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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition:L80||Vitiligo. Ayurveda Condition: KUSHTHAM, |
|
Intervention / Comparator Agent
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Comparator Arm | Procedure | - | aBya~ggaH, अà¤à¥à¤¯à¤‚ग | (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 | 2 | Intervention Arm | Drug | Classical | | (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.
“शà¥à¤µà¥‡à¤¤ वरà¥à¤£ पà¥à¤°à¤¾à¤ªà¥à¤¨à¥‹à¤¤à¤¿
इति शà¥à¤µà¤¿à¤¤à¥à¤°à¤‚†अरà¥à¤¥à¤¾à¤¤ 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. |