| CTRI Number |
CTRI/2024/03/064874 [Registered on: 28/03/2024] Trial Registered Prospectively |
| Last Modified On: |
27/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Effect of the test product in reducing dark spots |
|
Scientific Title of Study
|
A clinical study to assess the effectiveness of ayurvedic product in reduction in dark spots |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| XXX-QF01-UV-MH24; Version: 01; Dated: 15/03/2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Raji Patil |
| Designation |
Investigator |
| Affiliation |
MASCOT-SPINCONTROL India Pvt. Ltd. |
| Address |
3rd Floor, Kohinoor Estate, Sun Mill compound, Lower Parel Mumbai
Mumbai
MAHARASHTRA
400013
India |
| Phone |
02243349191 |
| Fax |
|
| Email |
raji@mascotspincontrol.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Raji Patil |
| Designation |
Investigator |
| Affiliation |
MASCOT-SPINCONTROL India Pvt. Ltd. |
| Address |
3rd Floor, Kohinoor Estate, Sun Mill compound, Lower Parel Mumbai
Mumbai
MAHARASHTRA
400013
India |
| Phone |
02243349191 |
| Fax |
|
| Email |
raji@mascotspincontrol.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mohit Lalvani |
| Designation |
Study Director |
| Affiliation |
MASCOT-SPINCONTROL India Pvt. Ltd. |
| Address |
3rd Floor, Kohinoor Estate, Sun Mill compound, Lower Parel Mumbai
Mumbai
MAHARASHTRA
400013
India |
| Phone |
02243349191 |
| Fax |
|
| Email |
mohit.CTRI@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hindustan Unilever Limited, Unilever House, B.D. Sawant Marg, Chakala, Andheri (E), Mumbai- 400 099 |
|
|
Primary Sponsor
|
| Name |
Hindustan Unilever Limited |
| Address |
Unilever House, B.D. Sawant Marg, Chakala, Andheri (E), Mumbai- 400 099 |
| Type of Sponsor |
Other [FMCG] |
|
|
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 Raji Patil |
Mascot Spincontrol India Pvt. Ltd. |
3rd Floor, Kohinoor Estate, Sun Mill compound, Lower Parel Mumbai
Mumbai
MAHARASHTRA |
02243349191
raji@mascotspincontrol.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Suraksa- Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Having Dark spots (Vyangam) |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Cream, Reference: NA, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 0.5(g), Frequency: bd, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 4 Weeks, Reference: NA, Route: NA, Dosage Form: Malahara/ Ointment/ Balm, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1.Healthy females volunteers between 20-45 years of age.
2.Subjects with self perceived dark spot problems.
3.Presence of 2-3 spots on face
4.Volunteer in good health condition as per the medical screening criteria with no disease state or physical condition that the Investigator believes could interfere with the interpretation of the data.
5.Subject free of excessive hair, acne, cuts, abrasions, fissures, wounds, lacerations, or any other active skin conditions on the face.
6.Subject who agree not to use of any other skin lightening product/treatment/soap bar/home remedy on their face during the study period other that the study product provided.
7.Subject who agrees not to carry out bleaching or any other skin care procedures on face during the study
8.Volunteer able to read, understand and sign an appropriate informed consent form indicating her willingness to participate.
|
|
| ExclusionCriteria |
| Details |
1.Volunteers who participated in a study with face as the target area within 4 weeks of the start of this study or is currently participating in such a study.
2.Volunteer pregnant or planning to become pregnant.
3.Volunteers who are breastfeeding or having stopped to breastfeed in the past three months.
4.Volunteers with any other signs of significant local irritation, erythema or skin disease on face as well as on the visible parts of the body skin site.
5.Volunteers with self-perceived sensitive skin.
6.Volunteers having chronic illness or had major surgery in the last year.
7.Volunteers undergoing any treatment of any skin condition on body.
8.Volunteers taking any oral antibiotic medication currently or within the last 8 weeks.
9.Volunteers taking medication
10.Volunteers taking medication for any condition which the Investigator believes may influence the interpretation of the data.
11.Volunteers on food supplements. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Significant reduction in severity of dark spots |
Baseline, 2week, 4 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
NA |
|
|
Target Sample Size
|
Total Sample Size="55"
Sample Size from India="55"
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)
|
06/04/2024 |
| 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="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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 objective of the present clinical study is to investigate the efficacy of test products in controlling /reduicng the severity of dark spots. Study volunteers will be selected basis inclusion and exclusion criteria. Post informed consent, volunteers will be enrolled into the study and undergo 3 days of wash off. Subjects are provided with the test product and usage instructions will be provided. Volunteers will visit the venue and dermatological and instrumental assessments will be performed at Baseline, week 2 and week 4. |