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CTRI Number  CTRI/2020/05/025254 [Registered on: 20/05/2020] Trial Registered Prospectively
Last Modified On: 22/05/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Unani 
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   To Study effectiveness and outcomes of Unani Medicine prophylactic interventions on population at risk of COVID-19 
Scientific Title of Study   Population based Prospective Study on effectiveness and outcomes of Unani Medicine prophylactic interventions on population at risk of COVID-19 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
CCRUM 05/2020/01 Version 1.0  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prof Asim Ali Khan 
Designation  Director General 
Affiliation  Central Council for Research in Unani Medicine (CCRUM) 
Address  Room No 523, 5th Floor Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri

South West
DELHI
110058
India 
Phone  01128525715  
Fax    
Email  unanimedicine@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Naheed Parveen 
Designation  Assistant Director 
Affiliation  Central Council for Research in Unani Medicine (CCRUM) 
Address  Room No 507, 5th Floor Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri

South West
DELHI
110058
India 
Phone  9213511298  
Fax    
Email  ccrum507@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Pradeep Kumar 
Designation  Research Officer (Pathology) S-IV 
Affiliation  Central Council for Research in Unani Medicine (CCRUM) 
Address  Room No 516, 5th Floor Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri

South West
DELHI
110058
India 
Phone  8800263300  
Fax    
Email  drpradeepkumar2001@yahoo.com  
 
Source of Monetary or Material Support  
Monetary Support : Central Council for Research in Unani Medicine (CCRUM), New Delhi  
 
Primary Sponsor  
Name  Central Council for Research in Unani Medicine CCRUM New Delhi  
Address  Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri, New Delhi-110058.  
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
Nil  Nil 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 7  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Maqbool Ahmed  Central Research Institute of Unani Medicine (CRIUM)  Basaha, Kursi Road
Lucknow
UTTAR PRADESH 
6386660524

ddcriumlko@gmail.com 
Prof Abdul Wadood  National Institute of Unani Medicine (NRIUM)  National Institute of Unani Medicine Campus, Kottigepalya, Magadi Main Road
Bangalore
KARNATAKA 
9916608881

crubangalore2000@gmail.com 
Dr Ahmad Minhajuddin  National Research Institute of Unani Medicine in Skin Diseases (NRIUMSD)  A G Colony Road, Opposite ESI Hospital, Erragadda
Hyderabad
TELANGANA 
9177376011

ahmedminhajuddin@yahoo.com 
Dr Arsheed Iqbal  Regional Research Institute of Unani Medicine (RRIUM)  Naseem Bagh Campus, University of Kashmir
Srinagar
JAMMU & KASHMIR 
9419078302

drarsheediqbal@gmail.com 
Dr H A Lari  Regional Research Institute of Unani Medicine (RRIUM)  Behind Eye Bank, Sir J J Hospital Compound, Byculla
Mumbai
MAHARASHTRA 
9335903933

halariccrum@gmail.com 
Dr Parvez Khan  Regional Research Institute of Unani Medicine (RRIUM)  Post Box 70, Shahjahan Manzil, Near AMU Riding Club, Qila Road
Aligarh
UTTAR PRADESH 
9411059371

rrium_aligarh@rediffmail.com 
Dr Shagufta Parveen  Regional Research Institute of Unani Medicine (RRIUM)  D-11, Abul Fazal Enclave, Jamia Nagar
South
DELHI 
9810068758

rridelhi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 7  
Name of Committee  Approval Status 
Central Research Institute of Unani Medicine (CRIUM), Lucknow  Approved 
National Institute of Unani Medicine (NRIUM), Bangalore  Approved 
National Research Institute of Unani Medicine in Skin Diseases (NRIUMSD), Hyderabad  Approved 
Regional Research Institute of Unani Medicine (RRIUM), Aligarh  Approved 
Regional Research Institute of Unani Medicine (RRIUM), Mumbai  Approved 
Regional Research Institute of Unani Medicine (RRIUM), New Delhi  Approved 
Regional Research Institute of Unani Medicine (RRIUM), Srinagar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  U07.1 COVID-19 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  nil  nil 
Intervention  Unani Joshanda (Decoction)and Tiryaq-e-Arba  Unani Joshanda (Decoction) lukewarm once daily in the evening,and Tiryaq e Arba 5g with lukewarm water in the morning for 20 days for 10000 patients 
Intervention  Unani Joshanda (Decoction)and Khameera Marwareed   Unani Joshanda (Decoction) lukewarm once daily in the evening and Khameera Marwareed 5g once daily in the morning for 20 days, for 10000 subjects 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  1. Individuals of either sex above 18 and below 68 years
2. Population as described in High/Moderate/Low Risk
3. Individuals who are from the identified containment zone/ quarantine facility with at least 1 confirmed COVID-19 positive case.
4. Subjects who are ready to provide written/digital informed consent and who are willing to participate and follow the protocol requirements of the clinical study 
 
ExclusionCriteria 
Details  1. Persons with severe primary respiratory disease or related complications that may be identified with COVID-19
2. Laboratory confirmed COVID-19 with or without symptoms
3. Pregnant and lactating mothers and those who have a pregnancy plan.
4. Persons with serious critical illness, or severe mental illnesses
5. Individuals with uncontrolled, unstable comorbidities
6. Immunocompromised individuals or those on immunosuppressants and steroids
7. Subjects having a past history of allergy to any medicine that is part of the Unani intervention. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Incidence of COVID-19 cases in control as well in interventional group
2.Improvement in immune status using Immune Status Questionnaire (ISQ)
 
20days 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="40000"
Sample Size from India="40000" 
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 3 
Date of First Enrollment (India)   29/05/2020 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="1"
Days="5" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Brief Summary  


This study is designed as a multicentric open label, Controlled, Prospective, Interventional, Community-based trial  to

compare occurrence of COVID 19 infection in clinically stable subjects receiving Unani regimen with those not receiving Unani Regimen in a community having at least 1 confirmed case with standard prophylactic care as control, in the identified containment zone/ quarantine facility. The study will be carried out on a total sample size of 40,000 (forty thousand subjects). Ten thousand in test group 1 ( Unani Joshanda (Decoction)and Khameera Marwareed)  and Ten thousand in test group 2 ( Unani Joshanda (Decoction)and Tiryaq e Arba) .  And twenty thousand subjects will be enrolled in the control group and will be advised to follow general prophylactic measurements without any medicinal intervention.

After screening, subjects will be enrolled if they satisfy inclusion and exclusion criteria. The patients will be assessed clinically at day 0 (baseline), day 10 (telephonic follow-up) and day 20 (end of the study). The subjective and objective clinical observations will be recorded in the CRF.  This includes Assessment of Immune status Questionnaire (ISQ). The total duration of treatment will be 20days. Test for Covid-19 will be done at any time during the study (if the symptoms develop) as per the guidelines of the central/state or local health authority. 

Details of study drugs

A.   First group will be given:

Unani Joshanda (Decoction) consisting of the following single drugs-

·       Behidana (Cydonia oblonga) 3 gm

·       Unnab (Zizyphus jujube), 5 in number

·       Sapistan (Cordia myxa), 9 in numbers

Preparation of Decoction by boiling these medicines in 250 ml of water, until it remains half and filtered.

To be used lukewarm once daily in the Evening.

KhameeraMarwareed

5 gm once daily in the morning

 

B.   Second group will be given:

Unani Joshanda (Decoction) consisting of the following single drugs-

·       Behidana (Cydonia oblonga) 3 gm

·       Unnab (Zizyphus jujube), 5 in number

·       Sapistan (Cordia myxa), 9 in numbers

Preparation of Decoction by boiling these medicines in 250 ml of water, until it remains half and filtered.

To be used lukewarm once daily in the Evening.

Tiryaq-e-Arba

5 gm once daily with lukewarm water in the Morning

 

Composition of Khameera Marwareed:

S. No.

Ingredients

Botanical/ English Name

Quantity

1.       

Marwareed

Mytilus margaritiferus

25g

2.       

Tabasheer

Bambusa arundinacea

25g

3.       

Sandal safaid

Santalum album

25g

4.       

Ambar Ash-hab

Ambra grasea

10g

5.       

Arq e Gulab

Rosa damascena

1Lit.

6.       

Arq e Bedmushk

Salix caprea

1Lit.

7.       

Qand safaid

Sugar

1.5kg


Composition of Tiryaq e Arba:

S. No.

Ingredients

Botanical/ English Name

Quantity

1.       

Juntiyana

Gentiana lutea

1part

2.       

Zarawand taweel

Aristolochia rotunda

1part

3.       

Habb-ul-Ghar

Laurus nobilis

1part

4.       

Mur Makki

Commiphora myrrha

1part

5.       

Asl or Qand safaid

Honey/Sugar

Q.S.


 
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