| CTRI Number |
CTRI/2025/09/094141 [Registered on: 03/09/2025] Trial Registered Prospectively |
| Last Modified On: |
|
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical study on Lip Balm participants with lip dryness |
|
Scientific Title of Study
|
Clinical Evaluation of efficacy and safety of Lip Balm in mild to moderate lip dryness |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| LB/EMAMI/2025/1, Version 1.0, 15th July 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Amruta Bhagwan More |
| Designation |
Consultant Physician |
| Affiliation |
Target Institute of Medical Education and Research Pvt Ltd. |
| Address |
Clinical Research Department, OPD no 1 Second floor,
Target Institute of Medical Education and Research Pvt Ltd.
Office 203, Jaymala Business Court, Takle Nagar Manjri BK. Hadapsar Pune-411028.
Pune
MAHARASHTRA
411028
India |
| Phone |
7350821611 |
| Fax |
|
| Email |
amrutam789@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjay Tamoli |
| Designation |
Director |
| Affiliation |
Target Institute of Medical Education and Research Pvt. Ltd |
| Address |
Target Institute of Medical Education and Research Pvt. Ltd
A wing 402 A/B/C, Jaswanti Allied Business Center,
Ramchandra Lane Extension,
Kachpada, Malad West, Mumbai 400064
Mumbai (Suburban)
MAHARASHTRA
400064
India |
| Phone |
9322522252 |
| Fax |
|
| Email |
targetinstitute@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjay Tamoli |
| Designation |
Director |
| Affiliation |
Target Institute of Medical Education and Research Pvt. Ltd |
| Address |
Target Institute of Medical Education and Research Pvt. Ltd
A wing 402 A/B/C, Jaswanti Allied Business Center,
Ramchandra Lane Extension,
Kachpada, Malad West, Mumbai 400064
MAHARASHTRA
400064
India |
| Phone |
9322522252 |
| Fax |
|
| Email |
targetinstitute@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Emami Ltd.
Tower 687, Anandpur, E. M. Bypass,
Kolkata 700107
|
|
|
Primary Sponsor
|
| Name |
Emami Ltd. |
| Address |
Tower 687, Anandpur, E. M. Bypass,
Kolkata 700107
|
| Type of Sponsor |
Other [Healthcare Industry] |
|
|
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 Amruta Bhagwan More |
Target Institute of Medical Education and Research Pvt Ltd. |
Clinical Research Department, OPD no 1 Second floor,
Target Institute of Medical Education and Research Pvt Ltd.
Office 203, Jaymala Business Court, Besides Satyam Prima, Takle Nagar Manjri BK. Hadapsar Pune-411028.
Pune
MAHARASHTRA |
7350821611
amrutam789@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kusum Independent Ethics Committee, Hadapsar, Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Lip Dryness |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | NIL | NIL | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Emami Lip Balm, Reference: NA, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 1(NA), Frequency: bd, Bhaishajya Kal: Samudga, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: Subjects will be asked to apply Emami Lip balm twice daily (morning after bath and before going to bed) for a period of 30 days. |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Subjects suffering from mild to moderate dryness of lips |
|
| ExclusionCriteria |
| Details |
1. History of lip injections or lip surgery, chronically dry or chapped lip
2. History of recent or ongoing use of medication that can have dryness as a side effect.
3. Subject with severe dermatological disorders that might interfere with the
study evaluation
4. Known cases of any Hypersensitivity to Lip balm ingredients
5. Subjects who have participated in any other clinical study since last 3 months
6. Other conditions, which in the opinion of the investigators, make patient
unsuitable for enrolment or could interfere with his/her participation in, and
completion of the study
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in dryness of lips |
Baseline visit (day 0), day 15 and end of study visit (Day 30) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Change in lips fine lines, hydration, colour
2. Global assessment of overall change in lip dryness
3. Assessment of skin patch test using Dermal Response Score.
4. Assessment of safety by observing episodes, severity and duration of any
allergic reactions and adverse events
|
Baseline visit (day 0), day 15 and end of study visit (Day 30) |
|
|
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 2 |
|
Date of First Enrollment (India)
|
03/09/2025 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
It is a clinical
study to evaluate efficacy and safety of Lip Balm in mild to moderate lip
dryness. The study will be carried out at one center in India. Subjects will be
asked to apply Emami Lip balm twice daily (morning after bath and before going
to bed) for a period of 30 days. Primary objective will be to assess change in
dryness of lips. The secondary objectives of the study will be to assess change
in lips fine lines, hydration, colour, global assessment of overall change in
lip dryness, skin patch test using Dermal Response Score, and safety by
observing episodes, severity and duration of any allergic reactions and adverse
events |