| CTRI Number |
CTRI/2025/07/090545 [Registered on: 09/07/2025] Trial Registered Prospectively |
| Last Modified On: |
09/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Homoeopathic intervention in preventing Dengue |
|
Scientific Title of Study
|
Efficacy of Homoeopathic intervention Eupatorium perfoliatum 30 in preventing Dengue at urban slums of Delhi - cluster-randomized, double-blind, placebo-control trial |
| Trial Acronym |
NIL |
|
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/ Scientist IV |
| Affiliation |
Central Council for Research in Homoeopathy |
| Address |
Epidemic cell, Room No. 303, Central Council for Research in Homoeopathy, 61-65, Institutional Area, opp. D block, Janakpuri
South West
DELHI
110058
India |
| Phone |
28525388 |
| Fax |
|
| Email |
drdnayak@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Debadatta Nayak |
| Designation |
Research Officer/ Scientist IV |
| Affiliation |
Central Council for Research in Homoeopathy |
| Address |
Epidemic cell, Room No. 303, Central Council for Research in Homoeopathy, 61-65, Institutional Area, opp. D block, Janakpuri
South West
DELHI
110058
India |
| Phone |
28525388 |
| Fax |
|
| Email |
drdnayak@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Debadatta Nayak |
| Designation |
Research Officer/ Scientist IV |
| Affiliation |
Central Council for Research in Homoeopathy |
| Address |
Epidemic cell, Room No. 303, Central Council for Research in Homoeopathy, 61-65, Institutional Area, opp. D block, Janakpuri
South West
DELHI
110058
India |
| Phone |
28525388 |
| Fax |
|
| Email |
drdnayak@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Homoeopathy, 61-65, Institutional Area, opp. D block, Janakpurin New Delhi 110058, India |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Homoeopathy |
| Address |
61-65, Institutional area, opp. D block, Janakpuri, New Delhi - 110058 |
| 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 |
| Debadatta Nayak |
Central Council for Research in Homoeopathy |
Department of Epidemic cell, Room 303, 61-65, institutional area, opp. D block, Janakpuri
South West
DELHI |
9873040412
drdnayak@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Central Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Dengue |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Eupatorium perfoliatum 30 |
02 pills in each dose of the Eupatorium perfoliatum 30, to be given per week from July to October to children. 04 pills in each dose of the Eupatorium perfoliatum 30, to be given per week from July to October to adults for 16 weeks. |
| Comparator Agent |
Placebo |
02 pills in each dose of the placebo, to be given per week from July to October to children. 04 pills in each dose of the placebo, to be given per week from July to October to adults for 16 weeks. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Voluntary written informed consent by the family head |
|
| ExclusionCriteria |
| Details |
Pregnant women and lactating mother
Child below age of 1 year
Individuals taking other preventive medicines for dengue.
Patients with malignancy, immune-compromised state, life threatening diseases, end stage diseases.
Symptom of acute febrile illness/ Dengue like illness at the time of enrolment.
Patient with symptoms of acute infectious illnesses at the time of enrolment.
Not willing to give written informed consent. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of Dengue between the groups |
Weekly |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Incidence of AUFI between the groups |
Weekly |
| Changes/severity of symptoms between the groups during post prophylactic/ climatic infections |
at the time of analysis |
| Mean duration of acute febrile illnesses between the cohorts |
Weekly |
|
|
Target Sample Size
|
Total Sample Size="10000"
Sample Size from India="10000"
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)
|
21/07/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Dengue has risen exponentially over the last two decades and has accorded a huge burden on economy and health infrastructure of countries especially those that are developing. Due to its high population density, India has shown vulnerability for rapidly evolving micro-organisms such as dengue. This cluster-randomized, double-blind, placebo-controlled trial aims to evaluate the efficacy of Eupatorium perfoliatum 30 in preventing dengue among residents of 20 urban slum clusters in Delhi. Participants will receive weekly doses of the intervention or placebo from July to October for two years, along with IEC materials. Primary outcome is incidence of dengue. Secondary outcomes include incidence and severity of acute undifferentiated febrile illness and mean duration of illness. The study will generate robust clinical evidence on the preventive role of homeopathy against dengue and other febrile illnesses.
|