| CTRI Number |
CTRI/2025/07/090095 [Registered on: 03/07/2025] Trial Registered Prospectively |
| Last Modified On: |
24/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Screening
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
An survey Study of Ekakushtha (Psoriasis) & Assessment of Dermato-toxicity And Efficacy of Ekakushthaari Lepa Against Psoriasis |
|
Scientific Title of Study
|
An Etiopathological Study of Ekakushtha (Psoriasis) & Assessment of Dermato-toxicity And Efficacy of Ekakushthaari Lepa Against Psoriasis : An In-Vivo Study |
| 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 Jamshed |
| Designation |
MD scholar |
| Affiliation |
National institute of ayurveda |
| Address |
Department of Roga nidana evum vikruti vijyana, room no 152, 1st floor, National institute of ayurveda, Amer road , Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
07015833721 |
| Fax |
|
| Email |
khan.jamshed615@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr BK Sevatkar |
| Designation |
Professor |
| Affiliation |
National institute of ayurveda |
| Address |
Department of roga nidana evum vikruti Vijayan, room no 151, National institute of ayurveda, Amer road , Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
9352311105 |
| Fax |
|
| Email |
drbks6@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jamshed |
| Designation |
MD scholar |
| Affiliation |
National institute of ayurveda |
| Address |
Department of roga nidana evum vikruti Vijayan, room no 152, first floor, National institute of ayurveda, Amer road , Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
07015833721 |
| Fax |
|
| Email |
khan.jamshed615@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda, Jaipur, Rajasthan, India, 302002 |
|
|
Primary Sponsor
|
| Name |
NATIONAL INSTITUTE OF AYURVEDA |
| Address |
National Institute of Ayurveda, Amer road, Jaipur 302002, India |
| 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 |
| Dr Jamshed |
National institute of ayurveda |
Department of roga nidana evum vikruti Vijayan, room no 152, first floor, National institute of ayurveda, Amer road , Jaipur
Jaipur
RAJASTHAN |
07015833721
khan.jamshed615@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee National Institute of Ayurveda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L409||Psoriasis, unspecified. Ayurveda Condition: EKAKUSHTHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Ekakusthari lepa, Reference: NA, Route: Topical, Dosage Form: Lepa Churna, Dose: 5(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Lifestyle | - | - | Dinacarya: wake up in brhammuhurta, eat laghu ahara, , Ritucarya: follow the ritucharya as per different ritu, Acara Rasayana:NA, Other:NA, Pathya/Apathya:no, Pathya:, Apathya: |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient with classical sign and symptoms of Ekakushtha like Aswednam, Matsyashakalvat, Mahavaastu.
2. Patients of either sex and age greater than 18-60 years.
|
|
| ExclusionCriteria |
| Details |
1. The patients suffering from severe systemic disorders.
2. Patient less than 18 years and more than 60 years of age.
3. Known case of skin malignancy.
4. Other skin diseases like fungal infections etc..
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Strength of association of Etiopathological factors with Ekakushtha (Psoriasis) |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of size of Psoriatic lesions on the completion of study. |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
15/08/2025 |
| 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="1"
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
|
INTRODUCTION Charming personality and good looks are prerequisite for success in 21st century Everyone wants to be presentable by maintaining beauty and personality In todays era due to change in life style lack of physical exercise alter food habits, pollutions chemical exposure number of skin diseases increased markedly Psoriasis is one of the most dreadful dermatological condition affecting upto 2- worldwide and 0.4-2.8 in India Psoriasis is a disease with reddish plaque and silvery scales It is a papulosquamous skin disease and is chronic non-contagious multisystemic and inflammatory in nature It is a autoimmune disorder of skin results in hyperproliferation of skin According to Ayurveda all the skin diseases has been grouped under Kushtha roga 7 Maha kushtha and 11 Kshudra kushtha Ekakushtha is a type of Kshudra kushtha and it is a Vata-Kaphaja disorder Ekakushtha resembles as Psoriasis because of its distribution pattern and characteristic features HYPOTHESIS
NULL HYPOTHESIS
There is no association of
Etiopathological factors with Ekakushtha Psoriasis
ALTERNATIVE HYPOTHESIS
There is association of Etiopathological factors with
Ekakushtha Psoriasis
AIM To assess the association of Etiopathological factors
of Ekakushtha Psoriasis
OBJECTIVES
PRIMARY OBJECTIVE
To
conduct the survey study of Etiopathological factors of Ekakushtha Psoriasis
SECONDARY OBJECTIVE
To review compile and evaluate the available
literature related to Ekakushtha and Psoriasis |