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CTRI Number  CTRI/2020/07/026462 [Registered on: 09/07/2020] Trial Registered Prospectively
Last Modified On: 13/10/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Unani 
Study Design  Single Arm Trial 
Public Title of Study
Modification(s)  
A study to observe and assess the safety and efficacy of Unani regimen in preventing the progression of severity of asymptomatic mild to moderate symptomatic cases. 
Scientific Title of Study
Modification(s)  
A prospective, interventional, case control study to observe and assess the safety and efficacy of Unani regimen in preventing the progression of severity of the disease in hospitalized SARS-CoV2 tested positive asymptomatic /mild to moderate symptomatic COVID-19 cases, managed as per Govt of India COVID-19 management guidelines, at a COVID-19 management facility 
Secondary IDs if Any  
Secondary ID  Registry 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prof Asim Ali Khan 
Address  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 Contact Person
Scientific Query
 
Name  Dr Usama Akram 
Address  Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri

South West
DELHI
110058
India 
Phone  9540606010  
Fax    
Email  usamakramdr@gmail.com  
 
Details Contact Person
Public Query
 
Name  Dr Nauman Saleem 
Address  Department of Ilmul Saidla, A and U Tibbiya college, Karol Bagh

Central
DELHI
110005
India 
Phone  9871505359  
Fax    
Email  nauman.saleem14@gmail.com  
 
Source of Monetary or Material Support  
Central Council for Research in Unani Medicine Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri, New Delhi-110058. 
 
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    
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 1  
Contact Person  Name of Site  Site Address  Phone/Fax/Email 
Dr Naseem Akhtar  A K Tibbia College Hospital  Covid Care Centre, A and U Tibbiya college Hospital, Ajmal Khan Road, Karol Bagh
Central
 
9354925042

drkhannaseem.akhtarkhan@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ayurvedic & Unani Tibbia College & Hospital Institutional Ethics Committee, New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Coronavirus as the cause of diseases classified elsewhere 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Khameera Marvareed  5 g once daily, Orally for 14 days along with the standard care of treatment as recommended by MOHFW guidelines for COVID-19 patient care 
Comparator Agent  NIL  NIL 
Intervention  Unani Joshanda/ Decoction  Lukewarm once daily, for 14 days along with the standard care of treatment as recommended by MOHFW guidelines for COVID-19 patient care 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Patients of either sex aged between 18-65 years
2. Patients who have been tested positive with SARS-CoV2 virus
Asymptomatic Patients
or
Patients with mild symptoms
or
Patients with moderate symptoms with respiratory rate < 30 per minute and oxygen
saturation > 90%
3. Voluntariness to participate in the trial
USCDC classification mild to moderate, severe and critical stages of COVID-19
Stage Features
Asymptomatic No specific clinical symptoms of COVID-19 disease
Mild to Moderate Mild clinical symptoms up to mild pneumonia
Severe Dyspnea, hypoxia, or >50% lung involvement on imaging
Critical Respiratory failure, shock, or multiorgan system dysfunction 
 
ExclusionCriteria 
Details  The subject must be excluded from participating in the trial if they fulfill anyone of the criteria as
mentioned below:
1. COVID-19 patients with symptoms classified as severe or critical.
2. Suspected COVID-19, not tested positive for COVID-19 by RT-PCR
3. Persons with severe primary respiratory disease or pneumonia
4. Pregnant and lactating women
5. Persons with serious diseases such as Cancer, Heart Disease, Stroke, Disabilities, Mental
illnesses, etc., and who are considered to be excluded from the study as evaluated by the
investigators
6. COVID-19 positive cases participating as subjects in the interventional arm of other
COVID-19 clinical trials 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome
Modification(s)  
Outcome  TimePoints 
Time taken to get COVID-19 RT-PCR test negative.
Incidence of patients progressing to next stage with regards to severity 
14 days 
 
Secondary Outcome  
Outcome  TimePoints 
Duration of subsidence of fever, respiratory and other COVID-19 symptoms  14days 
 
Target Sample Size   Total Sample Size="124"
Sample Size from India="124" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   20/07/2020 
Date of First Enrollment (Global)  No Date Specified 
Estimated Duration of Trial
Modification(s)  
Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not yet 
Brief Summary
Modification(s)  
This study is designed as an Open label, Controlled, Non randomised, Interventional Clinical trial in hospitalized SARS-CoV2 tested positive asymptomatic / mild to moderate symptomatic COVID 19 cases at a COVID 19 management facility.  After screening, volunteers will be enrolled if they satisfy inclusion and exclusion criteria and will be treated with Khameera Marwareed 5 gm once daily in the morning and Unani Joshanda (Decoction) once daily in the Evening for 14 days, as an add-on therapy along with the standard care of treatment as recommended by MOHFW guidelines for COVID-19 patient care.  The patients will be assessed clinically at day 0 (baseline), day 7 and day 14 (end of the study). The subjective and objective clinical observations will be recorded in the CRF.

Details of Study drugs:


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 filter it

Use lukewarm decoction once daily in the Evening.



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




 

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