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Objectives: The primary objectives of the study are to determine the effectiveness of the Kaba Sura Kudineer (KSK) & Nilavembu Kudineer (NVK) along with standard Allopathy Treatment to compared with Placebo (Decaffeinated Tea) with standard Allopathy Treatment in the management of Symptomatic COVID 19 patients and also in reduction of Hospital Stay Time & Changes in Immunological (IL6) and Bio Chemical Markers (Ferritin, CRP, D-Dimer and LDH). The secondary objectives are to evaluate the safety of the trial medicines and their effects in the reduce the risks of the disease. In addition, to document the profile of Symptomatic COVID 19 patients as per Siddha Principles.
Trial design: A Double Blinded, Three arm, Single Centre, Placebo Controlled, Exploratory and comparative Randomized Controlled Trial PARTICIPANTS: Patients who were admitted to the COVID Care Centre at Govt. Institute of Medical Sciences. Noida in India will be recruited. These will be patients with Mild and Moderate symptoms with laboratory confirmed COVID 19 (RT - PCR Tested Positive) aged 18-65, willing and consenting to participate.
Intervention and comparator: Arm I: Decaffeinated Tea (Placebo - similar in taste and appearance to the other Two Decoctions), 60 Ml Morning and Night after Food, along with standard Allopathy Treatment for 10 days. Arm II: Nilavembu Kudineer (The Siddha Medicines which is used as a standard Anti-Viral drug for the past Pandemics by Siddha Physicians) 60 Ml Morning and Night after Food, along with standard Allopathy Treatment for 10 days. Arm III: Kaba Sura Kudineer (The Siddha Medicine which is proposed to be used as a Treatment for COVID 19 based on Siddha Literature) 60 Ml Morning and Night after Food, along with standard Allopathy Treatment for 10 days. The investigational drugs are registered products under the Govt.of India and bought from GMP Certified Manufacturing Units.
Randomisation: The assignment of the participants into 3 Groups will be allocated in 1:1:1 Ratio through randomization Blocks in Microsoft Excel by a Statistician who is not involved in the study. The allocation scheme will be made by another statistician by using a closed envelope after the assessment of eligibility and Informed consent procedures. The groups will be balanced for age and sex with 3:1 Ratio in each group for mild: severe COVID-19 symptoms.
Numbers to be randomized (sample size): Sample size could not be calculated, Since there are no prior trials on KSK and NVK as a comparative trial. In addition, there are no prior trials on KSK and NVK in this region. A total Number of 120 Patients, 40 each in 3 groups will be recruited in 1:1:1 Ratio.
Trial status: Protocol Number : SCRUND GIMS Noida Study 1,Version: 2.0 Protocol Date : 20.08.2020 The recruitment period is completed for the trial. The Trial started its recruitment on 22.8.2020. We anticipate study including data analysis will finish in January 2021. This is to state that it was a late submission from authors for publication of the protocol to the BMC, after enrolment in the study was over.
Trial registration: The trial protocol was registered with CTRI (Clinical Trial Registry of India) and number is CTRI/2020/08/027286 on 21.08.2020 FULL PROTOCOL: The full Protocol is attached as an additional file, Accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated. This letter serves as a summary of the key elements of the full protocol. The Study protocol has been reported in accordance with the SPIRIT guidelines.
Tamil is one of the longest-surviving classical languages in the world.[10][11] A. K. Ramanujan described it as "the only language of contemporary India which is recognizably continuous with a classical past".[12] The variety and quality of classical Tamil literature has led to it being described as "one of the great classical traditions and literatures of the world".[13] Recorded Tamil literature has been documented for over 2000 years.[14] The earliest period of Tamil literature, Sangam literature, is dated from c. 300 BC until AD 300.[15][16] It has the oldest extant literature among Dravidian languages. The earliest epigraphic records found on rock edicts and 'hero stones' date from around the 3rd century BC.[17][18] About 60,000 of the approximately 100,000 inscriptions found by the Archaeological Survey of India in India are in Tamil Nadu. Of them, most are in Tamil, with only about 5 percent in other languages.[19] Tamil language inscriptions written in Brahmi script have been discovered in Sri Lanka and on trade goods in Thailand and Egypt.[20][21] The two earliest manuscripts from India,[22][23] acknowledged and registered by the UNESCO Memory of the World register in 1997 and 2005, were written in Tamil.[24]
In 1578, Portuguese Christian missionaries published a Tamil prayer book in old Tamil script named Thambiran Vanakkam, thus making Tamil the first Indian language to be printed and published.[25] The Tamil Lexicon, published by the University of Madras, was one of the earliest dictionaries published in Indian languages.[26] According to a 2001 survey, there were 1,863 newspapers published in Tamil, of which 353 were dailies.[27]
Tamil belongs to the southern branch of the Dravidian languages, a family of around 26 languages native to the Indian subcontinent.[28] It is also classified as being part of a Tamil language family that, alongside Tamil proper, includes the languages of about 35 ethno-linguistic groups[29] such as the Irula and Yerukula languages (see SIL Ethnologue).
The closest major relative of Tamil is Malayalam; the two began diverging around the 9th century AD.[30] Although many of the differences between Tamil and Malayalam demonstrate a pre-historic divergence of the western dialect,[31] the process of separation into a distinct language, Malayalam, was not completed until sometime in the 13th or 14th century.[32]
Additionally, Kannada is relatively close to Tamil language and shares the format of formal ancient tamil language. There are some variations from tamil language inbibed but still preserves a lot from its roots. Being part of the southern family of indian languages and in midst relatively near to north part of india, it also shares some sanskrit words as in malayalam. Tamil has seen its formats formerly used words still has been preserved with little change in kannada. It shows relative parallel to tamil even as tamil has some changes in the modern ways of the talking tamil.
Tamil, like other Dravidian languages, ultimately descends from the Proto-Dravidian language, which was most likely spoken around the third millennium BC, possibly in the region around the lower Godavari river basin. The material evidence suggests that the speakers of Proto-Dravidian were of the culture associated with the Neolithic complexes of South India.[33]
In 2004, a number of skeletons were found buried in earthenware urns dating from at least 696 BC in Adichanallur. Some of these urns contained writing in Tamil Brahmi script, and some contained skeletons of Tamil origin.[38]
Between 2017 and 2018, 5,820 artifacts have been found in Keezhadi. These were sent to Beta Analytic in Miami, Florida, for Accelerator Mass Spectrometry (AMS) dating. One sample containing Tamil-Brahmi inscriptions was claimed to be dated to around 580 BC.[39][40]
According to Hindu legend, Tamil or in personification form Tamil Thāi (Mother Tamil) was created by Lord Shiva. Murugan, revered as the Tamil God, along with sage Agastya, brought it to the people.[45]
The earliest extant Tamil literary works and their commentaries celebrate the Pandiyan Kings for the organization of long-termed Tamil Sangams, which researched, developed and made amendments in Tamil language. Even though the name of the language which was developed by these Tamil Sangams is mentioned as Tamil, the period when the name "Tamil" came to be applied to the language is unclear, as is the precise etymology of the name. The earliest attested use of the name is found in Tholkappiyam, which is dated as early as late 2nd century BC.[46][47] The Hathigumpha inscription, inscribed around a similar time period (150 BCE), by Kharavela, the Jain king of Kalinga, also refers to a Tamira Samghatta (Tamil confederacy)[48]
Southworth suggests that the name comes from tam-miḻ > tam-iḻ "self-speak", or "our own speech".[50] Kamil Zvelebil suggests an etymology of tam-iḻ, with tam meaning "self" or "one's self", and "-iḻ" having the connotation of "unfolding sound". Alternatively, he suggests a derivation of tamiḻ < tam-iḻ < *tav-iḻ < *tak-iḻ, meaning in origin "the proper process (of speaking)".[51] However, this is deemed unlikely by Southworth due to the contemporary use of the compound 'centamiḻ', which means refined speech in the earliest literature.[50]
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