| CTRI Number |
CTRI/2020/06/026045 [Registered on: 22/06/2020] Trial Registered Prospectively |
| Last Modified On: |
22/06/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
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Type of Study
|
Homeopathy |
| Study Design |
Other |
Public Title of Study
Modification(s)
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A study to improve the resistance against Covid 19 illness with the help of Homoeopathic remedies. |
|
Scientific Title of Study
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Evaluating the immune boosting ability of a homoeopathic therapeutic strategy involving a nosode Tuberculinum 1M, followed by Zincum Metallicum 6C, Chininum Arsenicosum 6C and Calc Phos 6x in asymptomatic novel corona virus disease (Covid-19 illness) vulnerable risk group. |
|
Secondary IDs if Any
|
| Secondary ID |
Registry |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr M K Kamath |
| Address |
Department of Practice of Medicine
Father Muller Homoeopathic Medical College
University Road
Deralakatte
Mangalore
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9448409624 |
| Fax |
|
| Email |
drmkkamath@gmail.com |
|
Details Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Dilip B Dikshit |
| Address |
Kapilavastu
Building No.1 A Wing
Opp.PratapCinema
Kolbad Thane(W)
University Raod, Deralakatte
Mangalore - 575018
Thane
MAHARASHTRA
400601
India |
| Phone |
9757247179 |
| Fax |
|
| Email |
dr.dilip.dixit@gmail.com |
|
Details Contact Person
Public Query
|
| Name |
Dr M K Kamath |
| Address |
Department of Practice of Medicine
Father Muller Homoeopathic Medical College
University Road
Deralakatte
Mangalore
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9448409624 |
| Fax |
|
| Email |
drmkkamath@gmail.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Father Muller Homoeopathic Medical College University Road
Deralakatte
Mangalore 575018 |
|
Primary Sponsor
Modification(s)
|
| Name |
Father Muller Homoeopathic Medical College |
| Address |
University Road Deralakatte Mangalore 575018
|
| Type of Sponsor |
Private medical college |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 1 |
| Contact Person |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr M K Kamath |
Father Muller Homoeopathic Medical College and Hospital |
Department of Practice of Medicine Father Muller Homoeopathic Medical College
University Road
Deralakatte Mangalore
Dakshina Kannada 575018
Dakshina Kannada
|
9448409624
drmkkamath@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Father Muller Institutional Ethics Committee (FMIEC) |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Asymptomatic vulnerable risk group for novel corona virus disease (Covid-19) |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homoeopathic Medicines a therapeutic strategy consisting of Tuberculinum 1M followed by Zincum Metallicum 6C Chininum Arsenicosum 6C and Calc Phos 6x plus health monitoring |
Known Homoeopathic Pharmacopial preparations
These subjects will be observed for a total of 2 months (60 days), and data is collected against predetermined criteria every 15 days to determine how their exposure status to Covid-19 changes the outcome |
| Comparator Agent |
Matching Control Arm Health monitoring |
No intervention
These subjects will be observed for a total of 2 months (60 days), and data is collected against predetermined criteria every 15 days to determine how their exposure status to Covid-19 changes the outcome |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. All existing co-morbidities.
2. High risk front line workers
|
|
| ExclusionCriteria |
| Details |
1.Those with end stage renal disease and progressive liver dysfunctions
2.Pregnant and lactating females
3.Anyone who has taken HCQS and / or Homoeopathic prophylaxis Ars alb 30 / any other similar medicines for boosting the immunity against Covid-19 illness
|
|
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Method of Generating Random Sequence
|
Stratified randomization |
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Method of Concealment
|
Not Applicable |
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Blinding/Masking
|
Not Applicable |
Primary Outcome
Modification(s)
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| Outcome |
TimePoints |
There will be a difference in the incidence rate of Covid-19 between control and intervention group.
Incidence rate will be assessed with the help of RT PCR Covid-19 test. Patients in both the groups will be monitored for development of symptoms related to Covid-19.
|
Subjects from both group will undergo evaluation on day 0, Day 15, day 30, day 45 and day 60 on predetermined parameters.
Over and above these time points the patient will be provided with a help line and a physician for reporting symptoms on any given date. |
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Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| There will be a difference in the number of patients developing symptoms of Covid-19 illness between control and intervention group. |
Subjects from both group will undergo evaluation on day 0, Day 15, day 30, day 45 and day 60 on predetermined parameters
The predetermined parameters are
1. Fever
2. Myalgia
3. Malaise
4. Arthralgia
5. Headache
6. Confusion
7. Diarrhea
8. Vomiting
9. Dry cough
10. Cough with Sputum
11. Rhinorrhoea
12. Sore throat
13. Dyspnea
14. Chest pain
15. Alteration of taste and smell
16. Chills
17. Rigors
18. RT PCR Covid 19 test
|
|
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Target Sample Size
|
Total Sample Size="800"
Sample Size from India="800" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/07/2020 |
| Date of First Enrollment (Global) |
No Date Specified |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
The manuscript of the trial will be prepared
Research publication will be done in indexed peer reviewed journal
|
|
Brief Summary
|
This is a prospective, analytic, and interventional study of a homoeopathic therapeutic strategy with matching no treatment concurrent control to verify the incidence of Covid-19 and occurrence of symptoms. The homoeopathic strategy aims preventing the development of symptoms related to Covid-19 illnesses, in asymptomatic novel corona virus disease vulnerable risk group. The intervention arm will receive homoeopathic strategy consisting of Tuberculinum 1M, 4 pills followed by Zincum metallicum 6C, China ars 6C and Calc phos 6X twice daily for 14 days, followed by periodic health monitoring based on predetermined parameters. The matching control group/arm will not receive any intervention( no treatment), but will undergo a periodic health monitoring very similar to intervention group. The subjects will be observed for a total of 2 months (Sixty days), once in every 15 days to determine how their exposure status to Covid-19 changes the outcome. The difference in the incidence rate of Covid-19 and the occurrence of symptoms between intervention group and matching control will be analysed using quantitative statistical methods. |
