The CCRAS (Central Council for Research in Ayurvedic Sciences), an autonomous body of the Ministry of AYUSH, had developed "AYUSH-64" which promised to treat malaria without side effects. The malarial fevers have been identified as a distinct clinical condition in Ayurveda from ancient times. Malaria was widely prevalent all over the world and has claimed millions of lives over the past decades. However, the extreme toxicity of modern antimalarial drugs leave the person with severe side effects including problems in vision, despite being beneficial in malaria. In view of wide prevalence of malaria in India, CCRAS has developed a herbal anti-malarial preparation called AYUSH-64.
AYUSH-64 - Contents
Four known anti-pyretic Ayurvedic drugs have been selected and put together to form a combination as an anti-malarial.
- Alstonia scholaris (L.) R.Br. [Blackboard Tree, saptaparṇā (San)]Bark Aqueous Extract 100 mg
- Picrorhiza kurroa Royle ex Benth [Kutki, kaṭukī (San)] Root 100 mg
- Swertia chirata Buch.-Ham. ex Wall. [Indian gentian, kirātatikta (San)] Whole plant 100 mg
- Caesalpinia crista L. [Indian elm, pūtika (San)] Seed powder 200 mg
Method of Preparation
Aqueous extracts of the various parts of four different types of plants e.g. root, stem, leaf, flower and fruit are prepared in relevant proportions. From each extract of three plants, decoction is made with water in the prescribed ratio. The decoction is boiled to reduce the volume of the extract of given level. The concentrated extract is dried after filtration.
The powders obtained from the aqueous extracts of the three plant materials and 100 mesh powder extracted from the fourth plant are mixed in the prescribed proportion along with some additives like starch, gum acacia, etc. and sodium benzoate. Prescribed quantities of herbal extracts in powder form & additives are fed into a ball mill for uniform mixing and the fine grinding. The mass is then granulated. The granules are dried at 70oC in a hot air drier. The granules of the desired size are fed to a heavy-duty tablet making machine. The tablets are strip packed to protect them from the atmospheric moisture.
Claims on AYUSH-64
The studies reveal that the prescribed dosage AYUSH-64 in the recommended time period is safe and non-toxic. It has demonstrated effectiveness both in curing and prevention. AYUSH-64 has been reported as a wonder drug for malaria in an article published by Hindu. Another article in The Hans India had also reported that AYUSH-64 is highly effective against malaria.
CCRAS claims to have conducted several uncontrolled and controlled field trials in collaboration with the Malaria Epidemic Control Program in the 1980’s and 1995 for testing Ayush-64. They report to have treated 3,600 and 10,000 P. vivax cases with this drug at Rajasthan and Assam.
CCRAS had earlier conducted a study on AYUSH-64 in 1981. They had tested the response on 55 malaria positive cases. Although they reported 80% response with the drug, there were several major inadequacies in their study:
- Lack of Controls and Standards: This was an uncontrolled study with no mention of whether it was randomised or blinded, which makes us believe that it was neither. Also, the treatment response was not compared with any standard anti-malarial drug.
- Effect studied for a short duration: The drug’s response was followed up for only three, six or nine days. Additionally, the patients who responded after three or six days were never followed up later. Since relapse is common in malaria, it is possible that some patients may have shown resurgence of the infection after initial clearance. However, such cases would have been misinterpreted here as “cured”.
- Unaccounted Parasite Counts: The parasite counts were not measured and accounted for analysis. Hence, there could be highly variable initial parasite counts among the patients, which could have directly affected their response.
- Longer response time in mixed infections: Many of the patients with mixed infections of the two strains (P. vivax and P. Falciparum) showed a much longer response time of up to nine days with the AYUSH drug.
Contradictory to the CCRAS study, this was a more structured and comparative study. In phase II randomised controlled trial, the patients were followed up for 28 days. The cure rate with AYUSH-64 was found to be less than 50% as compared to 100% with the standard drug. Considering poor efficacy of the drug and risk of complications, the authors had even suggested against its testing for the more severe P. Falciparum species.
Another pilot study was conducted at Raja Ramdeo Anandilal Podar Central Ayurveda Research Institute for Cancer, Mumbai between June 2018 and July 2019 to evaluate the safety and efficacy of AYUSH-64 in clinically diagnozed ILI (Influenza Like Illnesses- a wide range of viral infections). It was observed that a week's intervention of AYUSH-64 helped recovery and the frequency of usage of standard medications for ILI like acetaminophen and antihistaminic could be reduced. The biochemical and hematology parameters affirmed the safety of the formulation. However, it was concluded that AYUSH-64 is not a stand-alone remedy and may be used as an add-on to standard care for ILI for an early recovery and better outcome.
Ayush-64 and Covid 19
In the second week of April, Prime Minister Narendra Modi had appealed the citizens to follow the guidelines laid down by the Ministry of AYUSH. The guidelines were encompassed of ways to improve one's immunity and improve your body's strength to fight off against COVID-19. The guidelines from the Ministry of AYUSH are rooted in Ayurveda, where they promote the use of natural herbs and plants to build a strong immune system.
According to recent reports, the Indian government is planning to conduct clinical trials on three Ayurvedic herbs and one medicine. The trials will be done not only to find a cure but also to validate the efficacy of traditional medicines and collect scientific evidence regarding the same. YUSH-64 is added to the list of possible remedy for COVID-19 after hydroxychloroquine, an anti-malarial drug, showed efficacy in treating the coronavirus infection.
In a recent positive development, Ministry of AYUSH, in collaboration with the Council of Scientific & Industrial Research (CSIR) has started clinical trials testing formulation of four important Ayurvedic herbs in fighting the novel coronavirus. The medicines under study include ashwagandha, guduchi, yasthimadhu, pippali and the formulated drug- 'AYUSH-64'.
The trials, which will be done on health workers first will be conducted in high-risk zones identified by the Arogya Setu App first. Reports say that over 50 lakh people from cities like Delhi, Mumbai, Ahmedabad and Pune will be a part of the clinical trial. Ayush ministry is also studying the impacts of Ayush-based prophylactic interventions in some preventive cases. In the first phase, patients are likely to be administered ashwagandha and later, the other drugs will be given to patients, depending on how they react or severity of the symptoms. The findings of these studies are pivotal as far as AYUSH-64 is concerned. From the three previous studies, AYUSH-64 can best be used as an add-on management along with the standard treatments for Influenza Like Illneses. More studies and clinical trials are required to establish its usage as a stand-alone drug for influenza and especially COVID 19.
Study 3: https://doi.org/10.1016/j.jaim.2020.05.010