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CTRI Number  CTRI/2023/10/059120 [Registered on: 26/10/2023] Trial Registered Prospectively
Last Modified On: 25/10/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Diagnostic 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Management Of Shwitra By Ayurveda 
Scientific Title of Study   A Comparative Clinical Study Of Dhatrikhadir Kwatha (Internal) & Aaragvadhadi Tail (External) In The Management Of Shwitra (Vitiligo) 
Trial Acronym  Nill 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Deepak Singh Rajpurohit 
Designation  M D Scholar 
Affiliation  Post Graduate Institute Of Ayurved Jodhpur 
Address  P.G.Department Of Kayachikitsa, Post Graduate Institute Of Ayurved, Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur

Jodhpur
RAJASTHAN
342037
India 
Phone  08005868072  
Fax    
Email  drdeepaksinghrajpurohit1616@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Pramod Kumar Mishra 
Designation  Professor and hod 
Affiliation  Post Graduate Institute Of Ayurved Jodhpur 
Address  P.G.Department Of Kayachikitsa, Post Graduate Institute Of Ayurved, Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur

Jodhpur
RAJASTHAN
342037
India 
Phone  9001009793  
Fax    
Email  drpramodmishra4@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Deepak Singh Rajpurohit 
Designation  M D Scholar 
Affiliation  Post Graduate Institute Of Ayurved Jodhpur 
Address  P.G.Department Of Kayachikitsa, Post Graduate Institute Of Ayurved, Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur

Jodhpur
RAJASTHAN
342037
India 
Phone  8005868072  
Fax    
Email  drdeepaksinghrajpurohit1616@gmail.com  
 
Source of Monetary or Material Support  
Post Graduate Institute Of Ayurved Jodhpur 
 
Primary Sponsor  
Name  Post Graduate Institute Of Ayurved Jodhpur 
Address  P.G.Department Of Kayachikitsa, Post Graduate Institute Of Ayurved, Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur, Rajasthan 342037 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
DR Deepa Singh Rajpurohit  P.G.Department Of Kayachikitsa, Post Graduate Institute Of AYURVED, Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur, Rajasthan 342037 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Deepak Singh Rajpurohit  Post Graduate Institute Of Ayurved Jodhpur, Rajasthan  P.G. Department Of Kayachikitsa, Post Graduate Institute Of Ayurved, Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpurp.G. Department Of Kayachikitsa, Post Graduate Institute Of Ayurved, Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur
Jodhpur
RAJASTHAN 
8005868072

drdeepaksinghrajpurohit1616@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University, Jodhpur, Post Graduate Institute of Ayurved, Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L80||Vitiligo. Ayurveda Condition: KUSHTHAM,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-aBya~ggaH, अभ्यंग  (Procedure Reference: Charak Chikitsa 7, Procedure details: Oil Will Use On Affected Areas Of Vitiligo)
(1) Medicine Name: Aaragvadhadi Tail, Reference: chakardatt 50/122, Route: Topical, Dosage Form: Taila, Dose: 10(ml), Frequency: bd, Duration: 60 Days
2Intervention ArmDrugClassical(1) Medicine Name: Dhatrikhadir Kwatha , Reference: chakardatt 50/70, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: No, Additional Information: Bakuchi Churna Add As A Prakshyap Drvya
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  a)Patients having signs and symptoms Mainly Twak Vaivarnya (skin depigmentation) will select for the present study.
b)Patients diagnosed as Shwitra based on clinical features mentioned in Ayurvedic texts.
c)Sex- either sex.
d)Patients who are between 20-60 years will be selected.
e)Patient willing to sign the consent form.
f)Patient should be capable of obeying Pathya–apathya.
 
 
ExclusionCriteria 
Details  a)Patient below the age of 20 years and above 60 years.
b)Children with Albinism were excluded.
c)White non-sensational spots, which are characteristic of leprosy.
d)Any systemic disease.
e)Any adverse reaction with treatment.
f)White spots by trauma and burn.
g)Patches in the genital area are excluded from the study.
h)Vitiligo patches complicated by eczema.
i)Patients with long-term steroid and cytotoxic treatment.
j)Patients with evidence of malignancy.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To Assessment of Subjective and Objective Parameters before and After Treatment   60DAYS 
 
Secondary Outcome  
Outcome  TimePoints 
To observe any side effects if occur during clinical trial   60 days 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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   N/A 
Date of First Enrollment (India)   07/11/2023 
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="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  

Ayurved is the science of life that is different from other traditional medical fields because of its psychosomatic methodology. It has been considered a way of life rather than medical science. Acharyas have tried to imbibe these principles in today’s life itself Because they were aware of the upcoming lifestyle disorders.    

       In the modern era, we can see changes in the expected lifestyle of the person due to ignorance of lifestyle, food, and other activities. This resulted in certain genetic mutations as well as other health problems.

       All the human beings of the world are classified on the basis of their skin color and their character varies based on the geographical location of those places, this character is important for the humans of that place and is also responsible for their external identity, in today’s era of appearance if human’s character is not according to his will or according to the demands of the world. So, this situation is one of the main problems of that humans, along with this problem of the world, if there are white spots on the skin of that person, then this problem makes it difficult for that person to live personally and socially in today’s era.

       Vitiligo is prevalent worldwide. It is estimated that about 1 - 2 percent of the world’s population which accounts for approximately 100 million people suffer from this disease. The prevalence in different countries ranges from less than 0.1% to more than 8% of the general population. In India, an estimated 2-3 percent of the population suffers from this condition. The rate is higher in coastal areas like Andhra Pradesh, West Bengal, and Kerala.

“श्वेत वर्ण प्राप्नोति इति श्वित्रं” अर्थात  In Ayurveda, the skin of any part of the body becomes white and unpleasant, then it is called Shwitra, in Ayurveda scriptures, the disease is described by the names of Kilas, Varuna, Darun, etc.

            as per modern, vitiligo is a cutaneous condition an acquired condition with localized loss of pigmentation of the skin that may occur after any inflammatory skin conditions, burns, intralesional steroid injections, postdermabrasion, etc. It is primarily a cosmetic issue and neither infectious nor communicable. 
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