Corona kit or con: Examining Patanjali's coronavirus treatment

You’ve probably heard recently that Patanjali, an Indian FMCG company started by the famous yogi, Baba Ramdev, has found a cure for COVID-19! Apparently, this bendy, bearded baba’s unicorn has been running clinical trials, and they’ve already cured hundreds of people with a 100% success rate. My word! Golly Gosh! Arre wah!

This “Corona Kit” consists of a bottle of Coronil, which is a mixture of Ashwagandha, Tulsi, Giloy, and other herbs and minerals along with Shwasari Juice and Anu Tel. Of course, we can know nothing more until Patanjali releases their clinical trial data and submits it for peer review, following which it should get published in a reputed journal (that’ll be the day...or century).

Even the Ministry of AYUSH has (surprisingly) told them to stop selling the product until their claims and promises of this being a 100% successful cure are verified. I definitely wasn’t expecting this, but I did love it...for about 5 seconds, which is when I realised something. The Ministry’s standards of evidence are so non-existent that Patanjali could do a puppet show and they would pass it off as a peer-reviewed RCT.

Let's just say I am very sceptical that they'll manage to do all that successfully without some sort of deceit. But I have a terrible feeling these guys are going to slip away without a scratch, no matter what the outcome, since they're covered with so much snake-oil and slime already. But let me check my biases. If they come up with a robust placebo-controlled, double-blinded clinical trial, as they are claiming, and survive peer review and publication in a reputed journal, I will turn right around, apologise and change my mind. 

So I'm going to break down whatever I've seen in press releases and any other information that I can get to see if this magic potion holds some promise. Or not. 

Claims made to the press

In an article by Scroll.in, Acharya Balkrishna, the chairman and co-founder of Patanjali, has stated that the company appointed a team of scientists after the outbreak began. He said:

 “First, the simulation was done and compounds were identified which can fight the virus and stop its spread in the body,” he told reporters in Uttarakhand. “Then, we conducted a clinical case study on hundreds of positive patients and we have got 100% favourable results.”

He added that the company is currently conducting controlled clinical trials and will release evidence in less than a week. “After taking our medicine, Covid patients recovered in 5-14 days and then tested negative,” Balkrishna said. “So, we can say the cure for Covid is possible through Ayurveda.”

Speaking for each ingredient, Acharya Balakrishna said the following as reported on the English section of Jagran.com 

He said that Ashwagandha does not allow COVID-19's RBD to mix with the ACE of the human body, which prevents it from entering the healthy cells of the patient. He added that Giloy also works as Ashwagandha.

He said that Tulsi has also been used in the medicine, which constrains the rate of coronavirus' increase in the infected body by attacking the RNA-polymerases of the infection.

Speaking about the Shvasari juice, the Patanjali CEO said that it prevents the formation of thick mucus and reduces inflammation of the lungs by eliminating saliva.

Apparently, Anu Tel is a nose drop that's supposed to "build immunity" which is pretty much the same as boosting immunity, which I've already talked about in an earlier article. 

Of course, we will have to wait for their study findings to really be able to say anything about this preparation's potential in treating the coronavirus if the study is rigorous in the first place. I definitely want them to publish something because I want to see their work. Making claims of 100% cure rate is a bit ridiculous. Nothing, and I mean NOTHING has a cure rate of 100% – not penicillin, not Digene, not paracetamol and not your mom's ginger tea. 

But we'll come back to that a bit later. 

First, let's go through each one of these claims and see if they have any evidence to back them up. 

The Evidence

Claim 1: Ashwagandha and Giloy stop COVID-19's RBD to connect with the ACE receptors in the human body 

So coronaviruses are covered with little spikes or the "corona" or "crown", which is where coronaviruses get their name from. These spikes have proteins on them that help them bind to host cells. 

Diagram of Receptor Binding Domain of a virus connecting to a cell receptor. Source: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3630917/

In the case of COVID-19, the RBDs are keys that unlock the ACE2 receptors on the cells in our bodies and walk right in to infect them.

Ashwagandha

For Ashwagandha, I found only one Molecular Dynamics (MD) Simulation study in the Journal of Biomolecular Structure and Dynamics. It says that the essential molecules of the main chemicals found in the extract, Withanone (Wi-N) (along with a molecule called CAPE (caffeic acid phenethyl ester) derived from propolis, which is made by bees) may be able to stop SARS-CoV-2 from reproducing and infecting cells. 

This is a computer model, and it’s not even a lab test or even close to a human trial, so this is still just a hypothesis, a possibility. Nothing close to concrete. However, IIT Delhi is already studying this combination with the National Institute of Advanced Industrial Science and Technology (AIST), Japan, to see if it can treat or prevent COVID-19. Hopefully, their study will be thorough and will be able to tell us something more concrete about these chemicals. (The headline to the article I linked is overly optimistic about the findings so don’t give it too much credence until we have some results)

Another MD Simulation found that Withaferin A, another active ingredient of Ashwagandha, could bind to Herpes and restrict its reproduction. But again, this is a computer model and has little to no significance in real life. Plus, the study is about Herpes, not SARS-CoV-2. 

Prof D Sundar, Coordinator of DAILAB at the IIT, Delhi, and Head of the Department of Biochemical Engineering and Biotechnology at the IIT, Delhi, said (the typos are his): 

“While well-trusted reputation of Ashwagandha as an immunity enhancer forms a basis of the recent initiative of the Government of India in forming an Interdisciplinary Task Force (joint initiative of Ministry of AYUSH, Ministry of Health and Family Welfare, Council of Scientific and Industrial Research (CSIR) with Indian Council of Medical Research [ICMR]) and launch its clinical research studies related to SARS-CoV-2 and the COVID-19 disease, the current research report of this team provides hints on its direct anti-viral activities.

As sceptical as I am about the promise of this research, I hope they conduct rigorous research unlike most of the studies on complementary and alternative medicine (CAM). 

Giloy

Now, let’s look at Giloy. Again, it’s Molecular Docking studies done on both Giloy and Ashwagandha by Tech Mahindra and Radiation Biology & Health Sciences Division, Bhabha Atomic Research Centre, Anushaktinagar, Mumbai. Their results say that the active molecules in these extracts can dock well with the SARS-CoV-2 virus. But, again, this isn’t substantial evidence of anything. Just an indication that these compounds need to be tested in labs, then in animals and later in humans if they pass all the rounds. To give you an idea of all the steps it takes to get a chemical to the shelves, check out this video: 

Claim 2: Tulsi constrains the rate of the coronavirus’ increase in the infected body by attacking the RNA-polymerases of the infection.

I could find absolutely no studies that corroborate this claim. If you know of any RCT, animal or even in-vitro studies, let me know.

Claim 3: Shvasari juice prevents the formation of thick mucus and reduces inflammation of the lungs by eliminating saliva.

Otherwise referred to as Divya-Swasari-Ras (DSR), this is an ayurvedic preparation that’s supposed to lower inflammation and mucus levels. I’ve only found one rat study where an allergic reaction was induced and DSR seemed to have a promising effect to reduce the symptoms. This is just a one-shot study though. It doesn’t seem to have been replicated in other animal studies or even in humans. So we really don’t know for sure if these effects are real or not. Also, this was tested on allergic reactions and not to viral infections, so it’s even less relevant. 

Claim 4: Anu Tel builds immunity

I found one study if one can call it that, using it for chronic sinusitis. It was a small study of 30 people, it wasn’t controlled, and each subject was given multiple ayurvedic treatments including steam inhalation. So we don’t know if the symptoms regressed to the mean or if any one of the treatments actually worked. Or was it the steam inhalation? 

We just don’t know. It’s a tiny, horrible little study and it should be ignored. 

The Verdict

FAIL! The evidence is nearly non-existent. And so far, so is their clinical trial with which they are claiming that this “tested and verified medicine from Patanjali Research Institute” had a 100% success rate. None of their claims has panned out. So, until they really manage to do magic, I’d recommend that you don’t buy this treatment or believe anything Patanjali’s people say about it. Or anyone else for that matter.

But, for the sake of remaining rationable, I will wait for that study to see if it really holds water. Keep an eye on this space to see what we found in it, if they ever release it. 

However, there is something they did release – their permission for the study. Check out this thread from Anant Bhan – Researcher, Bioethics, Global Health, Health Policy, about the registration of the study with the Clinical Trials Registry India (CTRI): 

The medication the participants are meant to receive wasn’t Coronil tablets, but rather a whole bunch of tablets of all the supposed ingredients that we’ve already talked about. Also, they apparently were planning to give the COVID-19 patients just a placebo and not standard treatment. That’s not very ethical, is it? 

The study enrolled the first patient on 29th May 2020, is still recruiting as on 23rd June while they declared it a success via a press conference? Do you smell the faeces yet? 

I have a feeling they probably are making asses of us all. 

Dr Sumaiya Shaikh, PhD Neurophysiology, also called BS on these shenanigans in this tweet where she points out that the documents Patanjali submitted to the Ministry of AYUSH didn’t include the clinical trial they supposedly carried out. It was just the approval of the RCT from the CTRI and two studies – one was a mouse model of asthma and a simulation of the Giloy extract binding to the ACE receptor spike protein (that I cited above). No human trials at all: 

Conclusion

So there you have it. Patanjali’s claims are still just big talk. Even the component ingredients have nothing promising to show. 

Don’t get me wrong, I would like nothing more than for a cure for COVID-19 to finally be released so we can all get on with our lives. But it’s a tall order that many researchers have been trying to fill for several months with no success. 

That’s because finding a new medicine to treat a new infection is a long, arduous task. We need to make sure the drug has a high level of benefit with minimal risks. That’s why RCTs are necessary to figure out both with a high degree of certainty. And not just one, we need multiple human trials to make sure the findings aren’t a fluke and can be replicated. This takes months at least, but they usually take years to find a high level of confidence. 

Meanwhile, Patanjali seems to have a high level of confidence with nothing to show for it. Unfortunately, many people believe more in confidence than in evidence, and this allows quacks and conmen to take advantage of them. 

Ayurveda itself may potentially have many preparations that could lead to future medicines. After all, it uses real materials and molecules in their preparations which could have significant therapeutic benefits along with potentially dangerous side-effects and drug interactions that could genuinely harm people.

 If the active molecules are not isolated and just used directly from the plant, for example, each dose may contain different levels of the active ingredients, which makes the dosage unreliable and maybe even unsafe. Also, Ayurvedic therapies have been mainly found through millennia of trial and error, with any real evidence possibly clouded with anecdotal evidence, regression to the mean and placebo effects (which I’ve explained here). It may have been called science hundreds or thousands of years ago, but science has evolved a lot over this time. Randomised clinical trials and the scientific method, in general, have been developed specifically to minimise the effects of biases and maximise the objective results of the medicines we make. Clinical trials are also essential, as I’ve mentioned before, to figure out all the effects a remedy can have, the side effects and the dosage, along with the medical interactions so it doesn’t screw up the effects of another medicine you may be taking. That’s why it takes so much time to develop new ones. We need to make sure people are helped and are kept safe. 

Also, nothing, and I mean nothing, in the field of medical science is 100% effective and 100% safe. Why? Because every human is different. Our bodies are so amazingly complex, with so many proteins, enzymes and hormones sloshing around in there, the exact effect of any medicine will change from person to person and from time to time. Have you taken paracetamol for a headache but the headache just wouldn’t go? Have you taken a Digene (an antacid) and couldn’t get rid of the acidity? It just happens. That’s why your doctor asks you to check in after a couple of days to see if the medicine is having a positive effect or she will probably change your drug or dosage. 

Brazenly stating a medicine is 100% effective means you’re being lied to. 

Now can you see why I have a high level of confidence that Patanjali is lying to us about their Corona Kit? 

Let me know.