| CTRI Number |
CTRI/2025/09/094142 [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 Antiseptic Cream in skin cuts, scratches, chapping and dryness |
|
Scientific Title of Study
|
Clinical Evaluation of efficacy and safety of Antiseptic Cream in mild to moderate skin cuts, scratches, chapping and dryness |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ASC/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 |
Skin cuts, wounds, scratches, chapped skin, lips, and cracked heels |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Emami Antiseptic cream, 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 Antiseptic cream on skin cuts, scratches, chapping and dryness twice daily for a period of 30 days | | 2 | Comparator Arm (Non Ayurveda) | | - | NIL | NIL |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects with cuts, scratches on skin and dryness of skin
2. Willing to comply with all requirements of the study
|
|
| ExclusionCriteria |
| Details |
1.Subjects with a known current history of chronic skin diseases or autoimmune diseases, such as atopic dermatitis, psoriasis, chronic urticaria, vitiligo and rosacea
2. Subjects with a tattoo, a scar, moles, too many hairs or anything on the Right leg which might interfere with the evaluation.
3. Subjects with intensive exposure to sunlight or UV-rays within the previous month and foreseen during the study.
4. Subjects who have used facial blemish-lightening products, topical or oral whitening drugs. Moisturizing cream, lotion or oil within 21 days before entering the trial
5. Subjects on any other investigational products within 1 month prior to randomization
6. Subjects with known current tuberculosis, HIV, ischemic heart disease, cancer, kidney failure, liver failure
7. Pregnant and lactating women
8. Known hypersensitivity to any of the ingredients of Emami Antiseptic Cream
9. 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 |
1. Change in healing of minor cuts, wounds, scratches, chapped skin, lips, and cracked heels
2. Number of days require for healing of minor cuts, wounds, scratches, chapped skin, lips, and cracked heels
|
Baseline visit (day 0), day 15 and end of study visit (Day 30) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Change in skin cutaneous moisturization
2. Change in overall skin texture/roughness (Tactile) and (Visual)
3. Change in overall skin desquamation
4. Change in softness in chapped skin and lips
5. Change in skin softness and glow
6. Skin patch test using Dermal Response Score.
7. Global assessment for overall change
8. Adverse events/adverse drug reactions including vitals.
|
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 Antiseptic Cream in mild to moderate skin cuts, scratches, chapping and dryness. The study will be carried out at one center in India. Subjects will be asked to apply Emami Antiseptic cream on skin cuts, scratches, chapping and dryness twice daily for a period of 30 days. The primary objectives will be to assess change in healing of minor cuts, wounds, scratches, chapped skin, lips, and cracked heels, and number of days require for healing of minor cuts, wounds, scratches, chapped skin, lips, and cracked heels. The secondary objectives will be to assess change in skin cutaneous moisturization, change in overall skin texture/roughness (Tactile) and (Visual), change in overall skin desquamation, change in softness in chapped skin and lips, change in skin softness and glow, skin patch test using Dermal Response Score, global assessment for overall change and adverse events/adverse drug reactions including vitals. |