| CTRI Number |
CTRI/2019/07/020286 [Registered on: 22/07/2019] Trial Registered Prospectively |
| Last Modified On: |
22/07/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Homoeopathic intervention in prevention of dengue, chikungunya and influenza like illness
|
|
Scientific Title of Study
|
Effectiveness of Homoeopathic intervention vis-à -vis health awareness in preventing dengue, chikungunya & influenza like illness fever during outbreak – comparative cohort study 2019
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Debadatta Nayak |
| Designation |
Research Officer |
| Affiliation |
Central Council for Research in Homoeopathy |
| Address |
Epidemic cell, Room No.303, Central Council for Research in Homoeopathy, 61-65, Opp D Block, Institutional Area, Janakpuri, New Delhi.
Central Council for Research in Homoeopathy, 61-65, Opp D Block, Institutional Area, Janakpuri, New Delhi.
South West
DELHI
110058
India |
| Phone |
011-28525388 |
| Fax |
|
| Email |
drdnayak@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Debadatta Nayak |
| Designation |
Research Officer |
| Affiliation |
Central Council for Research in Homoeopathy |
| Address |
Epidemic cell, Room No.303, Central Council for Research in Homoeopathy, 61-65, Opp D Block, Institutional Area, Janakpuri, New Delhi.
Central Council for Research in Homoeopathy, 61-65, Opp D Block, Institutional Area, Janakpuri, New Delhi.
South West
DELHI
110058
India |
| Phone |
011-28525388 |
| Fax |
|
| Email |
drdnayak@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anil Kumar Khurana |
| Designation |
Director General I/C |
| Affiliation |
Central Council for Research in Homoeopathy |
| Address |
Central Council for Research in Homoeopathy, 61-65, Opp D Block, Institutional Area,
room No. 408, Epidemic cell,
Janakpuri, New Delhi.
Central Council for Research in Homoeopathy, 61-65, Opp D Block, Institutional Area, room No. 408, Epidemic cell,Janakpuri, New Delhi.
South West
DELHI
110058
India |
| Phone |
011-28525388 |
| Fax |
|
| Email |
anilnaman@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Homoeopathy, Ministry of AYUSH, Govt of India, AYUSH Bhawan, B block, CGO Complex, INA Colony, New Delhi- 1100023. |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Homoeopathy New Delhi |
| Address |
Central Council for Research in Homoeopathy, 61-65, Opp D Block, Institutional Area, Janakpuri, New Delhi.
|
| Type of Sponsor |
Government funding agency |
|
|
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 Debadatta Nayak |
Central Council for Research in Homoeopathy |
Epidemic cell,Room No. 303, 61-65 Institutional Area,
Janakpuri
South West
DELHI |
09873404012
drdnayak@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Prevention of Dengue, Chikungunya & Influenza like Illnesses |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homoeopathic medicine (Influenzinum 30 and Eupatorium perfoliatum 30) along with information education and communication for dengue, chikungunya and Influenza like illness (ILI) |
Dose:2 pills to children and 4 pills to adults, once a week for 10 weeks along with Information, Education and communication (IEC) through information pamphlets on Dengue, chikungunya and Influenza like illness (ILI)
Potency: 30 potency
Repetition: 4 pills once in week for 10 weeks
Duration: Total duration of 03 months.
Route of administration: Oral. |
| Comparator Agent |
Information education and communication (IEC) about dengue, chikungunya and Influenza like illness (ILI) |
IEC about dengue, chikungunya and Influenza like illness (ILI) through information pamphlets shall be given to participants every week till 10 weeks. frequency: every week for 10 weeks.
Duration of therapy: 03 months Route of administration: Verbal Discussion. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthy individuals of either sex, aged 1year and above living in same community
2. Informed consent by head of family
3. No symptom of dengue, chikungunya and ILI at the time of enrollment |
|
| ExclusionCriteria |
| Details |
1. Symptoms of dengue, chikungunya and ILI/fever in last 7 days at the time of enrolment
2. Pregnant women and lactating mother
3. Child below the age of 1 year
4.Individuals taking other preventive medicines for dengue, chikungunya and Influenza like illness (ILI)
5. Patients with malignancy, immuno-compromised state, life threatening disease, end stage disease
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in incidence of acute febrile illness between the cohorts at weekly interval. |
Assessment of the participants every 7 days for 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. changes in incidence of dengue & chikungunya fever between the cohorts at weekly interval.
2. Changes in incidence of influenza like illness between the cohorts at weekly interval.
3. Changes in weekly reporting of acute febrile illness between the cohorts.
4. Changes in intensity, duration of acute febrile illness between the cohorts. |
Assessment of the participants every 7 days for 3 months |
|
|
Target Sample Size
|
Total Sample Size="30000"
Sample Size from India="30000"
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)
|
26/07/2019 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NOT APPLICABLE |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This shall be comparative cohort study
wherein apparently healthy participants will be enrolled from the slum areas.
The study shall be conducted at JJ colony of Mayapuri, Piragadi, and Zakira at
New Delhi. There shall be 03 cohorts as below:
|
Cohort 1
|
Influenzinum 30 for first 5
weeks followed by Eupatorium perfoliatum 30 for next 5 weeks with
information, Education & communication (IEC) for prevention of dengue,
chikungunya & ILI.
|
|
Cohort 2
|
Eupatorium perfoliatum 30 for
10 weeks with IEC for preventive of dengue chikungunya & ILI.
|
|
Cohort 3
|
Only IEC for preventive of
dengue chikungunya & ILI.
|
Enrolled individuals shall receive
homoeopathic medicine and/or IEC as per their respective cohorts once in week
for 10 weeks & further shall be under observation till 6 weeks or till the
outbreak is over.
|