| CTRI Number |
CTRI/2024/11/076773 [Registered on: 13/11/2024] Trial Registered Prospectively |
| Last Modified On: |
12/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Management of Kushtha Roga(Psoriasis)through Ayurveda |
|
Scientific Title of Study
|
An Exploratory Study ofABHYARISTADI CHURNA And ARAGVADHPATRALEPAIn the Management of KITIBHA KUSHTHA(PSORIASIS) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr POOJA |
| Designation |
MD SCHOLAR |
| Affiliation |
Post Graduate Institute Of Ayurveda jodhpur Rajasthan |
| Address |
PG Department of Kayachikitsa Post Graduate Institute of Ayurved Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur
Rajasthan India 342037
Jodhpur
Rajasthan
342037
India
Jodhpur
RAJASTHAN
342037
India |
| Phone |
8619561840 |
| Fax |
|
| Email |
poojagujjar034@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr POOJA |
| Designation |
MD SCHOLAR |
| Affiliation |
Post Graduate Institute Of Ayurveda jodhpur Rajasthan |
| Address |
PG Department of Kayachikitsa Post Graduate Institute of Ayurved Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur
Rajasthan India 342037
Jodhpur
Rajasthan
342037
India
Jodhpur
RAJASTHAN
342037
India |
| Phone |
8619561840 |
| Fax |
|
| Email |
poojagujjar034@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pramod Kumar Mishra |
| Designation |
PROFESSOR AND HOD |
| Affiliation |
Post Graduate Institute Of Ayurveda jodhpur Rajasthan |
| Address |
PG Department of Kayachikitsa Post Graduate Institute of Ayurved Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur
Rajasthan India 342037
Jodhpur
Rajasthan
342037
India
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9001009793 |
| Fax |
|
| Email |
drpramodmishra4@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Institute of Ayurved Jodhpur Rajasthan 342037 |
|
|
Primary Sponsor
|
| Name |
Post Graduate Institute of Ayurved Jodhpur Rajasthan 342037 |
| Address |
PG Department of Kayachikitsa Post Graduate Institute of Ayurved Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur
Rajasthan India 342037
Jodhpur
Rajasthan
342037
India |
| Type of Sponsor |
Government medical college |
|
|
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 Pooja |
Post Graduate Institute Of Ayurveda jodhpur Rajasthan |
PG Department of Kayachikitsa Post Graduate Institute of Ayurved Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur
Rajasthan India 342037
Jodhpur
Rajasthan
342037
India
Jodhpur
RAJASTHAN |
08619561840
poojagujjar034@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
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: KUSHTHAM, (2) ICD-10 Condition:L00-L99||Diseases of the skin and subcutaneous tissue. Ayurveda Condition: KUSHTHAM, (3) ICD-10 Condition:L409||Psoriasis, unspecified. Ayurveda Condition: KUSHTHAM, (4) ICD-10 Condition:L409||Psoriasis, unspecified. Ayurveda Condition: KUSHTHAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Abhyaristadi Churna And Aragvadhpatralepa, Reference: Chakradatt, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: - luke warm water), Additional Information: -drug A-Abhyaristadi churna - oral route
drug B -ARAGVADHAPATRALEPA-local application ,prepared in kanji. |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.patients diagnosed as Kitibha Kushtha(Psoriasis)based on clinical features mentioned in Ayurvedic texts &on basis of PASI score.2.Patients who are between 18-60years of either sex will be selected.3.Subject of female gender or non-pregnant ,non-lactating females.4.patient willing to sign consent form.5.Patient should capable of obeying pathya-Apathya |
|
| ExclusionCriteria |
| Details |
1.Patient below the age of 18 years and above 60 years.2.Patient suffering from any kind of malignancy or any severe illness to avoid overlapping of symptoms.3.Pregnant women and lactating mother.4. Allergic diseases. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in the subjective parameters. |
60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in the objective parameters. |
60 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
15/12/2024 |
| 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="0"
Months="9"
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
|
Number of patients-40 Type of study-open labelled procedure-drugA-oral route drugB- local application Randomization-simple Duration of Study-60 days with follow up on every 30th day Purpose of study-i have choosen this subject and medicine because due to changing lifestyle and westernisation in eating habits the incidences of Psoriasis has increased so having keen interest in this topic i choosed this topic. No work has been done on Kitibha Kushtha with ABHYARISTADI CHURNA AND ARAGVADHPATRALEPA combination so,i want to work on it. |