Herbal cocktails but trials still on Centre issues protocol

The protocol lists traditional homemade remedies such as warm gargles, turmeric-laced milk and warm decoctions of spices. It also recommends 500mg ashwagandha, 500mg guduchi and 10gm chyavanaprash for preventive care and a mix of guduchi and pipali and AYUSH 64 for patients with asymptomatic or mild Covid-19.

G.S. Mudur   |   TT   |   New Delhi   |   07.10.20  :  The Centre on Tuesday released a protocol that prescribes specific dosages of herbal cocktails to prevent and treat the new coronavirus infection although clinical trials to assess their effect on Covid-19 are yet to be completed.

The Union ayurveda, yoga, unani, siddha, and homeopathy (Ayush) ministry has listed several remedies, including formulations based on ashwagandha, guduchi and a product called AYUSH 64, for the prevention or treatment of asymptomatic or mild Covid-19.

The ministry said the recommendations had emerged from a panel of medical experts and were based on “knowledge from ayurveda classics and experience from clinical practice, empirical evidence and biological plausibility, and emerging trends of ongoing clinical studies”.

The protocol lists traditional homemade remedies such as warm gargles, turmeric-laced milk and warm decoctions of spices. It also recommends 500mg ashwagandha, 500mg guduchi and 10gm chyavanaprash for preventive care and a mix of guduchi and pipali and AYUSH 64 for patients with asymptomatic or mild Covid-19.

“These remedies should go along with standard precautions such as masks and physical distancing — they should not convey a false sense of security,” Ayush secretary Rajesh Kotecha said.

“We believe based on accumulated evidence that these remedies will help in early cures.”

Kotecha said the expert medical panel led by former Indian Council of Medical Research chief Vishwa Mohan Katoch had taken into account in-silico (on computer), experimental, clinical and safety studies done over the years in making the recommendations.

There are 254 experimental and 30 clinical studies on ashwagandha showing its immuno-modulatory and anti-viral effects and five in-silico studies suggest that ashwagandha can block the entry of SARS-C0V-2, the virus that causes Covid-19, into human cells, Kotecha said.

Similarly, he said, 38 clinical studies have already established the immuno-modulatory and anti-viral effects of guduchi, while 25 experimental studies and eight clinical studies have shown the potential benefits from AYUSH 64.

The Ayush ministry had earlier this year initiated multiple clinical trials at sites across India to assess the efficacy of various Ayush remedies, including ashwagandha, guduchi and AYUSH 64, specifically against Covid-19. “We are also seeing positive trends from these ongoing trials,” Kotecha said.

However, several principal investigators engaged in the trials told The Telegraph on Tuesday that the trials themselves or their data analysis was yet to be completed.

Data from a nationwide trial by the Central Council for Research in Ayurvedic Sciences seeking to test the efficacy of guduchi as a preventive agent on around 30,000 people living in containment zones are still “under analysis”, a senior CCRAS official told this newspaper.

The Ayush ministry has initiated six trials on AYUSH 64, of which one trial in Jamnagar, Gujarat, has been completed, the trials’ investigators said. The AYUSH 64 trials in Chandigarh, Delhi, Jodhpur, Hassan (Karnataka) and Ahmedabad are not complete yet, they said.

Some medical experts have questioned the decision to recommend dosages without sufficient evidence. “None of the remedies listed in the protocol has proved their mettle through controlled trials,” said Shri Prakash Kalantri, professor of medicine at the Mahatma Gandhi Institute of Medical Sciences, Wardha.

Kalantri questioned the absence of peer-reviewed published evidence demonstrating the magnitude of the benefits from each of the remedies. “We must note that a sick person may attribute symptomatic relief to an otherwise ineffective therapy due to the placebo effect or the natural recovery from the infection,” he said.

Kalantri and other doctors cautioned that unproven health recommendations could lead to some individuals forgoing potentially effective treatment such as dexamethasone. “In waiting, they may lose the opportunity to obtain timely treatments,” he said.

The Indian Medical Association, the country’s largest body of modern medicine doctors, has also questioned what it has described as the government’s effort to introduce traditional systems of medicine into Covid-19 treatment without adequate evidence of their efficacy.

“Science should be based on double-blind controlled clinical trials,” said R.V. Asokan, secretary-general of the IMA. “It is for the claimants to bring evidence of credibility.”