| CTRI Number |
CTRI/2024/03/063912 [Registered on: 11/03/2024] Trial Registered Prospectively |
| Last Modified On: |
26/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
observational |
| Study Design |
Other |
|
Public Title of Study
|
Testing mosquito repellents effect of a plant essential oil |
|
Scientific Title of Study
|
A within-subject laboratory and field trial for testing
repellents effect of a plant essential oil |
| 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 J Hareendran Nair |
| Designation |
Managing Director |
| Affiliation |
Pankajakasthuri Herbal Research Foundation |
| Address |
Room No 1
Department of R and D
Pankajakasthuri Herbal Research Foundation Pankajakasthuri Ayurveda Medical college Kattakkada Trivandrum
Thiruvananthapuram
KERALA
695572
India |
| Phone |
9447096201 |
| Fax |
|
| Email |
md@pkhil.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shan Sasidharan |
| Designation |
Director |
| Affiliation |
Pankajakasthuri Herbal Research Foundation |
| Address |
Room No 2
Department of R and D
Pankajakasthuri Herbal Research Foundation Pankajakasthuri Ayurveda Medical college Kattakkada Trivandrum
Thiruvananthapuram
KERALA
695572
India |
| Phone |
09188325339 |
| Fax |
|
| Email |
drshan@pkhil.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shan Sasidharan |
| Designation |
Director |
| Affiliation |
Pankajakasthuri Herbal Research Foundation |
| Address |
Room No 2
Department of R and D
Pankajakasthuri Herbal Research Foundation Pankajakasthuri Ayurveda Medical college Kattakkada Trivandrum
KERALA
695572
India |
| Phone |
09188325339 |
| Fax |
|
| Email |
drshan@pkhil.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Nehru Tropical Botanic Garden and Research Institute, Palode, Trivandrum |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Nehru Tropical Botanic Garden and Research Institute JNTBGRI |
| Address |
Palode
Trivandrum
Kerala |
| Type of Sponsor |
Research institution |
|
|
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 Shan Sasidharan |
Pankajakasthuri Ayuvedic medical College and PG centre |
Room No 2
Department of R and D
Pankajakasthuri Ayurveda Medical College Campus, Killy, Kattakada,
Kerala, India,
Thiruvananthapuram
KERALA |
09188325339
drshan@pkhil.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Independent Ethics Committee of Pankajakasthuri Herbal Research Foundation |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Mosquito repellent study |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
nil |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Willing to sign consent form
2. Men and Women aged 40 years or greater and not older than 65 years.
3. Participant has a good understanding of the procedures of the study and agrees to abide to these
4. Participant is able to communicate well with the investigator, and attend the laboratory for all aspects of the laboratory studies
5. Participant has no known history of skin allergies or hypersensitivity to topical creams
6. Participant agrees to a pre-trial skin reactivity test for all the repellents that will be used in the trial
7. Participant agrees not to use any perfumed or scented product, including bathing products, for a 24-hour period before each laboratory session
8. Participant has signed informed consent
9. Participant is not a smoker, and will agree to refraining from smoking for the 12 hours before each laboratory trial |
|
| ExclusionCriteria |
| Details |
1. Subjects with known allergy to any of the ingredients of the drug product.
2. Pregnant or Lactating women |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To measure the protective efficacy (personal protection) of a plant essential oil, by comparison of the inhibition of mosquito contacts on participants before and after their application. |
After the application of essential its repellent efficacy will be observed
after 15 min, then 30 min followed by 45 minutes. After wards its efficacy will be observed after 1 hour of application. Finally, the repelling efficacy will be observed after 6 h.
This is well accepted procedures by WHO for testing the efficacy of mosquito repellents.
WHO- GUIDELINES FOR EFFICACY TESTING OF MOSQUITO REPELLENTS FOR HUMAN SKIN
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare the duration of protection offered by different repellent products using the median Complete Protection Time (mCPT)
2. To compare the effectiveness of protection offered by different repellent products
3. To assess the acceptability of the repellent products tested in the field trials using qualitative data from participants. |
After the application of essential its repellent efficacy will be observed after 15 min, then 30 min followed by 45 minutes. After wards its efficacy will be observed after 1 hour of application. Finally, the repelling efficacy will be observed after 6 h.
This is well accepted procedures by WHO for testing the efficacy of mosquito repellents.
WHO- GUIDELINES FOR EFFICACY TESTING OF MOSQUITO REPELLENTS FOR HUMAN SKIN
|
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
18/03/2024 |
| 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)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
This study investigates the efficacy of a plant essential oil as a repellent against insects through a comprehensive within-subject laboratory and field trial. With a rising demand for natural alternatives to synthetic repellents, the potential of plant-derived solutions is of great interest. Utilizing a controlled laboratory setting, participants will be exposed to simulated insect environments with and without the application of the plant essential oil. Their responses, including attraction, landing, and biting frequencies, will be recorded and analyzed. Subsequently, a field trial will be conducted to assess the repellent’s performance in real-world conditions. Participants will apply the oil during outdoor activities, and their experiences will be compared to control conditions. This dual approach aims to provide a holistic understanding of the plant essential oil’s effectiveness as an insect repellent, offering insights into both controlled and natural settings. The findings of this study could contribute to the development of eco-friendly alternatives for insect control and public health protection. |