| CTRI Number |
CTRI/2025/03/082506 [Registered on: 17/03/2025] Trial Registered Prospectively |
| Last Modified On: |
12/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Exploring medicated Ghee as a remedy for hyperpigmentation: A Clinical Trial |
|
Scientific Title of Study
|
Evaluation of vyanghar effect of vyanghar ghrita - an open label clinical trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sayongeeta Dhananjay Patil |
| Designation |
PG scholar |
| Affiliation |
Bharati vidyapeeth ayurved college(deemed to be university), pune |
| Address |
Department of Rasashastra evum Bhaishjya Kalpana,Bharati Vidyapeeth(Deemed to be university
)College of Ayurved, Dhanakwadi educational campus, katraj,satara road, pune-411043
Pune
MAHARASHTRA
411043
India |
| Phone |
9892597079 |
| Fax |
|
| Email |
Sayongeeta.patil-ayurved@bvp.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Swati Gadgil |
| Designation |
Associate professor |
| Affiliation |
Bharati vidyapeeth ayurved college(deemed to be university), pune |
| Address |
Department of Rasashastra evam Bhaishjya kalpana, Bharati Vidyapeeth(Deemed to be university) College of Ayurved, Dhanakwadi educational campus, satara road, pune-411043
Pune
MAHARASHTRA
411043
India |
| Phone |
9370221200 |
| Fax |
|
| Email |
swati.gadgil@bharatividyapeeth.edu |
|
Details of Contact Person
Public Query
|
| Name |
Sayongeeta Dhananjay Patil |
| Designation |
PG scholar |
| Affiliation |
Bharati vidyapeeth ayurved college(deemed to be university), pune |
| Address |
Department of Rasashastra evam Bhaishjya kalpana, Bharati Vidyapeeth(Deemed to be university) College of Ayurved, Dhanakwadi educational campus, satara road, pune-411043
Pune
MAHARASHTRA
411043
India |
| Phone |
9892597079 |
| Fax |
|
| Email |
Sayongeeta.patil-ayurved@bvp.edu.in |
|
|
Source of Monetary or Material Support
|
| Bharati Vidyapeeth(Deemed to be university) college of ayurved and hospital, Pune-43 |
|
|
Primary Sponsor
|
| Name |
Dr Sayongeeta Dhananjay Patil |
| Address |
Department of Rasashastra, Bharati Vidyapeeth(Deemed to be University)College of Ayurved, Dhankawadi, Pune
MAHARASHTRA
411043
India |
| Type of Sponsor |
Other [self] |
|
|
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 |
| DrSayongeeta Patil |
Bharati vidyapeeth (Deemed to be university), college of ayurved and hospital, pune |
kayachikista OPD, ground floor,OPD NO-04, Bharati Vidyapeeth college of Ayurved and hospital,Dhanakwadi educational campus, satara road, pune-411043
Pune
MAHARASHTRA |
09892597079
Sayongeeta.patil-ayurved@bvp.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bharati vidyapeeth (Deemed to be University), Pune (India) COLLEGE OF AYURVED Pune-Satara road, Pune-411043 ETHICS COMMITTEE [BV(DU)COA-EC] |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L818||Other specified disorders of pigmentation. Ayurveda Condition: VYANGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: vyanghar ghrita, Reference: NA, Route: Oral, Dosage Form: Ghrita, Dose: 4(drops), Frequency: bd, Bhaishajya Kal: Samudga, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with symptoms of Vyang on face
2. Age group- 20-55.
3. Chronicity less than 1 year.
4. Post inflammatory hyperpigmentation.
5. Melasma.
6. Post injury hyperpigmentation.
7. patient showing no irritancy in patch.
|
|
| ExclusionCriteria |
| Details |
1. Postburn injury hyperpigmentation.
2. K/C/O Malignant melanoma.
3. Patient on steroids or other medication for hyperpigmentation.
4. Hyperpigmentation due to systemic and endocrinal diseases.
5. Hyperpigmentation since birth.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Vyanghar regimen may show positive results in reducing Vyang on face offering even complexion.
|
Duration of study- This study will be conducted over 30 days. Follow ups will be conducted every 10 days. Size of the vyang will be assessed by fitzpatric scale and dermascope.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| not applicable |
|
|
|
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)
|
05/05/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 study will be conducted after obtaining permission from institutional ethics
committee and will be registered prospectively with CTRI, INDIA. . As per inclusive/exclusive criteria, patients will be selected.
3. Whole research procedure and aim will be clearly informed to the subject and
informed written consent (ICF) will be collected from the
subject and case record form (CRF) will be used to obtain
history and total information of subject regarding disease that is vyang. Once a patient will be enrolled on day 0, a patch test will be conducted. Procedure to perform a patch test. Product will be applied to a small patch of skin where a person is unlikely to
accidentally wash or rub it away. Good areas may include the inside of the arm
or bend of the elbow. Product will be applied to a quarter-sized patch of skin. A person should apply
the product as thickly as they would when using it regularly.
c. Product will be leave on the patch of skin for as long as it would normally be
on the skin A reaction may not happen immediately, so it is important to keep it for
e. 24-48hrs. If a person’s skin reacts to the product, they should wash it off as
soon as possible and stop using it. A person can use a cold compress or
shatadhauta ghrita lepa/dashang lepa to relieve the skin if needed. If the subject fails the patch test, then they will not be included in the study. Case report format will be used to obtain history of patient. Local application of ghrita 5-10 drops day and night time every day for 30
days. Follow ups will be conducted every 10 days (about 1 and a half week) |