| CTRI Number |
CTRI/2020/04/024905 [Registered on: 28/04/2020] Trial Registered Prospectively |
| Last Modified On: |
28/04/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A Clinical Trial to study the effectiveness of Homoeopathy as an additional mode of treatment in combating Corona Virus infection |
|
Scientific Title of Study
|
Effectiveness of Homoeopathy as an ancillary mode of treatment and management in combating Corona Virus infection - A Randomized, placebo-controlled, Single Blind Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| C-2020/01 dated 7th April 2020 Version 1 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shaurabh Kumar |
| Designation |
Assistant Professor |
| Affiliation |
Naiminath Homoeopathic Medical College, Hospital and Research Centre |
| Address |
N.H.-19, Firozabad Road, Nawalpur, Behind Maruti Truevalue Showroom,Etmadpur, Agra - 283202
Agra
UTTAR PRADESH
283202
India |
| Phone |
8193896315 |
| Fax |
|
| Email |
deepeshg1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shaurabh Kumar |
| Designation |
Assistant Professor |
| Affiliation |
Naiminath Homoeopathic Medical College, Hospital and Research Centre |
| Address |
N.H.-19, Firozabad Road, Nawalpur, Behind Maruti Truevalue Showroom,Etmadpur, Agra - 283202
Agra
UTTAR PRADESH
283202
India |
| Phone |
8193896315 |
| Fax |
|
| Email |
deepeshg1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shaurabh Kumar |
| Designation |
Assistant Professor |
| Affiliation |
Naiminath Homoeopathic Medical College, Hospital and Research Centre |
| Address |
N.H.-19, Firozabad Road, Nawalpur, Behind Maruti Truevalue Showroom,Etmadpur, Agra - 283202
Agra
UTTAR PRADESH
283202
India |
| Phone |
8193896315 |
| Fax |
|
| Email |
deepeshg1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Homoeopathy |
| Naiminath Homoeopathic Medical College, Hospital and Research Centre |
|
|
Primary Sponsor
|
| Name |
Naiminath Homoeopathic Medical College Hospital and Research Centre |
| Address |
N.H.19, Firozabad Road, Nawalpur, Kuberpur, Etmadpur, Agra - 283202 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Central Council for Research in Homoeopathy |
61-65, Institutional Area, Opposite D Block, Janakpuri, New Delhi - 110058 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shaurabh Kumar |
F.H. Medical College and Hospital |
F.H. Medical College and Hospital, Near Etmadpur, Railway over Bridge, NH2, Firozabad, Uttar Pradesh 283201
Firozabad
UTTAR PRADESH |
8193896315
deepeshg1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC - Naiminath Homoeopathic Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J80||Acute respiratory distress syndrome, (2) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere, (3) ICD-10 Condition: R05||Cough, (4) ICD-10 Condition: R060||Dyspnea, (5) ICD-10 Condition: R509||Fever, unspecified, (6) ICD-10 Condition: R068||Other abnormalities of breathing, (7) ICD-10 Condition: J128||Other viral pneumonia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homoeopathic Medicine: Arsenic Album, Bryonia Alba, Gelsemium, Antimonium Tartaricum, Crotalus Horridus |
100 ml water with 1 drop of indicated Homoeopathic Medicine in 30/ 200/ 1M potency every 2 hourly. Oral route of Administration.
Duration of therapy will be 30 days |
| Comparator Agent |
Placebo |
100 ml Water having 1 drop of Rectified Spirit |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
•Patients suffering from COVID-19 along with subjective and objective symptoms.
•Patients with age groups of 5-70 years.
•Patients of both genders.
•Patients who are willing to give informed consent.
|
|
| ExclusionCriteria |
| Details |
•More than 70 years of age and less than age of 5 years.
•Pregnant females and lactating females.
•Subjects considered not suitable for the study by the researchers.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Primary outcome of this trial will be measured in terms of clinically recovered case (Covid-19 negative) or death. |
21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Recovery in the case where patient is experiencing severe acute respiratory syndrome |
2 hours |
| Decrease in the usage of life supportive equipment like ventilator usage, etc |
5 days |
| Improvement in the quality of life including virulent symptoms of the patients |
24 hours |
| Decrease in the frequency of the dosage of drugs of modern medicine/ conventional treatment according to the standard treatment protocol. |
3 days |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
05/05/2020 |
| 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
|
The
primary aim of this study is to assess the effectiveness of Homoeopathy as an
ancillary mode of treatment to the standard treatment protocol for coronavirus.
Through
this study we will also be able to assess the time of recovery in the case
where patient is experiencing severe acute respiratory syndrome. This will
ultimately prove to be effective in tackling infected patients having acute
respiratory syndrome where homoeopathic intervention will prove to be
beneficial for their recovery. It will also help in assessing the time of
recovery of virulent symptoms. During the study, homoeopathic intervention will
be given to the patients and calculation of relapse rate will be done for these
patients. People with pre existing medical conditions appear to be more
vulnerable to becoming severely ill with the virus. Effective Homoeopathic treatment
for this section of patients can be a game changer in the standard treatment
protocol for Corona virus. |