| CTRI Number |
CTRI/2023/09/057704 [Registered on: 15/09/2023] Trial Registered Prospectively |
| Last Modified On: |
13/09/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Ayurvedic Proprietary Medicine] |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Effect of the test product on dandruff control |
|
Scientific Title of Study
|
A clinical study to evaluate the Anti-dandruff efficacy of ayurvedic products |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| XXX-XI01-UV-JY23; Version: 01; Dated: 11/08/2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Raji Patil |
| Designation |
Principal Investigator |
| Affiliation |
MASCOT-SPINCONTROL India Pvt. Ltd. |
| Address |
3rd Floor, Kohinoor Estate, Sun Mill compound, Lower Parel Mumbai (Suburban) MAHARASHTRA 400013 India
Mumbai
MAHARASHTRA
400013
India |
| Phone |
02243349191 |
| Fax |
|
| Email |
raji@mascotspincontrol.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Raji Patil |
| Designation |
Principal Investigator |
| Affiliation |
MASCOT-SPINCONTROL India Pvt. Ltd. |
| Address |
3rd Floor, Kohinoor Estate, Sun Mill compound, Lower Parel Mumbai (Suburban) MAHARASHTRA 400013 India
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 (Suburban) MAHARASHTRA 400013 India
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
|
| Name |
Address |
| NIL |
Not applicable |
|
|
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 (Suburban) MAHARASHTRA 400013 India
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 Dandruff (Dharunaka) |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: BD-53, Reference: NA, Route: Topical, Dosage Form: Taila, Dose: 10(drops), Frequency: od, Bhaishajya Kal: Muhurmuhu, Duration: 4 Weeks, anupAna/sahapAna: No, Additional Information: -Application will be three times in a week for period of 4 weeks | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: LT-56, Reference: NA, Route: Topical, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 10(drops), Frequency: od, Bhaishajya Kal: Muhurmuhu, Duration: 4 Weeks, anupAna/sahapAna: No, Additional Information: Application will be three times in a week for period of 4 weeks | | 3 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: DX-34, Reference: NA, Route: Topical, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 10(drops), Frequency: od, Bhaishajya Kal: Muhurmuhu, Duration: 4 Weeks, anupAna/sahapAna: No, Additional Information: -Application will be three times in a week for period of 4 weeks | | 4 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: KT72, Reference: NA, Route: Topical, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 10(drops), Frequency: od, Bhaishajya Kal: Muhurmuhu, Duration: 4 Weeks, anupAna/sahapAna: No, Additional Information: -Application will be three times in a week for period of 4 weeks | | 5 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: AM-21, Reference: NA, Route: Topical, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 10(drops), Frequency: od, Bhaishajya Kal: Muhurmuhu, Duration: 4 Weeks, anupAna/sahapAna: No, Additional Information: Application will be three times in a week for period of 4 weeks |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. Volunteer presenting moderate to severe dandruff (at least shoulder length hair for females) as per dermatological assessment.
2. 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.
3. Volunteer able to read, understand and sign an appropriate informed consent form indicating her willingness to participate.
4. Volunteers agreeing to comply with following study restrictions:
- Volunteers Willing to refrain from application of any other product/treatment on their scalp and hair shafts during the study period.
- Not to apply any cosmetic, hair care product, test product and/or water 48 hours before scheduled visits.
- Willing not to colour or dye their hair just before the study visits and during the study period
|
|
| ExclusionCriteria |
| Details |
1. Volunteer pregnant or planning to become pregnant.
2. Volunteers who are breastfeeding or having stopped to breastfeed in the past three months.
3. Volunteers with any other signs of significant local irritation, erythema or skin disease on scalp as well as on the visible parts of the body skin site.
4. Volunteers with self-perceived sensitive skin.
5. Volunteers having chronic illness or had major surgery in the last year.
6. Volunteers undergoing any treatment of any skin condition on body.
7. Volunteers taking medication continuously/regularly every day such as corticosteroids or non-steroidal anti-inflammatories, topically for four weeks or orally for eight weeks prior to the study.
8. Volunteers taking medication for any condition which the Investigator believes may influence the interpretation of the data.
9. Volunteers on food supplements |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Significant reduction in dandruff flakes |
Basline, Week 1, Week 2, Week 4. Week 5 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Significant reduction in scalp itch |
Basline, Week 1, Week 2, Week 4. Week 5 |
|
|
Target Sample Size
|
Total Sample Size="275"
Sample Size from India="275"
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)
|
21/09/2023 |
| 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="4"
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 dandruff condition. Study volunteers will be selected basis inclusion and exclusion criteria. Post informed consent, volunteers will be enrolled into the study and undergo 2 weeks of wash off period. 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 week 1, week 2 and week 4. Test product treatment duration is 4 weeks, followed by 1 week of regression period. |