| CTRI Number |
CTRI/2025/02/080060 [Registered on: 07/02/2025] Trial Registered Prospectively |
| Last Modified On: |
30/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Retrospective study |
| Study Design |
Other |
|
Public Title of Study
|
TO ESTABLISH THE NIDANPANCHAK OF ANKYLOSING SPONDYLITIS ON THE BASIS OF AYURVEDIC
CONCEPT |
|
Scientific Title of Study
|
CRITICAL ANALYSIS OF ANKYLOSING SPONDYLITIS TO
ESTABLISH THE NIDANPANCHAK ON THE BASIS OF AYURVEDIC CONCEPT |
| 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 Renu Dhanraj Jungare |
| Designation |
PG Scholar |
| Affiliation |
Institute For Ayurved Studies And Research Shree Krishna Ayush University Kurukshetra |
| Address |
98 Department of Rog Nidana Evum Vikriti Vigyan Faculty of
Ayurved Institute for Ayurved studies and Research Shri Krishna
Ayush University Kurukshetra
Kurukshetra
HARYANA
136118
India
Kurukshetra
HARYANA
136118
India |
| Phone |
9850722478 |
| Fax |
|
| Email |
renujungare87@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Randhir Singh |
| Designation |
Associate Professor |
| Affiliation |
Institute for Ayurved studies and Research Shri Krishna Ayush University Kurukshetra |
| Address |
94 Department of Rog Nidana Evum Vikriti Vigyan Faculty of
Ayurved Institute for Ayurved studies and Research Shri Krishna
Ayush University Kurukshetra
Kurukshetra
HARYANA
136118
India
Kurukshetra
HARYANA
136118
India |
| Phone |
7015167849 |
| Fax |
|
| Email |
singhrandhir13476@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Renu Dhanraj Jungare |
| Designation |
PG Scholar |
| Affiliation |
Institute For Ayurved Studies And Research Shree Krishna Ayush University Kurukshetra |
| Address |
98 Department of Rog Nidana Evum Vikriti Vigyan Faculty of
Ayurved Institute for Ayurved studies and Research Shri Krishna
Ayush University Kurukshetra
Kurukshetra
HARYANA
136118
India
Kurukshetra
HARYANA
136118
India |
| Phone |
9850722478 |
| Fax |
|
| Email |
renujungare87@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute For Ayurved Studies and Research Umri road Sector 8 Kurukshetra 136118 Haryana INDIA |
|
|
Primary Sponsor
|
| Name |
Dr Renu Dhanraj Jungare |
| Address |
98 Department of Rog Nidana Evum Vikriti Vigyan Faculty of
Ayurved Institute for Ayurved studies and Research Shri Krishna
Ayush University Kurukshetra
Kurukshetra
HARYANA
136118
India |
| 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 Renu Dhanraj Jungare |
Institute of Ayurved studies and research |
OPD No 71 Dept of Rog Nidan Evam Vikriti vigyan
Kurukshetra
HARYANA |
09850722478
renujungare87@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical committee of University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M459||Ankylosing spondylitis of unspecified sites in spine. Ayurveda Condition: AMADOSHAH, |
|
|
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 |
Already diagnosed patients of Ankylosing spondylitis on the basis of-
Pain in low back and stiffness of spine or restriction of spinal mobility for more than 3 months and not relieved by rest
HLAB27 positive patients
Radiological changes (bamboo spine)
Schober’s test |
|
| ExclusionCriteria |
| Details |
Age less than 20 and more than 60 years
Patients with Cancer MI Pulmonary TB
Patients on prolonged medications with Corticosteroid Anti-depressant
Patient not willing for consent |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Nidanpanchaka will be formed by knowing Nidanas purvaroopa and roopa from history of patient and samprapti by assessing all the doshas |
1 day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Ayurvedic management protocol of ankylosing spondylitis will be improved |
18 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
15/02/2025 |
| 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 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
|
Ankylosing Spondylitis is characterised by chronic inflammatory arthritis predominantly affecting the sacroiliac joint & axial Skeleton. The usual age of onset is 25 years, and onset beyond 40 years of age is extremely uncommon, with a male pre-ponderance of about 3:1. The HLA B27 gene is known to have a strong connection with the disease. The frequency of HLA B27 is directly correlated with the occurrence of Ankylosing Spondylitis in a given community. In the population of northern India, the frequency of HLA B27 is 6%. About 85% of cases of chronic low back pain are associated with stiffness in the morning. Ankylosing spondylitis is linked to dactylitis, hip and buttock pain, impaired spinal movement, and postural problems. Extra skeletal symptoms such as IBS (50%), psoriasis (10%) and acute anterior uveitis (25–35%). The two main symptoms are stiffness in the morning that spreads to the buttocks or back thighs, and low back pain. Movement relieves symptoms and inactivity exacerbates them. The illness usually progresses gradually, eventually affecting the entire spine, though certain spots exhibit the cervical or thoracic spine. The vertebrae may merge in severe cases of this. When the vertebrae merge, the spine may become hard and inflexible. One common complaint is fatigue. Pain is the cause of persistent sleep disruption. |