FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
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 
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  
Status 
Not Applicable 
 
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 Kuṣṭha 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. 

 
Close