Clinical study evaluates role of herbal immunomodulators as adjuvant treatment in COVID-19 management

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The Himalaya Drug Company, India’s leading wellness brand, shared the results of the clinical study they commissioned to evaluate the role of their well-known herbal products (Tab Septilin and Tab Bresol in combination) as an adjuvant treatment in mildly symptomatic and asymptomatic COVID-19–positive patients.

The clinical trial was conducted under the supervision of Dr CR Jayanthi (MBBS, MD), Dean and Director of the prestigious Victoria Hospital (BMCRI – Bangalore Medical College and Research Institute), Bengaluru.

Septilin is a well-known proprietary Ayurvedic formulation with time-tested ingredients such as Guggulu, Yashtimadhu, and Guduchi, and possesses strong immunomodulatory property. The safety and efficacy of Septilin have been extensively evaluated in multiple clinical and preclinical studies.

Septilin is also backed by a meta-analysis study and has been recommended by doctors extensively for the past 60 years. Bresol is a respiratory wellness product with well-known Ayurvedic ingredients such as Haridra, Tulasi, and Vasaka, and is recommended in the management of various respiratory conditions. Bresol exhibits a potent anti-inflammatory effect because of its ability to downregulate proinflammatory cytokines.

The study was conducted with a strong rationale that both Septilin and Bresol have been proven, in preclinical and clinical studies, to provide support and have a positive, multifaceted influence on immunity and respiratory functions. These products adhere to stringent quality parameters, which makes them ideal to be tested against COVID-19 without any concern whatsoever.

The role of an immunomodulator and a respiratory wellness support in combination (Tab Septilin + Tab Bresol) was evaluated as an adjuvant therapy in a group of patients (group 1) who received standard of care (SOC) against another group that received only standard of care (group 2).

Dr Jayanthi said, “Patients treated with Septilin and Bresol along with SOC demonstrated a better trend of reduction of inflammatory cytokines (especially interleukin-6, lactate dehydrogenase, and neutrophil–lymphocyte ratio) as compared with patients who received SOC alone.

“Normalization of D-dimer level was observed in all the subjects treated with Bresol and Septilin. This clinical trial has demonstrated that adding Septilin and Bresol as adjuvants may have additional long-term benefits in reducing inflammation and may prevent further injury and associated complications”.

Available literature on the COVID-19 pandemic shows a significant increase in the D-dimer level in COVID-19–positive patients and is associated with disease severity and mortality trends.

In the convalescence period of COVID-19 (after recovery from active COVID-19 infection), the combination of Septilin and Bresol was found to further benefit the individuals struggling to overcome a range of troubling residual symptoms.

It was observed that the combination of Septilin and Bresol brought about a statistically significant improvement in the energy levels, appetite, and concentration in patients in group 1 compared with those in group 2. Patients suffering from body pain, restricted joint movements, disturbed sleep, recurrent respiratory tract infection, and shortness of breath also demonstrated noteworthy improvement, compared with that at the beginning of the study.

“Post-COVID care is extremely important, and it is equally essential to monitor patients in the recovery stage. We believe that these findings may go a long way in helping patients who recover from COVID-19, lead healthier lives. After obtaining encouraging results from this study, Himalaya is further considering expansion of such evaluation methods. It is expected that the addition of these products (which are already available in the market) to the standard treatment protocol, may support the “integrated holistic approach” of COVID-19 management,” said Dr Rajesh Kumawat MBBS, MD, Head-Medical Services and Clinical Development, The Himalaya Drug Company.

Quality of life (QOL), which is a big concern in those suffering from COVID-19, was evaluated through a WHO questionnaire. Patients in group 1 reported feeling cheerful, relaxed, and active as compared to patients in group 2. A substantial improvement (statistically significant) was noticed in the overall QOL of patients in group 1.

Fatigue, an intense concern in patients recovering from COVID-19, was assessed, and patients in group 1 demonstrated a significant improvement in the fatigue assessment score (FAS). All patients (100%) in group 1 were completely devoid of fatigue after the treatment, while, 35% of patients in group 2 continued to experience fatigue.

This study has proved that adjuvant therapy with Septilin and Bresol along with SOC supports immunity and controls inflammation in COVID-19–positive patients. It also aids in the recovery of symptoms of “post-COVID-19 illness” and improves the overall well-being (including QOL and Fatigue) of COVID-19 infected patients suffering from “post-COVID-19 syndrome”.

The current study reaffirms the following: 

  • Adjuvant therapy with Septilin and Bresol along with SOC supports immunity and controls inflammation in COVID-19–positive patients
  • It helps in the recovery of symptoms of “post-COVID-19 illness”
  • It improves the overall well-being (including QOL and fatigue) of COVID-19–positive patients suffering from “post-COVID-19 syndrome”

 

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