| CTRI Number |
CTRI/2020/05/025272 [Registered on: 20/05/2020] Trial Registered Prospectively |
| Last Modified On: |
20/05/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy
Preventive |
| Study Design |
Cluster Randomized Trial |
Public Title of Study
Modification(s)
|
A study to assess the efficacy of Homoeopathic medicine in the prevention of Covid-19
|
Scientific Title of Study
Modification(s)
|
Efficacy Of Homoeopathic Prophylactic Intervention On Covid-19 Pandemic-A Double Blind Randomised Controlled Trial
|
|
Secondary IDs if Any
|
| Secondary ID |
Registry |
| NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Boban J |
| Address |
District Medical Officer, (Department Of Homoeopathy)
District Medical Office, Chathapuram P.O,
Kalpathy, Palakkad, Kerala.
Palakkad
KERALA
678003
India |
| Phone |
9846066505 |
| Fax |
|
| Email |
bobandoctor@gmail.com |
|
Details Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Pramod P |
| Address |
Government Homoeo Dispensary,
Department Of Homoeopathy, Mathur. Pallanchathanoor P O
Palakkad
KERALA
678571
India |
| Phone |
9447240762 |
| Fax |
|
| Email |
drppramod@yahoo.co.in |
|
Details Contact Person
Public Query
Modification(s)
|
| Name |
Dr S Balamani |
| Address |
Government Homoeo Dispensary, Department Of Homoeopathy, Kandathpara,
Marutharoad.
Palakkad
KERALA
678007
India |
| Phone |
9446326041 |
| Fax |
|
| Email |
balanairvenugopal@gmail.com |
|
Source of Monetary or Material Support
Modification(s)
|
| facilities available in the Department of Homoeopathy,Kerala |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
NOT applicable |
| Type of Sponsor |
Other [nil] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 1 |
| Contact Person |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr J Boban |
District Medical Office (Homoeo), Palakkad |
District Medical Office(Homoeo), Department Of Homoeopathy,
Palakkad, Kalpathy,
Chathapuram P.O 678003.
Palakkad
|
9846066505
bobandoctor@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Ahalia Foundation Eye Hospital, Ahalia International Foundation, Kozhipara P O, Palakkad 678557 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Preventive intervention on Covid-19 related Quarantined persons, Primary and Secondary contacts of Covid-19 patients |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Arsenicum album 30 |
Arsenicum album 30 /
4 pills to be taken in the morning on empty stomach for three consecutive days.
Any oral intake is restricted for 30 minutes after this.
On the 30th, 31st and 32nd days of the first dose again 4 pills are to be taken in the morning on empty stomach.
Any oral intake is restricted for 30 minutes after this.
|
| Comparator Agent |
No.40 size Globules medicated with alcohol 90% v/v is used as Comparator agent(Placebo) |
Placebo / 4 pills to be taken in the morning on empty stomach for three consecutive days. Any oral intake is restricted for 30 minutes after this.
On the 30th, 31st and 32nd days of the first dose again 4 pills are to be taken in the morning on empty stomach. Any oral intake is restricted for 30 minutes after this. |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1) People who are under institutional (Covid-19 care centre) or home quarantine (in Palakkad district Kerala) related to Covid-19 after returning from other states or from abroad.
2) People who are under institutional (Covid-19 care centre) or home quarantine (in Palakkad district Kerala) related to Covid-19
3) Adults aged 18 and above; Children aged 12 and above, with assent of parents.
4) Primary contacts of Covid-19 positive cases
5) Secondary contacts of Covid-19 positive cases
|
|
| ExclusionCriteria |
| Details |
1) All people who are not willing to take part in the study.
2) People who are having Covid-19 symptomatology.
3) People who are taking medications for liver or renal diseases.
4) Children below 12 years.
5) Critically ill patients.
6) Pregnant ladies
7) Persons on chemotherapy
8) People under medication following Organ transplantation.
9) Persons who are taking any other medicine for preventive purposes for Covid-19/ flu like illness
10) RT PCR positive persons before the intervention.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess in quarantined persons related to Covid-19 in Palakkad District
1)the incidence of symptoms of flu like illness/Covid- 19 infection
2)the relative risk of flu like illness/Covid-19 infection among persons under Homoeopathic prophylactic intervention when compared to the control population
|
28th and 56 th day
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To analyse in quarantined persons related to Covid 19 in Palakkad district
1)the bio psychosocial variables
2)the bio psychosocial variables after Homoeopathic intervention.
3)the selected biomarkers before and after Homoeopathic intervention.
|
28th and 56 th day |
|
|
Target Sample Size
|
Total Sample Size="800"
Sample Size from India="800" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/05/2020 |
| Date of First Enrollment (Global) |
No Date Specified |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
This study will be published in an indexed journal |
|
Brief Summary
|
Arsenicum album 30 has been proved to be effective in the treatment of influenza like illness. This study proposes to assess the efficacy of Arsenicum album 30 as a deterrent/preventive to the present prevailing flu like illness/ Covid 19 infection in quarantined persons who include persons who had a travel history from other states or abroad or are primary or secondary contacts of Covid 19 positive cases. This study is also intended to analyse the bio psychosocial variables of quarantined persons related to Covid 19 in Palakkad district and compare these before and after Homoeopathic intervention.
|
