An open label, randomized, multicenter, comparative, three arm Phase II clinical study to evaluate the safety and efficacy of mixture of five species of Ocimum in subjects with acute common cold

Abstract

Ba sil and its variou s species are known to ha ve an effect on common cold and possess immunomodulatory properties. This paper describes a clinical trial of a herbal formulation, Panchtulasi drops in acute common cold; the formulation consists of essential oils of five species of ocimum, namely; Ocimum sanctum Linn., Ocimum basilicum Linn., Ocimum gratissimum Linn., Ocimum citriodorum Linn. and Ocimum canum Linn.This was an open label, three arm Phase II study to determine the safety and effica cy of Panchatulasi drops in patients with acute common cold. The primary endpoint was reduction in symptoms of cold and number of days of illness. This was assessed using SF-8 and WURSS21 questionnaires. The secondary endpoint was changes in serum interleukin-8 and neutrophil count. The study duration was 8 days with telephonic follow-up on 10 th day. A total of 60 patients were randomized to treatment, placebo and a control (standard medication) in a radio of 2:1:1.The symptom severity, quality of life and number of days of illness measured by questionnaire was significantly reduced in the treatment arm between baseline and day 4 (p<0.05). The physical component score and overall health score of the SF-8 questionnaire also improved considerably in the treatment arm compared to placebo and control arms between baseline and day 4. However, mental component score did not improve significantly until day 6. Concentration of IL-8 did not show any statistically significant change in any of the study arms due to high variability. Neutrophil count, on the other hand, decreased in the treatment arm (p=0.0153) compared to placebo and control arms where it increased. Panchatulasi drops is an effective herbal remedy for common cold and can be used as an alternative to current treatments. There was a significant reduction in days of illness, severity of symptoms, and improvement in quality of life compared to placebo and control groups.

Effect of nanocurcumin supplementation on the severity of symptoms and length of hospital stay in patients with COVID‐19: A randomized double‐blind placebo‐controlled trial

“…The analysis of WURSS‐24 revealed that the separate score of domains 3 and 4 of this questionnaire (score for cold specific functional impairment and change in global cold severity, respectively) and the total score significantly decreased in patients who consumed nanocurcumin supplements. Previous studies have revealed the potential efficacy of herbal extracts rich in polyphenols such as a combination of ginger and goldenrod extracts and various species of basil in alleviating symptoms of similar diseases like common cold measured by WURSS, which is in line with our results (Guay, Champagne, Guibord, & Gruenwald, 2012; Shelke et al, 2016).…”

“…of domains 3 and 4 of this questionnaire (score for cold specific functional impairment and change in global cold severity, respectively) and the total score significantly decreased in patients who consumed nanocurcumin supplements. Previous studies have revealed the potential efficacy of herbal extracts rich in polyphenols such as a combination of ginger and goldenrod extracts and various species of basil in alleviating symptoms of similar diseases like common cold measured by WURSS, which is in line with our results(Guay, Champagne, Guibord, & Gruenwald, 2012;Shelke et al, 2016).The radiological findings of our study did not show any significant differences in the score of pulmonary involvement by SARS-CoV-2 between the nanocurcumin and placebo groups. CT findings obtained from COVID-19 patients have shown that at the early stages of the disease (0-4 days), mainly the lower zones of the lungs are involved with ground-glass opacity and its subtypes.…”