| CTRI Number |
CTRI/2020/05/024969 [Registered on: 01/05/2020] Trial Registered Prospectively |
| Last Modified On: |
28/09/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Homoeopathy as adjuvant in management of Covid-19 infection |
|
Scientific Title of Study
|
Effect of adjuvant homoeopathy with standard treatment protocol in management of covid-19: a randomised, open label, placebo controlled, parallel group study
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Dr Pradeep Kumar Gupta |
| Designation |
Principal |
| Affiliation |
Naiminath Homoeopathic Medical College, Hospital and Research Centre |
| Address |
N.H.19, Firozabad Road, Nawalpur, Etmadpur,
Agra, Uttar Pradesh
Agra
UTTAR PRADESH
283202
India |
| Phone |
9765270885 |
| Fax |
|
| Email |
nhmcagra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Debadatta Nayak |
| Designation |
Research Officer/Scientist-II |
| Affiliation |
CCRH |
| Address |
61-65, Sewa Marg, Opp D Block, Institutional Area, Janakpuri, New Delhi, Delhi 110058
61-65, Sewa Marg, Opp D Block, Institutional Area, Janakpuri, New Delhi, Delhi 110058
South West
DELHI
110058
India |
| Phone |
09873404012 |
| Fax |
|
| Email |
drdnayak@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anil Khurana |
| Designation |
Director General Incharge |
| Affiliation |
CCRH |
| Address |
61-65, Sewa Marg, Opp D Block, Institutional Area, Janakpuri, New Delhi, Delhi 110058
61-65, Sewa Marg, Opp D Block, Institutional Area, Janakpuri, New Delhi, Delhi 110058
South West
DELHI
110058
India |
| Phone |
09911127619 |
| Fax |
|
| Email |
anilnaman@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| 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, Etmadpur,
Agra, Uttar Pradesh – 283202
|
| Type of Sponsor |
Private medical college |
|
|
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 |
| Prof Dr Pradeep Kumar Gupta |
F.H. Medical College and Hospital |
Near Etmadpur, Railway over bridge,
N.H -2 , Agra, Uttar Pradesh - 283201
Agra
UTTAR PRADESH |
9765270885
nhmcagra@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee-F H Medical College |
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 |
Homoeopathic medicine |
Homoeopathic medicines will be given to this group patients as an add-on to standard treatmet. Following Individualization medicines will be selected keeping in view pathological aspect of disease. Dose and potency will be according to the frequency, intensity and duration of signs and symptoms. Repetitions will vary from cae to case basis cosidering disease state and vitality of patient. Range of potency from 30, 200, 1M etc will be used. |
| Comparator Agent |
Placebo |
Placebo group patients will receive identical placebo (globules moistened with dispensing alcohol) as an add on to standard protocol treatment. Dose repetition will be a in similar pattern to medicine group. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
o Symptomatic RT-PCR confirmed cases of
Covid-19 infection.
o Both sexes
o Age between 18 years to 80 years and
o Willing to give signed written informed
consent
|
|
| ExclusionCriteria |
| Details |
1. Patients requiring ventilatory support
2. Patients with compromised immunity
3. Severe heart, lung, kidney, brain, blood
diseases or other important systemic
diseases
4. Subjects unable to complete the study, or
not suitable for the study by
researchers.
5. Women during pregnancy
6. Lactating mothers
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Clinical outcome in terms of recovery of patient or requirement of life support (ventilator)/ death. |
Ever 24 hr. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
i. Time to progression to critical stage
ii. Time to fever clearance
iii. Time to resolution of pneumonia
iv. Change in severity of symptoms as per clinical syndromes associated with COVID - 19 infection.
v. Time to recovery in terms of 2 negative test for Covid-19
vi. Period of hospital stay
vii. Requirement of conventional medication till clinical improvement
|
Ever 24 hr. |
|
|
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)
Modification(s)
|
15/10/2020 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/10/2020 |
| 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
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The results of the study will be able to predict the role of add on homoeopathic treatment for management of Covid-19 infected. In the absence any known anti-viral and vaccine the positive results of this study will decrease the morality and morbidity due to this pandemic. Further the cost-effectiveness of homoeopathy will enable developing countries in controlling such deadly disease effectively. |