| CTRI Number |
CTRI/2024/12/078014 [Registered on: 12/12/2024] Trial Registered Prospectively |
| Last Modified On: |
09/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Anaemia in Amavata (arthritis) |
|
Scientific Title of Study
|
A Preliminary Study of Raktakshaya (Anemia) in Amavata (Inflammatory Polyarthritis) |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
D. Shrikant Wagh |
| Designation |
Ph D Scholar |
| Affiliation |
Lupus Clinic |
| Address |
Dr D Y Patil College of Ayurved and Research Centre,
PIMPRI, PUNE
Centre for Arthritis and Rheumatism, 1078, Shukrawar Peth, Tilak Road, Pune 411002
Pune
MAHARASHTRA
411018
India |
| Phone |
9822032373 |
| Fax |
|
| Email |
sywagh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shrikant Wagh |
| Designation |
Ph D Scholar |
| Affiliation |
Dr. D. Y. PATIL COLLEGE OF AYURVED AND RESEARCH CENTRE |
| Address |
Dr. D. Y. PATIL COLLEGE OF AYURVED AND RESEARCH CENTRE,
PIMPRI, PUNE-18
Mandar, 31, Motibag Society,
Satara Road, Pune 411037
Pune
MAHARASHTRA
411018
India |
| Phone |
9822032373 |
| Fax |
|
| Email |
sywagh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shrikant Wagh |
| Designation |
Ph D Scholar |
| Affiliation |
Lupus Clinic |
| Address |
Department of Rognidan and Vikruti-Vigyan, 2nd floor, Dr D Y Patil College of Ayurveda and Research Centre, Pimpri, Pune
Lupus Clinic, Centre for Arthritis and Rheumatism, 1078, Shukrawar Peth, Tilak Road, Pune 411002
Pune
MAHARASHTRA
411018
India |
| Phone |
9822032373 |
| Fax |
|
| Email |
sywagh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Monitory Support: Nil
Material Support: (OPD Patients at) Lupus Clinic, Centre for Arthritis and Rheumatism, 1078, Shukrawar Peth, Tilak Road, Pune 411002 |
|
|
Primary Sponsor
|
| Name |
Dr Shrikant Wagh |
| Address |
Lupus Clinic, Centre for Arthritis and Rheumatism, 1078, Shukrawar Peth, Tilak Road, Pune 411002 |
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| None |
Not applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Shrikant Wagh |
Lupus Clinic |
Tejas Apartment, 1078, Shukrawar Peth, Tilak Road, Pune 411002
Pune
MAHARASHTRA |
9822032373
sywagh@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:M056||Rheumatoid arthritis with involvement of other organs and systems. Ayurveda Condition: AMAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with ≥5 painful and swollen joints
2. Age above 18 years
3. Patients who sign the informed consent form and are willing to give correct information
|
|
| ExclusionCriteria |
| Details |
1. Pregnancy
2. Post-partum period (up to nine months)
3. Joint pain and swelling following trauma
4. Patients with fever (axillary temperature more than 990 F)
5. Neurological disorders that limit the mobility e. g., hemiplegia, paraplegia, Parkinsonism, lumbar canal stenosis
6. History of endocrine disorders e.g., diabetes mellitus, hypothyroidism
7. History of chronic gastrointestinal disorder e.g., GERD, inflammatory bowel disease
8. Long-acting glucocorticoids or disease modifying antirheumatic drugs during previous three months
9. Nonsteroidal anti-inflammatory drugs or glucocorticoids within previous 24 hours of examination
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Correlation between disease activity of amavata (rheumatoid arthritis) and anaemia |
Single patient visit (cross-sectional study) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The correlation between anaemia & severity of ama in the patients of rheumatoid arthritis amavata |
Single patient visit (cross-sectional study) |
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
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)
|
01/01/2025 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Introduction
Rheumatoid
arthritis (RA) is a prototype of amavata. Ama is one of the causes of
dhatukshaya which is not mentioned in the listed features of amavata. No studies attempt to establish the association of dhatukshaya in amavata.
Raktakshaya can be easily assessed by laboratory tests such as a complete hemogram.
A preliminary study is, therefore, planned to understand the association of
amavata and raktakshaya.
Materials
and Methods
A minimum of 25
OPD patients suffering from amavata (RA as per ACR/EULAR criteria 2010) will be
studied at Lupus Clinic, Pune 411002. Clinical features of amavata including
their severity, and the features of ama and its severity (assessed by validated
instrument) will be evaluated along with features of raktakshaya described in
Ayurveda and a complete hemogram with red cell morphology.
Outcome
Analysis and
interpretation of study findings to know the correlation between the clinical
features of amavata (RA) and hemogram along with features of raktakshaya. The
results will be disseminated on an appropriate platform (conference
paper/journal article) |