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Example 001

The document provides details of a clinical trial registered under CTRI Number CTRI/2021/05/033623, focusing on the effects of AYUSH drugs Ayush-64 and Kabasura Kudineer in Covid-19 patients in home isolation. The trial is interventional and conducted by the Central Council for Research in Ayurvedic Sciences, with Dr. Narayanam Srikanth as the principal investigator. The study involves multiple research sites across India and is sponsored by the Ministry of AYUSH, Government of India.

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0% found this document useful (0 votes)
80 views14 pages

Example 001

The document provides details of a clinical trial registered under CTRI Number CTRI/2021/05/033623, focusing on the effects of AYUSH drugs Ayush-64 and Kabasura Kudineer in Covid-19 patients in home isolation. The trial is interventional and conducted by the Central Council for Research in Ayurvedic Sciences, with Dr. Narayanam Srikanth as the principal investigator. The study involves multiple research sites across India and is sponsored by the Ministry of AYUSH, Government of India.

Uploaded by

asanyog
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 14

PDF of Trial

CTRI Website URL - http://ctri.nic.in

Clinical Trial Details (PDF Generation Date :- Tue, 30 May 2023 09:58:32 GMT)

CTRI Number CTRI/2021/05/033623 [Registered on: 16/05/2021] - Trial Registered Prospectively


Last Modified On 14/05/2021
Post Graduate Thesis No
Type of Trial Interventional
Type of Study Ayurveda
Siddha
Study Design Single Arm Study
Public Title of Study Recording of the effects of select AYUSH drugs, Ayush-64 and Kabasura Kudineer in Covid-19
patients in home isolation.
Scientific Title of Documentation of efficacy of select AYUSH Interventions Ayush-64 and Kabasura Kudineer in
Study asymptomatic & mild to moderate Covid-19 patients in home isolation.
Secondary IDs if Any Secondary ID Identifier
NIL NIL
Details of Principal Details of Principal Investigator
Investigator or overall
Name Dr Narayanam Srikanth
Trial Coordinator
(multi-center study) Designation Director General I/C, CCRAS
Affiliation Central Council for Research in Ayurvedic Sciences, Ministry of
AYUSH, Govt.of India
Address CCRAS,JLN Bhartiya Chikitsa evam Homoepathy Anusandhan
Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri,(Ministry
of AYUSH, Government of India)
New Delhi
DELHI
110058
India
Phone
Fax
Email srikanthccras@gmail.com
Details Contact Details Contact Person (Scientific Query)
Person (Scientific
Name Dr Narayanam Srikanth
Query)
Designation Director General I/C, CCRAS
Affiliation Central Council for Research in Ayurvedic Sciences, Ministry of
AYUSH, Govt.of India
Address CCRAS,JLN Bhartiya Chikitsa evam Homoepathy Anusandhan
Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri,(Ministry
of AYUSH, Government of India)
New Delhi
DELHI
110058
India
Phone
Fax
Email srikanthccras@gmail.com
Details Contact Details Contact Person (Public Query)
Person (Public Query)
Name Dr Narayanam Srikanth
Designation Director General I/C, CCRAS
Affiliation Central Council for Research in Ayurvedic Sciences, Ministry of
AYUSH, Govt.of India
Address CCRAS,JLN Bhartiya Chikitsa evam Homoepathy Anusandhan

page 1 / 14
PDF of Trial
CTRI Website URL - http://ctri.nic.in

Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri,(Ministry


of AYUSH, Government of India)
New Delhi
DELHI
110058
India
Phone
Fax
Email srikanthccras@gmail.com
Source of Monetary or Source of Monetary or Material Support
Material Support
> Ministry of AYUSH Govt of India
Primary Sponsor Primary Sponsor Details
Name Ministry of AYUSH Govt of India
Address AYUSH BHAWAN, B Block, GPO Complex, INA, NEW DELHI -
110023
Type of Sponsor Government funding agency
Details of Secondary Name Address
Sponsor
NIL NIL
Countries of List of Countries
Recruitment
India
Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email
Investigator
DrSheereenAfza Regional Research Regional Research 9412596543
Institute of Unani Institute of Unani
Medicine, Aligarh Medicine, Aligarh rrium_aligarh@rediffmai
Aligarh l.com
UTTAR PRADESH
DrHakimuddin Khan Regional Research Regional Research 9437436408
Institute of Unani Institute of Unani
Medicine, Bhadrak Medicine, Bhadrak rriumbdk_unani@yahoo
Bhadrak .co.in
ORISSA
Dr Seema Akbar Regional Research Regional Research 9419051024
Institute of Unani Institute of Unani
Medicine, Srinagar Medicine, Srinagar rrium.srinagar@gmail.c
Srinagar om
JAMMU & KASHMIR
Vd UmeshTagade All India Institute of All India Institute of 9004344017
Ayurveda, New Delhi Ayurveda (AIIA)
Mathura Road, Gautam director@aiia.gov.in
Puri Sarita Vihar, Delhi
- 110076
New Delhi
DELHI
DrPLBharati RO Ay Central Ayurveda Central Ayurveda 8319845531
Research Institute, Research Institute,
Borsojai Borsojai (Bhetapara), plbharati@gmail.com
Beltola,
Guwahati-781028,
Assam
North Cachar Hills
ASSAM
Dr SKGiri Central Ayurveda Central Ayurveda 9483159755
Research Research Institute, #12,

page 2 / 14
PDF of Trial
CTRI Website URL - http://ctri.nic.in

Institute,Bengaluru UttarahalliManavartheK giridr@yahoo.co.in


aval, Uttarahalli (Hobli),
Bangalore South (Tq.)
Kanakapura Main
Road, Talaghattapura
Post, Bengaluru –
560109
Bangalore
KARNATAKA
Dr Kshirod Kumar Central Ayurveda Central Ayurveda 9874612213
Ratha Research Research Institute, At &
Institute,Bhubaneswar Post – Bharat Pur, Near drkkratha@gmail.com
Kalinga Studio,
Bhubaneswar-751029
Baleshwar
ORISSA
Dr AchintyaMitra Central Ayurveda Central Ayurveda 9836727927
Research Research Institute,
Institute,Kolkata 4-CN Block, Sector – V, achintyamitra1@gmail.c
Bidhannagar, Kolkata – om
700
Kolkata
WEST BENGAL
DrShaiziLayeeq Central Ayurveda Central Ayurveda 8630184149
Research Institute,New Research Institute,
Delhi Road No.66, Punjabi drshaizi@gnail.com
Bagh New Delhi – 110
026
New Delhi
DELHI
Dr Sanjeev Kumar Central Ayurveda Central Ayurveda 9310133831
Research Research Institute, Moti
Institute,Patiala Bagh Road, drsanjivji@gmail.com
Patiala-147001
Patiala
PUNJAB
Dr Mohan Rao Central Council for Central Council for 9015044233
Research in Yoga & Research in Yoga &
Naturopathy Rohini, Naturopathy Rohini, dramrao96@gmail.com
Delhi Delhi
New Delhi
DELHI
Dr Md Nafees Khan Central Research Central Research 9140705710
Institute of Unani Institute of Unani
Medicine Medicine, Lucknow ddcriumlko@gmail.com
Lucknow
UTTAR PRADESH
DrNitin Kumar Saklani Central Research Central Research 8744021902
Institute(H), Rajasthan Institute(H) C-26,Pratap
Nagar,Jaipur-302033 ccrhnitinsaklani@gmail.
Rajasthan com
Jaipur
RAJASTHAN
Dr Amir Faisal Khan Clinical Research Unit Clinical Research Unit 9827082483
(CRU), Bhopal (CRU), Bhopal
Bhopal crubpl.incharge@gmail.
MADHYA PRADESH com
Dr Amir Faisal Khan Clinical Research Unit Clinical Research Unit 9827082483
(CRU), Burhanpur (CRU), Burhanpur

page 3 / 14
PDF of Trial
CTRI Website URL - http://ctri.nic.in

Barwani crubpl.incharge@gmail.
MADHYA PRADESH com
Dr Aijaz Ahmed Clinical Research Unit Clinical Research Unit 8943706335
(CRU), Kerala (CRU), Kerala
Kannur crukerala@gmail.com
KERALA
DrMohdTarique Clinical Research Unit Clinical Research Unit 9012843253
(CRU), Meerut (CRU), Meerut
Meerut crumeerut@gmail.com
UTTAR PRADESH
DrPawan Sharma Clinical Research Unit Clinical Research Unit 9007659042
(H), Mizoram (H) 3rd floor AYUSH
Building, Block-D Civil pawan.sharma154@gm
Hospital, Dawrpui, ail.com
Aizawl-796001 Mizoram
Aizawl
MIZORAM
DrUttam Singh Clinical Research Unit Clinical Research Unit 9899144235
(H), Port-Blair (H), M.B. 31, Middle
Point, Mahatma Gandhi druttam01@gmail.com
Road, Port-Blair –
744101
Andamans
ANDAMAN &
NICOBAR ISLANDS
Dr Ravi kumarSadarla Clinical Research Unit Clinical Research Unit 9444181243
(H), Puducherry (H) No. 13, 1st Cross,
Mangalakshmi Nagar, drrvkumar64@gmail.co
(Behind New Bus m
Stand), Seram Post,
Puducherry-605013
Pondicherry
PONDICHERRY
DrSunil Prasad Clinical Research Unit Clinical Research Unit 7909034188
(H), Ranchi (H) Arsunday, Boreya
Road, Opp. SBI Bank sunil.prasad12@yahoo.
P.O. Boreya, Ranchi – com
835240
Ranchi
JHARKHAND
Dr G Ravi Chandra Clinical Research Unit Clinical Research Unit 9441208007
Reddy (H), Tirupati (H), Old Maternity
Hospital Campus, dr.grcreddy@gmail.com
Tirupati – 517507
Chittoor
ANDHRA PRADESH
Dr Clinical Research Unit Clinical Research Unit 9239297736
BaidurjyaBhattacharjee (T), Darjeeling (T) Gokhel Road,
Arabindopally (Near baibhms@gmail.com
West Bengal
Matrimandir), Darjeeling
, Siliguri – 734006
Darjiling
WEST BENGAL
DrSantosh Kumar Clinical Research Unit Clinical Research Unit 825033221
Tamang (T), Gangtok (T) Development Area,
Near SangramBhawan, orchid.rit@gmail.com
Gangtok - 737101
East

page 4 / 14
PDF of Trial
CTRI Website URL - http://ctri.nic.in

SIKKIM
DrVibha Clinical Verification Unit Clinical Verification Unit 9840771619
(H), Patna (H), 2nd Floor, S. Guru
Govind Singh Hospital, dsucrhyd@gmail.com
Patna – 800008 Bihar
Patna
BIHAR
Dr AMULYA RATNA Dr Abhin Chandra Extension Centre (H), 8763721546
SAHOO Homoeopathic Medical Dr Abhin Chandra
College & Hospital Homoeopathic Medical drarsahoo@gmail.com
College & Hospital, Unit
- III, Kharavela Nagar,
Bhubaneswar – 751001
Odisha1
Khordha
ORISSA
DrSubhashKaushik DR. D. P. Rastogi DR. D. P. Rastogi 9810788976
Central Research Central Research
Institute Institute (H),A-1/1, subhashccrh@gmail.co
Sector 24, Noida, m
GautamBudh
Nagar-201301 Uttar
Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
DrMunawar H Kazmi Drug Standardisation Drug Standardisation 9030168455
Unit(H), Hyderabad Unit(H), Vikram Puri,
Habsiguda, Hyderabad criumhyderabad@rediff
Hyderabad mail.com
TELANGANA
Dr Mohammad Fazil Hakim Ajmal Khan Hakim Ajmal Khan 9818345757
Institute for Literary & Institute for Literary &
Historical Research in Historical Research in lriumnew1986@gmail.c
Unani Medicine Unani Medicine, New om
Delhi
New Delhi
DELHI
DrLipipushpaDebata Homoeopathic Drug Homoeopathic Drug 7755014040
Research Institute (H), Research Institute (H),
Lucknow Campus of National drlipi08@gmail.com
Homoeopathic Medical
College & Hospital, 1,
VirajKhand, Gomti
Nagar, Lucknow-
226010
Lucknow
UTTAR PRADESH
Dr D Karthikeyan Homoeopathy Homoeopathy 8281488685
Research Institute Research Institute
Disabilities,Chennai Disabilities, Room drkarthikeyanmd@gmai
No.136, N.I.E.P.M.D l.com
Campus, ECR Road,
Muttukadu,
Chennai-603112
Chennai
TAMIL NADU
Vd Nilesh Bhatt ITRA,Gujarat Ayurveda ITRA,Gujarat Ayurveda 9428127701
University, Jamnagar University, Jamnagar
Jamnagar dipayurved@gmail.com

page 5 / 14
PDF of Trial
CTRI Website URL - http://ctri.nic.in

GUJARAT
Dr V B Kumawat M.S. Regional M.S. Regional 8003514251
Ayurveda Research Ayurveda Research
Institute, Jaipur Institute, Indira Colony, vinodbihari100@gmail.c
Bani Park, Jhotwara om
Road, Jaipur-302016
Jaipur
RAJASTHAN
Dr Ishwar N Acharya Morarji Desai National Morarji Desai National 9868609884
Institute of Yoga, New Institute of Yoga 68,
Delhi Ashoka Road, Near acharyaishwar@gmail.c
Gole Dak Khana, New om
Delhi - 110 001
New Delhi
DELHI
DrPPPradeep Kumar National Ayurveda National Ayurveda 9048929886
Research Institute for Research Institute for
Panchakarma, Panchakarma, vaidyanpradeep@gmail
Cheruthuruthy Cheruthuruthy, Via .com
Shoranur Thrissur Distt.
Kerala-679531(Kerala)
Thrissur
KERALA
DrSKarunakaraMoorthi National Homoeopathy National Homoeopathy 8281502571
Research Institute in Research Institute in
Mental Health Mental Health drjaiguru@gmail.com
Sachivothamapuram,
Kottayam-686532
Kerala
Kottayam
KERALA
Prof Pawan Kumar National Institute of National Institute of 8005841032
Godatwar Ayurveda Ayurveda Jorawar
Singh Gate Amer Road pgodatwar@gmail.com
JAIPUR - 302002
Jaipur
RAJASTHAN
Dr Austin Jose National Institute of National Institute of 9007431779
Homoeopathy Homoeopathy, Sector
A-5, Narela drtajnih@gmail.com
New Delhi
DELHI
Dr P Yuvaraj Paul National Institute of NATIONAL INSTITUTE 9444730430
Naturopathy OF NATUROPATHY,
(Ministry of AYUSH, yuvrajbnys@gmail.com
Govt. of India) Bapu
Bhavan, Matoshree
Ramabai Ambedkar
Rd.(Tadiwala Road),
Pune – 411 001
Pune
MAHARASHTRA
Dr K Suresh National Institute of National Institute of 9962571137
Siddha(NIS) Siddha, Tambaram,
Chennai drsureshherbal@gmail.
Chennai com
TAMIL NADU
Prof Abdul Nasir Ansari National Institute of National Institute of 9379165162
Unani Medicine (NIUM) Unani Medicine (NIUM)

page 6 / 14
PDF of Trial
CTRI Website URL - http://ctri.nic.in

Bangalore abdulnasiransari@gmai
Bangalore l.com
KARNATAKA
Dr Munawar H Kazmi National Research National Research 9030168455
Institute of Unani Institute of Unani
Medicine for Skin Medicine for Skin ahmedminhajuddin@ya
Disorders Disorders, Hyderabad hoo.com
Hyderabad
TELANGANA
Dr BishnuChoudhury North Eastern Institute North Eastern Institute 9366540943
of Ayurveda and of Ayurveda and
Homoeopathy Homoeopathy, drbishnuchoudhury@g
(NEIAH), Shillong, mail.com
Meghalaya - 793018
South Garo Hills
MEGHALAYA
Dr Imlikumba North Eastern Institute North Eastern Institute 8414895879
of Folk Medicine of Folk Medicine,
Pasighat- 791102, imlikumba@gmail.com
Arunachal Pradesh
East Siang
ARUNACHAL
PRADESH
DrImlikumba North Eastern Institute North Eastern Institute 8414895879
of Folk Medicine of Folk Medicine,
Pasighat, Arunachal imlikumba@gmail.com
Pradesh
East Siang
ARUNACHAL
PRADESH
Mr Surender Sandhu Post Graduate Institute Post Graduate Institute 9990204555
of Yoga and of Yoga and
Naturopathy Education Naturopathy Education sandhusyoga@gmail.co
and Research Jhajjar, and Research Jhajjar, m
Haryana Haryana
Jhajjar
HARYANA
Dr Vadiraj HS Post Graduate Institute Post Graduate Institute 9350147313
of Yoga and of Yoga and
Naturopathy Education Naturopathy Education vadiraj77@gmail.com
and Research, and Research
Karnataka Nagamangala,
Karnataka
Mandya
KARNATAKA
DrLaxmanBhurke Raja Raja 9086087677
RamdeoAnandilalPodar RamdeoAnandilalPodar
(RRAP) Central (RRAP) Central dewa2007@rediffmail.c
Ayurveda Research Ayurveda Research om
Institute,Mumbai Institute, RA Podar
College, Worli,
Mumbai-400018
Mumbai
MAHARASHTRA
N Ramakrishnan Rashtriya Ayurveda Rashtriya Ayurveda 9350948873
Vidyapeeth(RAV) Vidyapeeth, New Delhi
New Delhi ramruk_99@yahoo.co.u
DELHI k
Dr SojeetraNiral Regional Ayurveda Regional Ayurveda 7990875088

page 7 / 14
PDF of Trial
CTRI Website URL - http://ctri.nic.in

Research Research Centre, 135,


Centre,Agartala Ramnagar Road, No.4, sojitra.niral227@gmail.c
Opp. Raj Bhandar om
Agartala, Tripura –
799002
West Tripura
TRIPURA
Dr Deepak Rahangdale Regional Ayurveda Regional Ayurveda 8302203962
Research Research Centre CMO
Centre,Nagaland Building, District liveayubest@gmail.com
Hospital Colony
Dimapur, Nagaland –
797112
Dimapur
NAGALAND
Dr Arvind Kumar Regional Ayurveda Regional Ayurveda 9660033435
Research Institute Research Institute, New
Itanagar-791111 dr.arvindaggarwal@gm
(Arunachal Pradesh) ail.com
Papum Pare
ARUNACHAL
PRADESH
Dr Akashlal M Regional Ayurveda Regional Ayurveda 9447755650
Research Institute, Port Research Institute,
Blair Quarter No. NGII - 1/3, akashlalm@gmail.com
Chakkargaon (PO),
Opp. Municipal
Complex, Near Ganesh
Temple, Chakkargaon,
Port Blair, South
Andaman-744112
Andamans
ANDAMAN &
NICOBAR ISLANDS
DrEmySSurendran Regional Ayurveda Regional Ayurveda 9995832813
Research Institute, Research Institute,
Thiruvananthapuram Poojapura emy.ssurendran@gmail
Thiruvananthapuram, .com
-695012
Thiruvananthapuram
KERALA
Dr Anil Avhad Regional Ayurveda Regional Ayurveda 9510176085
Research Research Institute,
Institute,Ahmedabad Block A & D, 2nd Floor, dranil.avhad@gov.in
BahumaliBhavan,
Manjushree Mill
Compound, Near
Girdharnagar Over
Bridge, Asarwa,
Ahmedabad-380004
Ahmadabad
GUJARAT
Dr K Prameela Devi Regional Ayurveda Dr. AchantaLakshmipati 9445812604
Research Regional Ayurveda
Institute,Chennai Research Institute, VHS kprameel@gmail.com
Medical Centre, TTTI
Post, Chennai-600113
Chennai
TAMIL NADU

page 8 / 14
PDF of Trial
CTRI Website URL - http://ctri.nic.in

Dr Anil Mangal Regional Ayurveda Regional Ayurveda 9755412502


Research Research Institute,
Institute,Gwalior Govt. Ayurvedic dranilmangal1@gmail.c
Hospital, Amkho, om
Gwalior-474009
Gwalior
MADHYA PRADESH
Dr Aaditya Shah Regional Ayurveda Regional Ayurveda 9033236720
Research Research Institute, JDA
Institute,Jammu Housing Colony, Ban dr.aadityashah@gmail.
Talab, Rajender Nagar, com
Jammu -181123, Union
Territory of Jammu &
Kashmir
Jammu
JAMMU & KASHMIR
Dr Sanjay Kumar Singh Regional Ayurveda Regional Ayurveda 9532013013
Research Research Institute, Plot
Institute,Lucknow No. in S-106, Sector drsksinghraried@gmail.
-25,Near Sherwood com
Academy, Indira Nagar
Lucknow- 226 016
Lucknow
UTTAR PRADESH
Dr VineetaNegi Regional Ayurveda Regional Ayurveda 8219256906
Research Research Institute,
Institute,Mandi Siyog (Jaral) Pandoh, drvineetanegi@gmail.c
Tehsil Sadar, Distt. om
Mandi -175124 (H.P.)
Mandi
HIMACHAL PRADESH
Dr NUR Shekar Regional Ayurveda Regional Ayurveda 8055595355
Research Research Institute,
Institute,Nagpur Near GharkulParisar, shilpasekhar2k5@yaho
Near Venkatesh Nagar, o.com
NIT Complex
Nandanwan.
Nagpur-440009
Nagpur
MAHARASHTRA
Dr DS Rotwar Regional Ayurveda Regional Ayurveda 7987135761
Research Research Institute, D
Institute,Patna Block, Rajindra dsrotwar7@gmail.com
Memorial Res. Institute
Building, AgamKuan,
Patna-800007
Patna
BIHAR
Dr Tarun Kumar Regional Ayurveda Regional Ayurveda 9990167451
Research Research Institute,
Institute,Ranikhet Village Thapla dr.tarunbams3887@gm
P.O.Ganiadyoli, ail.com
Via-Ranikhet,
Distt.Almora,
Pin-263645
Almora
UTTARANCHAL
Dr Rahul D Ghuse Regional Ayurveda Regional Ayurveda 7066104329
Research Research Institute,

page 9 / 14
PDF of Trial
CTRI Website URL - http://ctri.nic.in

Institute,Sikkim Tadung, Gangtok, ghuserahul@gmail.com


Sikkim-737102
West
SIKKIM
Dr SujataDhoke Regional Ayurveda Regional Ayurveda 7016289621
Research Research Institute, New
Institute,Vijayawada Rajiv Nagar, Payakapur sujubasic@gmail.com
am,Vijayawada-520
015 (A.P.), India
Nellore
ANDHRA PRADESH
Dr Ashok Kumar Regional Research Regional Research 9450619024
Center, Allahabad Center, Allahabad
Allahabad rrcallahabad@gmail.co
UTTAR PRADESH m
DrRatan Chandra Shil Regional Research Regional Research 9383065434
Institute (H), Agartala Institute (H) Joy Krishna
Kobra Para Road, 78rcshil@gmail.com
Khumulwng,
Agartala-799045.Tripur
a
West Tripura
TRIPURA
DrAmitSrivastav Regional Research Regional Research 8371007898
Institute (H), Imphal Institute (H), New
Checkon, Bazar Road, dramit911@gmail.com
Opp. Tribal Colony,
Imphal East District –
795001 Manipur
Imphal East
MANIPUR
DrAKPrusty Regional Research Regional Research 9778461673
Institute (H), Puri Institute (H), CCRH
Building, Marchikote Prustyakshayakumar@
Lane, Near gmail.com
LabanikhiaChaak, Puri
– 752001
Puri
ORISSA
DrBrundaBezawada Regional Research Regional Research 9550173744
Institute (H),Gudivada Institute (H), Dr GGH
Medical College bezawadabrunda@gma
Campus, Eluru Road, il.com
Gudivada-521301
Krishna
ANDHRA PRADESH
DrParthaPratim Pal Regional Research Dr Anjali Chatterjee 8910890779
Institute (H),Kolkata Regional Research
Institute (H), 50, justdoit.partha@gmail.c
RajendraChatterjee om
Road, Kolkata -700035
Kolkata
WEST BENGAL
Dr B S Rawat Regional Research Regional Research 8080483012
Institute (H),Mumbai Institute (H), MTNL Hall
No.-4, Sector– 9, rawatdrbirendrasingh@
Shopping Centre, CBD, yahoo.co.in
Belapur, Navi Mumbai
-400614

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CTRI Website URL - http://ctri.nic.in

Mumbai
MAHARASHTRA
DrSunilRamteke Regional Research Regional Research 9418211118
Institute (H),Shimla Institute (H), C-5,
Lane-1, Sector-2, sunilramtek@gmail.com
Below B.C.S. New
Shimla-171009
Shimla
HIMACHAL PRADESH
Dr Younis Iftikhar Regional Research Regional Research 9419086700
Munshi Institute of Unani Institute of Unani
Medicine, Kolkata Medicine, Kolkata kolrrium@gmail.com
Kolkata
WEST BENGAL
Dr Md Ishtiyaq Alam Regional Research Regional Research 8210015355
Institute of Unani Institute of Unani
Medicine, Patna Medicine, Patna rriumpatna@gmail.com
Patna
BIHAR
Dr N Zaheer Ahmed Regional Research Regional Research 9884764658
Institute of Unani Institute of Unani
Medicine, Chennai Medicine, Chennai rriumchennai@gmail.co
Chennai m
TAMIL NADU
Dr Haseeb Alam Lari Regional Research Regional Research 9335903933
Institute of Unani Institute of Unani
Medicine, Mumbai Medicine, Mumbai rrium.mumbai@gmail.c
Mumbai om
MAHARASHTRA
Dr Rahat Raza Regional Research Regional Research 7827208191
Institute of Unani Institute of Unani
Medicine, New Delhi Medicine, New Delhi rridelhi@gmail.com
New Delhi
DELHI
DrLiyiKarso Regional Research Regional Research 7628990495
Institute(H), Guwhati Institute(H), Ground
Floor, Old Building liyikarso@gmail.com
NEIARI (Ayurvedic
Campus) Barsojai,
Bhetapara, Beltola,
Guwahati-781028
Assam
North Cachar Hills
ASSAM
Dr P Sathyarajeswaran Siddha Central Siddha Central 9443579540
Research Institute Research Institute,
Chennai. siddha2k6@gmail.com
Chennai
TAMIL NADU
Dr M Siddha Clinical Siddha Clinical 9362905234
HariharaMahadevan Research Unit, Research Unit,
Bengaluru Bengaluru drharihara@gmail.com
Bangalore
KARNATAKA
Dr B Akila Siddha Clinical Siddha Clinical 7208152857
Research Unit, New Research Unit, New
Delhi Delhi drakila10@gmail.com
New Delhi

page 11 / 14
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DELHI
Dr K Sivaranjani Siddha Clinical Siddha Clinical 9842962962
Research Unit, Research Unit,
Palayamkottai Palayamkottai sivagsmcmd@gmail.co
Tirunelveli m
TAMIL NADU
Dr KSamraj Siddha Clinical Siddha Clinical 9080907048
Research Unit, Tirupati Research Unit, Tirupati
Chittoor samraj.mailme@gmail.c
ANDHRA PRADESH om
Dr A Rajendra Kumar Siddha Regional Siddha Regional 9884956693
Research Institute , Research Institute ,
Puducherry Puducherry rksiddha@hotmail.com
Pondicherry
PONDICHERRY
Dr A Kangarajan Siddha Regional Siddha Regional 9442178440
Research Institute, Research Institute,
Thiruvanathapuram Thiruvanathapuram dr.kanagarajan@yahoo.
Thiruvananthapuram co.in
KERALA
Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics
Committee Committee?
CENTRAL ETHICS Approved 13/05/2021 Yes
COMMITTEE
Regulatory Clearance Status Date
Status from DCGI
Not Applicable No Date Specified
Health Condition / Health Type Condition
Problems Studied
Patients Other specified viral diseases
Intervention / Type Name Details
Comparator Agent
Intervention AYSUH 64/Kabasura Kudineer AYUSH 64- Asymptomatic
-2-0-2 for 20 days
Mild/moderate 2-2-2 for 20 days
Kabasura Kudineer 60 ml twice
daily for 20 days
Comparator Agent NA NA
Inclusion Criteria Inclusion Criteria
Age From 18.00 Year(s)
Age To 60.00 Year(s)
Gender Both
Details • Individuals of any gender within the age group 18-60 years<br/> •
Individuals diagnosed as COVID 19 and categorized as
asymptomatic, mild or moderate disease <br/> • within < One week
of confirmation of COVID 19 disease<br/> • Patients in home
isolation under standard care as per the government guidelines<br/>
• Patients providing informed consent and willing to participate in the
clinical study<br/>
Exclusion Criteria Exclusion Criteria
Details • Patients not willing to use the Ayush interventions(AYUSH-64
&KabasuraKudineer)
• Pregnant, lactating women and other vulnerable population
• Use of immunosuppressive doses of corticosteroids prior to the
enrollment in the study and planned use of immunosuppressive
doses of corticoids
• Any other condition that, in the opinion of the principal investigator

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PDF of Trial
CTRI Website URL - http://ctri.nic.in

or his/her representative physician, could put the safety of potential


participants at risk or prevent them from complying with this protocol.
• Patients who were diagnosed as having severe disease or
receiving oxygen support.
• People who are unable to take oral medication
• People whose SpO2 levels are fluctuating within the range of
90-94.

Method of Generating Not Applicable


Random Sequence
Method of Not Applicable
Concealment
Blinding/Masking Not Applicable
Primary Outcome Outcome Timepoints
• Demographic profiling of COVID 19 patients in Day 1, Day 20
home isolation, who received Ayush
interventions(AYUSH 64 / Kabasurakudineer) as
adjunct to standard care for asymptomatic, mild,
and moderate COVID 19 in terms of geographic
location, age, gender, education status, and
domicile, based on the data reported through the
Ayush Sanjivani app
Secondary Outcome Outcome Timepoints
• Documentation of patients perception on the Day 1, Day 20
benefit obtained by use of AYUSH
interventions(AYUSH 64 / Kabasurakudineer)
through self reported change in appetite, bowel
habits, sleep, and physical health as reported
through Ayush Sanjivani app
• Mean duration of the time taken for clinical Day 1, Day 20
recovery (symptom free in the last 48 hours) as
reported by the patients.
• Proportion of COVID 19 patients in home DAY 1, Day 20
isolation, who received Ayush interventions
(AYUSH 64 / Kabasurakudineer) as adjunct to
standard care for asymptomatic, mild, and
moderate COVID 19, across India
• Proportion of patients who underwent Day 20
progression of disease to severe
• Proportion of patients who required Day 1, Day 20
hospitalization
• Proportion of patients who required oxygen Day 1, Day 20
support
• Proportion of patients who required ventilator Day 1, Day 20
support
• Proportion of patients who reported any AE Day 1, Day 20
during the use of the medicine
• Assessment of compliance in the patients who Day 1, Day 20
were issued with AYUSH 64/Kabasura Kudineer
Target Sample Size Total Sample Size=500000
Sample Size from India=500000
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 4
Date of First 22/05/2021

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PDF of Trial
CTRI Website URL - http://ctri.nic.in

Enrollment (India)
Date of First No Date Specified
Enrollment (Global)
Estimated Duration of Years=0
Trial Months=4
Days=0
Recruitment Status of Not Applicable
Trial (Global)
Recruitment Status of Not Yet Recruiting
Trial (India)
Publication Details NA
Brief Summary The study will be conducted as an open label prospective ecommunity
based study designed to capture the desired objectives of the study, based
on pre-defined close ended and certain open-ended questions to collect
the data through an mobile based application i.e AYUSH SANJEEVANI
APP. The data will be filled up in this app in a predesigned format by the
COVID 19 patient, who is in home isolation and also by the treating
AYUSH Physician.

The patients would be given either AYUSH 64 or Kabasura Kudineer for a


period of 20 days and the data recorded through the respective formats in
the AYUSH Sanjivani App would be synthesized to analyze the desired
outcomes of the study.

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