| CTRI Number |
CTRI/2024/11/077193 [Registered on: 21/11/2024] Trial Registered Prospectively |
| Last Modified On: |
11/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Assessment of Ojavikruti in Amavata (Rheumatoid Arthritis):An Observational Study |
|
Scientific Title of Study
|
An Observational Study to assess Ojavikruti in Amavata (Rheumatoid Arthritis) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pratiksha Popatrao Kolhe |
| Designation |
PG Scholar |
| Affiliation |
Tilak Ayurved Mahavidyalaya , Pune |
| Address |
Rognidan Department,Tilak Ayurved Mahavidyalaya ,Rasta peth, Pune, Maharashtra- 411011
Pune
MAHARASHTRA
411011
India |
| Phone |
7741034033 |
| Fax |
|
| Email |
gaurikolhe02@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manjiri Deshpande |
| Designation |
Professor MD PhD Rognidan |
| Affiliation |
Tilak Ayurved Mahavidyalaya Rastapeth Pune |
| Address |
Rognidan Department,Tilak Ayurved Mahavidyalaya Rasta Peth Pune 411011
Pune
MAHARASHTRA
411011
India |
| Phone |
9960081113 |
| Fax |
|
| Email |
drmanjirideshpande24@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manjiri Deshpande |
| Designation |
Professor MD PhD Rognidan |
| Affiliation |
Tilak Ayurved Mahavidyalaya Rastapeth Pune |
| Address |
Rognidan Department Tilak Ayurved Mahavidyalaya Rasta Peth Pune 411011
Pune
MAHARASHTRA
411011
India |
| Phone |
9960081113 |
| Fax |
|
| Email |
drmanjirideshpande24@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tilak Ayurved Mahavidyalaya Rasta Peth Pune Maharashtra-411011 |
|
|
Primary Sponsor
|
| Name |
Tilak Ayurved Mahavidyalaya |
| Address |
Tilak Ayurved Mahavidyalaya Rasta Peth Pune Maharashtra 411011 |
| 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 Pratiksha Popatrao Kolhe |
Tilak Ayurved Mahavidyalaya , Seth Tarachand Ramnath Chartiable Ayurved Hospital , Pune |
Rognidan Department,Tilak Ayurved Mahavidyalaya ,Rasta Peth, Pune, Seth Tarachand Ramnath Charitable Ayurved Hospital ,Rasta Peth, Pune-411011
Pune
MAHARASHTRA |
7741034033
gaurikolhe02@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| TILAK AYURVEDA MAHAVIDYALAYA AND SETH TARACHAND RAMNATH CHARITABLE HOSPITAL INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M049||Autoinflammatory syndrome, unspecified. Ayurveda Condition: AMAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
0.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1.Participants diagnosed with Amavata will be selected as per case record format specially designed for study.
2.Participants will be selected irrespective of age, sex, marital status, socioeconomic status, race, religion. |
|
| ExclusionCriteria |
| Details |
1.Participants suffering from major illness who need intensive care
2. Patients of age more than 90 years. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study Ojavikruti Lakshana in Amavata |
18 months and 0 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study relation between Ojavikruti and Chronicity of Amavata
To study stroto dushti and dhatu dushti in relation to Oja kshaya in pathophysiology of Amavata |
18 months and 0 weeks |
|
|
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
|
N/A |
|
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="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
|
To study Oja vikruti lakshana in Amavata . To study relation between Oja Vikruti and chronicity of Amavata. To study stroto dushti and dhatu dushti in relation to oja kshaya in pathophysiology of Amavata . |