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CTRI Number  CTRI/2020/06/025530 [Registered on: 02/06/2020] Trial Registered Prospectively
Last Modified On: 01/11/2020
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 Prevention and Treatment of Viral Fevers including COVID19 
Scientific Title of Study   Evaluating the Efficacy of Homeopathic Combinations for Prophylaxis and Treatment of Viral Fevers including COVID19 
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 Agarwal 
Designation  Principal Investigator 
Affiliation  SGPGIMS 
Address  Cancer Aid Society, 402, 4th Floor Sunshine Court Phase 2, 66C Prag Narain Road,
Raibareli Road
Lucknow
UTTAR PRADESH
226001
India 
Phone  8004904589  
Fax    
Email  anil_sgpgi@hotmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr AK Gupta 
Designation  Co Investigator 
Affiliation  Homeopathic Drug Research Institute 
Address  Cancer Aid Society, Head Office, 402, 4th Floor Sunshine Court Phase 2, 66C Prag Narain Road,
National Homeopathic Medical College, 1 Viraj Khand, Gomtinagar
Lucknow
UTTAR PRADESH
226001
India 
Phone  8318457904  
Fax    
Email  drgupta_hema@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr Piyush Gupta 
Designation  Co Investigator 
Affiliation  Cancer Aid Society 
Address  402,4th Floor Sunshine Court Phase 2, 66C Prag Narain Road,
404, 4th Floor Sunshine Court Phase 2, 66C Prag Narain Road,
Lucknow
UTTAR PRADESH
226001
India 
Phone  9335166600  
Fax    
Email  piyushgupta@canceraidsocietyindia.org  
 
Source of Monetary or Material Support  
Cancer Aid Society 4th Floor, Sunshine Court 2, 66C Prag Narain Road, Lucknow, UP 226001 
 
Primary Sponsor  
Name  Cancer Aid Society 
Address  4th Floor, Sunshine Court Phase 2, 66C Prag Narain Road 
Type of Sponsor  Other [Not for Profit NGO] 
 
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 
Dr Piyush Gupta  Cancer Aid Society  Head Office 401, Sunshine Court Phase 2, 66C Prag Narain Road
Lucknow
UTTAR PRADESH 
9335166600

piyushgupta@canceraidsocietyindia.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Cancer Aid Society Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Sanitary Workers and Officers of Nagar Nigam 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Use of Homeopathic Medicines in Prophylaxis/ Treatment of Viral Fevers/ COVID19  Combination of Aconite 30, Arsenic Album 30, Allium Cepa 30, Influenzum 30, Gelsmium 30, Eupatorium 30, Echinacia 0, Thuja 0 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  All the Sanitary Workers and other Staff of Lucknow Nagar Nigam 
 
ExclusionCriteria 
Details  Patients of COVID19 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
How many people get Viral Fever/ COVID19 after taking the Medicine  6 Weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Recording the duration of recovery for existing patients having fever and frequency of administering medicine  One week 
 
Target Sample Size   Total Sample Size="10000"
Sample Size from India="10000" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="17500" 
Phase of Trial   N/A 
Date of First Enrollment (India)   18/06/2020 
Date of Study Completion (India) 28/10/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="2"
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 the Annual Report of Cancer Aid Society 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

Final Research Report (June 2nd, 2020 to October 28th, 2020)

Project title: Evaluating the Efficacy of Homeopathic Combinations for Prophylaxis and treatment of Viral Fevers including COVID 19

CTRI registry no: CTRI/2020/06/025530 dated 2nd June 2020

Principal Investigator: Dr. Anil Agarwal, HOD Anaesthesiology, Sanjay Gandhi Post Graduate Institute of Medical Sciences

Co-Investigators:

1. Dr. Piyush Gupta, Secretary PEO Cancer Aid Society & Secretary NAPCAIM

2. Dr. AK Gupta, (Retd. Assistant Director & Scientist 4th, Homeopathic Drug Research Institute), Assistant Vice President National Association of Palliative Care For AYUSH & Integrative Medicine UP Chapter

3. Dr Prateek Singh Bais, Assistant Professor Anaesthesiology (ATC), Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow

Start Date    :  2nd June 2020

End Date      :  28th October 2020

Status          :  Finished

Objectives   :  To conduct evidence based scientific research in evaluating efficacy of Homeopathic Combinations for Prophylaxis and treatment of Viral Fevers including COVID 19. 

Since most of these medicines are used as a single remedy for associated symptoms hence the study focused on evaluating their combined efficacy in mixtures to provide prophylaxis/ handle viral fevers/ covid19 with multiple symptoms.

Methodology: An open non randomized interventional trial was conducted on the consenting participants (employees of various Government Departments by distributing the combinations of existing homeopathic medicines already being used mostly singly for associated symptoms such as Arsenicum Album, Allium Cepa, Aconitum Napellus, Influenzinum, Gelsmium Sempervirens, Eupatorium Perfoliatum all in 30 CH potency and Tinctures of Thuja Occidentalis, Echinacea Angustifolia.

Sealed bottles of SBL were procured and mixed in equal quantities in an empty bottle and resulting mixture was shaken to prepare a homogeneous solution of the medicines. One packet (450 gms) of 20 No.Globules were put in an air tight plastic container with lid and 30 ml of the above mixture of medicines was poured on the globules and mixed by shaking so that all the globules absorbed the liquid. The Globules soaked with Medicines were packed in Half Dram Bottles containing about 225 Pills.

The starting dose prescribed was set as 3 pills BD for 3 Days for all family Members (the morning dose to be taken before breakfast and night dose before sleeping).  The Medicine was to be repeated every 10 Days to continue the prophylactic effect. 1 bottle of pills was given to each family head for the entire family with instructions as above. Since the data and sample size was huge and movement and contact was restricted hence supervisors were allotted for managing the group of participants and a whatsapp group of all supervisors was formed so as to share the feedback information and reporting of COVID19 Infection or Viral Fever in persons who were taking medications.

Summary on progress:  Medications approved in trial were distributed to a large subset of consenting participants in Lucknow, Uttar Pradesh to about 17500 families and the feedback response was collected.  

Medicines were distributed in as follows:

No. of Families, Date, Place Lucknow

200, 3rd June, Jal Sansthan

250, 4th  June, Gautampalli Police Station 

300, 5th  June, Government Railway Police

400, 15th June, Railway Protection Force

300, 15th June, Hazratganj Police Station

12000, 18th June, Lucknow Nagar Nigam 

500, 22nd June, UP Nirman Nigam

2750, 11th July, Reserve Police Lines

500, 26th August, Health Directorate of UP

300 families on various dates between from June 2nd  2020 till October 26th 2020.

Initial feedback and response has been very encouraging with good acceptance in the society in terms of participants and positive outcomes in terms of feedback.

15 patients who were having undiagnosed Fever when they took the Medicine were advised to take three globules every ten minute for three times and repeat it TDS for a week, it was observed that the Fever got cured within 1 Day, however they were advised to continue it for a week to prevent relapse.

In one family Husband and Wife were already having fever, the husband took medicine under trial however the wife refused, on being advised to take COVID19 test both of them went to a private hospital, where husband who took medicine was negative for COVID19 however the wife tested positive for COVID19 pointing towards its efficacy in prevention.

Other findings/ data collected is recorded and is being evaluated statistically.

Research Work which remains to be done under the project: Finished

Any publications: Annual Report of Cancer Aid Society 2020 - 21

Any patents applied for: None

IF additional budget / staff is required for remaining part of project, pls give justifications and details: Nil

Conclusion: The study has been successful in prophylaxis from Viral Fever / COVID19 however more research is required to check its efficacy in treatment of COVID19 patients.

Relevance and usefulness of the study:

a) IPR values: Homeopathic combination developed above has high IPR Value as no such combination exists presently. This research has established the scientific use of Homeopathic combinations generating Intellectual Property Right in favour of the Sponsor Cancer Aid Society.

b) Translational Value: This research has 100% translational value establishing the fact that by using the existing Homeopathic Medicines being used safely since hundreds of years in health care are effective in prophylaxis / treatment of Viral Fevers/ Covid19 as the Scientists Globally are busy in fighting the invisible enemy weather in its prevention or cure. As several Homeopathic Medicines are available we need to explore further about the efficacy of Homeopathic Medicines in Treatment of COVID19 patients including their role in advance symptom management as several medicines are indicated for managing the symptoms associated with co-morbidities as well as caused due to COVID19 infection.

In spite of contacting all concerned departments who are controlling COVID19 patients we were not successful in using the developed combination in Treatment as we were not permitted to have an access to the COVID19 patients.

Whereas scientific use of Homeopathic Medicines is lacking, some team members have exclusive research on. We now plan to.

 c) Utilization of outcomes of project: The successful research outcome has instilled confidence empowering us to conduct the scientific research on homeopathic interventions in chronic pain where substantial relief up to 50% was reported in several patients within a week; during an inhouse study conducted by the Homeopathic Dispensary of Cancer Aid Society which has been validated through the patient’s interviews. Fast/ immediate response of Homeopathic combinations has been noted even in accidental, post operative, acute and chronic pain management of different ailments.

Homeopathic combinations of dilutions if  developed and used shall unfold a new dimension in providing effective and economical health care across the Country,  as integration of Allopathy and Homeopathy shall address the existing shortage of Medical infrastructure.

Prepared  on 1st of November 2020 by Dr. Piyush Gupta, Secretary & PEO of Cancer Aid Society and National Secretary of National Association of Palliative Care for AYUSH & Integrative Medicine.

 
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