| CTRI Number |
CTRI/2023/06/053785 [Registered on: 12/06/2023] Trial Registered Prospectively |
| Last Modified On: |
20/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Prevalence of amavata w.s.r to rheumatoid arthritis on the basis Of etiological factors, blood group, prakriti and janamrashi of patients |
|
Scientific Title of Study
|
An observational study to find out the prevalence of amavata w.s.r to rheumatoid arthritis on the basis of etiological factors, blood group, prakriti and janmrashi of patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shruti agnihotri |
| Designation |
PG Scholar |
| Affiliation |
Shri krishna Govt Ayurvedic college and Hospital |
| Address |
Room no 97 P.G. Department of Rog Nidan Avum Vikriti Vigyan,
Shri krishna Govt Ayurvedic college and Hospital, Umri road, Sector
8 Kurukshetra Haryana pin code 136118 India
Kurukshetra
HARYANA
136118
India |
| Phone |
9584717190 |
| Fax |
|
| Email |
shru8800@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shruti agnihotri |
| Designation |
PG Scholar |
| Affiliation |
Shri krishna Govt Ayurvedic college and Hospital |
| Address |
Room no 97 P.G. Department of Rog Nidan Avum Vikriti Vigyan,
Shri krishna Govt Ayurvedic college and Hospital, Umri road, Sector
8 Kurukshetra Haryana pin code 136118 India
Kurukshetra
HARYANA
136118
India |
| Phone |
9584717190 |
| Fax |
|
| Email |
shru8800@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shruti agnihotri |
| Designation |
PG Scholar |
| Affiliation |
Shri krishna Govt Ayurvedic college and Hospital |
| Address |
Room no 97 P.G. Department of Rog Nidan Avum Vikriti Vigyan,
Shri krishna Govt Ayurvedic college and Hospital, Umri road, Sector
8 Kurukshetra Haryana pin code 136118 India
Kurukshetra
HARYANA
136118
India |
| Phone |
9584717190 |
| Fax |
|
| Email |
shru8800@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri krishna Govt Ayurvedic college and Hospital, kurukshetra Haryana |
|
|
Primary Sponsor
|
| Name |
Shri krishna Govt Ayurvedic college and Hospital, kurukshetra Haryana |
| Address |
Shri krishna Govt Ayurvedic college and Hospital, Sector-8, Umri
road, kurukshetra Haryana 136118 |
| 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 Sunil Kumar Godara |
Shri Krishna Government Ayurvedic College and Hospital |
Room no 97 P.G. Department of Rog Nidan Avum Vikriti Vigyan,
Shri krishna Govt Ayurvedic college and Hospital, Umri road, Sector
8 Kurukshetra Haryana pin code 136118 India
Kurukshetra
HARYANA |
8813020507
dr.skgodara@gmail.com |
|
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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. Ayurveda Condition: AMAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
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Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Diagnosed patients of Amavata (Rheumatoid Arthritis).
2. Patients of Amavata (Rheumatoid Arthritis) in the age group of 20-60 years.
3. Patients with willing consent for the study.
4. Patients of both sexes (Male & Female) will be taken. |
|
| ExclusionCriteria |
| Details |
1. Patients except age group of 20 -60 years.
2. Patients not willing for consent.
3. Patients with communicable diseases.
4. Patients with cancer and H/o Trauma |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Information collected from Rheumatoid Arthritis diagnosed patients on the basis of a questionnaire |
2 hours/patient |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study the prevalence of Amavata on the basis of different Etiological factors.
-To study the prevalence rate of Amavata in different Blood Group.
-To study the prevalence rate of Amavata in different Prakriti.
-To study the prevalence rate of Amavata in different Janmarashi.
-To study the possible correlation of Amavata with Rheumatoid Arthritis. |
2 years |
|
|
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)
|
01/07/2023 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
With the study of concern topic regarding Amavata (Rheumatoid Arthritis) & its prevalence on the basis of etiological factors, blood group, Prakriti and Janmarashi, it will help to understand the said disease in a better way. No such work is done on inter relation between Prakriti , Janmarashi & Blood Group and their co-relation with etiology of Amavata (Rheumatoid Arthritis).Thus in order to assess the association between the etiological factors of Rheumatoid Arthritis, Prakriti, Blood Group and Janmrashi in people who are diagnosed with Rheumatoid arthritis, an observational study will be conducted. We will find prevalence of etiological factor WSR Blood Group, Prakriti and janmrashi with the help of questionnaire and Software for Kundli and test for blood group will be done for each participant. Then result will be analyzed on the basis of all collected information. |