; suffering from mild to moderate erectile dysfunction (ED), participated in this study. Subjects were randomized to receive VXP or placebo at a dose of two capsules twice daily for 12 weeks. The international index of erectile function (IIEF) was the primary outcome measure of efficacy. Other efficacy measures were: Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS), Serum testosterone, Semen analysis, Investigator’s Global assessment and Subjects’ opinion.ResultsIn subjects receiving VXP, the IIEF-Erectile Function (EF) scores improved significantly as compared to placebo. After 12 weeks of treatment, the mean (sd) IIEF-EF score at baseline increased from 16.08 (2.87) to 25.08 (4.56) in the VXP group versus 15.86 (3.24) to 16.47 (4.25) in the placebo group (P < 0.0001). Similar results were observed in each of the remaining four domains of the IIEF (orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction).There was a significant difference for VXP versus placebo comparison of mean (sd) EDITS scores of patients: 82.31(20.23) vs 36.78(22.53) and partners :(82.75(9.8) vs 18.50(9.44);P < 0.001. Thirty-five out of 39 (90%) subjects from the VXP group and one (3%) from the placebo group wished to continue with the treatment they received. Investigator’s global assessment rated VXP therapy as very good to excellent in more than 50% patients and placebo therapy as fair to good in about 25% of patients. Incidence of side effects and subject’s rating for tolerability of treatment was similar in both groups.ConclusionsVigRX Plus was well tolerated and more effective than placebo in improving sexual function in men.Trial RegistrationClinical Trial Registry India, CTRI/2009/091/000099, 31-03-2009

Objectives Primary Objective • To assess the efficacy of herbal extracts in boosting innate immunity of patients with COVID-19 infection. Secondary Objectives • To assess the efficacy of herbal extracts in restoring respiratory health • To assess the efficacy of Cap. IP in early recovery of patients and decline in viral load • To assess the safety of herbal extracts Trial design This is a single centre, randomized, 2-arm, parallel group, double blind, 1:1 ratio, controlled, exploratory trial with a study period of 30 days from the day of enrolment. Participants Patients attending the COVID treatment centre at Yashwantrao Chavan Memorial Hospital, Nehrunagar, Pimpri, Pune, India were screened for their participation in the study. Patients who were known COVID-19 positive (with positive RT-PCR), eligible and willing were enrolled in the study. Intervention and comparator The intervention in the trial has a background in ‘Ayurved’. Intervention Arm: Two capsules, Investigational Product (IP) - 1 - 400mg and Investigational Product - 2 - 450mg, containing herbal extracts (a blend of water and CO2 extracts) of Shunthi (Zingiber officinale (Ginger), Vidanga (Embelia ribes), Yashtimadhu (Glycyrrhiza glabra), Haritaki (Terminalia chebula), Guduchi (Tinospora cordifolia), Shatavari (Asparagus racemosus), Aamalaki (Emblica officinalis), Pippali (Piper longum) and calcined Zinc, Shankha bhasma. Placebo Arm: Edible starch ~ 450 mg. The look and feel of IP and of Placebo boxes were very similar. Patients are to take two capsules (one each of IP-1 and IP-2) twice a day for 15 days, and from the 16th day, one capsule of IP-2 twice a day up-to day 30. Capsules are to be administered orally with plain water. The IP is to be taken with all other concomitant medicines prescribed by the treating physician/doctor. The dose of each component in the IP is very safe to administer. The investigational products are registered products with the Indian Government and have been used for more than 6 months in various health conditions but not for COVID-19. Main outcomes Primary Outcome: Efficacy of the herbal extracts in COVID 19 positive patients (in declining viral load: time-point: 4 days and early recovery) Secondary Outcomes: Efficacy of the herbal extracts as an immune-modulator - TH1, TH2, Th17, IL6, NK Cells and CD markers; Immunoglobulin IGG (Serum); Immunoglobulin IGM (Serum) - at 30 days. Efficacy of the investigational product in reducing sequela of the disease Safety analysis (Liver Function Test and Kidney Function Test) including serious allergic reaction of: rash, itching/swelling, severe dizziness, trouble breathing. Randomisation An alphanumeric coded set of IP/Placebo containers will be used. Participants will be automatically randomized to two groups in the ratio 1:1. Blinding (masking) Participants, caregivers and investigators were blinded. Numbers to be randomised (sample size) A total of more than 60 and up to 75 patients were to be enrolled in the study into the two groups, considering drop-outs. 72 were enrolled with 37 into the intervention group and 35 into the placebo group. Trial Status Protocol number: CoviQuest-01 Protocol version number: 1.2 Protocol Date: 1st July 2020 The recruitment period is completed for the trial. Date of 1st patient enrolment was 11th Aug 2020 and the last patient was enrolled on 3rd of September 2020. This is to state that it was a late submission from authors for publication of the protocol to the BMC, after enrolment in the study was over. Last Participant’s last follow-up is scheduled on 5th October 2020 Trial registration The trial was prospectively registered with the CTRI (Clinical Trial Registry of India). Registration number is CTRI/2020/07/026570. Registered on 14 July 2020 Full protocol The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.

Objective: To 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) Methods: Laboratory 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. Results:In 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. Conclusion: This 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. Keywords: COVID-19, herbal medication, viral load, immuno modulation.

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