| CTRI Number |
CTRI/2018/11/016336 [Registered on: 14/11/2018] Trial Registered Prospectively |
| Last Modified On: |
12/11/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
Herbal Oil application in the prevention of Mosquito bite |
|
Scientific Title of Study
|
A community-based, randomized, controlled study to evaluate the efficacy of topical mosquito repellent BMB essential oil for the control of Malaria |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| GOS / CMS/21 / 2018 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jitendra Singh Kushwaha |
| Designation |
Sr. Consultant Physician |
| Affiliation |
Prakhar Hospital Pvt. Ltd. |
| Address |
Room No. 405, Clinical Research Room, Fourth Floor, 8/150, Arya Nagar Road,
Kanpur Nagar
UTTAR PRADESH
208002
India |
| Phone |
7906261455 |
| Fax |
|
| Email |
drortho2711@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jitendra Singh Kushwaha |
| Designation |
Sr. Consultant Physician |
| Affiliation |
Prakhar Hospital Pvt. Ltd. |
| Address |
Room No. 405, Clinical Research Room, Fourth Floor, 8/150, Arya Nagar Road,
Kanpur Nagar
UTTAR PRADESH
208002
India |
| Phone |
7906261455 |
| Fax |
|
| Email |
drortho2711@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jitendra Singh Kushwaha |
| Designation |
Sr. Consultant Physician |
| Affiliation |
Prakhar Hospital Pvt. Ltd. |
| Address |
Room No. 405, Clinical Research Room, Fourth Floor, 8/150, Arya Nagar Road,
Kanpur Nagar
UTTAR PRADESH
208002
India |
| Phone |
7906261455 |
| Fax |
|
| Email |
drortho2711@gmail.com |
|
|
Source of Monetary or Material Support
|
| Gods Own Store LLP A Amritpuri opp Iskcon Temple East of Kailash New Delhi India |
|
|
Primary Sponsor
|
| Name |
Gods Own Store LLP |
| Address |
Amritpuri opp Iskcon Temple East of Kailash New Delhi India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Jitendra Singh Kushwaha |
Prakhar Hospital Pvt Ltd |
Room No 405,Clinical Research Room, Fourth Floor, 8/150, Arya Nagar Road, Near Indian Overseas Bank
Kanpur Nagar
UTTAR PRADESH |
7906261455
drortho2711@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE OF THE PRAKHAR HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Prevention of Malaria Disease |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
BMB mosquito repellent and standard mosquito net |
Both should be used in this arm. BMB is a long lasting, pleasantly fragrant, moisturizing essential oil blend that is applied on the exposed areas of the body by rubbing a few drops with finger tips. One application protects against mosquito bites for up to 8 hours.
Standard mosquito net that should be undamaged in condition and available in adequate number for the entire household. It will be installed over the bed and used mainly indoors for duration of 6 months. |
| Intervention |
BMB mosquito repellent oil |
The test product BMB mosquito repellent predominantly composed of extracts of Citronella, Lavender, Neem, Tulsi, Gugal and Catnip.
BMB is a long lasting, pleasantly fragrant, moisturizing essential oil blend that is applied on the exposed areas of the body by rubbing a few drops with finger tips. One application protects against mosquito bites for up to 8 hours. In case of heavy perspiration or exposure to rainfall, it is advisable to re-apply after 4 hours.
BMB oil to be applied for 6 months duration.
|
| Comparator Agent |
Standard mosquito net |
Standard mosquito net that should be undamaged in condition and available in adequate number for the entire household. It will be installed over the bed and used mainly indoors for duration of 6 months. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Communities consisting of multiple households, living in proximity of each other will be chosen.
2. The communities should have similar environment and mosquito prevalence.
3. The communities should be accessible for the survey.
4. Participants should be willing to sign a written consent for participation in the study.
5. Participants must be willing to commit to use of intervention and assessment visits for evaluation.
6. Participants must be willing to refrain from using any other means for protection from mosquitoes, such as mosquito repellent devices, cream, sprays etc, from the outset of the study until final evaluation (if patient force to take above said medicine, subject will be dropped from the study).
7. Participants must agree to maintain hygienic life style.
|
|
| ExclusionCriteria |
| Details |
1. Communities that are distant from each other or inaccessible.
2. Communities with dissimilar living environments and mosquito prevalence.
3. Children under the age of one year.
4. Participants with history of malaria, dengue or chikangunya in past 6 months.
5. Participants with evidence or history of significant systemic, immunological, gastro-enteric or gastrointestinal disorder (People with hypothyroidism who are on adequate and stable thyroid replacement will not be excluded).
6. Any participant who is not able to give adequate informed consent.
7. Patients reporting use of prescription or non-prescription drugs that has not been pre-approved by the study physician.
8. Participant with known allergies to the main components of the test or comparator product.
9. Participation in another clinical trial or taking an investigational product in the past three months
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
. Criteria for efficacy are:
1. Decrease in incidence of mosquito bites, both inside and outside household and
2. Decrease in incidences of malaria transmitted by mosquitoes.
|
Day 0
Day 90
Day 180 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary endpoints comprise of the safety analyses i.e. adverse event including SAEs |
Day 0
Day 90
Day 180
|
|
|
Target Sample Size
|
Total Sample Size="600"
Sample Size from India="600"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
15/11/2018 |
| 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="2"
Days="14" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Publication will be done post study completion as per Sponsor Requirement |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Eligible households from the selected communities screened in baseline interview will be randomized into three groups to use either the test product BMB or the comparator, mosquito net or both (BMB and net) to repel mosquitoes in their daily lives. The baseline interview with individual household head will collect demographic data of the entire household, presently used mosquito repellent, presence of adequate number of undamaged mosquito nets etc. Households will also be asked questions pertaining their past medical history, especially occurrence of mosquito transmitted diseases such as malaria and dengue. Subjects will be evaluated at the end of every three months (assessment surveys) for upto 6 months, Participants will be inquired about any changes in incidences of mosquito bites, as experienced, after application of test product. In case subjects report fever with chills a blood samples will be collected to test for malaria parasite during follow-up surveys to test for incidence of malaria. The primary outcome of the study is detection of malaria parasites (P. falciparum and/or P. vivax) through examination of microscopic blood slides collected from finger-pricks. Safety analyses will be done at each visit. Any allergy or other adverse reactions to the test product will also be recorded. Participants’ opinion about the aesthetic nature of the test product will also be noted in Diary card. |