| CTRI Number |
CTRI/2025/06/089301 [Registered on: 23/06/2025] Trial Registered Prospectively |
| Last Modified On: |
20/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [TREATMENT ] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Randomised Comparative Study Of Marichyadi Taila And Somaraji Taila In The Management Of Shwitra With Special Reference To Vitiligo |
|
Scientific Title of Study
|
A Randomised Comparative Study Of Marichyadi Taila And Somaraji Taila In The Management OF Shwitra With Special Reference To vitiligo |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ishwari Satish Chavan |
| Designation |
Post Graduate scholar |
| Affiliation |
Ashvin Rural Ayurved College Manchi Hill Sangamner |
| Address |
Left Wing Room No.3 kayachikitsa Department Ashvin Rural Ayurved College & Hospital Sadvi Preetisudhaji Maharaj Nagar Manchi Hill
Ashvi Bk Tal Sangamner Dist
Ahmadnagar
Ahmadnagar
MAHARASHTRA
413714
India |
| Phone |
9356263951 |
| Fax |
|
| Email |
ishwaric24@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjeev Lokhande |
| Designation |
Head of department |
| Affiliation |
Ashvin Rural Ayurved College Manchi Hill Sangamner |
| Address |
Left Wing Room No 3 kaychikista Department Ashvin Rural Ayurved College & Hospital Sadvi Preetisudhaji Maharaj Nagar Manchi Hill Ashvi Bk Tal Sangamner Dist Ahmednagar
Ahmadnagar
MAHARASHTRA
413714
India |
| Phone |
9373788599 |
| Fax |
|
| Email |
lokhandesanjeev13@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ishwari Satish Chavan |
| Designation |
Post Graduate scholar |
| Affiliation |
Ashvin Rural Ayurved College Manchi Hill Sangamner |
| Address |
Left Wing Room No 3 kaychikista Department Ashvin Rural Ayurved College & Hospital Sadvi Preetisudhaji Maharaj Nagar Manchi Hill Ashvi Bk Tal Sangamner Dist Ahmednagar
Ahmadnagar
MAHARASHTRA
413714
India |
| Phone |
9356263951 |
| Fax |
|
| Email |
ishwaric24@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kayachikitsa Department OPD And IPD Ashvin Rural Ayurved
College & Hospital Manchi Hill Ashvi Bk Tal Sangamner Dist Ahmadnagar Maharashtra India
413714 |
|
|
Primary Sponsor
|
| Name |
Dr Ishwari Satish Chavan |
| Address |
Left Wing Room No 3 kayachikitsa Department Ashvin Rural Ayurved College &
Hospital Sadvi Preetisudhaji
Maharaj Nagar Manchi Hill
Ashvi Bk Tal Sangamner Dist
Ahmadnagar Maharashtra India 413714 |
| Type of Sponsor |
Other [Self] |
|
|
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 Ishwari Satish Chavan |
Ashvin Rural Ayurved College & Hospital |
Kayachikitsa department OPD and IPD Ashvin Rural Ayurved College & Hospital Sadhvi Preetisudaji Maharaj Nagar Manchi Hill Ashvin Bk Tal Sangamner
Ahmadnagar
MAHARASHTRA |
9356263951
ishwaric24@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ashvin Rural Ayurved College Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L00-L08||Infections of the skin and subcutaneous tissue. Ayurveda Condition: SVITRAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Marichyadi Taila , Reference: Bhaishajya Ratnavali , Route: Topical, Dosage Form: Taila, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 30 Days, Reference: No, Route: -, Dosage Form: Taila, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Somaraji Taila , Reference: Bhaishajya Ratnavali , Route: Topical, Dosage Form: Taila, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 30 Days, Reference: No, Route: -, Dosage Form: Taila, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
A diagnosed case of localized vitiligo
Chronicity less than 1 year
|
|
| ExclusionCriteria |
| Details |
Pregnant and lactating mothers
Vitiligo with other skin diseases
White patches due to burn or any scar due to injury
K/C/O systemic disorders like Diabetes and Hypertension |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effect of Marichyadi Taila and Somaraji Taila in the management of Shwitra by using subjective and objective criteria |
Total duration of external application will be 30 days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NOT APPLICABLE |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
10/07/2025 |
| 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 - NO
|
|
Brief Summary
|
Dietary and behavioral alterations evokes the tridosha In Shwitra Rakta gets vitiated due to excessive intake of nidanas three doshas such as vayu pitta and kapha agrrevated in association with twak rakta mamsa and udak as result varieties of skin diseases are caused such as Shwitra Vitiligo also called as leucoderma is the most common depigmenting skin condition affecting between 0.5%to 25% of the world population Medication -1- Somaraji Taila Reference Bhaishajya Ratnavali Form - local application Dose - As per affected area Medication -2- Marichyadi Taila Reference Bhaishajya Ratnavali Form - local application Dose - As per affected area |