| CTRI Number |
CTRI/2025/03/083332 [Registered on: 25/03/2025] Trial Registered Prospectively |
| Last Modified On: |
10/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Use of Shwitrari tail and Shwitra Nashan churna on Viruddha Aahar Jnyanya Shwitra(Vitiligo). |
|
Scientific Title of Study
|
TO STUDY THE VIRUDDHA AAHAR JANYA SHWITRA W.S.R.TO VITILIGO AND THE ROLE OF SHWITRARI TAIL AND SHWITRA NASHAN CHURNA. |
| Trial Acronym |
Vitiligo |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr MUKESH KUMAR |
| Designation |
BAMS, MD(Scholar) |
| Affiliation |
Shri NPA Ayurveda college Raipur C.G. |
| Address |
Department of Agad Tantra evam Vidhi Ayurveda Shri NPA Government Ayurveda college Raipur (C.G.)
Near NIT Raipur C.G.
Raipur
CHHATTISGARH
492010
India |
| Phone |
08319418639 |
| Fax |
|
| Email |
aryan2jaiswal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S.R. inchulkar |
| Designation |
Professor & HOD AgadTantra evam Vidhi Ayurveda |
| Affiliation |
Shri NPA GOVT. Ayurveda college Raipur C.G. |
| Address |
Department of Panchakarma Shri NPA GOVT. Ayurveda college Raipur C.G.
Raipur
CHHATTISGARH
492010
India |
| Phone |
8770151486 |
| Fax |
|
| Email |
sinchulkar@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ranjip Kumar Dass |
| Designation |
Professor & HOD Panchakarma |
| Affiliation |
Shri NPA GOVT. Ayurveda college Raipur C.G. |
| Address |
Department of Panchakarma Shri NPA GOVT. Ayurveda college Raipur C.G.
Raipur
CHHATTISGARH
492010
India |
| Phone |
9017418807 |
| Fax |
|
| Email |
drranjipayu@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Shri Khudadad Dunga ji GOVT. Ayurvedic hospital Raipur C.G.492010 |
|
|
Primary Sponsor
|
| Name |
Dr MUKESH KUMAR |
| Address |
Shri NPA GOVT Ayurveda college Raipur Chhattisgarh 492010 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Dr Mukesh Kumar |
Shri Khudadad Dunga ji GOVT. Ayurvedic hospital Raipur C.G. |
OPD N0.9 Department of Panchakarma Shri Khudadad Dunga ji GOVT. Ayurvedic hospital Raipur C.G. Pin 492010.
Raipur
CHHATTISGARH |
8319418639
aryan2jaiswal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE GOVT AYURVEDA COLLEGE RAIPUR CHHATTISGARH 492010 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L00-L99||Diseases of the skin and subcutaneous tissue. Ayurveda Condition: SVITRAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Shwitra Nashan Churna, Reference: 193/20 Rasratna Samuchya, Route: Oral, Dosage Form: Churna/ Powder, Dose: 12(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -Dugdha), Additional Information: - (2) Medicine Name: Shwitrari Tail, Reference: 186/20 Rasratna Samuchya, Route: Topical, Dosage Form: Taila, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: No, Additional Information: -Quantity of Shwitrari tail will be used as per need depending on the body surface and size of patches(3) Medicine Name: Triphla Churna, Reference: Bhavprakash Nighantu, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: hs, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -Sukhoshna Jal), Additional Information: -Dose of Triphla churna depends on bowel movement. |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Patient between the age of 18-60 years
2 Patient with history of Vairodhik Aahar
3 Sex- Both male and female
4 Diagnosed patient with clinical features of Shwitra(Vitiligo) according to Ayurveda and Morden
|
|
| ExclusionCriteria |
| Details |
1 Patient having complaints for more than 10 years
2 Spread over more than 50% of body
3 Patient in whom history of Virudhha aahar will not found
4 Patient below the age of 18 year and above 60 years
•Patient who have history of burn or injury that cause discoloration.
•Patient who have any other systemic diseases like HIV, TB, DM, Thyroid etc.
•Women using oral contraceptives, pregnant women and lactating mother.
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
Subjective parameter
1 Percentage of area affected
2 Number of patches present
3 Area of Patches
4 Color of patches
5 Itching in patch
6 Color of hair in affected part
Objective Parameter
1 Measurement of size of patches.
2 Photographs for compare.
Laboratory investigation
1 Hb
2 TLC
3 DLC
4 ESR |
60 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Viruddha Aahara is incompatible diet It is referred in terms of food to food interaction or food processing interaction which develops toxicity because of antagonism. Ayurveda clearly defines good food habits along with certain diet & its bad combination that creat Toxicity in the body tissues. Many people are consuming incompatible food like Junk food fast food deep fried food etc in current era unknowingly Long term consuming of such Viruddha aahar incompatible food may leads to cause various diseases like Shwitra Vitiligo & other skin diseases |
60 days |
|
|
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
15/05/2025 |
| 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="0"
Months="3"
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
|
Viruddha Aahara, or incompatible diet, is a key
concept in Ayurveda, referring to food combinations that lead to toxic effects
in the body. These incompatibilities disturb the digestive fire, Jatharagni,
which is crucial for proper digestion and nourishment of body tissues. The
consumption of Viruddha Aahara is believed to cause Agnimandya (indigestion)
and Ama (toxicity), leading to various disorders, including skin conditions
such as Shwitra (Vitiligo). Vitiligo is characterized by depigmented patches on
the skin and is often associated with psychological and social challenges.
This study aims to evaluate the efficacy of two
Ayurvedic formulations—1.Shwitrari Tail 2. Shwitra Nashan Churna—in the
management of Shwitra caused by Viruddha Aahara. The formulations, composed of
herbal ingredients like Ankola, Nimba, Nirgundi, and Bakuchi, are believed to
possess properties that balance the Tridosha, promote skin health, and detoxify
the body. A clinical trial involving 30 patients between the ages of 18 and 60,
diagnosed with Shwitra, will be conducted over a 90-day period. The study will
assess the therapeutic effects through both subjective and objective
parameters, including the percentage of affected skin area, the number of
patches, itching, and the color of patches, along with laboratory tests.
The primary objective is to investigate the literary
aspect of Viruddha Aahara Janya Shwitra in Ayurveda, understand the
pathophysiology of Shwitra and Vitiligo, and assess the clinical efficacy of
the formulations. Additionally, the study will evaluate the safety and
potential adverse effects of the treatments. The anticipated outcome is to
provide evidence on the effectiveness of Ayurvedic treatments in managing
Vitiligo and to contribute to the understanding of Ayurvedic approaches to
dietary incompatibility-related disorders.
Keywords:
Viruddha Aahara, Ayurveda, Shwitra, Vitiligo, Incompatible Diet, Clinical
Study, Ayurvedic Treatment. |