FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2021/04/033073 [Registered on: 23/04/2021] Trial Registered Prospectively
Last Modified On: 31/08/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Using Homeopathic Combinations for the Treatment of Fever due to COVID19 and addressing the associated Respiratory distress. 
Scientific Title of Study   Evaluating the Efficacy of Homeopathic Combinations for the Treatment of Fever due to COVID19 and its effect on addressing the associated Respiratory distress. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Deepak Malviya 
Designation  Principal Investigator 
Affiliation  Ram Manohar Lohia Institute of Medical Sciences 
Address  Department of Anesthesiology, Ram Manohar Lohia Institute of Medical Sciences, Lucknow
Gomtinagar, Lucknow
Lucknow
UTTAR PRADESH
226010
India 
Phone  0522-4918555  
Fax    
Email  drdm58@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Anurag Agarwal  
Designation  Co Investigator 
Affiliation  Ram Manohar Lohia Institute of Medical Sciences 
Address  Department of Anesthesiology Ram Manohar Lohia Institute of Medical Sciences, Lucknow
Gomtinagar, Lucknow
Lucknow
UTTAR PRADESH
226010
India 
Phone  7388970385  
Fax    
Email  dranurag11@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Piyush Gupta 
Designation  Co Investigator 
Affiliation  Cancer Aid Society 
Address  4th Floor Sunshine Court 2, 66C Prag Narain Road, Lucknow
4th Floor Sunshine Court 2, 66C Prag Narain Road, Lucknow
Lucknow
UTTAR PRADESH
226001
India 
Phone  09335166600  
Fax    
Email  piyushgupta@canceraidsocietyindia.org  
 
Source of Monetary or Material Support  
Cancer Aid Society, 4th Floor Sunshine Court 2, 66C Prag Narain Road, Lucknow 
 
Primary Sponsor  
Name  Cancer Aid Society 
Address  4th Floor, Sunshine Court 2, 66C Prag Narain Road, Lucknow 
Type of Sponsor  Other [Registered Society engaged in Health Care] 
 
Details of Secondary Sponsor  
Name  Address 
Zuhause Heilen Pvt Ltd  21/N, 7 Tilak Marg, Dalibagh, Lucknow 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Deepak Malviya  Ram Manohar Lohia Institute of Medical Sciences  Room No. 16, HOD Anesthesia, Ram Manohar Lohia Institute of Medical Sciences, Gomtinagar, Lucknow
Lucknow
UTTAR PRADESH 		 8176007063

drdm58@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Cancer Aid Society Ethics Committee  Approved 
Cancer Aid Society 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
Modification(s)  
Type  Name  Details 
Comparator Agent  Not Applicable  Not Applicable 
Intervention  Using Homeopathic Combinations for the Treatment of Fever due to COVID19 and associated Respiratory distress, comparator not available  Arsenicum Album, Allium Cepa, Aconitum Napellus, Influenzinum, Gelsmium Sempervirens, Eupatorium Perfoliatum, Echinecia, Thuja Occidentalis, Senega, Aspidosperma quebracho, Arnica Montana, Crataegus oxyacantha, Chelidonium majus Homeopathic Combinations X & Y with the beginning dose of 3 pills to be taken sublingually six times every 10 minutes, then six times every hour and finally six times daily. 
 
Inclusion Criteria
Modification(s)  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  COVID +VE PATIENTS
Patients having Fever or Respiratory Distress or Both being treated by Ram Manohar Lohia Institute of Medical Sciences / COVID -ve Patients with COVID Symptoms, through Telephonic Consultation  
 
ExclusionCriteria 
Details  COVID -VE PATIENTS
Patients with Comorbidities
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome
Modification(s)  
Outcome  TimePoints 
Treatment of fever and respiratory distress of
patients suffering from COVID19 infection / post COVID complications. 		 1 Week for normal and 1 Month for serious patients  
 
Secondary Outcome  
Outcome  TimePoints 
Decreased Viral Load/ Cure from COVID19   1 week 
 
Target Sample Size
Modification(s)  		 Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   N/A 
Date of First Enrollment (India)   24/04/2021 
Date of Study Completion (India) 06/08/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial
Modification(s)  		 Years="0"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 To be published in Cancer Aid Society Annual Report, Website and other Journals 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

Final Report of Clinical Trial CTRI Registration No.: CTRI/2021/04/033073

 

Titled: Evaluating the Efficacy of Homeopathic Combinations for the Treatment of Fever due to COVID19 and its effect on addressing the associated Respiratory distress.

 

An Homeopathic, Interventional, Non-randomized, Active Controlled Trial conducted jointly by Dept. of Anaesthesia Ram Manohar Lohia Institute of Medical Sciences, Cancer Aid Society & Zuhause Heilen Pvt. Ltd.

 

Ethical Clearance obtained from: Cancer Aid Society Ethics Committee 

CDSCO Registration No.: ECR/331/Indt/UP/2020


Investigational Team

 

Principal investigator:

1.     Dr. Deepak Malviya, MD, FICA

Professor & Head, Department of Anesthesiology,

Ram Manohar Lohia Institute of Medical Sciences, Lucknow

 

Co-Investigator(s):

1.     Dr. Anurag Agarwal, MBBS, MD, PDCC (Pain Management)

Professor, Department of Anesthesiology

Ram Manohar Lohia Institute of Medical Sciences, Lucknow


2.     Dr. Shivani Rastogi, MBBS, MD

Ram Manohar Lohia Institute of Medical Sciences, Lucknow

 

3.     Dr. R.K. Jaiswal, BHMS, CCYP

Assistant Professor Department of Physiology & Biochemistry

National Homoeopathic Medical College & Hospital, Lucknow

 

4.     Dr. Piyush Gupta, BSc, PGDIRPM, LLB, MA, Fellowship in Palliative Care, PhD

Fellow National Cancer Institute, National Institute of Health - USA

Secretary Cancer Aid Society & National Association of Palliative Care for AYUSH & Integrative Medicine, Lucknow 226001

 

Background:

An extension of successfully completed a Clinical Trial No. CTRI/2020/06/025530 [Registered on: 02/06/2020] on using the Homeopathic Combination for the Prophylaxis of Viral Fevers/ COVID19. Same combination was tested for treating the patients suffering from COVID19 infection and associated Fever along with another combination for Treating the decreased SpO2.

Outcome:

Initially the Trial was to pe conducted on indoor patients however it was observed that in absence of injections it was not possible to give Homeopathic Medicines Orally at very short intervals as all the patients were on Oxygen hence the study was amended for the patients on home quarantine observing all the requirements of COVID19 Lockdown.

 

The Medicines were delivered to the patients contacting telephonically and the study was conducted in 30 patients. 

 

Google Form was created for recording the data having requisite fields and responses obtained for assessment on the following options followed by RTPCR Test after treatment:

  • Temperature (high) above 98.7 & SpO2 (low) 90% to 94%
  • Temperature (high) above 98.7 & SpO2 (low) less than 90%
  • Temperature (normal) upto 98.7 & SpO2 (low) 90% to 94%
  • Temperature (normal) upto 98.7 & SpO2 below 90%
  • Temperature (high) above 98.7 & SpO2 (NORMAL) 94% and above
  • Temperature (NORMAL) upto 98.7 & SpO2 (NORMAL) 94% and above

 

  1. Before starting Homeopathic Combinations                    

1 Patients was RTPCR +ve but asymptomatic and became RTPCR -ve

 

  1. 1 Day after starting Homeopathic Combinations

4 Patients recorded Normal Temperature upto 98.7 & SpO2 over 94%

(2 Patients had Temperature (high) above 98.7 & SpO2 (low) 90% to 94%,

1 Patient had Temperature (high) above 98.7 & SpO2 (NORMAL) 94% and above,

1 Patient had Temperature (normal) upto 98.7 & SpO2 below 90%)

 

  1. 2 Days after starting Homeopathic Combinations

6 Patients recorded Normal Temperature upto 98.7 & SpO2 over 94%

1 Patients recorded Temperature (normal) upto 98.7 & SpO2 (low) 90% to 94% recovered from below 90%

(2 Patients had Temperature (high) above 98.7 & SpO2 (NORMAL) 94% and above

 3 Patients had Temperature (high) above 98.7 & SpO2 (low) 90% to 94%

 1 Patients had Temperature (normal) upto 98.7 & SpO2 (low) 90% to 94%

 1 Patients had Temperature (normal) upto 98.7 & SpO2 below 90%)

 

  1. 4 Days after starting Homeopathic Combinations  

7 Patients recorded Normal Temperature upto 98.7 & SpO2 over 94%

3 Patients recorded Temperature (normal) upto 98.7 & SpO2 (low) 90% to 94% recovered from below 90%

1 Patient recorded Temperature (high) above 98.7 & SpO2 (low) 90% to 94% recovered from below 90%

(7 Patients had Temperature (high) above 98.7 & SpO2 (low) 90% to 94%

2 Patients had Temperature (normal) upto 98.7 & SpO2 (low) 90% to 94%

1 Patients had Temperature (normal) upto 98.7 & SpO2 below 90%)

 

  1. 5 Days after starting Homeopathic Combinations 

1 Patients recorded Normal Temperature upto 98.7 & SpO2 over 94%

(1 Patient had Temperature (normal) upto 98.7 & SpO2 below 90%)

 

  1. 7 Days after starting Homeopathic Combinations  

4 Patients recorded Normal Temperature upto 98.7 & SpO2 over 94%

1 Patients recorded Temperature (normal) upto 98.7 & SpO2 (low) 90% to 94% recovered from below 90%

1 Temperature (high) above 98.7 & SpO2 (low) 90% to 94%

(2 Patients had Temperature (high) above 98.7 & SpO2 (low) 90% to 94%

1 Patient had Temperature (high) above 98.7 & SpO2 (low) less than 90%

1Patient had Temperature (normal) upto 98.7 & SpO2 below 90%)

1 Patient had Temperature (high) above 98.7 & SpO2 (low) 90% to 94%, this lady came from USA to look her RTPCR -ve father admitted in ICU for low SpO2, got RTPCR +ve while returning, took the combination and became RTPCR -ve on 6th Day, when she was advised to switch on the AC her temperature became normal)

 

Note:

  • Three Patients had increased sugar levels due to use of Steroids were able to maintain Sugar Levels using separate homeopathic combination.
  • 4 Patients have uncontrolled cough which was controlled using separate homeopathic combination.
  • 2 Patients had severe constipation which was relieved using separate homeopathic combination.
  • Two of the Patients who were on Oxygen at home for over two months without any improvement showed remarkable recovery with One Week of using Homeopathic Combinations where SpO2 Level improved between 90% to 94% however they were advised to continue treatment till full recovery.

 

Conclusion:

Homeopathic Combinations were highly successful in treating effectively the COVID19 infection, associated temperature and decreased SpO2 Levels showing improvement after 1 day of taking the combination. All the patients were Satisfied and gave encouraging remarks regarding the combination. Needless to mention that a few of the Care Givers belonged to the System of Modern Medicine who reported the Homeopathic Combination as being effective.

 

Link of Graphical representation:  https://drive.google.com/file/d/1ke1OWQxv6CZlCUJsbG2tDxV3qetzPOS1/view?usp=sharing


 
Close