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CTRI Number  CTRI/2021/11/038011 [Registered on: 12/11/2021] Trial Registered Prospectively
Last Modified On: 06/09/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Effect of chitrak rasayan and bakuchyadi lepa on leucoderma 
Scientific Title of Study   Fundamental studies on shvitra (vitiligo) & effect of Chitrak rasayan And Bakuchyadi lepa 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr kiran kumari  
Designation  MD scholar 
Affiliation  Government ayurveda college,patna 
Address  Government Ayurvedic college Kadamkuan near Buddh murti patna Bihar-800003
village jorpura post office jorpura police station shahpur patory district samastipur Bihar
Samastipur
BIHAR
800003
India 
Phone  8310148030  
Fax    
Email  kiranarayofhope26@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vijay Shankar Pandey 
Designation  Professor, MD (Ayu) 
Affiliation  Government ayurveda college,patna 
Address  Government Ayurvedic college Kadamkuan near Buddh murti patna Bihar 800003

Patna
BIHAR
800003
India 
Phone  9334124587  
Fax    
Email  vijmrs@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr kiran kumari  
Designation  MD scholar 
Affiliation  Government ayurveda college,patna 
Address  Government Ayurvedic college Kadamkuan near Buddh murti patna Bihar-800003
village jorpura post office jorpura police station shahpur patory district samastipur Bihar

BIHAR
800003
India 
Phone  8310148030  
Fax    
Email  kiranarayofhope26@gmail.com  
 
Source of Monetary or Material Support  
GACH PATNA 
 
Primary Sponsor  
Name  Government Ayurvedic College Patna Bihar 
Address  Government Ayurvedic COllege Kadamkuan Patna Bihar 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR KIRAN KUMARI  GACH  Department of Skin and VD Room no 10
Patna
BIHAR 
8310148030

kiranarayofhope26@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC GACH PATNA  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: SHVITRA,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: chitrak rasayan, Reference: Ashtang hrudaya, Route: Oral, Dosage Form: Churna/ Powder, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: Go mutra), Additional Information:
(2) Medicine Name: , Reference: Bakuchyadi lepa, Route: charak samhita, Dosage Form: Churna/ Powder, Dose: 39(6), Frequency: g, Bhaishajya Kal: bd, Duration: Abhakta, anupAna/sahapAna: No, Additional Information: Go mutra
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  As per classical signs and symptoms described in ayurvedic text and modern
literature.
16yrs-60yrs of both sex
Patient willing for trial.
 
 
ExclusionCriteria 
Details  > 60 yrs
Chronicity >10yrs
Spread >75 % of body involvement
Another de-pigmentary disorders
Pregnancy
7-8 asadhya symptoms 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
assessment of total effect of therapy an average of subjective and objective parameters will be taken
size
color
texture

 
2 MONTHS

 
 
Secondary Outcome  
Outcome  TimePoints 
assessment of total effect of therapy an average of subjective and objective parameters will be taken
size
color
texture

 
3 MONTHS 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "26"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   N/A 
Date of First Enrollment (India)   22/11/2021 
Date of Study Completion (India) 12/03/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

In Ayurveda skin is considered as one of the five gyanendriyas which is responsible for sparsh gyan. It is an important organ of communication with the external world. Important functions of skin include protection, thermal regulation, excretion, vitamin D formation, perception of stimuli etc. Skin reveals both external and internal pathological state of an individual. It is one of the essential sense organ as skin covers the whole body. According to Ayurveda all skin diseases come under Kushtha rogadhikar. Kushtha is mainly a tridoshaja vyadhi.   Shvitra (vitiligo) is not a disease of present era but its description is available since Vedic period. The word Shvitra has its root in the Sanskrit word ‘श्वित्र’1which means white. Acharya Charaka has mentioned Shvitra in Kushtha rogadhikar. According to काश्यप संहिता Shvitra is श्वेतभावात् श्वित्र2 this means reflection of white color. This is more similar to Vitiligo in modern science, popularly known as Leucoderma or white spots. It is a chronic disorder characterized by patches of the skin losing their pigment. Cardinal symptom is white colored patches whose cause in modern science is unknown. Worldwide incidence of vitiligo is observed in 2% of world population. It does not spare any age or sex.

                         Vitiligo is a common autoimmune pigmentary disorder of great socio-medical importance. Due to side effects and limitations of the contemporary science, some harmless and potent medicines are expected from Ayurveda. Ayurveda has such potent formulations for the treatment of such auto immune diseases with chronic in nature.  Here formulations namely Chitrak Rasayan from Ash.Hr U 39/65 and Bakuchyadi lepa from Ch.Chi 7/169 which are indicated for shvitra have been taken for study.  

NEED OF STUDY

In present era due to modernization the prevalence of skin diseases has become very common due to faulty dietary habits and lifestyles, excessive use of chemicals, unhygienic practices, overuse of antibiotics and steroids. Ayurveda play an important role in this aspect as it is a life science whose purpose is to prevent the disease and to cure the diseases well described in Ayurveda in Ch.Su 30/26.                                       

 Shvitra is a cosmetic disfigurement so it affects human’s life psychology & have negative impact on quality of life. Acharya Charaka has said regarding the relationship between the Mann and twacha. Twacha is considered as chetah samvayi that is skin has the eternal relationship between the twacha and Mann. Therefore more than physical deformity it produces mental anxiety, depression and other problems which affect quality of life. Patient of skin diseases always experience physical, emotional, and socio-economic embarrassment in the society which further leads to aggravation of the symptoms of the existing diseases. It is a common cause of loss of work due to social stigma. Since shvitra is a progressive disease, its treatment should be started as early as possible. Treatment in modern science for dermatology has greatly advanced but there is no specific cure for shvitra (vitiligo). Treatment like steroids and PUVA are used in modern science which produce serious side effects in body and are relatively expensive. So people are looking towards Ayurveda so that they can be treated with least side effects and get permanent cure of their illness. So it becomes a burning topic in present era where there is a great need of research.

 
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