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CTRI Number  CTRI/2020/07/026841 [Registered on: 28/07/2020] Trial Registered Prospectively
Last Modified On: 27/07/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A clinical trial to study the effects of an Ayurvedic medicine, Haldi 30 ( Turmeric extract ) drops in patients with Corona virus infection. 
Scientific Title of Study   Efficacy of Ayurvedic Medicine Haldi 30 drops as an Add on medication to standard of care in adult patients of mild to moderate COVID 19. A Phase II randomized, single - blind, parallel group, placebo - controlled trial. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sarang Phadke 
Designation  Ayurvedic Physician 
Affiliation  Sahyadri Hospitals Limited 
Address  Sahyadri Hospitals Limited
Plot no 9 B, Neeta Society, S No 1484 / B, Paud Road, Kothrud,
Pune
MAHARASHTRA
411038
India 
Phone  9561071607  
Fax    
Email  nmission21@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Sarang Phadke 
Designation  Ayurvedic Physician 
Affiliation  Sahyadri Hospitals Limited 
Address  Sahyadri Hospitals Limited
Plot no 9 B, Neeta Society, S No 1484 / B, Paud Road, Kothrud,
Pune
MAHARASHTRA
411038
India 
Phone  9561071607  
Fax    
Email  nmission21@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Sarang Phadke 
Designation  Ayurvedic Physician 
Affiliation  Sahyadri Hospitals Limited 
Address  Sahyadri Hospitals Limited
Plot no 9 B, Neeta Society, S No 1484 / B, Paud Road, Kothrud,
Pune
MAHARASHTRA
411038
India 
Phone  9561071607  
Fax    
Email  nmission21@yahoo.co.in  
 
Source of Monetary or Material Support  
Sahyadri Hospitals Limited Plot no 9 B, Neeta Society, S No 1484 / B, Paud Road, Kothrud,Pune, Maharashtra, India 
 
Primary Sponsor  
Name  Dr Sarang Phadke 
Address  8 , Vinayak Apartments , 8 , Gananjay Society Unit no2 , Kothrud, Pune 411038 MAHARASHTRA India  
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
Col Suresh Purushottam Gadgil  ShriKripa, Plot no 26, Lokmanya housing society, Pandharpur road, Miraj, Sangli 416410 
Mr Anant Krishnaji Joshi  Plot no 17 B, Chandragupta co operative housing society, Poud road, Kothrud, Pune 411038 
Mr Narahar Krishna Phadke  8 , Vinayak Apartments , 8 , Gananjay Society Unit no2 , Kothrud , Pune , Maharashtra , 411038 , India  
Mr Nikhil Vishwas Ranade  Srushti, Plot no 36, Swaroop colony, Anandnagar, Sinhagad road, Pune 411051 
Mr Sunil Danekar  A 601, Shreemanyogi, Shivraj Nagar, Rahatani, Pune 411017 
Mr Vishwas Digambar Ranade  Srushti, Plot no 36, Swaroop colony, Anandnagar, Sinhagad road, Pune 411051 
Sanmarga Pratishthan  8 , Vinayak Apartments , 8 , Gananjay Society Unit no2 , Kothrud , Pune , Maharashtra , 411038 , India  
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sarang Phadke  Sahyadri Hospital, Kothrud branch 2  Branch 2 of Sahyadri Hospitals Limited , PMC listed COVID 19 dedicated hospital ( All wards and all rooms ), Plot no 9 B, Neena Society, S No 1484A and B, Paud Road, Kothrud, Pune 411038
Pune
MAHARASHTRA 		 9561071607

nmission21@yahoo.co.in 
Dr Sarang Phadke  Sahyadri Superspeciality Hospital, Deccan Gymkhana branch 1  Branch 1 of Sahyadri Hospitals Limited,COVID 19 Isolation wards, 6th and 8th floor, Plot no 30 C, Erandwane, Deccan Gymkhana, Pune
Pune
MAHARASHTRA 		 9561071607

nmission21@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sahyadri Hospitals Ltd Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Standard of care plus Haldi 30 drops  Standard of care plus 3 drops PO at 6 AM, 10 AM, 2 PM, 6 PM, 10 PM. No liquid or solid food or oral medication up to 20 minutes after drug administration.  
Comparator Agent  Standard of care plus Sesame oil drops  Standard of care plus 3 drops PO at 6 AM, 10 AM, 2 PM, 6 PM, 10 PM. No liquid or solid food or oral medication up to 20 minutes after drug administration.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  COVID 19 positive patients
1 Mild category
Group A Asymptomatic but positive for COVID 19.
Group B Symptomatic URTI without comorbidity.
Group C Symptomatic URTI with comorbidity.
2 Moderate category Pneumonia
hypoxia , fever , cough including SpO2 less than 94 percent Range 90 to 94 percent on room air. Respiratory Rate more or equal to 24 per minute.
3. Male or non-pregnant female of Age ≥ 18 years at time of consent.
4. Women of child bearing potential agree to abstinence or one primary form of non-hormonal contraception during the study period.
5. Subject / LAR willing to give informed consent for the study and agrees not to participate in another clinical trial for COVID-19 during the course of this study and further agrees to be randomized to any treatment arm of the study. 
 
ExclusionCriteria 
Details  COVID 19 positive patients
1 Stage II B Group E Pneumonia LRTI with respiratory failure.
2 Stage III Group F Pneumonia LRTI with respiratory failure multi organ dysfunction syndrome.
3 Physician makes the decision that trial is not in the best interest of the patient.
4 Anticipated discharge to another hospital within 72 hours.
5 Subject already on another trial for COVID-19
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Time to Recovery   Time to Recovery as defined on the Ordinal Scale censured at day 7 
 
Secondary Outcome  
Outcome  TimePoints 
1 Change from baseline in monitored laboratory values
2 Change from baseline in Ordinal scale assessment
3 Mortality at day 7
4 Duration of hospitalization, use of NIV/HFNO
5 Incidence of new use of IMV/ECMO 		 Day 3, Day 5 ,Day 7

 
 
Target Sample Size   Total Sample Size="260"
Sample Size from India="260" 
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 Enrollment (India)   03/08/2020 
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="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None yet. 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   This study is a phase II, randomized, single blind, parallel group, placebo controlled to assess the efficacy of Haldi 30 drops ( Curcuma Longa extract ) 3 drops 5 times daily for 7 days as an add on medication to the standard of care treatment in adult patients of mild to moderate COVID 19 Infection that will be conducted in two branches of Sahyadri Hospitals Limited at Pune, Maharashtra in India. The primary outcome measure will be time to recovery as defined on the eight category ordinal scale censured at day 7. The secondary outcome measures will be 1. Change from baseline in monitored laboratory values of RT PCR, IL 6 level, Ferritin level, Haemogram, D Dimer and X Ray Chest, 2. Change from baseline in the eight category ordinal scale assessment, 3. Incidence of use of Oxygen support.  
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