| CTRI Number |
CTRI/2025/10/095718 [Registered on: 08/10/2025] Trial Registered Prospectively |
| Last Modified On: |
06/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Placebo] |
| Study Design |
Other |
|
Public Title of Study
|
Acceptability (Swallowability and Palatability) Study of Placebo of Ivy leaf Orally Dispersible Film in Healthy Children of 2 to 5 years old |
|
Scientific Title of Study
|
Open label, Single-dose, Single Arm, Acceptability (Swallowability and Palatability) Study of Placebo of Ivy leaf 8 mg Orodispersible Film 2.5 cm2 of Wooshin LaPache d.o.o. in Normal, Healthy Children of 2 to 5 years old. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| PR/BE/25/095, Version-00, Date-26/09/25 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Raviraj Jagdhani |
| Designation |
Clinical Investigator |
| Affiliation |
Raptim Research Pvt. Ltd |
| Address |
A-226
T.T.C. Industrial Area, Mahape M.I.D.C.,
Navi Mumbai
Thane
MAHARASHTRA
400710
India |
| Phone |
9702212013 |
| Fax |
|
| Email |
raviraj.jagdhani@raptimresearch.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yashvant Khaire |
| Designation |
Head-Clinical Service |
| Affiliation |
Raptim Research Pvt. Ltd., |
| Address |
A-226 (Clinical Unit), T.T.C. Industrial Area, Mahape M.I.D.C., Navi Mumbai
Thane
MAHARASHTRA
400710
India |
| Phone |
912227781889 |
| Fax |
912227781889 |
| Email |
yashvant.khaire@raptimresearch.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Yashvant Khaire |
| Designation |
Head-Clinical Service |
| Affiliation |
Raptim Research Pvt. Ltd., |
| Address |
A-226 (Clinical Unit), T.T.C. Industrial Area, Mahape M.I.D.C., Navi Mumbai
Thane
MAHARASHTRA
400710
India |
| Phone |
912227781889 |
| Fax |
912227781889 |
| Email |
yashvant.khaire@raptimresearch.com |
|
|
Source of Monetary or Material Support
|
| Wooshin LaPache d.o.o.
Industrijska cesta 1 J,
1290 Grosuplje,
Slovenia. |
|
|
Primary Sponsor
|
| Name |
Wooshin LaPache d.o.o. |
| Address |
Industrijska cesta 1 J,
1290 Grosuplje,
Slovenia. |
| Type of Sponsor |
Other [Pharmaceutical and cosmetic company ] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Raptim Research Pvt Ltd |
A-226 T.T.C., Industrial Area, Mahape M.I.D.C.,
Navi Mumbai - 400 710,
Maharashtra, India |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Raviraj Jagdhani |
Raptim Research Pvt. Ltd., |
clinical unit-A-226
T.T.C., Industrial Area, Mahape M.I.D.C.,
Navi Mumbai,400710
India
Thane
MAHARASHTRA |
9702212013
raviraj.jagdhani@raptimresearch.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethicare Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Not applicable |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Placebo of Ivy leaf 8 mg Orodispersible Film 2.5 cm2 |
one Placebo of Ivy
leaf 8 mg Orodispersible Film 2.5 cm2 at ambient temperature in an upright
sitting position
Total Duration- Single addministration |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
Willing to provide written informed consent by parents and assent form if
possible by child for participation in the study, and an ability to comprehend the
nature and purpose of the study;
Willing to be available for the entire study period and to comply protocol
requirements;
Normal, healthy, children of 2 to 5 years (both inclusive) of age;
Normal health status as determined by baseline medical and medication history,
vital signs measurements and physical examination at the time of screening as
well as check-in of study period;
Normal Developmental milestones according to age
|
|
| ExclusionCriteria |
| Details |
Consumption of anything which may alter taste sensation 2 hours prior to dosing;
Significant history or current evidence of malignancy or chronic - infectious,
cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic
(endocrine), hematological, gastrointestinal, dermatological, immunological or
psychiatric diseases, or organ dysfunction;
Any major illness or hospitalized within 90 days prior to check-in;
Any illness observed by the parents within 30 days prior to check-in;
Use of any prescribed medication (including herbal medicines and vitamin
supplements) or OTC products within 30 days prior to check-in and requirement
of the same throughout the study;
History or presence of significant gastric and/or duodenal ulceration;
History or presence of significant oral condition which might impact assessment
of acceptability;
Difficulty in swallowing or oral conditions affecting saliva production;
Participated in any clinical investigation in past 30 days prior to check-in;
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the Acceptability (Swallowability and
Palatability) of Placebo of Ivy leaf 8 mg Orodispersible Film 2.5 cm2 in
normal, healthy children of 2 to 5 years old |
To assess the Acceptability (Swallowability and
Palatability) of Placebo of Ivy leaf 8 mg Orodispersible Film 2.5 cm2 in
normal, healthy children of 2 to 5 years old |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess safety and tolerability of Placebo of Ivy
leaf 8 mg Orodispersible Film 2.5 cm2. |
Vital signs measurements (blood pressure, pulse/heart rate, body
temperature and respiratory rate) and general well-being will be assessed
within 0.50 hour prior to dosing and at 0.50 and 1.00 hour post-dose (± 30
minutes of scheduled time) during the in-house stay
Post-study safety evaluations will be performed after 2.00 hours post-dose
or after children withdrawal/termination. |
|
|
Target Sample Size
|
Total Sample Size="18"
Sample Size from India="18"
Final Enrollment numbers achieved (Total)= "18"
Final Enrollment numbers achieved (India)="18" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
19/10/2025 |
| Date of Study Completion (India) |
04/11/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="2" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
The
purpose of the study is to acceptability (Swallowability and Palatability)
Study of Placebo of Ivy leaf 8 mg Orodispersible Film 2.5 cm2 of Wooshin
LaPache d.o.o. in Normal, Healthy Children of 2 to 5 years old. The primary objective
of the study is To assess the Acceptability (Swallowability and Palatability)
of Placebo of Ivy leaf 8 mg Orodispersible Film 2.5 cm2 in normal, healthy
children of 2 to 5 years old and the secondary objective is To assess safety
and tolerability of Placebo of Ivy leaf 8 mg Orodispersible Film 2.5 cm2. The safety of childrens will be assessed by
monitoring for occurrence of any AE as well as vital signs and general
well-being during the in-house stay.No diet restrictions are required in the
study. Childrens will be checked out after 2.00 hours post-dose. Post-study
safety evaluations will be performed after 2.00 hours post-dose or after
children withdrawal or termination |