CTRI Number |
CTRI/2019/01/017000 [Registered on: 09/01/2019] Trial Registered Prospectively |
Last Modified On: |
10/03/2021 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Ayurveda Diagnostic Preventive |
Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
Public Title of Study
|
Etiopathological Study of Vipadika Kushtha (rhageades) and its Management with special reference to Raktadushti (vitiation of blood) |
Scientific Title of Study
|
Etiopathological Study of Vipadika Kushtha and its Management with special reference to Raktadushti |
Trial Acronym |
ESOVKAIMWSRTR |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
DEVENDRA SINGH |
Designation |
P.G.SCHOLAR |
Affiliation |
NATIONAL INSTITUTE OF AYURVEDA,JAIPUR |
Address |
P.G.SCHOLAR IN P.G. DEPARTMENT OF ROGA VIGYAN IN NATIONAL INSTITUTE OF AYURVEDA,JAIPUR
Jaipur RAJASTHAN 302002 India |
Phone |
9610477630 |
Fax |
|
Email |
DRDVNDRCHOUDHARY888@GMAIL.COM |
|
Details of Contact Person Scientific Query
|
Name |
DRSISIR KUMAR MANDAL |
Designation |
ASSISTANT PROFESSOR |
Affiliation |
NATIONAL INSTITUTE OF AYURVEDA,JAIPUR |
Address |
P.G.SCHOLAR IN P.G. DEPARTMENT OF ROGA VIGYAN IN NATIONAL INSTITUTE OF AYURVEDA,JAIPUR
Jaipur RAJASTHAN 302002 India |
Phone |
9982343576 |
Fax |
|
Email |
DRSKMANDAL2008@REDIFFMAIL.COM |
|
Details of Contact Person Public Query
|
Name |
DRSISIR KUMAR MANDAL |
Designation |
ASSISTANT PROFESSOR |
Affiliation |
NATIONAL INSTITUTE OF AYURVEDA,JAIPUR |
Address |
P.G.SCHOLAR IN P.G. DEPARTMENT OF ROGA VIGYAN IN NATIONAL INSTITUTE OF AYURVEDA,JAIPUR
RAJASTHAN 302002 India |
Phone |
9982343576 |
Fax |
|
Email |
DRSKMANDAL2008@REDIFFMAIL.COM |
|
Source of Monetary or Material Support
|
PHARMACY OF NATIONAL INSTITUTE OF AYURVEDA, JAIPUR |
|
Primary Sponsor
|
Name |
NATIONAL INSTITUTE OF AYURVEDA JAIPUR |
Address |
NATIONAL INSTITUTE OF AYURVEDA, AMER ROAD, JORAVAR SINGH GATE, JAIPUR PIN-302002 |
Type of Sponsor |
Research institution and hospital |
|
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 |
DEVENDRA SINGH |
NATIONAL INSTITUTE OF AYURVEDA, JAIPUR |
ROGA NIDANA EVAM VIKRITI VIBHAGE ,
OPD NO.-17 Jaipur RAJASTHAN |
9610477630
DRDVNDRCHOUDHARY888@GMAIL.COM |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
INSTITUTIONAL ETHICS COMMITTEE NATIONAL INSTITUTE OF AYURVEDA, JAIPUR |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: L309||Dermatitis, unspecified, PATIENTS OF EITHER SEX HAVING 16 YEARS TO 70 YEARS OF AGE WITH WITH THE CLASSICAL SIGN AND SYMPTOMS OF VIPADIKA KUṢṬHA AS MENTIONED IN CLASSICAL AYURVED TEXT PANIPADA SPHUTANAM TIVRAVEDANAM, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Khadira (Acacia catechu Linn.) |
Dose- 6gm dose with lukewarm water, both time after meal for one month |
Comparator Agent |
Manjistha (Rubia cordifolia Linn.) |
Dose- 6gm dose with lukewarm water, both time after meal for one month |
Intervention |
VIPADIKAHARA GHRITA-TAILA |
CONTENTS-Paya(Cow Milk), Jivanti (Ledtadeni areticulata Linn.), Manjistha(Rubia cordifolia Linn.),Darvi(Berberis aristata Linn.),Kampillaka (Mallotu sphilippinensis Linn.),TUTTHA(Copper sulphate)(CuSO4),Ghrita(Go-ghrita)TILA taila (seed) (Sesamum indicum),Sarajarasa (Shorea robusta Gaertn), Madhuchishtha
FOR LOCAL APPLICATION AS PER AREA
1gm local application square cm area of affected area for one month |
|
Inclusion Criteria
|
Age From |
16.00 Year(s) |
Age To |
70.00 Year(s) |
Gender |
Both |
Details |
a.Patient with the classical sign and symptoms of Vipadika Kuá¹£á¹ha as mentioned in classical Ayurved text Panipadasphutanam Tivravedanam
b.Patients 16 years to 70 years of age will be included.
c.Patients belonging to either gender will be included.
|
|
ExclusionCriteria |
Details |
a.The patient suffering from malignant systemic disorders, specially those are mentioned as Asadhya Vyadhi as per clinical text of Ayurveda will be excluded.
b.The pregnant women and lactating mother will be excluded.
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
Improvement in Vipadika kushtha and relation in treatment protocol of kushtha and raktadusthi |
IN 2 MONTHS OF CLINICAL TRAIL |
|
Secondary Outcome
|
Outcome |
TimePoints |
efficay and safety of medicine |
IN 2 MONTHS OF TRAIL |
|
Target Sample Size
|
Total Sample Size="90" Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="95" |
Phase of Trial
|
Phase 4 |
Date of First Enrollment (India)
|
14/01/2019 |
Date of Study Completion (India) |
Date Missing |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="0" Months="1" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
yes |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Skin as an important organ of body because it interfaces with
environment and plays a major role in protecting the body against various
pathogens and it dose many work. Skin is the first organ of the body
interacting with the environmental agents like chemical, physical,&
biological.
Skin is the mirror that reflects our emotions,
internal and external pathology & thus helps in diagnosis of disease. It is
one of the five “Spershendriya†as
told by
Ayurveda, which is responsible for the perception of touch. Large
community prevalence studies have demonstrated that 20-30% of the population
have various skin problem requiring attention. (Davidson,18thedition)1. Skin disorders affects all ages
from the neonates to the elderly & its various etiological factor include
faulty food habits, changed work culture, heavy workload, lack of exercise,
& changing life style & increasing pollution.Maximum number of the skin disease in ancient
Indian classics has been described under the broad head ling of „Kushtha‟,
which are further divided into Maha Kushtha & Kshudra Kushtha. Kushtha runs as a chronic
disease which is generally considered
as difficult to cure. In Ayurveda all types of Kushtha have been described as“Rakta Pradoshaja†vikara. Vipadika is also
describe in Charak Samhita Kushtha Chikitsa – 7th
Chapter Vipadika Kustha comes
under eighteen subtypes of skin diseases in Ayurveda and it
severely damaged the palms and feet of the person. Therefore, patients present
with large fissures and cracks in their feet and palms (Panipadasphuthanam) with severe pain (Tivravedanam).Vaipadikaṃ Paṇipada Sphuá¹anaṃ
Tivravedanam||22|| cracks in palms and soles of feet as well as excruciating pain.
It occurs due to increase of Vata and
Kapha Dosha.Though Saptadravaya is a basic pathological concept for each and every Kuhstha but Kushtha is predominantly
diagnose and treat after observing the Dosha
dominancy in a particular disease.In modern sciene Vipadik Kushtha known as plantar-palamar psoriasis.it is deficult to treat in modern medicine. so in this work my primary outcome to treat this disease with minimum side effect and better improvement. |