| CTRI Number |
CTRI/2011/09/002025 [Registered on: 27/09/2011] Trial Registered Retrospectively |
| Last Modified On: |
20/09/2011 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Tinea versicolor is a long-term (chronic) fungal infection of the skin. This study has been conducted to see Effectiveness and Safety of medication (Enhanced Virgin Coconut Oil Cream) used under the study |
|
Scientific Title of Study
|
To Assess The Efficacy and Safety Of Enhanced Virgin Coconut Oil Cream in Tinea Versicolor |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SRC/CD/268 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Priyam kembre |
| Designation |
Investigator |
| Affiliation |
The KET’s, “Scientific Research Centre”, |
| Address |
Cosmetology Division,
4th floor,
V. G. Vaze college campus,
Mithagar Road, Mulund (E)
Mumbai
MAHARASHTRA
400081
India |
| Phone |
9833022264 |
| Fax |
- |
| Email |
drpriyamkembre@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aliya Shakeel |
| Designation |
Medical Writer |
| Affiliation |
Vedic Lifesciences Pvt Ltd |
| Address |
118, Morya House Off. New Link Road,
Andheri (West)
Mumbai
MAHARASHTRA
400053
India |
| Phone |
022-42025703 |
| Fax |
- |
| Email |
medical@vediclifesciences.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Sakshi Pawar |
| Designation |
Project Manager |
| Affiliation |
Vedic Lifesciences Pvt Ltd |
| Address |
118, Morya House Off. New Link Road,
Andheri (West)
Mumbai
MAHARASHTRA
400053
India |
| Phone |
022-42025710 |
| Fax |
- |
| Email |
sakshi.p@vediclifesciences.com |
|
|
Source of Monetary or Material Support
|
| Biotropics Malaysia Berhad
Level 52,North Wing, Menara TM,Jalan Pantai Baharu,
50672 Kuala Lumpur, Malaysia
|
|
|
Primary Sponsor
|
| Name |
Biotropics Malaysia Berhad |
| Address |
Level 52,North Wing, Menara TM,Jalan Pantai Baharu,
50672 Kuala Lumpur, Malaysia |
| Type of Sponsor |
Research institution |
|
|
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 |
| Sagar Samant |
The Kelkar Scientific Research Centre |
The Kelkar Scientific Research Centre,V. G. Vaze College Campus, Mulund-400 081
Mumbai
MAHARASHTRA |
022-25639644
-
kelkarcosmetology@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Kelkar Education Trusts INDEPENDENT SCIENTIFIC ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Tinea Versicolor, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
VIRGIN COCONUT OIL |
Apply the product twice a day for 2 weeks on affected/Fungal Infected area. |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Male and/or female subjects who have been diagnosed with tinea Versicolor.
2) Subjects over 19 years of age.
3) Subjects with moderate to severe grade tinea versicolor.
4) Subjects who have not used any topical antifungal products to the affected area in the
past 30 days and topical steroid in the past 14 days.
5) Subjects willing to give a written informed consent and come for regular follow up.
|
|
| ExclusionCriteria |
| Details |
1) Use of topical antifungal to the affected area in past 30 days
2) Use of topical steroid to the affected area in the past 14 days
3) Pregnant and breast feeding women
4) Patient with dermatological condition that may interfere with the study result
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
dermatological
evaluation, subject self assessment, Photography whereas Mycological assessment will be
done on Screening, Week 2 and Week 4 visit. |
Screening
visit,
Baseline, Week 1, Week 2, Week 4 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
15/03/2011 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="30" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
The results of this research study may be presented at meetings or in
publications |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A mono-centered, single arm, open label study to evaluate the efficacy and safety of IP in reducing the itchiness associated with Tinea versicolor infection in adult subjects |