| CTRI Number |
CTRI/2020/05/025049 [Registered on: 06/05/2020] Trial Registered Prospectively |
| Last Modified On: |
05/05/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
A CLINICAL TRIAL TO STUDY THE EFFICACY OF HOMOEOPATHIC MEDICINE IN PREVENTION AND CURE OF CORONA VIRUS DISEASE 19 |
|
Scientific Title of Study
|
PROVING THE EFFICACY OF HOMOEOPATHIC TREATMENT IN PREVENTION AND CURE 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 |
DR DHIRENDRA TIWARI |
| Designation |
DIRECTOR |
| Affiliation |
SAI NIDAN HOMOEOPATHY CLINIC |
| Address |
SAI NIDAN HOMOEOPATHY CLINIC
NEAR SAI MANDIR , BANARAS ROAD, AMBIKAPUR,CHHATTISGARH,
Surguja
CHHATTISGARH
497001
India |
| Phone |
8770568212 |
| Fax |
|
| Email |
drdhiren16@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
DR DHIRENDRA TIWARI |
| Designation |
DIRECTOR |
| Affiliation |
SAI NIDAN HOMOEOPATHY CLINIC |
| Address |
SAI NIDAN HOMOEOPATHY CLINIC
NEAR SAI MANDIR , BANARAS ROAD, AMBIKAPUR,CHHATTISGARH,
CHHATTISGARH
497001
India |
| Phone |
8770568212 |
| Fax |
|
| Email |
drdhiren16@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
DR DHIRENDRA TIWARI |
| Designation |
DIRECTOR |
| Affiliation |
SAI NIDAN HOMOEOPATHY CLINIC |
| Address |
SAI NIDAN HOMOEOPATHY CLINIC
NEAR SAI MANDIR , BANARAS ROAD, AMBIKAPUR,CHHATTISGARH,
CHHATTISGARH
497001
India |
| Phone |
8770568212 |
| Fax |
|
| Email |
drdhiren16@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| LATE VEDVATI DUBEY SIKSHAN SAMITI, AMBIKAPUR, CHHATTISGARH
497001
|
| SAI NIDAN HOMOEOPATHY CLINIC
NEAR SAI MANDIR , BANARAS ROAD, AMBIKAPUR,CHHATTISGARH,
497001
|
|
|
Primary Sponsor
|
| Name |
SAI NIDAN HOMOEOPATHY CLINIC |
| Address |
NEAR SAI MANDIR , BANARAS ROAD, AMBIKAPUR,CHHATTISGARH,
497001
|
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| DR ASHISH DUBEY |
LATE VEDVATI DUBEY SIKSHAN SAMITI, AMBIKAPUR, CHHATTISGARH
497001
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR DHIRENDRA TIWARI |
SAI NIDAN HOMOEOPATHY CLINIC |
NEAR SAI MANDIR , BANARAS ROAD, AMBIKAPUR,CHHATTISGARH,
497001
Surguja
CHHATTISGARH |
9926190306
drdhiren16@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| CG H R I INSTITUTIONAL ETHICS 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 |
ARSENIC ALBUM 30 |
HOMOEOPATHIC MEDICINE ARSENIC ALBUM IN POTNTISED FORM OF 30 CENTICIMAL POTENCY OD DAILY FOR 3 DAYS |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
MALES OR FEMALES WITH A DIAGNOSIS OF COVID 19 AND MALES OR FEMALES QUARANTINE PERSON FOR COVID 19 |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Primary endpoint of this trial will be measured in terms of clinically recovered cases (covid 19 negative)or death |
1 MONTH |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in the quality of life w.r.t. activity, appetite , sleep and general condition of patient. fever clearance , changes in severity of symptoms, resolution of pneumonia |
every 7 days |
| Suspected cases in quarantine confirmed as negative |
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 2/ 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
|
THIS
STUDY IS A CLUSTER RANDOMIZED TRIAL OF HOMOEOPATHIC MEDICINE ARSENIC ALBUM 30
OD DAILY 3 DAYS IN COVID 19 POSITIVE PERSONS AND SUSPECTED QUARANTINE PERSONS
THAT WILL BE CONDUCTED IN 4 CENTRES IN INDIA. THE PRIMARY OUTCOME MEASURES WILL
BE EFFICACY IN CURING AND PREVENTION OF COVID19. THE SECONDARY OUTCOME WILL BE
PREVENTION OF COVID19. |