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CTRI Number  CTRI/2020/08/027005 [Registered on: 05/08/2020] Trial Registered Prospectively
Last Modified On: 04/12/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Investigation of effect of homoeopathic remedy as add on therapy to standard of care (regular treatment) in adult patients with moderate to severe COVID-19 
Scientific Title of Study   A Phase 2 evaluation of the efficacy of homoeopathic remedy Zincum Muriaticum as an adjuvant therapy to standard of care in adult patients with moderate to severe COVID-19: Randomized, double-blind, parallel group, placebo controlled, multicenter trial (ZIMCOV) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Anil Habbu 
Designation  Col (Hony) 
Affiliation  Homoeocon Foundation 
Address  B-5 Abhimanshree Society, Pashan road, Pune

Pune
MAHARASHTRA
411008
India 
Phone  020-25658688  
Fax    
Email  drahabbu@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Anil Khurana 
Designation  Director General Incharge 
Affiliation  Central Council for Research in Homoeopathy  
Address  61-65 Institutional Area, Opp D Block, Janak Puri, New Delhi

New Delhi
DELHI
110058
India 
Phone  011-28525523  
Fax  011-28521060  
Email  ccrhindia@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Anil Khurana 
Designation  Director General Incharge 
Affiliation  Central Council for Research in Homoeopathy  
Address  61-65 Institutional Area, Opp D Block, Janak Puri, New Delhi

New Delhi
DELHI
110058
India 
Phone  011-28525523  
Fax  011-28521060  
Email  ccrhindia@gmail.com  
 
Source of Monetary or Material Support  
Homoeocon Foundation, B-5 Abhimanshree Society, Pashan road, Pune-411008, Maharashtra 
 
Primary Sponsor  
Name  Homoeocon Foundation 
Address  Homoeocon Foundation, B-5 Abhimanshree Society, Pashan road, Pune-411008  
Type of Sponsor  Other [Non-Profit Organization] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrPrachee Deshpande   Bharati Hospital and Research Centre  Pune Satara Road
Pune
MAHARASHTRA 
9011073840

drprachee@gmail.com 
Dr Gajanan Kurundkar  Smt. Kashibai Navale General Hospital  Department of General Medicine, S.No. 49/1, Narhe, Off Mumbai - Pune Bypass, Pune- 411041
Pune
MAHARASHTRA 
9921244263

gbkurundkar@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee Bharati Hospital Deemed University   Approved 
Institutional Ethics Committee, Smt. Kashibai Navale Medical College and General Hospital   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 
Comparator Agent  Identical Plaebo  Sucrose globules premedicated with liquid potency will be administered per orally. A single dose will consist of two globules of size 40. The dosage will be six times a day at an interval of 3 hours between two successive doses In case patents are intubated, they will receive reconstituted dilution PO Dosing frequency will be02 drops two hourly eight times a day. Upon discharge, the dosage will be three times a day at an interval of 6 hours between two successive doses  
Intervention  Zincum muriaticum 200C   Sucrose globules premedicated with liquid potency will be administered per orally. A single dose will consist of two globules of size 40. The dosage will be six times a day at an interval of 3 hours between two successive doses In case patents are intubated, they will receive reconstituted dilution PO Dosing frequency will be02 drops two hourly eight times a day. Upon discharge, the dosage will be three times a day at an interval of 6 hours between two successive doses  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  A subject will be considered eligible for inclusion in this study only if ALL of the following criteria apply:
1. Hospitalized patient with laboratory-confirmed SARS-CoV-2 infection as determined by polymerase chain reaction (PCR) (or any other confirmatory test to diagnose SARS-CoV-2 infection if there is such change in guidelines issued time to time by the Government of India, Task Force for COVID or any other concerned authority/body assigned for this purpose) as documented by either of the following:
PCR positive in sample collected < 72 hours prior to randomization; OR
PCR positive in sample collected ≥ 72 hours prior to randomization with documented inability to obtain a repeat sample (e.g. due to lack of testing supplies, limited testing capacity, results taking >24 hours, etc.)
2. Subject (or legally acceptable representative) understands and agrees to comply with planned study procedures and provides informed consent prior to initiation of study procedures.
3. Male or non-pregnant female adult ≥18 years of age at time of enrolment.
4. Illness with ≤12 days duration, and at least one of the following:
Radiographic infiltrates by imaging captured during the period between date of admission to date of enrolment that is chest x-ray, CT scan, lung ultrasound.
Presence of clinical features of dyspnea and or hypoxia, fever cough including Respiratory rate > 24 breaths/min OR SpO2 < or equal to 94 on room air
Requiring supplemental oxygen
Requiring HFNO/NIV
5. Women of childbearing potential must agree either to abstinence or to use at least one primary form of contraception not including hormonal contraception from the time of screening till end of the study.
6. Subject (or legally acceptable representative) agrees to not participate in another clinical trial for the treatment of COVID-19 or SARS-CoV-2 till end of this study.
7. Subject (or legally acceptable representative) is willing to be a study participant and to accept randomization to any assigned treatment arm.



 
 
ExclusionCriteria 
Details  1. Physician makes a decision that trial involvement is not in patient’s best interest, or there is any condition that does not allow the protocol to be followed safely.
2. There is anticipated discharge from the hospital or transfer to another hospital which is not a study site within 72 hours.
3. Patient already in another clinical trial of an experimental treatment for COVID-19
4. Patient has a PaO2/FiO2 ratio < 200 or is requiring IMV/ECMO at baseline. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
TTR (Time to Recovery)  Censored at Day 28
TTR is defined as the time (in days) from randomization of study treatment (active or placebo) until Day of recovery. Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the eight category ordinal scale 
 
Secondary Outcome  
Outcome  TimePoints 
Change from baseline in Alanine Transaminase (ALT)  Time Frame: Day 3 through Day 28 or discharge whichever is earlier 
Change from baseline in Aspartate Transaminase (AST)  Time Frame: Day 3 through Day 28 or discharge whichever is earlier 
Change from baseline in Total Bilirubin  Time Frame: Day 3 through Day 28 or discharge whichever is earlier 
Change from baseline in Prothrombin Time (PT)  Time Frame: Day 3 through Day 28 or discharge whichever is earlier 
Change from baseline in Creatinine  Time Frame: Day 3 through Day 28 or discharge whichever is earlier 
Change from baseline in Haemoglobin  Time Frame: Day 3 through Day 28 or discharge whichever is earlier 
Change from baseline in Total WBC count  Time Frame: Day 3 through Day 28 or discharge whichever is earlier 
Change from baseline in Differential WBC count  Time Frame: Day 3 through Day 28 or discharge whichever is earlier 
Change from baseline in Platelet count  Time Frame: Day 3 through Day 28 or discharge whichever is earlier 
Change from baseline in Serum Ferritin levels  Time Frame: Day 3 through Day 28 or discharge whichever is earlier 
Change from baseline in D-dimer levels  Time Frame: Day 3 through Day 28 or discharge whichever is earlier 
Change from baseline in ESR  Time Frame: Day 3 through Day 28 or discharge whichever is earlier 
Change in National Early Warning Score (NEWS)  Time Frame: Day 3 through Day 28 or discharge whichever is earlier 
Clinical status using Ordinal scale  Time Frame: Day 3 through Day 28 or discharge whichever is earlier 
Duration of hospitalization: Measured in days  Time Frame: Day 0 through Day 28 
Duration of NIV or HFNO use: Measured in days  Time Frame: Day 0 through Day 28 
Incidence of new NIV or HFNO use  Time Frame: Day 0 through Day 28 
Incidence of IMV or ECMO use  Time Frame: Day 0 through Day 28 
Mean change in the Ordinal scale  Time Frame: Day 3 through Day 28 
Percentage of subjects reporting each severity rating on an 8-point Ordinal scale  Time Frame: Day 12 
Subject 12-day mortality: Date and cause of death (if applicable)  Time Frame: Day 0 through Day 12 
Subject 28-day mortality: Date and cause of death (if applicable)  Time Frame: Day 0 through Day 28 
Time to an improvement of one category using an Ordinal scale   Time Frame: Day 0 through Day 28 
Time to an improvement of two categories using an Ordinal scale  Time Frame: Day 0 through Day 28 
Time to discharge or to a National Early Warning Score (NEWS) of or equal to 2, whichever occurs first  Time Frame: Day 0 through Day 28 
 
Target Sample Size   Total Sample Size="96"
Sample Size from India="96" 
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)   12/08/2020 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details
Modification(s)  
None 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

The study is being conducted to evaluate the efficacy of homoeopathy as an adjuvant therapy to standard of care in adult patients with moderate to severe COVID-19.

This is a 12-month prospective, randomized, parallel group, double blind, placebo-controlled trial on homoeopathy medicine Zincum muriaticum 200C to assess the effect ( efficacy) of homoeopathy as an adjuvant therapy to standard of care in adult patients with moderate to severe COVID-19 virus infection versus the patients receiving identical placebo in addition to standard of care. The study will be conducted in 96 subjects (male and female), aged more than 18 years. 
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