CTRI/2024/01/061619 [Registered on: 19/01/2024] Trial Registered Prospectively
Last Modified On:
06/04/2024
Post Graduate Thesis
Yes
Type of Trial
Interventional
Type of Study
Drug Ayurveda
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
Treatment of shwitra w.s.r to vitiligo in children through ayurvedic line of management.
Scientific Title of Study
A controlled clinical study to evaluate the repigmentation effect of Navaneetakadi lepa over
Avalgujadi lepa in the management of shwitra (Vitiligo) in children.
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
NIL
NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Dipak Pandurang Dhangar
Designation
2nd year M.D [Ayu] scholar
Affiliation
Shree jagadguru gavisiddeshwara ayurvedic medical college
Address
Department of post graduate studies in Kaumarabhritya Shree
jagadguru gavisiddeshwara ayurvedic medical college post graduate
studies and research center Koppal
KARNATAKA
583231
India
Koppal KARNATAKA 583231 India
Phone
7020450128
Fax
Email
drdipakdh321@gmail.com
Details of Contact Person Scientific Query
Name
Dr Radhika Injamuri
Designation
Associate professor
Affiliation
Shree jagadguru gavisiddeshwara ayurvedic medical college
Address
Department of Post-graduate Studies in Kaumarabhritya Shree
Jagadguru Gavisiddeshwara Ayurvedic Medical College Postgraduate
studies and research centre Koppal
KARNATAKA
583231
India
Koppal KARNATAKA 583231 India
Phone
9108304745
Fax
Email
radhikainjamuri.17@gmail.com
Details of Contact Person Public Query
Name
Dr Radhika Injamuri
Designation
Associate professor
Affiliation
Shree jagadguru gavisiddeshwara ayurvedic medical college
Address
Department of Post-graduate Studies in Kaumarabhritya Shree
Jagadguru Gavisiddeshwara Ayurvedic Medical College Postgraduate
studies and research centre Koppal
KARNATAKA
583231
India
Koppal KARNATAKA 583231 India
Phone
9108304745
Fax
Email
radhikainjamuri.17@gmail.com
Source of Monetary or Material Support
Shree jagadguru gavisiddheshwara ayurvedic medical college post graduate studies
and research centre
Primary Sponsor
Name
Shree jagadguru gavisiddeshwara ayurvedic medical college post graduate studies and research center
Address
Shree jagadguru gavisiddeshwara ayurvedic medical college post
graduate studies and research center, Gavimath Campus,opp. to
Gavimath.
Type of Sponsor
Research institution and hospital
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 Dipak P Dhangar
Shree jagadguru gavisiddeshwara ayurvedic medical college post graduate studies and research center
Department of
Kaumarabhritya
OPD
Koppal
KARNATAKA Koppal KARNATAKA
7020450128
drdipakdh321@gmail.com
Details of Ethics Committee
No of Ethics Committees= 1
Name of Committee
Approval Status
INSTITUTIONAL ETHICS COMMITTEE (IEC)
Approved
Regulatory Clearance Status from DCGI
Status
Not Applicable
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition:L988||Other specified disorders of the skin and subcutaneous tissue. Ayurveda Condition: SVITRAH, (2) ICD-10 Condition:L80||Vitiligo. Ayurveda Condition: SVITRAH,
Intervention / Comparator Agent
sno
Intervention/Comparator
Type
Drug-Type
Procedure Name
Details
1
Intervention Arm
Procedure
-
Pralep
(Procedure Reference: Priyavath Sharma, Acharya Chakrapani Datta, Chakra Datta (Sanskrit text with English translation), , editor, Ed. 2007 Varanasi; Chaukamba Orientalia, 50th chapter, verse70, 399pp. 12. Harita Samhita, (Text with Asha Hindi Commentary) 2008 Ramavalamba Shastri Varanasi Prachya Prakashan-, P-432, Procedure details: Using finger or cotton swab thin layer of lepa application over site of patches lepa (application time morning 7-9AM). • Thickness of lepa is (1/4th Anguli)4-5mm is applied over the site of patches. • Ask the patient to expose the lepa-applied part to the sun rays for 20-30 minutes. ) (1) Medicine Name: Navaneetakadi lepa, Reference: Aarogya raksha kalpadrumah, Route: Topical, Dosage Form: Churna/ Powder, Dose: 00(g), Frequency: od, Duration: 7 Days
2
Comparator Arm
Procedure
-
lepa, लेप
(Procedure Reference: Priyavath Sharma, Acharya Chakrapani Datta, Chakra Datta (Sanskrit text with English translation), , editor, Ed. 2007 Varanasi; Chaukamba Orientalia, 50th chapter, verse70, 399pp. 12. Harita Samhita, (Text with Asha Hindi Commentary) 2008 Ramavalamba Shastri Varanasi Prachya Prakashan-, P-432., Procedure details: ➢ POORVAKARMA:
• Nature of the study will be explained to the patients and consent will be taken.
• Patient is advised to sitting position.
➢ PRADHANA KARMA:
• Using finger or cotton swab thin layer of lepa application over site of patches lepa
(application time morning 7-9AM).
• Thickness of lepa is (1/4th Anguli)4-5mm is applied over the site of patches.
• Ask the patient to expose the lepa-applied part to the sun rays for 20-30 minutes.
➢ PASCHAT KARMA:
• Remove th)
3
Comparator Arm
Procedure
-
Pralep
(Procedure Reference: Priyavath Sharma, Acharya Chakrapani Datta, Chakra Datta (Sanskrit text with English translation), , editor, Ed. 2007 Varanasi; Chaukamba Orientalia, 50th chapter, verse70, 399pp. 12. Harita Samhita, (Text with Asha Hindi Commentary) 2008 Ramavalamba Shastri Varanasi Prachya Prakashan-, P-432, Procedure details: Using finger or cotton swab thin layer of lepa application over site of patches lepa (application time morning 7-9AM). • Thickness of lepa is (1/4th Anguli)4-5mm is applied over the site of patches. • Ask the patient to expose the lepa-applied part to the sun rays for 20-30 minutes.) (1) Medicine Name: Avalgujadi lepa, Reference: Harita Samhita, (Text with Asha Hindi Commentary) 2008 Ramavalamba Shastri Varanasi Prachya Prakashan-, P-432., Route: Topical, Dosage Form: Lepa Churna, Dose: 00(g), Frequency: od, Duration: 7 Days
4
Intervention Arm
Procedure
-
Pralep
(Procedure Reference: Priyavath Sharma, Acharya Chakrapani Datta, Chakra Datta (Sanskrit text with English translation), , editor, Ed. 2007 Varanasi; Chaukamba Orientalia, 50th chapter, verse70, 399pp. Harita Samhita, (Text with Asha Hindi Commentary) 2008 Ramavalamba Shastri Varanasi Prachya Prakashan-, P-432, , Procedure details: 1) (1) Medicine Name: Navaneetakadi lepa, Reference: Kaikkulangara Rama Warrier, Arogya Raksha Kalpadrumah, kerala`s Tradition of Ayurvedic Pediatric care, 2016 sri., editor. By Dr Lal Krishnan, Chowkhamba Sanskrit series Varanasi., Route: Topical, Dosage Form: Lepa Churna, Dose: 00(g), Frequency: od, Duration: 07 Days
5
Comparator Arm
Procedure
-
pralepa, पà¥à¤°à¤²à¥‡à¤ª
(Procedure Reference: Priyavath Sharma, Acharya Chakrapani Datta, Chakra Datta (Sanskrit text with English translation), , editor, Ed. 2007 Varanasi; Chaukamba Orientalia, 50th chapter, verse70, 399pp. 12. Harita Samhita, (Text with Asha Hindi Commentary) 2008 Ramavalamba Shastri Varanasi Prachya Prakashan-, P-432, Procedure details: 1) (1) Medicine Name: Avalgujadi lepa, Reference: Priyavath Sharma, Acharya Chakrapani Datta, Chakra Datta (Sanskrit text with English translation), , editor, Ed. 2007 Varanasi; Chaukamba Orientalia, 50th chapter, verse70, 399pp, Route: Topical, Dosage Form: Lepa Churna, Dose: 00(mg), Frequency: od, Duration: 07 Days
Inclusion Criteria
Age From
2.00 Year(s)
Age To
16.00 Year(s)
Gender
Both
Details
Children diagnosed with sadhya lakshana15 of Shwitra & Age group of 2-16 years
irrespective of gender, religion, occupation and children of parents who are allowing their
children to participate in the study after taking consent from parents will be included.
ExclusionCriteria
Details
Children with Shwitra diagnosed with asadhya lakshana15 like Shwitra presenting over the
genital areas, inner part of lips, palms & associated with depigmented hairs will be excluded.
Vitiligo associated with burnt areas, psoriasis, albinism or other skin diseases and any other
systemic diseases and autoimmune disorders will be excluded.
Method of Generating Random Sequence
Random Number Table
Method of Concealment
An Open list of random numbers
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
Repigmentation of skin in shwitra(vitiligo)
28 days
Secondary Outcome
Outcome
TimePoints
None
00
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"
Vitiligo is macular depigmentation of skin associated with destruction of melanocytes
which is typically characterized by non-scaly chalky white macule formation on the skin1
.
The prevalence of vitiligo ranges from 0.06 to 2.28%, whereas this was 0.0–2.16%
in children/adolescents populations2
. Males and females are equally affected. This may be
hereditary, medicine originated or side effects of radiation or chemotherapy.
Disease possesses a major cosmetic problem in the affected. The affected people feel
isolated from the society, they feel loss of self-esteem & get depressed psychologically,
especially school going children. Hence this condition has social stigma.
Management of vitiligo includes topical steroids, topical photochemotherapy,
minigrafting and depigmentation techniques. The present mainstay medications for vitiligo
include NB-UVB (Narrow band Ultraviolet B) phototherapy and PUVA (Oral psoralen +
Ultraviolet A) photochemotherapy3
. Of them, the former is the preferred method, which has
the short-term side effects of pruritus, xerosis, and burning, and the latter increases the risk
of skin cancer 4.
In children recurrent or prolonged arrhythmogenic UV exposure in early childhood
increases the likelihood of development of melanoma & non melanoma skin cancer5
The counterpart of Vitiligo in Ayurveda is Shwitra, also called Kilaasa, and Daruna.
It is considered to be resulting from misdeeds (papakarma) of present and past life
predominantly, and improper dietary habits (virodhi annam).6
It is one among the raktha
pradoshaja vikaras7
.
It is characterized by swetha mandala. It can be correlated to vitiligo in certain extent.
According to Ayurveda Vata & Bhrajaka pitta resides in skin. Any imbalance in Vata &
Bhrajaka pitta may causes skin diseases. As skin covers all over the body, Bhrajaka pitta
should be maintained in proper state.
Since the nidanas and lakshanas mentioned for Shwitra are not clinically sufficient,
it also opens up the space for different research on various aspects of etiopathology and
clinical manifestations of Shwitra. Description regarding stage-wise treatment of Shwitra
has been explained in the Ayurvedic classics.
Lepa, shodhana, raktha mokshana, rukshana and sakthu bhakshana are the
treatments8-9
explained for Shwitra in Ayurveda. In day-to-day practice physicians facing
lots of difficulties in doing shodhana procedures in children so focus has been made on LEPA chikitsa. Various Lepas Mentioned in Ayurveda, few of lepas have been proved their
repigmentation effect over shwitra by past Researches & Among them Navaneetakadi lepa
is mentioned as said to be cures shwitra within 7 days in the context of shwitra in Aarogya
Raksha Kalpa Dhrumah
10
.
Navaneetakadi lepa-This yoga is cost effective and can be prepared & applied
easily, so in this present study, repigmentation effects of Navaneetakadi lepa is compared