| CTRI Number |
CTRI/2025/02/081274 [Registered on: 25/02/2025] Trial Registered Prospectively |
| Last Modified On: |
22/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Oil Drop Test for Assessing Prognosis in Rheumatoid Arthritis (amavata): An Observational Study |
|
Scientific Title of Study
|
Evaluation of Taila Bindu Preeksha in assessment of sadhya- asadhyata of Amavata ( Rheumatoid Arthritis)
- An Observational Study
|
| 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 Huchappa Akki |
| Designation |
Post Graduate scholar |
| Affiliation |
SDM college of Ayurveda and Hospital Hassan |
| Address |
Department of Roga Nidana evum Vikruti Vijanan
SDM college of Ayurveda and Hospital Hassan
Hassan
KARNATAKA
573201
India |
| Phone |
9663231660 |
| Fax |
|
| Email |
hucheshakki@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mahesh Hirulal |
| Designation |
Associate professor |
| Affiliation |
SDM college of Ayurveda and Hospital Hassan |
| Address |
Department of roga nidana evam vikriti vijnana
SDM COLLEGE OF AYURVEDA AND HOSPITAL HASSAN
Hassan
KARNATAKA
573201
India |
| Phone |
9620854148 |
| Fax |
|
| Email |
maheshhirulal@sdmcahhassan.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mahesh Hirulal |
| Designation |
Associate professor |
| Affiliation |
SDM college of Ayurveda and Hospital Hassan |
| Address |
Department of roga nidana evam vikriti vijnana
SDM COLLEGE OF AYURVEDA AND HOSPITAL HASSAN
Hassan
KARNATAKA
573201
India |
| Phone |
9620854148 |
| Fax |
|
| Email |
maheshhirulal@sdmcahhassan.org |
|
|
Source of Monetary or Material Support
|
| Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM road Thanniruhalla hassan - 573201, Karnataka ,India |
|
|
Primary Sponsor
|
| Name |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
| Address |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital,BM Road Thanniruhalla Hassan 573201 Karnataka India |
| Type of Sponsor |
Private 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 Huchappa Akki |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
Laboratory of department of roga nidana evum vikruti vijnana
SDM College of ayurveda and hospital hassan
Hassan
KARNATAKA |
9663231660
hucheshakki@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan Karnataka India 573201 |
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 |
20.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Subjects who were fulfilling the diagnostic criteria
Clinically diagnosed case of Rheumatoid Arthritis based on ICD10 CM DIAGNOSIS
code MO6 9
Willing to participate with informed consent |
|
| ExclusionCriteria |
| Details |
Subjects with comorbidities like Hypertension, diabetes, which may interfere with the
course of study.
Any musculoskeletal disorders like Gouty arthritis, Osteo arthritis, Septic arthritis,
psoriatic arthritis |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 50 individuals fulfilling the inclusion criteria will be included for the study and assessing the sadhya asadhyata of amavata by using taila bindu pareeksha. based on some of the assessing parameters like shape of oil droplet, spreading time ,splitting time and direction of the oil droplet after 2hrs of collecting the sample of urine in the early morning |
The outcome will assessed at the baseline after the two hours of collecting the urine sample from the patients in the early morning as mentioned in the classics |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessing the sadhya asadhyata of amavata by using the taila bindu pareeksha based on the shape of oil droplet, spreading time, splitting time of oil droplet & directional movement of oil droplet as mentioned in the classics |
The outcome will assessed at the baseline after the two hours of collecting the urine sample from the patients as mentioned in the classics |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
10/03/2025 |
| 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
|
Taila Bindu Pareeksha helps
in assessing the Sadhya Asadhya (treatable and untreatable) of diseases, and it became out of practice in assessment of prognosis and
diagnosis of different diseases. There are very few studies of it. Hence,
there is a need of exploration of Taila Bindu Pareeksha. So an effort is
made to evaluate Taila Bindu Pareeksha
to assess the Sadhya- Asadhyata of Amavata. Presently ayurvedic diagnostic technique are not useful so much, so this study helps the ayurvedic physicians to use of taila bindu pareeksha as one of the diagnosis and prognostic method |