| CTRI Number |
CTRI/2024/12/077926 [Registered on: 10/12/2024] Trial Registered Prospectively |
| Last Modified On: |
06/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
VALIDATION OF TOOL |
| Study Design |
Other |
|
Public Title of Study
|
Validation of a diagnostic tool for assessing ama lakshana in rheumatic disorders |
|
Scientific Title of Study
|
validation of the tool for assessing ama lakshana in rheumatic disorders |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
RAJASREE GK |
| Designation |
PG SCHOLAR |
| Affiliation |
GOVT.AYURVEDA COLLEGE PARIYARAM KANNUR |
| Address |
Department of Kriyasareera
Government Ayurveda College ,Pariyaram
Kannur
Kannur
KERALA
670503
India |
| Phone |
7306176288 |
| Fax |
|
| Email |
rajasreegk95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pradeep K |
| Designation |
Associate Professor |
| Affiliation |
GOVT.AYURVEDA COLLEGE PARIYARAM KANNUR |
| Address |
Department of Kriyasareera
Government Ayurveda College,Pariyaram
Kannur
Kannur
KERALA
670503
India |
| Phone |
9846606351 |
| Fax |
|
| Email |
drpradeep601@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
RAJASREE GK |
| Designation |
PG SCHOLAR |
| Affiliation |
GOVT.AYURVEDA COLLEGE PARIYARAM KANNUR |
| Address |
Department of Kriyasareera
Government Ayurveda Collge ,Pariyaram
Kannur
Kannur
KERALA
670503
India |
| Phone |
7306176288 |
| Fax |
|
| Email |
rajasreegk95@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurveda Collage Hospital Kannur 670503 |
|
|
Primary Sponsor
|
| Name |
Rajasree GK |
| Address |
Department of Kriyasareera
Government Ayurveda College ,Pariyaram
Kannur |
| 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 |
| Rajasree GK |
Government Ayurveda college hospital Pariyaram |
OPD and IPD of all departments of Government Ayurveda Hospital
Kannur
KERALA |
7306176288
rajasreegk95@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Committee of Govt. Ayurveda College, Kannur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M00-M99||Diseases of the musculoskeletal system and connective tissue. Ayurveda Condition: AMADOSHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Individuals with diagnosed cases of RD of age group 30-60 years irrespective of gender.
Patients who have given informed consent. |
|
| ExclusionCriteria |
| Details |
should not have taken any long acting steroids or disease modifying antirheumatic drugs in the past 3 months which may have modified the status of ama related features.
participants with diagnosed cases of psychiatric illness.
chronic alcoholics |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Tool validation and reliability testing
Diagnostic test evaluation with CRP |
18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
20/12/2024 |
| 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 Applicable |
| 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
|
Ayurveda has its concepts like Dosha, Dushya, Mala, Agni, etc. among which the concept of Ama is the important fundamental principle in understanding the physio-pathology of diseases. Rheumatism refers to a diverse group of conditions that affect the joints, muscles, bones, and connective tissues of the body. Impairment of locomotor functions along with pain are the important manifestations of this disorder.The study design is descriptive and done in patients of OPD & IPD of Government Ayurveda College Kannur with an age limit of 30 to 60 years. The sampling is done consecutively for the validation of the tool. Finally obtained data will be statistically analyzed then the result will be scrutinized accordingly. |