| CTRI Number |
CTRI/2025/09/094319 [Registered on: 08/09/2025] Trial Registered Prospectively |
| Last Modified On: |
06/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effects of Green Charged Virgin Coconut Oil on Fungal Infections A Comprehensive Study |
|
Scientific Title of Study
|
Adjunctive Use of Green Color Charged Virgin Coconut Oil versus Virgin Coconut Oil Alone in the Management of Superficial Fungal Infections and Nonspecific Dermatitis A Comparative Double Blind Randomized Controlled Trial |
| Trial Acronym |
GVCOF |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Upasana Pathak |
| Designation |
PG Scholar Clinical Naturopathy |
| Affiliation |
Sant Hirdaram Medical College of Naturopathy and Yogic Sciences for Women |
| Address |
Sant Hirdaram Medical College of Naturopathy and Yogic Sciences for Women Room Number BS22 Department of Research Lake Road Bairagarh Bhopal
Bhopal
MADHYA PRADESH
462030
India |
| Phone |
7800367333 |
| Fax |
|
| Email |
upasana1809@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Saraswati Tewani |
| Designation |
Professor HOD Department Of Naturopathy |
| Affiliation |
Sant Hirdaram Medical College of Naturopathy and Yogic Sciences for Women |
| Address |
Sant Hirdaram Medical College of Naturopathy and Yogic Sciences for Women Room Number BS22 Department of Research Lake Road Bairagarh Bhopal
Bhopal
MADHYA PRADESH
462030
India |
| Phone |
9131588356 |
| Fax |
|
| Email |
jyotitewanimgps@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Upasana Pathak |
| Designation |
PG Scholar Clinical Naturopathy |
| Affiliation |
Sant Hirdaram College of Naturopathy and Yogic Sciences for Women |
| Address |
Sant Hirdaram Medical College of Naturopathy and Yogic Sciences for Women Room Number BS22 Department of Research Lake Road Bairagarh Bhopal
Bhopal
MADHYA PRADESH
462030
India |
| Phone |
7800367333 |
| Fax |
|
| Email |
upasana1809@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sant Hirdaram Medical College of Naturopathy and Yogic Sciences for Women |
|
|
Primary Sponsor
|
| Name |
Sant Hirdaram Medical College of Naturopathy and Yogic Sciences For Women |
| Address |
Sant Hirdaram Medical College of Naturopathy and Yogic Sciences for Women Room Number BS22 Department of Research Lake Road Bairagarh Bhopal MP
462030 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Upasana Pathak |
Sah Speciality Clinic |
Lane Number 17 Pandit Madan Mohan Malviya Road Ravindrapuri Colony Durgakund
Varanasi
UTTAR PRADESH |
7800367333
upasana1809@gmail.com |
| Upasana Pathak |
Sant Hirdaram Medical College of Naturopathy and Yogic Sciences for Women |
Sant Hirdaram Medical College of Naturopathy and Yogic Sciences for Women Room Number BS 22 Department of Research Lake Road Bairagarh
Bhopal
MADHYA PRADESH |
7800367333
upasana1809@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Sant Hirdaram Medical College of Naturopathy and Yogic Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L259||Unspecified contact dermatitis, unspecified cause, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Green Light Treated Virgin Coconut Oil |
The prepared oil will be applied topically in sufficient quantity to affected skin areas twice daily for 4 weeks |
| Comparator Agent |
Plain Virgin Coconut Oil |
Virgin Coconut Oil will be applied topically in sufficient quantity to affected skin areas twice daily for 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Participants with superficial fungal infection and non specific dermatitis.
2 Participants currently receiving the standardized conventional anti fungal treatment either oral or topical as per dermatological practice guidelines.
3 Willingness to continue the conventional treatment regimen throughout the study period.
4 Willing to provide informed consent
5 Willing to adhere to all study instructions and follow up visit
|
|
| ExclusionCriteria |
| Details |
1 Severe systemic or dermatological conditions
2 Known allergy to coconut oil
3 Immunocompromised status
4 Pregnant or lactating women
5 Participants not receiving any form of conventional treatment for superficial fungal infection or non specific dermatitis
6 Individual unable or unwilling to comply with follow up visits and study protocol |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
5D Pruritus Scale
|
Baseline Day 0 then on day 7 then day 14 and day 28
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Numeric Rating Scale
|
Baseline Day 0 Day 7 Day 14 Day 28
|
| Dermatological Life Quality Index |
Baseline Day 0 and Day 28 |
| Ruler Metric Scale |
Baseline Day 0 and Day 28 |
|
|
Target Sample Size
|
Total Sample Size="128"
Sample Size from India="128"
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)
|
18/09/2025 |
| 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="1"
Months="6"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [upasana1809@gmail.com].
- For how long will this data be available start date provided 13-12-2027 and end date provided 13-12-2032?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Fungal infections are among the most common dermatological conditions worldwide affecting millions of individuals across all age group. Virgin Coconut Oil has proven anti fungal properties and Green Color has bactericidal effect. This research aims to study the combined effects of Green Color and Virgin Coconut Oil. This randomised, double-blind, parallel group trial will compare the efficacy of Green Color Charged Virgin Coconut Oil in patients with superficial fungal infections and nonspecific dermatitis. The study will enroll adult participants aged 18–60 years and randomize them into two groups: one receiving Green Color Charged Virgin Coconut Oil and the other Virgin Coconut Oil, both along with standard antifungal therapy. The primary outcome measures will include clinical symptoms such as itching redness scaling and lesion size assessed over a 4-week period using validated scales 5 D Pruritus Scale for itch NRS Scoring for redness and lesion measurement with Ruler Metric Scale. Secondary outcomes will assess quality of life using the Dermatology Life Quality Index DLQI.This study aims to provide scientific evidence for the potential synergistic effect of Green Color Charged Virgin Coconut Oil in improving patient outcomes in superficial fungal infections and nonspecific dermatitis
|