CTRI Trial Data

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Clinical Trial Details (PDF Generation Date :- Fri, 01 Oct 2021 07:34:27 GMT)

CTRI Number CTRI/2020/07/026632 [Registered on: 16/07/2020] - Trial Registered Prospectively Last Modified On 16/07/2020 Post Graduate Thesis No Type of Trial Interventional Type of Study Siddha Study Design Single Arm Trial Public Title of Study Siddha Treatment for COVID 19- a Pilot Study Scientific Title of Effectiveness Of Siddha Medicine In The Treatment Of COVID 19 Patients- a Pilot study Study Secondary IDs if Any Secondary ID Identifier NIL NIL Details of Principal Details of Principal Investigator Investigator or overall Name Dr R Sasirekha Trial Coordinator (multi-center study) Designation Lecturer Affiliation Government Siddha Medical College Address Op No 2 Department of General Medicine Government Siddha Medical College Arumbakkam Chennai Chennai TAMIL NADU 600106 India Phone 9444832728 Fax Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Dr J Nikil Niva Query) Designation pg scholar Affiliation Government Siddha Medical College Address Op no 2 Department of General Medicine Government Siddha Medical College Arumbakkam Chennai Chennai TAMIL NADU 600106 India Phone 7200333774 Fax Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name Dr J Nikil Niva Designation pg scholar Affiliation Government Siddha Medical College Address Op no 2 Department of General Medicine Government Siddha Medical College Arumbakkam Chennai TAMIL NADU 600106 India Phone 7200333774

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Fax Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > Dr Ambedekar arts college Siddha covid care Center vyasarpadi Chennai 6000039 Primary Sponsor Primary Sponsor Details Name Government siddha medical college Address Government siddha medical college arumbakkam Chennai 600106 Type of Sponsor Government medical college Details of Secondary Name Address Sponsor Dr Ambedkar arts college Siddha COVID care Dr Ambedkar Arts college vyasarpadi Chennai center 6000039 Countries of List of Countries Recruitment India Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator Dr J Nikil Niva Dr Ambedkar Arts Dr Ambedkar arts 7200333774 College Siddha COVID college Department of Care Center Indian Medicine And [email protected] Homoeopathy Siddha COVID care center vyasarpadi Tondiarpet Zone IV Greater Chennai Corporation Chennai 6000039 Chennai TAMIL NADU Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? Instituitional Ethics Approved 08/07/2020 No Committe Regulatory Clearance Status Date Status from DCGI Not Applicable No Date Specified Health Condition / Health Type Condition Problems Studied Patients Coronavirus as the cause of diseases classified elsewhere Intervention / Type Name Details Comparator Agent Intervention 1. AAdathodai kudineer 2. 1. AAdathodai kudineer-15-30 thaalisathi chooranam thulasi ml bd with Oral Administration chooranam pavala parpam 3. -10 Days 2. thaalisathi bramanandha bairava mathirai chooranam thulasi chooranam 4. thoothuvalai nei pavala parpam -All the 3 ingredients are mixed -2gm bd with honey Oral Administration- 10 days 3. bramanandha bairava mathirai- 1bd with honey - oral administration-10 days 4. thoothuvalai nei 5-10ml bd- oral administration-10 days Comparator Agent nil nil Inclusion Criteria Inclusion Criteria Age From 18.00 Day(s)

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Age To 60.00 Day(s) Gender Both Details Patients with the diagnosis of laboratory confirmed COVID 19

Exclusion Criteria Exclusion Criteria Details 1. Patients With other Acute Respiratory Distress Syndrome or other comorbidities of lungs 2. Pregnant and Lactating Mothers 3. Patients with severe primary respiratory disease or other pathogenic microbial pneumonia that needs to be identified with COVID 19. 4. patients participating in other clinical trials Method of Generating Not Applicable Random Sequence Method of Not Applicable Concealment Blinding/Masking Open Label Primary Outcome Outcome Timepoints To determine the effectiveness of Siddha 3 month Medicine in Acceleration of recovery or Reduction in number of days to become test negative / symptom free in COVID 19 patients Secondary Outcome Outcome Timepoints To determine the reduction in risk of disease 3 month prognosis and Intensive care support

Target Sample Size Total Sample Size=40 Sample Size from India=40 Final Enrollment numbers achieved (Total)=Applicable only for Completed/Terminated trials Final Enrollment numbers achieved (India)=Applicable only for Completed/Terminated trials Phase of Trial Phase 2 Date of First 27/07/2020 Enrollment (India) Date of First No Date Specified Enrollment (Global) Estimated Duration of Years=0 Trial Months=3 Days=0 Recruitment Status of Not Applicable Trial (Global) Recruitment Status of Not Yet Recruiting Trial (India) Publication Details nil Brief Summary On 31st December 2019, 27 cases of pneumonia of unknown aetiology were identified in Wuhan City, Hubei province in China. Wuhan is the most populous city in central China with a population exceeding 11 million. These patients most notably presented with clinical symptoms of dry cough, dyspnoea, fever, and bilateral lung infiltrates on imaging. Cases were all linked to Wuhan’s Huanan Seafood Wholesale Market, which trades in fish and a variety of live animal species including poultry, bats, marmots, and snakes. The causative agent was identified from throat swab samples conducted by the Chinese Centre for Disease Control and Prevention (CCDC) on 7th January 2020, and was subsequently named Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). The disease was named COVID-19 by the World Health Organization (WHO). To date, most

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SARS-CoV-2 infected patients have developed mild symptoms such as dry cough, sore throat, and fever. The majority of cases have spontaneously resolved. However, some have developed various fatal complications including organ failure, septic shock, pulmonary oedema, severe pneumonia, and Acute Respiratory Distress Syndrome (ARDS). Notably, patients who required intensive care support were older and had multiple comorbidities including cardiovascular, cerebrovascular, endocrine, digestive, and respiratory disease. Those in intensive care were also more likely to report dyspnoea, dizziness, abdominal pain, and anorexia. On 30th January 2020, the WHO declared the Chinese outbreak of COVID-19 to be a Public Health Emergency of International Concern posing a high risk to countries with vulnerable health systems. Clinical features of COVID-19 include dry cough, fever, diarrhoea, vomiting, and myalgia. Individuals with multiple comorbidities are prone to severe infection and may also present with acute kidney injury (AKI) and features of ARDS. The WHO and CDC have both issued guidance on key clinical and epidemiological findings suggestive of a COVID- 19 infection. Extensive laboratory tests should be requested for patients with suspected infection. Patients may present with an elevated C-reactive protein, erythrocyte sedimentation rate, lactate dehydrogenase, creatinine, and a prolonged prothrombin time. Full genome sequencing and phylogenetic analysis on fluid from bronchoalveolar lavage can confirm COVID-2019 infection. As of 03 June 2020, following data has been reported throughout the world, India & Tamil Nadu. More than 6.19 million cases of COVID-19 have been reported in 185 countries and territories, resulting in more than 3,84,642 deaths. More than 3,100, 971 people have recovered.. The Ministry of Health and Family Welfare of India has confirmed a total of 201799 cases, 100302 recoveries (including 1 migration) and 5815 deaths in India. The Department of Health and Family Welfare of Tamil Nadu has confirmed a total of 24, 586 cases,

including 197 deaths and 13706 recoveries. Around 10683 active cases are reported. Outside the stream of Western or Allopathic medicine, Traditional Medicine System in India has been playing an important role in meeting the needs of Primary & Public health care in India & all over the world in recent times. Among six recognized streams of Indian Medicine System, Siddha medicine is one such traditional medicine originating in Tamil Nadu, India and practiced over centuries.Siddha system of medicine has played a major role in treating the diseases such as dengue, chikungunya. Both the TN Govt and union ministry of AYUSH has recommended an herbal siddha medicine called Nilavembu Kudineer as a treatment for dengue.TN govt have been distributing this medicine for several years to combat the surge of dengue and fever across the state. this study establish To determine the effectiveness of Siddha Medicine in treatment and accelerating the recovery of COVID19 patients and To determine the reduction in risk of disease prognosis and Intensive care support .

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