| CTRI Number |
CTRI/2024/10/074697 [Registered on: 03/10/2024] Trial Registered Prospectively |
| Last Modified On: |
08/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to find causes of some common rheumatological diseases in ayurveda |
|
Scientific Title of Study
|
Etiological study of some common rheumatological diseases in ayurveda with special reference to laboratory parameters |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Manisha Pathak |
| Designation |
Post Graduate Scholar |
| Affiliation |
Government Ayurvedic College and Hospital guwahati |
| Address |
Chatribari Krishnanagar House No.4 Guwahati Assam
Jalukbari Assam
Kamrup
ASSAM
781001
India |
| Phone |
8638622563 |
| Fax |
|
| Email |
manisha13456@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anup Baishya |
| Designation |
Professor and H.O.D |
| Affiliation |
Government Ayurvedic College and Hospital guwahati |
| Address |
Jalukbari Guwahati Assam
Jalukbari Assam
Kamrup
ASSAM
781014
India |
| Phone |
8638211711 |
| Fax |
|
| Email |
baishya.anup.815@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anup Baishya |
| Designation |
Professor and H.O.D |
| Affiliation |
Government Ayurvedic College and Hospital guwahati |
| Address |
Jalukbari Guwahati Assam
Jalukbari Assam
Kamrup
ASSAM
781014
India |
| Phone |
8638211711 |
| Fax |
|
| Email |
baishya.anup.815@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurvedic College and Hospital, guwahati Assam India pincode 781014 |
|
|
Primary Sponsor
|
| Name |
Dr Manisha Pathak |
| Address |
Chatribari Krishnanagar House No 4 , guwahati Assam India, pincode 781001 |
| 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 |
| Dr Anup Baishya |
Government Ayurvedic Collede and Hospital guwahati |
room no 11, depatment of Roga nidan, G.A.C.H ,Jalukbari A.E.C road Guwahati Assam India pincode 781014
Kamrup
ASSAM |
8638211711
baishya.anup.815@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:Z00-Z99||Factors influencing health status and contact with health services. Ayurveda Condition: AMAVATAH, (2) ICD-10 Condition:Z00-Z99||Factors influencing health status and contact with health services. Ayurveda Condition: SANDHIGATAVATAH, (3) ICD-10 Condition:Z00-Z99||Factors influencing health status and contact with health services. Ayurveda Condition: VATARAKTAM, (4) ICD-10 Condition:Z00-Z99||Factors influencing health status and contact with health services. Ayurveda Condition: ASTHIGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Lifestyle | - | - | Dinacarya: , Ritucarya: , Acara Rasayana:, Other:, Pathya/Apathya:, Pathya:, Apathya: |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Willing to participate in the study
Subjects having joint pain and body ache will be included |
|
| ExclusionCriteria |
| Details |
Not willing to participate
Patients having more than one rheumatological disease
Pregnant or lactating woman
Subjects with immunocompromised states like HIV, tuberculosis, hepatitis B AND C
SUBJECTS WITH MALIGNANCY |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. to study the etiology of some common rheumatological diseases mentioned in Ayurveda.
2. To explore relationship between etiological factors of rheumatological diseases mentioned in Ayurveda with different laboratory parameters. |
2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. To explore relationship between etiological factors of rheumatological diseases mentioned in Ayurveda with different laboratory parameters. |
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)
|
28/12/2024 |
| 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="2"
Months="0"
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
|
The study aims to find the etiology of common rheumatological diseases in ayurveda. It also aims to explore the relationship between the etiology of rheumatological diseases mentioned in ayurveda with different laboratory parameters. The study will be conducted on 200 subjects presenting with symptoms of joint pain and body ache as per necessary formalities under strict protocol to prevent bias and reduce errors. A properly designed proforma will be formulated to do the research work. The research will highlight the etiological factors leading to the rheumatological diseases and by avoiding the etiological factors patients can get some relief from the rheumatological disease. |