| CTRI Number |
CTRI/2025/08/092498 [Registered on: 06/08/2025] Trial Registered Prospectively |
| Last Modified On: |
05/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological
Preventive |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Testing the Safety of Herbal Mosquitocidal Fumigant for Human use |
|
Scientific Title of Study
|
Phase I Clinical Trial for Safety Assessment of an Innovative, Commercially Viable and Eco-Friendly Mosquitocidal Fumigant in Healthy Human Volunteers |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mythili Krishna Jeedigunta |
| Designation |
Assistant Professor |
| Affiliation |
Goa College of Pharmacy |
| Address |
Dept. of Pharmacognosy, Goa College of Pharmacy, Panaji, Goa - 403001
North Goa
GOA
403001
India |
| Phone |
9823615756 |
| Fax |
|
| Email |
jmythilikrishna@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Padmanabha Rataboli |
| Designation |
Professor and Head |
| Affiliation |
Gao Medical College |
| Address |
Dept. of Pharmacology, Goa Medical College, Bambolim, Goa
North Goa
GOA
403202
India |
| Phone |
9822386263 |
| Fax |
|
| Email |
rataboli_padmanabh@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mythili Krishna Jeedigunta |
| Designation |
Assistant Professor |
| Affiliation |
Goa College of Pharmacy |
| Address |
Dept. of Pharmacognosy, Goa College of Pharmacy, Panaji, Goa - 403001
GOA
403001
India |
| Phone |
9823615756 |
| Fax |
|
| Email |
jmythilikrishna@gmail.com |
|
|
Source of Monetary or Material Support
|
| Goa State Research Foundation |
|
|
Primary Sponsor
|
| Name |
Goa State Research Foundation |
| Address |
Market Complex, Alto Porvorim, Goa |
| 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 Mythili Krishna Jeedigunta |
Goa College of Pharmacy |
Room No.22, Goa College of Pharmacy, 18th June Road, Panaji
North Goa
GOA |
9823615756
jmythilikrishna@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee Goa Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Male and female volunteers between 18 to 45 years of age |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Herbal mosquitocidal fumigant |
Healthy human volunteers are exposed to fumes from ignited herbal fumigant for different time periods for assessing the safety and the data after 14 days of exposure is compared with the marketed product
|
| Comparator Agent |
Marketed mosquito repellant fumigant |
Healthy human volunteers are exposed to fumes from ignited marketed product for 14 days and compared with the herbal mosquitocidal fumigant |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Healthy volunteers male and female, of the age group 18 to 45 years |
|
| ExclusionCriteria |
| Details |
1. Pregnant or lactating women.
2. Allergy or sensitivity to fumigants or similar compounds.
3. Recent participation in another clinical trial.
4. Smoking, alcohol, or substance abuse.
5. Those on any medication.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Assessing the safety of the herbal fumigant
2. Acceptance of the herbal fumigant in comparison to marketed product |
Analysis will be performed at 0 to 14 days of exposure to the herbal fumigant for different time intervals, i.e., 1hr, 2hr and 3hr. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The following blood parameters will be checked:
1. Haemoglobin
2. Blood Urea, Serum Creatinine
3. Serum electrolytes - Sodium, Potassium and Chloride
4. Serum Bilirubin
5. SGOT, SGPT, ALP
|
Baseline at 0 day and after exposure for 14 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
18/08/2025 |
| 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="1"
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
|
A fumigant was prepared by using betel nut husk and natural binder and formulated into a cylindrical shaped product. This product upon ignition effuses fumes which are rich in phytoconstituents effective against different species of mosquitoes. After testing the efficacy in the mosquitoes and the pre-clinical trial in animal model, the present study is taken up to assess the safety and acceptability in healthy human volunteers. |