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
|
|
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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition:L80||Vitiligo. Ayurveda Condition: SHVITRA, |
|
Intervention / Comparator Agent
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Intervention Arm | Drug | Classical | | (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 ‘शà¥à¤µà¤¿à¤¤à¥à¤°â€™1which means white. Acharya Charaka has mentioned Shvitra in Kushtha rogadhikar. According to काशà¥à¤¯à¤ª संहिता Shvitra is शà¥à¤µà¥‡à¤¤à¤à¤¾à¤µà¤¾à¤¤à¥ शà¥à¤µà¤¿à¤¤à¥à¤°2 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. |