| CTRI Number |
CTRI/2025/03/081598 [Registered on: 04/03/2025] Trial Registered Prospectively |
| Last Modified On: |
28/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Understanding the link between Grahani(digestive disorder) and Amavata(joint disorder) |
|
Scientific Title of Study
|
Analytical and observational study to establish
correlation between Grahani and Amavata |
| 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 Chhavi |
| Designation |
PG Scholar |
| Affiliation |
Institute for Ayurved Studies and Research |
| Address |
Department Of Rog Nidan Evum Vikriti Vigyan,Institute for Ayurved
Studies and Research,Umri Road Sector 8 Kurukshetra
Kurukshetra
HARYANA
136118
India |
| Phone |
7027046873 |
| Fax |
|
| Email |
chhavikataria07@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepti Parashar |
| Designation |
Chairperson Department of Rog Nidan Evum Vikriti Vigyan |
| Affiliation |
Institute for Ayurved Studies and Research |
| Address |
PG Department of Rog Nidan Evum Vikriti Vigyan, Institute for
Ayurved Studies Research, Shri Krishna AYUSH University, Umri Road
Sector 8 Kurukshetra
Kurukshetra
HARYANA
136118
India |
| Phone |
9468319931 |
| Fax |
|
| Email |
drdeeptiamehta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chhavi |
| Designation |
PG Scholar |
| Affiliation |
Institute for Ayurved Studies and Research |
| Address |
Department Of Rog Nidan Evum Vikriti Vigyan,Institute for Ayurved
Studies and Research,Umri Road Sector 8 Kurukshetra
Kurukshetra
HARYANA
136118
India |
| Phone |
7027046873 |
| Fax |
|
| Email |
chhavikataria07@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute for Ayurved Studies Research, Shri Krishna Ayush University, Umri Road
Sector 8 Kurukshetra Haryana Pincode 136118 |
|
|
Primary Sponsor
|
| Name |
Institute for Ayurved Studies Research, Shri Krishna Ayush University |
| Address |
Umri Road Sector 8 Kurukshetra Haryana Pincode 136118 |
| Type of Sponsor |
Other [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 Chhavi |
Institute for Ayurved Studies and Research Hospital |
Room no 71D Rog Nidan
Evum Vikriti Vigyan
Department, Institute for
Ayurved Studies
Research, Shri Krishna
AYUSH University, Umri
Road Sector 8
Kurukshetra
Kurukshetra
HARYANA
Kurukshetra
HARYANA |
7027046873
chhavikataria07@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Shri Krishna AYUSH University |
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 |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age criteria: Between 20 yr to 60 yr.
Already diagnosed patients of Amavata and Grahani |
|
| ExclusionCriteria |
| Details |
Critical ill patients which are not diagnosed with Grahani and Amavata |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Finding a relationship between Grahani and Aamvata will further enhance the understanding of disease diagnosis and concept of Vyadhi Sankara , Gudhalinga Vyadhi, Nidanarthkara Roga as described in Ayurvedic text may have important clinical significance for patient care.
It will add to new knowledge in the field of disease diagnosis.
Timeline of assessment involve before intervention,during the study,end of the study.
|
20 MINUTES |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
It will support the development of screening guidelines,
therapeutic plans, and multidisciplinary care techniques meant to
address the coexisting symptoms.
It will have clinical significance in patient care and management.
It will add to new knowledge in the field of disease diagnosis |
10-15 Minutes |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
17/03/2025 |
| 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="1"
Months="6"
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
|
This analytical and observational study aims to establish a correlation between Grahani and Amavata, two disease conditions described in Ayurveda. Grahani, associated with Mandagni (weak digestive fire), leads to improper digestion and assimilation, resembling Irritable Bowel Syndrome (IBS) in modern medicine. On the other hand, Amavata results from Ama (toxins due to undigested food) and Vata dosha, leading to systemic inflammation, particularly in joints, resembling Rheumatoid Arthritis (RA) and Ankylosing Spondylitis (AS) in contemporary medical science.
The study reviews classical Ayurvedic texts, modern pathophysiological understandings, and laboratory analyses to explore whether Grahani predisposes individuals to Amavata or if both conditions coexist due to shared underlying mechanisms such as immune dysregulation, genetic predisposition, and environmental triggers. Given the emerging evidence linking IBS and RA, this study aims to bridge Ayurvedic and modern perspectives, offering potential insights into disease progression, diagnosis, and management. |