Tamil Nadu, which has initiated a number of clinical trials on the efficacy of Siddha formulations in the management of COVID-19, has completed a randomised study undertaken at the Stanley government hospital here in association with Siddha doctors. The outcome will be announced soon with the concurrence of the Ayush Ministry, researchers involved in the project said.
Nine other clinical trials involving Siddha medicine either as stand-alone or adjunct with allopathic medicine that were taken up throughout Tamil Nadu are in various stages of completion. Apart from studying the reduction of SARS-CoV-2 viral load and reducing the onset of symptoms in asymptomatic COVID-19 with Siddha formulation Kabasura Kudineer (KSK) compared to Vitamin C & Zinc (CZ) used as supplement in allopathy, the randomised trial examined the changes in the immunological markers of the Siddha medicine against control.
Also, the trial evaluated the safety of Siddha medicine and documented clinical profile of asymptomatic COVID-19 as per principles of Siddha system of medicine. ”The randomised clinical trial at Stanley GH by Siddha and allopathy doctors has been completed and a detailed manuscript is ready. The outcome will be announced after approval and concurrence of the Ayush ministry,” Dr K Kanakavalli, Director General, Central Council for Research in Siddha (CCRS), said.
A total of 233 COVID-19 clinical trials, involving various systems of medicine, were registered from India with the Clinical Trial Registry of India (CTRI) from March 1, 2020, to June 22, 2020, when the infection cases peaked. Out of these, 146 were interventional trials, 84 observational trials, and three post-marketing surveillance.
Randomised control trials are higher in number than non-randomised. Nearly 20 percent of the trials involved patients, and research institutions sponsored more than half of the trials, Dr P Sathiyarajeswaran, director in charge Siddha Central Research Institute, said. In most of these trials, the interventional agent is either multiple drug combinations or compound drug formulations compared to single drug administration.
”These are not normal clinical trials. These were taken up during the pandemic times involving the participation of patients. So, the outcome of the trials should be peer-reviewed before publication,” Dr Sathiyarajeswaran told P T I in an interaction.