| CTRI Number |
CTRI/2025/07/091879 [Registered on: 28/07/2025] Trial Registered Prospectively |
| Last Modified On: |
09/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
The management of kitibha kushta (Psoarisis ) with Siravedh (Ayurvedic Blood letting) followed by a herbal paste (Aragwadh kashay paan with Aragwadh patra lepa )help better in treatment. |
|
Scientific Title of Study
|
Single Arm Clinical Study To Assess The Role Of Siravedh Followed By Aragwadh Kashay Paan With Aragwadh Patra Lepa In Kitibh Kushta W.S.R. To Psoarisis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pradnya Kiran Sonone |
| Designation |
PG Scholar |
| Affiliation |
Yashwant ayurvedic college post graduate training and research centre, Kodoli. |
| Address |
Yashwant ayurvedic college post graduate training and research centre, panchkarma department OPD Kodoli, Tal. Panhala, Dist. Kolhapur, State Maharashtra, 416114,
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
7045775370 |
| Fax |
|
| Email |
sononepradnya13@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vidyanand Thorwat |
| Designation |
Professor |
| Affiliation |
Yashwant Ayurvedic College Post Graduate Training And Research Centre |
| Address |
Yashwant Ayurvedic College Post Graduate Training And Research Centre Panchkarma Department OPD Kodoli Kolhapur MAHARASHTRA 416114
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9011081819 |
| Fax |
|
| Email |
vidyanandthorwat@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vidyanand Thorwat |
| Designation |
Professor |
| Affiliation |
Yashwant Ayurvedic College Post Graduate Training And Research Centre |
| Address |
Yashwant Ayurvedic College Post Graduate Training And Research Centre Panchkarma Department OPD Kodoli Kolhapur MAHARASHTRA 416114
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9011081819 |
| Fax |
|
| Email |
vidyanandthorwat@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Yashwant Ayurvedic College Post Graduate Training And Research Centre Kodoli Kolhapur MAHARASHTRA 416114
|
|
|
Primary Sponsor
|
| Name |
Dr Pradnya Kiran Sonone |
| Address |
Yashwant Ayurvedic College Post Graduate Training And Research Centre Kodoli Kolhapur MAHARASHTRA 416114
|
| Type of Sponsor |
Other [self] |
|
|
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 Pradnya Kiran Sonone |
Yashwant Dharmartha Rugnalay |
Yashwant Ayurvedic College
Post GraduateTraining and
Research Centre, Kodoli
Panchkarma OPD No.11 Ground floor and IPD Second floor, Room No.
4 Panchakarma department.
Kodoli Tal Panhala Dist kolhapur 416114
Kolhapur
MAHARASHTRA |
7045775370
sononepradnya13@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Yashwant Ayurvedic College PGT and RC Kodoli Tal Panhala Dist Kolhapur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L00-L99||Diseases of the skin and subcutaneous tissue. Ayurveda Condition: KITIBAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | Aragwadh Kashay Paan – 80ml at night | (Procedure Reference: Sharangadhara Samhita of Pandita Sharangdharacharya with Dipika Hindi Commentary by Dr. Bramhanand Tripathi, Chaukhambla Surbharati Publication, Varanasi, 2021, Madhyam Khanda, Chapter 2/1, Page No-90. , Procedure details: Aragwadh Kashay
Paan – 80ml at night
)
| | 2 | Intervention Arm | Procedure | - | Aragwadh Patra Lepa | (Procedure Reference: Sharangadhara Samhita of Pandita Sharangdharacharya with Dipika Hindi Commentary by Dr. Bramhanand Tripathi, Chaukhambla Surbharati Publication, Varanasi, 2021, Uttar Khanda, Chapter 11/1, Page No-258. Bhavaprakasha Nighantu of Shri Bhavmishra with Hindi commentary by Prof. K.C.Chunekar edited by late Dr. G.S.Pandey Academy, Chaukhambha Bharati, Varanasi, 2010, Haritakyadi Varg, Page No-65-66. , Procedure details: Aragwadh Patra
Lepa – 5mm thickness
once in a day for45 days )
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients having classical signs and symptoms of kitibha kushta and psoriasis will be selected irrespective gender and religion
Patient age between 18 years to 60 years
Patient fit for siravedhana |
|
| ExclusionCriteria |
| Details |
Patient having any severe systemic disorder
Patient with prolonged BT CT
Patient with hemophilic disorders
Patient unfit for siravedhana
Patient with regular anti platelet consumption |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the role of siravedh followed by aragwadh kashay paan with aragwadh patra lepa in kitibha kushta |
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the role of aragwadh kashay paan in the quantity of 80 ml at night with aragwadh patra lepa of 5mm thickness till it gets completely dry daily for 45 days in kitibha kushta
To assess the efficacy of siravedh in kitibha kushta
To study etiopathology and reduce the signs and symptoms
To assess the improvement by its gradation of assessment criteria |
18 months |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
09/08/2025 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This study is Single arm clinical study to assess the role of Siravedh followed by Aragwadh Kashay paan with Aragwadh patra lepa in Kitibha Kushta w.s.r. to Psoarisis.The assesment of signs and symptoms will be done at regular follow ups. |