| CTRI Number |
CTRI/2025/07/090258 [Registered on: 07/07/2025] Trial Registered Prospectively |
| Last Modified On: |
05/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Other |
|
Public Title of Study
|
Homeopathic medicine for prevention of dengue |
|
Scientific Title of Study
|
Prophylactic effects of the homoeopathic medicine Eupatorium perfoliatum 30CH during the dengue outbreak in Kolkata: A comparative cohort study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1324-9025 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sangita Saha |
| Designation |
Professor |
| Affiliation |
D. N. De Homoeopathic Medical College and Hospital |
| Address |
Dept of Organon of Medicine, PG1 OPD, 12, Gobinda Khatick Road, Tangra
Kolkata
WEST BENGAL
700046
India |
| Phone |
9433989717 |
| Fax |
|
| Email |
dr.sangita78@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Subhranil Saha |
| Designation |
Lecturer |
| Affiliation |
D. N. De Homoeopathic Medical College and Hospital |
| Address |
Dept of Repertory, 12, Gobinda Khatick Road, Tangra
Kolkata
WEST BENGAL
700046
India |
| Phone |
9836187425 |
| Fax |
|
| Email |
drsubhranilsaha@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Amitava Paul |
| Designation |
Deputy Superintendent |
| Affiliation |
D. N. De Homoeopathic Medical College and Hospital |
| Address |
12, Gobinda Khatick Road, Tangra
Kolkata
WEST BENGAL
700046
India |
| Phone |
9433068789 |
| Fax |
|
| Email |
dr.amitavapaul@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dept of Science and Technology & Biotechnology, Govt of West Bengal, Vigyan Chetana Bhavan, 26/B, DD Block, Sector I, Salt Lake, Kolkata 700064, Landmark : City Centre I, Behind ILS Hospital, email : wbdstbt@gmail.com |
|
|
Primary Sponsor
|
| Name |
Department of Science and Technology, Govt of West Bengal |
| Address |
Vigyan Chetana Bhavan, Salt Lake, DD26/B, Sector I, Kolkata 700064 |
| 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 Sangita Saha |
D. N. De Homoeopathic Medical College and Hospital |
PG1 OPD, Dept of Organon of Medicine, 12, Gobinda Khatick Road, Tangra
Kolkata
WEST BENGAL |
9433989717
dr.sangita78@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of D. N. De Homoeopathic Medical College and Hospital |
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 30CH plus standard information education communication guidelines for prevention of dengue fever |
This group will receive Eupatorium perfoliatum 30CH,
weekly single dose for 5 months, from July to November, plus standard information education communication guidelines for prevention of dengue fever. Each dose will consist of 4 globules (no. 40) of cane sugar, moistened with the EP 30CH (preserved in 90% v/v ethanol), to be taken orally on a clean tongue with an empty stomach. Participants will be advised to refrain from handling the globules or
from eating, drinking, smoking, or brushing their teeth within 30 minutes of taking the globules and will be asked to suck the globules
rather than simply swallowing those. The medicine will be procured from a Good Manufacturing Practice (GMP)-certified firm. Duration of
therapy: 5 months. |
| Comparator Agent |
Standard information education communication guidelines for prevention of dengue fever |
This arm will receive standard information, education, and communication guidelines for the prevention of dengue fever for 5 months. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
a) Healthy individuals of either sex or transgender
b) Aged 1 year or above
c) Providing with written informed assent and/or consent voluntarily |
|
| ExclusionCriteria |
| Details |
a) Persons having symptoms of dengue-like illness or fever in the last 7 days
b) Individuals taking other preventive medicines for dengue
c) Individuals with self-reported immunocompromised states
d) Malignancies and other life-threatening or end-stage diseases
e) Pregnant, puerperal, and lactating women
f) Substance abuse and/or dependence
g) Simultaneous participation in any clinical trial |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Group differences in the occurrence of confirmed dengue fever
(DF) cases. |
Baseline and 5 months of the current year; to be repeated again for next two years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Group differences in the occurrence of probable dengue fever cases & hospitalization |
Baseline & 5 months of the current year; to be repeated again for next two years |
|
|
Target Sample Size
|
Total Sample Size="1614"
Sample Size from India="1614"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/09/2025 |
| 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="3"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [dr.sangita78@gmail.com].
- For how long will this data be available start date provided 01-01-2027 and end date provided 31-12-2031?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
Dengue is a major public health concern globally and a common cause of illness seen in primary care settings in tropical and subtropical countries. It is endemic in more than 100 countries in Africa, America, the Eastern Mediterranean, Southeast Asia, and the Western Pacific. This research on 1614 participants is aimed at contributing to the growing evidence base of prophylactic effects of the homeopathic medicine Eupatorium perfoliatum (EP) 30CH against dengue in Kolkata using a parallel cohort design. The primary objective of the study is to detect the group differences in the occurrence of confirmed dengue fever (DF) cases, while the secondary objective is to detect the group differences in the occurrence of probable DF cases and hospitalization. The homeopathic medication Eupatorium perfoliatum 30CH can be a promising preventive option for dengue, as evidenced by several preclinical and clinical findings. Effective dengue vaccines are yet to be developed and approved. In the meantime, this research may help reduce the occurrence of DF cases, thereby reducing the financial burden of the community. This work will add to the growing evidence base of the homeopathic medicine EP 30CH as a potent prophylactic for DF. |