| CTRI Number |
CTRI/2021/02/031061 [Registered on: 05/02/2021] Trial Registered Prospectively |
| Last Modified On: |
01/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
correlate classical features of rakta dushti with modern physical parameters in psoriasis. |
|
Scientific Title of Study
|
AN OBSERVATIONAL STUDY TO CORRELATE CALSSICAL FEATURES OF RAKT DUSHTI WITH PHYSICAL FEATURES OF BLOOD IN EKAKUSHTHA WITH SPECIAL REFERENCE TO PSORIASIS. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
VIVEK |
| Designation |
PG SCHOLAR |
| Affiliation |
ALL INDIA INSTITUTE OF AYURVEDA |
| Address |
ROGA NIDAN DEPARTMENT
ACADEMIC BLOCK THIRD FLOOR
ALL INDIA INSTITUTE OF AYURVEDA,GAUTAMPURI,SARITA VIHAR NEW DELHI
South
DELHI
110076
India |
| Phone |
09818818943 |
| Fax |
|
| Email |
vivekbams2013@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
ProfDr Anand More |
| Designation |
PROFESSOR |
| Affiliation |
ALL INDIA INSTITUTE OF AYURVEDA |
| Address |
ROGA NIDAN DEPARTMENT
ACADEMIC BLOCK THIRD FLOOR
ALL INDIA INSTITUTE OF AYURVEDA,GAUTAMPURI,SARITA VIHAR NEW DELHI
South
DELHI
110076
India |
| Phone |
9422025732 |
| Fax |
|
| Email |
drmoreanand@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
ProfDr Anand More |
| Designation |
PROFESSOR |
| Affiliation |
ALL INDIA INSTITUTE OF AYURVEDA |
| Address |
ROGA NIDAN DEPARTMENT
ACADEMIC BLOCK THIRD FLOOR
ALL INDIA INSTITUTE OF AYURVEDA,GAUTAMPURI,SARITA VIHAR NEW DELHI
South
DELHI
110076
India |
| Phone |
9422025732 |
| Fax |
|
| Email |
drmoreanand@gmail.com |
|
|
Source of Monetary or Material Support
|
| ALL INDIA INSTITUTE OF AYURVEDA,GAUTAM PURI,SARITA VIHAR NEW DELHI-110076 |
|
|
Primary Sponsor
|
| Name |
ALL INDIA INSTITUTE OF AYURVEDA |
| Address |
GAUTAM PURI,SARITA VIHAR,NEW DELHI 110076 |
| 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 VIVEK |
ALL INDIA INSTITUTE OF AYURVEDA |
OPD NO-5,HOSPITAL BLOCK ALL INDIA INSTITUTE OF AYURVEDA,GAUTAM PURI NEW DELHI 110076
South
DELHI |
9818818943
vivekbams2013@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L409||Psoriasis, unspecified, (2) ICD-10 Condition: L409||Psoriasis, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
-PATIENTS DIAGNOSED WITH PSORIASIS ATTENDING AIIA OPD AND IPD.
-PATIENTS WILLING TO PARTICIPATE IN THE STUDY. |
|
| ExclusionCriteria |
| Details |
-PATIENTS HAVING OTHER CONDITIONS LIKE DIABETES,HYPERTENSION,MALIGNANCY,TUBERCULOSIS ETC.
-PREGNANT AND LACTATING FEMALES.
-PATIENTS TAKING ANY BLOOD THINING DRUGS LIKE ASPIRIN. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| GET ASSUMED CHANGES IN THE PHYSICAL FEATURES OF BLOOD IN PATIENTS AS COMPARED WITH HEALTHY CONTROLS. |
9 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| INTERPRETATION OF CHANGES INTO DOSHIK PREDOMINANCE OF BLOOD. |
9 M0NTHS |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
21/03/2021 |
| Date of Study Completion (India) |
28/02/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
ARTICLE WILL PUBLISHED LATER IN THE UGC APPROVED JOURNAL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
ANCIENT AYURVEDIC SAGES HAS DESCRIBED DUSHIT RAKT(IMPURE BLOOD) AS ONE THE PATHOLOGICAL FACTORS VARIOUS DISEASES IN WHICH MOST ARE CONFINED TO SKIN. THE DOSH INVOLVED IN THE DUSHTI OF RAKT(PATHOGENESIS) IS DIAGNOSED MANLY BY THE PHYSICAL FEATURES OF BLOOD THE ASSESMENT OF WHICH IS IMPORTANT FOR THE DEVELOPMENT OF TREATMENT PROTOCOL. THE FEATUTRES GOING TO BE ASSESSED ARE:- | Classical feature | Modern parameter | | 1. Tanu | viscosity | | 2. Askandi | Coagulation time | | 3. Sheetal | temperature | | 4. Ushna | temperature | | 5. Cheersravi | Bleeding time | | 6. Bahal | Specific gravity | | 7. Varna | colour | |