| CTRI Number |
CTRI/2020/02/023515 [Registered on: 24/02/2020] Trial Registered Prospectively |
| Last Modified On: |
20/02/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
A study on causes of Rheumatoid Arthritis |
|
Scientific Title of Study
|
A etiopathological case control study of Aamvata disease(RA) in present context |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SHAGUFTA RAAHAT |
| Designation |
PG SCHOLAR |
| Affiliation |
ALL INDIA INSTITUTE OF AYURVEDA |
| Address |
Department of Rog Nidan Evum Vikariti Vigyan All India Institute Of Ayurveda Gatampuri Sarita Vihar New Delhi
South
DELHI
110076
India |
| Phone |
7375996727 |
| Fax |
|
| Email |
shagufta.nia@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SHALINI RAI |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
ALL INDIA INSTITUTE OF AYURVEDA |
| Address |
department of rog nidan evum vikariti vigyan All India Institute of Ayurveda gautampuri sarita vihar mathura road new delhi
South
DELHI
110076
India |
| Phone |
9389423843 |
| Fax |
|
| Email |
vd.raishalini@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SHALINI RAI |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
ALL INDIA INSTITUTE OF AYURVEDA |
| Address |
department of rog nidan evum vikariti vigyan All India Institute of Ayurveda gautampuri sarita vihar mathura road new delhi
South
DELHI
110076
India |
| Phone |
9389423843 |
| Fax |
|
| Email |
vd.raishalini@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD and IPD of All India Institute of Ayurveda gautampuri sarita vihar mathura road new delhi |
|
|
Primary Sponsor
|
| Name |
All india institute of ayurveda |
| Address |
All India Institute of Ayurveda gautampuri sarita vihar mathura road new delhi |
| Type of Sponsor |
Government 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 SHAGUFTA RAAHAT |
All india institute of ayurveda |
OPD and IPD of kayachikitsa and panchkarma department
South
DELHI |
7375996727
shagufta.nia@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M057||Rheumatoid arthritis with rheumatoid factor without organ or systems involvement, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Patients having clinical features of aamvat disease mentioned in classical texts/ classification criteria for rheumatoid arthritis |
|
| ExclusionCriteria |
| Details |
Patients of rheumatoid arthritis having any other feature like hypertension diabetes mellitus cardiac disease hypothyroidism osteoarthritis gout arthritis pregnant and lactating mother |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The etiopathological factors of Aamvat disease mentioned in the classical text may have some significance to develope Aamvat disease |
to check this outcome in five months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
24/02/2020 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Articcle will be publish in the reputed journal. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
to As per Ayurveda,
vitiated ama and vata simultaneously lodge in Trika and sandhi leading to
shotha (swelling), stabdha (stiffness) in the body and joints .
The condition is known as Aamvata. This condition is very similar
with disease Rheumatoid arthritis described in modern medicine. Rheumatoid
arthritis is a chronic multisystem disease of unknown cause. The
characteristics feature of rheumatoid arthritis is persistent inflammatory
synovitis usually involving peripheral joints in a symmetric distribution.
Modern medical
sciences has made so many advancement but exact aetiopathogenesis of rheumatoid
arthritis is yet not clear. According the classical Ayurvedic text, the root
cause behind the pathogenesis of Aamvata is Agnimandhya. The agni is important
factor in the digestion and metabolic process . Agnimandhya is a condition at
level of jathragni in which food remain partially digested which has been termed
"Aam". The etiological factors of Aamvata has been mentioned in the
Ayurvedic classics to develop Aam, which combines with vata dosh leading to the
development of Aamvata disease.
|