| CTRI Number |
CTRI/2024/07/069774 [Registered on: 01/07/2024] Trial Registered Prospectively |
| Last Modified On: |
29/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To study the effect of vidangadi lepa and tiktaka ghrita in the management of psoriasis |
|
Scientific Title of Study
|
Etiopathological study of ekakustha w.s.r to psoriasis and effect of vidangadi lepa and tiktaka ghrita |
| 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 Padmaja Rani Panda |
| Designation |
P G Scholar |
| Affiliation |
Govt Ayurvedic College And Hospital Balangir |
| Address |
Post Graduate Department of Roga Nidana Evam Vikriti Vigyana Govt Ayurvedic college and Hospital Balangir
Balangir
ORISSA
767001
India |
| Phone |
7749086320 |
| Fax |
|
| Email |
padmajaranipanda47@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Padmaja Rani Panda |
| Designation |
P G Scholar |
| Affiliation |
Govt Ayurvedic College And Hospital Balangir |
| Address |
Post Graduate Department of Roga Nidana Evam Vikriti Vigyana Govt Ayurvedic college and Hospital Balangir
ORISSA
767001
India |
| Phone |
7749086320 |
| Fax |
|
| Email |
padmajaranipanda47@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Padmaja Rani Panda |
| Designation |
P G Scholar |
| Affiliation |
Govt Ayurvedic College And Hospital Balangir |
| Address |
Post Graduate Department of Roga Nidana Evam Vikriti Vigyana Govt Ayurvedic college and Hospital Balangir
ORISSA
767001
India |
| Phone |
7749086320 |
| Fax |
|
| Email |
padmajaranipanda47@gmail.com |
|
|
Source of Monetary or Material Support
|
| Govt Ayurvedic College and Hospital Balangir 767001 Odisha India |
|
|
Primary Sponsor
|
| Name |
Dr Padmaja Rani Panda |
| Address |
Post Graduate Department of Roga Nidana Evam Vikrit Vigyana Govt Ayurvedic College and Hospital Balangir ODISHA 767001 |
| 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 Utkalini Nayak |
Govt Ayurvedic College and Hospital Balangir |
OPD & IPD of Post Graduate Department of Roga Nidana Evam Vikriti Vigyana
Balangir
ORISSA
Balangir
ORISSA |
8658483032
utkalini2006@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Goverment Ayurvedic College and Hospital Balangir |
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 | Classical | | (1) Medicine Name: Tiktaka Ghrita, Reference: Chakradatta, Route: Oral, Dosage Form: Ghrita, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -luke warm water), Additional Information: - | | 2 | Intervention Arm | Procedure | - | lepa, लेप | (Procedure Reference: Chakradutta, Procedure details: Take vidanga paste & apply it on affected area twice in a day for 30 days)
(1) Medicine Name: Vidangadi lepa, Reference: Chakradutta, Route: Topical, Dosage Form: Kalka/ Paste, Dose: 10(g), Frequency: bd, Duration: 30 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients who fulfill the diagnostic criteria of both Eka kustha and Psoriasis and Psoriasis without secondary infection |
|
| ExclusionCriteria |
| Details |
Patients are less than 20 years and more than 50 years of age Patients with any systemic diseases Patients having RA & ASO positive Patients having signs & symptoms of other skin diseases |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction of sign and symptoms like auspitzs sign candle grease sign reduction of sweating and patches |
30 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in Mental & Physical health along with development in Pasi score |
30 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 3 |
|
Date of First Enrollment (India)
|
10/07/2024 |
| 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 is an etiopathological study of Eka kustha and its Management with Vidangadi lepa and Tiktaka Ghrita w. s. r to Psoriasis. This is done compulsory part of Post Graduate Course. Total No. of Patients to be studied is 30 with duration of 30 days. |