FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2021/09/036162 [Registered on: 02/09/2021] Trial Registered Prospectively
Last Modified On: 19/05/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Study to Evaluate Efficacy and Safety of a Combination of Homeopathic Medications as an Add on Therapy in Patients with Severe to Critical COVID-19 Infection 
Scientific Title of Study   A Randomized, Open label Study to Evaluate Efficacy and Safety of a Combination of Homeopathic Medications as an Add on Therapy to Standard of Care in Patients with Severe to Critical SAR-COV-2 (COVID-19) Infection 
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 Sarman Singh 
Designation  Director and CEO 
Affiliation  All India Institute of Medical Sciences Bhopal 
Address  Department of Clinical Microbiology, All India Institute of Medical Sciences, Bhopal

Bhopal
MADHYA PRADESH
462020
India 
Phone    
Fax    
Email  director@aiimsbhopal.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Abhishek Singhai 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences Bhopal 
Address  Department of General medicine, All India Institute of Medical Sciences Bhopal

Bhopal
MADHYA PRADESH
462020
India 
Phone    
Fax    
Email  abhishek.genmed@aiimsbhopal.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Ashish Kumar Dixit 
Designation  Medical Officer (Homoeopathy) 
Affiliation  All India Institute of Medical Sciences Bhopal 
Address  Department of AYUSH, All India Institute of Medical Sciences Bhopal

Bhopal
MADHYA PRADESH
462020
India 
Phone    
Fax    
Email  ashish.ayush@aiimsbhopal.edu.in  
 
Source of Monetary or Material Support  
Dr Manoj Kuriakose, Hyderabad and All India Institute of Medical Sciences Bhopal 
 
Primary Sponsor  
Name  Dr Manoj Kuriakose 
Address  Avenue 6, Behind Care Hospital, Banjara Hills, Hyderabad 500034  
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
All India Institute of Medical Sciences Bhopal  All India Institute of Medical Sciences, Saket Nagar, Bhopal 462020 
 
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 Sarman Singh  Departments of General Medicine and Trauma & Emergency Medicine  All India Institute of Medical Sciences, Saket Nagar, Bhopal
Bhopal
MADHYA PRADESH 		 0755-2672317

director@aiimsbhopal.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
All India Institute of Medical Sciences Bhopal Institutional Human 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  Combination of homeopathic medication   Combination of homeopathic medication (Arsenicum Album +Bryonia Alba + Phosphorus) 
Comparator Agent  Standard of Care (SOC)  The Standard of Care (SOC) will be given as per the recent guidelines for management of COVID 19 infection and may include - Symptomatic treatment - Oxygenation - Conservative fluid management. - Corticosteroids: IV Methylprednisolone 1-2 mg/kg or Dexamethasone 0.2-0.4 mg/kg for 5-7 days - Anti-IL-6 therapy such as tocilizumab  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Subject (or legally authorized representative) provides informed consent prior to initiation of any study procedures.
2. Male and female subjects greater than 18 years of age.
3. Has laboratory-confirmed SARS-CoV-2 infection as determined by RT-PCR, Rapid Antigen Test, CBNAAT or CT suggestive of Pneumonia (CO-RADS 5 grade).
4. Adult with radiological signs of pneumonia (chest x-ray, CT scan, etc.) plus one of the following.
a. respiratory rate >30 breaths/min,
b. severe respiratory distress,
c. SpO2 <90% on room air.
d. With/without Oxygenation impairment: (Mild ARDS: 200 mmHg < PaO2/FiO2 ≤ 300 mmHg (with PEEP or CPAP ≥5 cm H2O); Moderate ARDS: 100 mmHg < PaO2/FiO2 ≤200 mmHg with PEEP ≥5 cm H2O); Severe ARDS: PaO2/FiO2 ≤ 100 mmHg with PEEP ≥5 cm H2O)
5. Patient with or without pre-existing significant co-morbidities (e.g. lung diseases, diabetes, hypertension) at the discretion of the investigator.
6. Women of childbearing potential and men who partner with a woman of childbearing potential must agree to use contraceptive methods.
7. Willingness and ability to comply with trial and follow-up procedures.
8. Ability to understand the nature of the trial and give written informed consent.
 
 
ExclusionCriteria 
Details  1. Patient with mild-moderate COVID-19 infection
2. Patients who are allergic to arsenic album products
3. Severely immunocompromised patients for example patients with a history of HIV infection, patients with solid organ transplantation or bone marrow transplantation, patients receiving chemotherapy/radiotherapy, patients with primary immunodeficiency.
4. ALT/AST > 5 times the upper limit of normal.
5. Stage 4 severe chronic kidney disease or requiring dialysis (eGFR <30 ml/min)
6. Subjects who is receiving Covid-19 directed alternative medication (e.g. Any ayurvedic, Unani or homeopathic)
7. Participation of patient in other investigational clinical studies
8. Pregnant or breastfeeding.
9. Concomitant disease or condition that could interfere with the conduct of the study, or for which the treatment could interfere with the conduct of the study, or that would in the opinion of investigator, pose an unacceptable risk to the subject in this study.
10. Inability or unwillingness to comply with study and/or follow-up procedures outlined in the protocol.
11. Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
● Patient clinical status (8-point ordinal scale) at Day 15.
1. Death
2. Hospitalized, on invasive mechanical ventilation or ECMO
3. Hospitalized, on non-invasive ventilation or high flow oxygen devices
4. Hospitalized, requiring supplemental oxygen
5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise)
6. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care.
7. Not hospitalized, limitation on activities and/or requiring home oxygen
8. Not hospitalized, no limitations on activities
 		 at day 15 
 
Secondary Outcome  
Outcome  TimePoints 
● To assess the Clinical Severity:
1. Ordinal scale:
- Time to an improvement of one category from admission using an ordinal scale.
- Subject clinical status using ordinal scale at Days 3, 5, 8, 11, and 29.
(Ordinal outcome will be assessed daily while hospitalized and on Days 15, 22 and 29)
2. National Early Warning Score (NEWS):
- The time to discharge or to a NEWS of ≤ 2 and maintained for 24 hours, whichever occurs first.
(NEWS will be assessed daily while hospitalized and on Days 15, 22 and 29)
3. Length of stay
- Length of stay (ICU or ward)in days.
4. Mortality in ICU patients
5. Need of admitting to ICU for patients admitted in wards.
● To evaluate the safety
- Incidence of serious adverse events (SAEs)
- Incidence of Grade 3 and 4 adverse events (AEs).
- Discontinuation or temporary suspension of study drug (for any reason).
 		 1. Subject clinical status using ordinal scale at Days 3, 5, 8, 11, and 29.
(Ordinal outcome will be assessed daily while hospitalized and on Days 15, 22 and 29)
2.National Early Warning Score (NEWS):
- The time to discharge or to a NEWS of ≤ 2 and maintained for 24 hours, whichever occurs first.
(NEWS will be assessed daily while hospitalized and on Days 15, 22 and 29
 
●Percentage change in the biomarkers such as IL-4, IL-6, CRP, ferritin, d-dimer and troponin C  on day 1,3,5,8 and 11 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   01/10/2021 
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)  		 Suspended 
Recruitment Status of Trial (India)  Suspended 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

This is a randomized, open-label, two-arm study of the combination of homoeopathic medications as add-on therapy in patients with severe to critical COVID-19 infection being conducted at AIIMS Bhopal. The objective of this study is to assess the efficacy and safety of a homoeopathic medication combination as add-on therapy in severe COVID 19 patients, as assessed by the Clinical Severity-Ordinal scale, the National Early Warning Score (NEWS), oxygenation, mechanical ventilation, hospitalisation, and mortality. Additionally, to assess changes in inflammatory markers.

 
Close