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CTRI Number  CTRI/2020/07/026757 [Registered on: 23/07/2020] Trial Registered Prospectively
Last Modified On: 22/07/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   An interventional study to access the effect of Homoeopathic medicine in positive cases of COVID-19. 
Scientific Title of Study   A prospective double blind randomised controlled trial of Eupatorium perfoliatum 30 C in asymptomatic and mild symptomatic cases of COVID-19.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prof Dr PK Goswami  
Designation  Director  
Affiliation  North Eastern Institute of Ayurveda and Homoeopathy (NEIAH)  
Address  Office of the Director Department of Samhita and Sanskrit Mawdiangdiang near police outpost
Mawdiangdiang Near police outpost Shillong India
East Khasi Hills
MEGHALAYA
793018
India 
Phone  9415385128  
Fax    
Email  pkgoswamibhu@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Tapan Nath 
Designation  Lecturer  
Affiliation  North Eastern Institute of Ayurveda and Homoeopathy (NEIAH)  
Address  Department of Case Taking and Repertory College of Homoeopathy Room no 24 NEIAH Mawdiangdiang near police outpost East Khasi Hills

East Khasi Hills
MEGHALAYA
793018
India 
Phone  8837349308  
Fax    
Email  tapanbngn@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Tapan Nath 
Designation  Lecturer  
Affiliation  North Eastern Institute of Ayurveda and Homoeopathy (NEIAH)  
Address  Department of Case Taking and Repertory College of Homoeopathy Room no 24 NEIAH Mawdiangdiang near police outpost East Khasi Hills

East Khasi Hills
MEGHALAYA
793018
India 
Phone  8837349308  
Fax    
Email  tapanbngn@gmail.com  
 
Source of Monetary or Material Support  
Ministry of AYUSH AYUSH Bhawan B BLOCK GPO Complex INA New Delhi 110023  
 
Primary Sponsor  
Name  Ministry of AYUSH 
Address  AYUSH Bhawan B BLOCK GPO Complex INA New Delhi 110023  
Type of Sponsor  Other [Union Ministry Governmnet of India] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Prof Dr P K Goswami  North Eastern Institute of Ayurveda and Homoeopathy   Office of Director First Floor Mawdiangdiang Shillong 793018 East Khasi Hills MEGHALAYA
East Khasi Hills
MEGHALAYA 		 9415385128

pkgoswamibhu@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC-NEIAH   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  Eupatorium perfoliatum 30 C  Eupatorium perfoliatum 30 C twice Daily for 5 consecutive days in empty stomach orally. One adult dose is 4 globules of no. 20 medicated globule. One child dose is 2 globules of no. 20 medicated globule. Total duration of intervention is five days.  
Comparator Agent  Placebo  Number 20 sugar gloubles will be used as placebo in the control arm 
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Subjects testing positive for SARS CoV-2 by RT-PCR, presenting with no symptoms or mild symptoms.
2. 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. Cases of COVID-19 with clinical severity ranging from moderate to critical.
2. Pregnant and lactating females.
3. Subjects having uncontrolled and unstable co morbidity.
4. Immunocompromised subjects or those taking any kind of immunosupressive therapy.
5. COVIC-19 positive cases participating as subjects in other COVID-19 clinical trails.
6. Subjects having past history of allergy to any medicine that is part of the Homoeopathic intervention. Other conditions, which in the opinion of the investigator, makes the patient unsuitable for enrollment or could interfere with his participation in, and completion of the protocol.  
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess the effectiveness of Homoeopathic medicine Eupatorium perfoliatum 30 C in preventing the progression of severity of the disease in the SARS-Cov-2 tested positive asymptomatic and mild cases of COVID-19.  3 month 
 
Secondary Outcome  
Outcome  TimePoints 
1. To assess the changes in Quality of Life (QoL) of the subjects using WHO QOL-BREF scale.
2. To assess the safety of Eupatorium perfoliatum 30 C drug by observing for adverse events. 		 3 months 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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)   31/07/2020 
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   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   This study is a prospective double blind randomized placebo controlled interventional trial to assess the effectiveness of Eupatorium perfoliatum 30 C, 2 or 4 globules (child/adult dose respectively) twice daily for five days as an add on therapy in 200 participants of asymptomatic and mild symptomatic cases of COVID-19 in one centre in India. The primary outcome will assess the effectiveness of Eupatorium perfoliatum 30 C in preventing the progression of severity of the disease in SARS -CoV 2 tested positive asymptomatic and mild cases of COVID-19 and the secondary outcome will assess the changes in Quality of Life (QoL)  of the participants taking the medicine Eupatorium perfoliatum 30 C.  
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