| CTRI Number |
CTRI/2020/04/024947 [Registered on: 30/04/2020] Trial Registered Prospectively |
| Last Modified On: |
30/04/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Clinical trial on effects of homeopathic medicine made from cadamba on COVID-19 |
|
Scientific Title of Study
|
Drug Proving & checking its effectiveness in treatment of COVID 19 |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prashant katre |
| Designation |
Doctor |
| Affiliation |
Homoeo clinic |
| Address |
dr katre house
homoeo clinic civil line
homoeo clinic civil line
Gondiya
MAHARASHTRA
441601
India |
| Phone |
9325259285 |
| Fax |
|
| Email |
priti.katre@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prashant katre |
| Designation |
Doctor |
| Affiliation |
Homoeo clinic |
| Address |
dr katre house
homoeo clinic civil line
homoeo clinic civil line
Gondiya
MAHARASHTRA
441601
India |
| Phone |
9325259285 |
| Fax |
|
| Email |
priti.katre@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prashant katre |
| Designation |
Doctor |
| Affiliation |
Homoeo clinic |
| Address |
dr katre house
homoeo clinic civil line
homoeo clinic civil line
Gondiya
MAHARASHTRA
441601
India |
| Phone |
9325259285 |
| Fax |
|
| Email |
priti.katre@gmail.com |
|
|
Source of Monetary or Material Support
|
| at present in basic level i have arranged raw material on my own |
|
|
Primary Sponsor
|
| Name |
Dr Priti katre |
| Address |
Homoeo clinic civil line locoshed road Gondia Maharashtra 441601 |
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Prashant katre |
homoeo clinic |
Gondia homeopathic institute surya tola Gondia Maharashtra
Gondiya
MAHARASHTRA |
9325259285
priti.katre@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Gondia homoeopathic medical college and hospital research ethic review committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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 |
cadamba drug therapy |
1st 3 days 6 doses in every 2 hours
QID 3 days
then TDS for weeks
potency 200
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1 COVID affected individual (serologically positive) symptomatic, mild hospitalized
2 asymptomatic (serologically positive) |
|
| ExclusionCriteria |
| Details |
1.Malabsorption or inadequate oral intake
2.unexplained, chronic diarrhea, defined as more than 3 loose stool per day persisting for 2 weeks or more within the month prior to study entry.
3. Active malignancy or anticipated need for chemotherapy during the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
with refrance to time scale T1-T4 --
from 5-7 weeks we expect complete recovery of patient who presented with initial symptoms.
1 patient should be asymptomatic with gental recovery (with serologically negative blood test) within 7-14 days after administration of 1st dose of medicine.
2 asymptomatic patient (serologically positive) will remain asymptomatic and should be serologically negative after 7-14 days of treatment. |
with refrance to time scale T1-T4 --
from 5-8 weeks we expect complete recovery of patient who presented with initial symptoms. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
with refrance to time scale T1-T5
if patient have late symptoms with initial pathological changes in vital organs we expect recovery by day 14
1 we can conclude after the study is complete.
|
(T1 to T5)
T1- presentation before medicine intake.
T2- observation for 1-3 days after drug intake.
T3- 3 to 7days gradual disappearance of initial symptoms.
T4- after 7 days recovery expected.
T5- If associated with other secondary complaints expected recovery is by 7-14 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)
|
08/05/2020 |
| 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
|
chemical components of this drug help us to resolve · Anti-viral· Anti-inflammatory
·
Anti-pyretic
·
Anti-diarrheal
·
Wound healing properties
·
Strong immuno-modulator
Blood
purifier also the raw material of drug resembles to that of the virus which full fills the criteria of homoeopathy that is doctrine of signature so i hope this drug of mine can help us fight covid 19 pandemic |