| CTRI Number |
CTRI/2024/05/067095 [Registered on: 09/05/2024] Trial Registered Prospectively |
| Last Modified On: |
27/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Assessment of Sama Nirama differntiation in patients with Rheumatoid Arthritis |
|
Scientific Title of Study
|
The development and validation of a diagnostic tool for sÄma nirÄma differentiation in patients with 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 |
DurgalakshmiS |
| Designation |
Associate professor |
| Affiliation |
Amrita School of Ayurveda,, Amrita Vishwa Vidyapeetam, |
| Address |
Dept. Of
Roganidana, Amrita School of Ayurveda, Amritapuri, Amrita
Vishwa Vidyapeetam, India.
Santhinikethanam, Temple road, thiruvalla, pathanamthitta, kerala
Pathanamthitta KERALA 690546 India |
| Phone |
9495701156 |
| Fax |
|
| Email |
dr.durgalakshmis@ay.amrita.edu |
|
Details of Contact Person Scientific Query
|
| Name |
DurgalakshmiS |
| Designation |
Associate professor |
| Affiliation |
Amrita School of Ayurveda,, Amrita Vishwa Vidyapeetam, |
| Address |
Dept. Of
Roganidana, Amrita School of Ayurveda, Amritapuri, Amrita
Vishwa Vidyapeetam, India.
Santhinikethanam, Temple road, thiruvalla, pathanamthitta, kerala
Pathanamthitta KERALA 690546 India |
| Phone |
9495701156 |
| Fax |
|
| Email |
dr.durgalakshmis@ay.amrita.edu |
|
Details of Contact Person Public Query
|
| Name |
DurgalakshmiS |
| Designation |
Associate professor |
| Affiliation |
Amrita School of Ayurveda,, Amrita Vishwa Vidyapeetam, |
| Address |
Dept. Of
Roganidana, Amrita School of Ayurveda, Amritapuri, Amrita
Vishwa Vidyapeetam, India.
Santhinikethanam, Temple road, thiruvalla, pathanamthitta, kerala
Pathanamthitta KERALA 690546 India |
| Phone |
9495701156 |
| Fax |
|
| Email |
dr.durgalakshmis@ay.amrita.edu |
|
|
Source of Monetary or Material Support
|
| Amrita school of Ayurveda,Amritapuri,Amrita Vishwa Vidyapeetam, Vallikkavu, Clappana.P.O,
Kollam.
|
|
|
Primary Sponsor
|
| Name |
nil |
| Address |
nil |
| Type of Sponsor |
Other [nil] |
|
|
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 Durgalakshmi S |
Amrita school of Ayurveda |
Dept.Of Roganidana
Room no 17
Vallikkavu, Clappana.P.O,
Kollam
Kerala
India
Kollam KERALA |
9495701156
dr.durgalakshmis@ay.amrita.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Amrita school of ayurveda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M060||Rheumatoid arthritis without rheumatoid factor. Ayurveda Condition: AMAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients already diagnosed as Rheumatoid Arthritis as Per 1987 Revised ACR Classification Criteria
· Subjects between age group 16 to 60 yrs.
· Patients of either sex irrespective of socioeconomic status..
· Patients fulfilling diagnostic criteria. |
|
| ExclusionCriteria |
| Details |
History of inflammatory joint disease other than RA which might interfere the
Study e.g.; Systemic lupus erythematous, ankylosing spondylitis, osteoarthritis.
· Subject with other major systemic illness that may interfere with the study.
· Patients who were under steroid therapy.
· Patients with tumors, metabolic diseases of bone.
· Heart diseases or severe hypertension, any endocrine diseases
Such as hyperthyroidism, and severe infection |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To develop a tool for assessing SÄma and NirÄma avastha in patients with confirmed diagnosis of rheumatoid arthritis.
To assess the SÄma NirÄma avastha in patients using the developed and validated tool. |
Team meeting with experts 24 weeks
Questionnaire preparation 24 weeks
Using delphi method analysing the findings 12 weeks
Tool development and validation 9 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
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)
|
20/05/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/05/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Rheumatoid Arthritis is an immune-inflammatory systemic disorder with clinical signs and symp-toms mainly affecting synovial joints. Effective treatment of Rheumatoid arthritis has been ham-pered by the heterogeneity of the disease. Although early intervention can result in disease remis-sion, it requires early diagnosis and current diagnostic tests are not sufficiently accurate or sensitive in the early stages of RA. As a result, RA is typically diagnosed only once damage to the joints has already begun, a time at which the window for optimal treatment may have been missed. On the other hand Ayurveda Physicians do treat the patients of RA based on the Dosha evaluation and SÄma NirÄma differentiation. But there are difference of opinions among Ayurveda practitioners regarding the diagnosis, SÄma NirÄma Differentiation and management. Concept of ama is a unique one which helped in understanding the disease and classifying the dis-ease in to sÄma and nirÄma avastha. In classical literature of Ayurveda, the concept of SÄmavastha and NirÄmavastha of the doshas and diseases is given importance because it plays a key role in proper management of the disease and from the diagnostic point of view. Also the line of treatment for both these stages are different from one another. Specific parameters are required to understand and confirm the prevalence of Ama, its severity and also the NirÄma stage in the body for the selec-tion of the accurate therapeutic measure. So this study is aimed to develop and evaluate a tool de-signed to understand and confirm the prevalence of Ama, its severity and also the NirÄma stage in the body which ease the task of screening and management of rheumatoid arthritis may be one of the needed interventions .The tool will be validated and grades will be included on the basis attainment of sÄma nirÄma lakshana. |