A PERSPECTIVE ON ‘BALASARVANGAM’ AS A ‘DEVELOPMENTAL MEDICINE’ FOR THE MANAGEMENT OF DIFFICULT TO TREAT NEUROLOGICAL & IMMUNOLOGICAL DISORDERS

Dr. G. Rajmohan, MBBS, PhD

HINDLABS Diagnostic Centre, HLL Lifecare Ltd.

Independent Expert Opinion

Balasarvangam is a complex poly-herbal, multi-ingredient medicine formulated by Santhigiri Ashram and is of special significance owing to the fact that our beloved Guru had given special instructions during the development of this drug in the Ashram. Over the past decades, doctors at Santhigiri Ashram have successfully treated and managed difficult to treat disorders like child-hood epilepsy and other adult neurological and Immunological disorders using Balasarvangam. I am happy to know that the research team of Santhigiri Research Foundation (SRF) has taken up the detailed scientific and clinical validation of Balasarvangam, which would enable Santhigiri Ashram to introduce this wonderful drug to the larger clinical community in India.

This brief article puts forward a hypothesis about Balasarvangam, on those lines the SRF team can plan to pursue its research studies. After collectively reviewing and understanding the experience of the medical team at SA in using Balasarvangam, it is proposed that Balasarvangam acts as a Developmental Medicine.

A ‘Developmental medicine’ is proposed or hypothesized as a separate class of drugs containing multiple molecules that synergistically act in the human body to correct any disturbance or disorder that may have risen in an organ during its developmental evolution, especially in relation to the nervous system and brain. The disorder in the organ function may also rise in later stages of life due to trauma or degenerative conditions. In modern medicine, research groups primarily are exploring the use of stem cells or stem cell derivatives for this purpose. For example, the exploration of the use of stem cells for the treatment of Parkinson’s disease of the brain. We all know that the brain and the central nervous system has the least regenerative potential and it is interesting to note that compounds from the Indian plant, ‘Aswagandha’ have shown potential for nerve cell repair. In the approach of the traditional medical system of India, as an alternative to use of stem cells directly to repair the functional disorder at the organ/tissue level, a combination of herbs and other ingredients are brought together to work synergistically to rectify the disorder and restore function. We propose, from the past clinical experience with Balasarvangam, that it is a potent medicine that restores function in serious neurological and immunological diseases. It is the task of the team at SRF to scientifically validate this claim.

This article intends to briefly outline the research plan for Balasarvangam to be pursued by SRF in the current year. Before delving into the research plan for Balasarvangam, it would be worthwhile to share a few random thoughts about the immense potential of this drug. Every human being begins as a single cell in the womb and starts rapidly multiplying to form a mass of cells, which is composed of embryonic stem cells. Each of these cells has the full information to form a human body encoded in its DNA or genetic material.  As the embryo evolves, a complex phenomenon of differentiation sets in, resulting in formation of different layers like ectoderm, endoderm and mesoderm. As further development takes place, these layers differentiate to form structures that are more complex and slowly a fetus develops with highly differentiated organs and tissues. We now know that this development is due to selective differentiation of cells by control of their gene expression. The mystery remains how millions and millions of cells are instructed to carry out their tasks.  Cell to cell communications and chemical messengers does not fully explain this incredibly complex phenomenon of the development of a human baby from a single cell. Even after birth, active re-modelling of the brain with the formation of neural networks continues to happen in the brain of the growing child. In the adult stage, stem cells are stored in special places of the body like the bone marrow of large bones and these stem cells take care of repair and regeneration of the human body. Modern science has discovered many of the pathways by which these stem cells initiate repair of the body and therapeutic interventions involving both gene editing as well by using drugs to activate or accelerate this repair and healing process innate to the human body. For example, a team of research scientists led by the Japanese scientist, Shinya Yamanaka used a mixture of molecules to convert adult human cells back into stem cells, these molecules made changes in gene expression that converted them back into the original stem cell state. Shinya Yamanaka received the Nobel Prize for his important discoveries in 2012.

On similar lines, as stated earlier, Balasarvangam is known to function as a developmental medicine that can alter, repair and correct the functional disorder/damage present in the nervous and immunological systems. It has been successfully used by Santhigiri doctors to successfully treat childhood epilepsy, for the quick recovery from viral infection, management of cerebral stroke etc. Balasarvangam, made from numerous carefully selected ingredients is expected to contain hundreds of bioactive molecules that synergistically act in our human body, possibly making changes in gene expression of cells similar to the molecular mix of Yamanaka and effecting the healing process. If a research team tries to undertake a task to independently come out with a mix of molecules that can perform similar to Balasarvangam, it may take a huge team of researchers working using large amounts of funds and still take decades to come out with a similar formulation. This is when we realize how lucky Santhigiri Ashram is to receive the grace of Guru to be able to formulate this potent medicine, Balasarvangam.

SRF plans to undertake the scientific validation of Balasarvangam in a phased manner that will introduce this drug to the wider clinical community in India and may be, in countries abroad in the future. The first phase of research activity undertaken by SRF is for a duration of 8 months and is expected to be completed by January 2021.

The key activities in the first phase are;

• A 6 month closely monitored case study in patients suffering from arthritis using Balasarvangam alone: SRF has initiated a closely monitored case study with Balasarvangam in 25 patients suffering majorly from arthritic symptoms. Most of these patients have raised inflammatory markers like ESR in their baseline reading and these patients are to be evaluated regularly up to 6 months. The patient group has completed 2 months with the treatment with Balasarvangam and the results are encouraging as conveyed by the SRF team, though too early to be shared in this article. A preliminary report is expected to be released by 3rd month (August 2020) and the full data by 6 month. SRF expects valuable insights to be gained during the course of this case study and can be published. This would prove valuable for marketing to improve their sales of Balasarvangam.
• Molecular signature studies of Balasarvangam: SRF team plans to carry out molecular chromatographic studies with Balasarvangam in collaboration with Institutes like CSIR NIIST, Trivandrum. This will give an insight into the molecular profile of Balasarvangam and can be used as a reference for product standardization.
• Gene expression studies: A very critical study is planned with Balasarvangam that will evaluate its effect in human stem cells and its gene expression profile. It would be especially interesting to assess whether it affects the expression of key developmental genes. This will give clues to the possible mode of action of Balasarvangam.
• Development of a study design for a large clinical study with Balasarvangam: Once the above tasks are completed, SRF can set about to prepare the study design of a large scale clinical study fulfilling International criteria. Undertaking of such a study and its successful completion may result in the approval of Balasarvangam to be used for serious neurological and immunological disorders across all streams of medicine and hospitals, including usage by doctors of modern medicine. This is because any drug that successfully completes a randomized double blind clinical study qualifies to be used in the protocol of ‘Evidence based Medicine’.
• Application for research grants: SRF has already taken the initiative to apply for research grants to pursue its activities from Governmental Organizations like Department of Biotechnology (DBT) etc.
• Strengthening in-house research facility of SRF: SRF has taken steps to strengthen the in-house research facilities which will be essential to pursue serious research on Balasarvangam and other drugs.
• Sharing of data to Marketing team for improving existing sales of Balasarvangam: By January 2021, SRF hopes to consolidate the data from the first phase of the validation study for Balasarvangam and share monographs and publications, which can be used as an effective tool by the marketing team to widen and improve the sales and revenue generated from Balasarvangam.

In conclusion, let us all pray and support the young dynamic team of SRF to achieve its mission of presenting the potent medicine, Balasarvangam to the wider clinical community of India. We have to remember at this juncture, that modern biotechnology drugs developed for serious neurological and immunological diseases are mostly in countries like the US and are not available for patients in India. Also, the average cost of such therapies ranges from 5 lakhs to 50 lakhs for a course of full treatment. In this background, we can realize the importance of bringing out Balasarvangam for the benefit of such patients.