On 23 June 2020, Yoga Guru Baba Ramdev and Acharya Balakrishna launched Divya Coronil Tablet and Kit for the treatment of Covid-19 (Corona Virus), which includes coronil tablets, Shwasari Vati and Anu taila. They claim that it can cure corona virus disease 100%. According to them, they have also collected evidence (evidence) by doing a clinical trial. Let’s know about this:
Baba Ramdev and Acharya Balakrishna claimed that their Patanjali Research Institute (PRI) and National Institute of Medical Science (NIMS), Jaipur have discovered the drug for corona virus and also conducted a clinical trial where 69% of corona patients have negative corona test report after 3 days and 100% patients had negative corona negative test report after 7 days. They were accompanied by Dr. Balvir Singh Tomar, Director, NIMS, Dr. Ganpat Devpura, Professor, Department of Medicine, NIMS, Assistant Professor Dr. Abhishek Sharma, and Dr. Anurag Varshney of PRI during the launch. According to them, the drug was tested in the Medical College Hospital of NIMS. Vaidya Deepak Bhandari of Ayurveda was also involved in this.
According to Baba Ramdev, initially the drug was given to around 280 clinical cases in Delhi, Ahmedabad and many cities and case studies were carried out. (Clinical case study is done by giving a medicine to a patient and studying the changes before and after taking his medication, it is not considered to be very scientific credibility, but it can be understood with a hint based on which research Studies can be planned). According to them, positive results were found in all 280 corona patients, with 100% recovery, no deaths were seen, symptomatic and systemic improvement were also observed and it also controls the complications of Corona as per Baba Ramdev.
After this, a clinical study was planned to study it properly and scientifically, for which PRI and NIMS came together. This study was done on 100 patients, out of which 95 completed this trial. Among all the corona patients who were given this drug, 69% found improvement in health in 3 days and corona reported negative, all (100%) patients recovered within 7 days and got corona test negative; In patients who were given placebo (a substance that has no medical effect), only 65% of the patients could recover in 7 days. There were no death occurred in this trial. They say that all the principles of drug discovery were followed properly.
During the trial, the patients were given Ashwagandha, Giloy and Tulsi extract, Shwasari vati and Anu tail (administration of Anu tail was done through nostrils). According to Ramdev, coronil and its components (Ashwagandha, Tulsi and Giloy) are also effective in having immunity booster, diabetes, diabetes, high blood pressure, high heart beats, nervous disease. (Ayurveda texts also speak about components and many research papers have also been published, and we believe the same). Respiratory system works on alveoli (the smallest unit of lungs) in the respiratory system, cures the respiratory diseases and lated research papers have been published to prove this. The Anu tail also works on the respiratory system and protects it from diseases such as corona.
According to Dr. Tomar and Dr. Devpura from NIMS, this trial was completed by following all the parameters. This was a double-blind placebo-controlled clinical trial. Trial started after registration in Clinical Trials Registry- India (CTRI) after passing it from the Institutional Ethical Committee (IEC). All the 100 corona patients taken in trial were of age 15–65 years, among them 90 completed the trial, out of which 45 were given Ashwagandha, Giloy extract, Tulsi extract, Shwasari Vati and Anu oil, the remaining 45 were given a placebo. First group got 69% recovery rate in 3 days and 100% recovery rate in 7 days while placebo group got 52% recovery in 3 days and 65% recovery rate in 7 days. The p value -0.033 was obtained in statistical analysis, which proves it effective. RT PCR test for corona screening before and after trial and in addition oxygen saturation, CRP (C Reactive protein) and interleukin-6 were also investigated, which showed effective improvement after drug administration. Apart from this, blood chemistry and other routine tests were also done in all patients. It was also seen that most of the patients were male, most of the patients were 31-50 years of age. Patients who had oxygen saturation less than 90%, lowered life expectancy, or who were suffering from acute respiratory disease were excluded from the study.
[We found that the trial registered in CTRI as we found it on the CTRI website. Its registration number is CTRI/2020/05/025273 and was registered on 20 May 2020. Its public title is “Impact of effect of Ayurvedic treatment on novel Corona virus disease” and scientific title is “Impact of Indian traditional Ayurvedic treatment regime for nCoV-2 (COVID-19)”. The principal investigator of this project is Dr. Ganpat Devpura, primary sponsor of the project is Patanjali Research Institute governed by Patanjali Reserach Foundation Trust, Haridwar, Uttrakhand. In this trial, a project has been taken to take 120 patients aged 15–80 years, who were suffering from Respiratory failure, having COVID-19 test positive, in which symptoms do not appear (Asymptomatic patients), Mildly symptomatic patients, Or moderately symptomatic patients who are willing to participate in the trial, patients with severe and acute symptoms (SaO2 <90%) were excluded from this trial. On the 3rd, 7th and 14th day of the trial, samples from the nose or throat (nasopharyngeal swab) have been tested for the virus with RT PCR test, along with the changes in symptoms, C-reactive protein, ESR, IL-6 and hematological parameters on these timelines. Follow-up of the patients involved would also be done on the 14th and 30th days. The first patient in this trial was registered on May 29th, 2020 and it is very unusual thing that within 25 days, trial has been completed and drug has been launched. If one will see the registered trial till launch date not a single patient has completed the follow up. This study is Interventional Randomized parallel group placebo controlled, single centric trial. In this registration process it is claimed that about 100 to 1000 phytochemicals of medicinal plant were screened by them and then Ashwagandha (Withania somnifera), Tulsi (Ocimum sancatum), Giloy (Tinospora cordifolia) were selected. In the group where Ayurvedic intervention was given, the patient was given 4 drops of Anu tail in each nostrils 1 hour before breakfast in the morning, 30 minutes after that 2 grams of Shwasari Rasa with lukewarm water and after 30 minutes of breakfast, 2 tablets of Giloy extract (1 tablet – 500 mg), 1 tablet Ashwagandha (500 mg) and 1 tablet of Tulsi extract (500 mg) were given with lukewarm water. Similarly, 30 minutes before dinner, 2 grams of inhaled juice with lukewarm water and after 30 minutes of eating, 2 tablets (1 tablet- 500 mg) of Giloy extract, 1 tablet Ashwagandha (500 mg) and 1 tablet Tulsi extract (500 mg) were given with lukewarm water. Placebo was given in the second group. However, in today’s time, it is doubtful to allow the placebo control trail keeping human interest in mind.]
According to PRI’s Dr. Anurag Varshney, they are working on this corona since December 2019, when corona patients started getting diagnosed in China. (Although this seems a bit strange because China informed the World Health Organization (WHO) on 31 December 2019 that a pneumonia-like disease is spreading in their country and 41 people have been infected, so out of China by December Its information in the world was very limited). They screened and studied about 100 medicinal plants and 150 phytochemicals (biologically active compounds found in plants. Chemicals found in plants that act on the biological body). In this, they found Withanone from Ashwagandha (Withania somnifera), Tinocordiside from Giloya (Tinospora cordifolia), and Scutellarein from Tulsi (Ocimum sanctum) as effective compound. Related to this they (PRI) have also released a document with the title Indian Traditional Ayurvedic Treatment Regime For Novel Coronavirus, COVID-19
[According to the study, Withanone prevents the virus from entering the host cell, the corona virus bind with host cell ACE2 through its spike protein Receptor Binding Domain (RBD) and forms the AEC2-RBD complex. Withanone reduces these and also prevents them from being formed. (Agarwal, R., Diwanay, S., Patki, P., & Patwardhan, B. (1999). Studies on immunomodulatory activity of Withania somnifera (Ashwagandha) extracts in experimental immune inflammation. Journal of Ethnopharmacology, 67 (1), 27–35.)
Tinocordiside found in Giloy is also effective in preventing infection by joining the AEC2-RBD complex. Giloy also strengthens the immune system.
Scutellarein, a natural flavone found in basil, has been found to be effective in inhibiting the action of the RDRP enzyme (RNA Dependent RNA Polymerase) of the corona virus. This enzyme is responsible for the rapid increase in the number of viruses.]
According to Dr. Varshney, they are engaged in gathering more effective evidence on this medicine. It is undergoing studies on experimental models (animals). Apart from this, in vitro bio chemical assay (studies on enzymes or cell line, which can explain the binding and activity of the drug on its cell or enzymes). He claimed that PRI is working with two international organizations, one from Germany and the other from the US. In India, this animal trial will be done on zebra fish and in Singapore on mice and rats. (For more information on Ayurveda medicine testing, click here to read our article)
According to Acharya Balakrishna, they wanted to trial it in Madhya Pradesh too, but could not get his permission due to political turmoil there. According to him, they will provide the complete kit of this medicine (Divya Corona Kit), which includes coronil tablets, Shwasari vati and Anu tail for Rs 545. For this, they are starting an online store, from where you can order and get it delivered to your house in 2 hours, apart from this it will also be available at all Patanjali stores.
Balkrishna said that the Shwasari Rasa was found more effective in respiratory disease (allergic asthma) than dexamethasone in animal model. [It reduces excess mucus production, reduce inflammation in lungs by reducing pro-inflammatory cytokines and pro-inflammatory cytokines through airway remodeling.
Acharya Balakrishna said that clinical trial of Ayurvedic medicine is very difficult, no trial of Ayurveda has ever happened. [This is a wrong fact, many clinical trials of Ayurveda medicines have been done. Clinical trials are also underway on the Corona Virus Disease at the National Institute of Ayurveda, Jaipur.] He claimed that this (Coronil+Shwasari Rasa+Anu tail) is the first authentic Ayurvedic medicine to work on the corona virus. They have claimed that the drug is effective in cure and prevention both.
However, more information will come in public domain only after publication of the research paper on medicine and the trial. On 23 June, the Ministry of AYUSH has issued a written statement saying that they have no information about the medicine launched by Patanjali Ayurved Private Limited, although the state licensing authority has given permission to manufacture medicines, and NIMS & The PRI also made the letter public which was filed on 2 June to inform the Central Council for Research in Ayurveda Sciences, the research department of AYUSH, informing about the trial. The Ministry has considered it a violation of The Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954. Ministry has asked the organization to present all the information related to the trial in full detail.
By the evening of 23 June, PRI and NIMS have made available their answer and all the related information to the ministry, this answer is also going viral on social media.
On 24 June 2020, Acharya Balkrishna also shared the Consolidated Receipt of the documents received by the Ministry of AYUSH on his media handle.
If the Indian government approves this medicine for corona, it will be the fourth and the first medicine in Ayurveda to be used for corona in India. Earlier, Cipremi, covifor and fabiflu have been approved for use in Covid-19. Cipremi and covifor are generic versions of the antiviral drug Ramdesivir. At the same time, fabiflu influenza drug is the generic version of favipiravir, all three are modern allopathic medicine. However, there is a need to do further research work like metacentric trial for its authenticity and as PRI has stated that they are also doing a lot of research and in the coming time they will also publish it; they will test the medicine also on critical patients who have serious symptoms ( sever patients). So far, evidences, which have been put till now suggests that this medicine seems effective. Even if it is assessed according to Ayurvedic principles and published research work, it is found effective. There is also an opportunity for Ayurveda and other traditional medicine in the time of such a global pandemic, so if this ministry encourages it by keeping a full eye and knowledge on it, better results may come.