| CTRI Number |
CTRI/2026/01/100061 [Registered on: 01/01/2026] Trial Registered Prospectively |
| Last Modified On: |
29/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Correlation of Dhatugata Amagati with Hematological Findings in Patients with Amavata (Rheumatoid Arthritis) |
|
Scientific Title of Study
|
An Analytical Study to Evaluate the Association between Dhatugata Amagati and Rakta Pariksha (Blood Examination) in Amavata WSR to Rheumatoid Arthritis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
HSV Jayasuriya |
| Designation |
MD Scholar |
| Affiliation |
National Institute of Ayurveda, Jaipur |
| Address |
Department of Roga Nidana Evum Vikriti Vigyana, National Institute of Ayurveda, Jaipur, Rajasthan
Jaipur
RAJASTHAN
302002
India |
| Phone |
8290883005 |
| Fax |
|
| Email |
shehanvidurangaja@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Surendra Kumar Sharma |
| Designation |
HOD, Professor |
| Affiliation |
National Institute of Ayurveda, Jaipur |
| Address |
Room No 129, Department of Roga Nidana Evum Vikriti Vigyana, National Institute of Ayurveda, Jaipur, Rajasthan
Jaipur
RAJASTHAN
302002
India |
| Phone |
9414361874 |
| Fax |
|
| Email |
ssurendra452@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
HSV Jayasuriya |
| Designation |
MD Scholar |
| Affiliation |
National Institute of Ayurveda, Jaipur |
| Address |
Department of Roga Nidana Evum Vikriti Vigyana, National Institute of Ayurveda, Jaipur, Rajasthan
Jaipur
RAJASTHAN
302002
India |
| Phone |
8290883005 |
| Fax |
|
| Email |
shehanvidurangaja@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda |
| Address |
Jorawar singh gate, Amer road, Jaipur, 302002 |
| 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 HSV Jayasuriya |
National Institute of Ayurveda Hospital |
Jorawar Singh Gate, Amer Road, Jaipur, Rajasthan, 302002
Jaipur
RAJASTHAN |
2890883005
shehanvidurangaja@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IECNIA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M058||Other rheumatoid arthritis with rheumatoid factor. Ayurveda Condition: AMAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
24.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed cases of Amavata (According to Signs and Symptoms) as well as Diagnosed cases of Rheumatoid Arthritis |
|
| ExclusionCriteria |
| Details |
Patients with chronic diseases such as (Malignancy, CKD, T1DM, Primary
HTN, Heart diseases.), Pregnant and lactating mothers, Patients who are undergoing treatments for any other diseases, Patients with acute infections within the past 4 weeks
Patients who have undergone major surgery within the past 3 months, Patients with severe psychiatric disorders, Patients with a history of alcohol or drug abuse, Patients unwilling to adhere to the study protocol |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Correlation coefficient (r) between Dhatugata Ama severity and blood examination parameters (Ayurveda and modern aspects) |
At the end of the study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Identification of Dhatu-specific hematological markers for
Amavata |
At the end of the study |
|
|
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)
|
10/08/2026 |
| 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 Yet Recruiting |
| 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 research aims to analyze the association between Dhatugata Amagati and Rakta Pariksha parameters in Amavata (Rheumatoid Arthritis) patients by integrating Ayurvedic diagnostic concepts with modern hematological findings. The primary objective is to establish correlations between the severity of Dhatugata Ama and blood test parameters, while secondary objectives include evaluating Rakta Pariksha Bhava, identifying Dhatu-specific hematological markers, and developing an integrative diagnostic framework. This analytical cross-sectional study will be conducted over 24 months at NIA Hospital, Jaipur, using convenience sampling to recruit 50 patients diagnosed with Amavata/RA. Ayurvedic assessments (Ama lakshanas, Dhatu involvement, Rakta qualities) and laboratory investigations (CBC, ESR, CRP, RA factor, anti-CCP, lipid profile, calcium, enzymes, hormones) will be performed once at baseline. Outcomes include correlation coefficients and the identification of diagnostic biomarkers. Ethical clearance, informed consent, and data confidentiality will be ensured. The time plan includes phases for literature review, ethical approval, recruitment, laboratory analysis, data analysis, and thesis writing, following the provided Gantt chart. The study ultimately seeks to strengthen scientific validation of Ayurvedic diagnostics and contribute to integrative approaches for Amavata assessment. |