| CTRI Number |
CTRI/2025/02/081446 [Registered on: 28/02/2025] Trial Registered Prospectively |
| Last Modified On: |
27/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To study the causes and factors affecting cervical spondylosis & etiopathogenesis |
|
Scientific Title of Study
|
An Observational Study To Explore Ayurvedic Etiopathogenesis Of Cervical Spondylosis |
| 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 Mini P |
| Designation |
Associate Professor |
| Affiliation |
Government Ayurveda College Tripunithura |
| Address |
Department of
Roganidana
Government Ayurveda College Tripunithura
Ernakulam
KERALA
682301
India |
| Phone |
9387076549 |
| Fax |
|
| Email |
drminiktr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mini P |
| Designation |
Associate Professor |
| Affiliation |
Government Ayurveda College Tripunithura |
| Address |
Department of
Roganidana
Government Ayurveda College Tripunithura
Ernakulam
KERALA
682301
India |
| Phone |
9387076549 |
| Fax |
|
| Email |
drminiktr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mini P |
| Designation |
Associate Professor |
| Affiliation |
Government Ayurveda College Tripunithura |
| Address |
Department of
Roganidana
Government Ayurveda College Tripunithura
Ernakulam
KERALA
682301
India |
| Phone |
9387076549 |
| Fax |
|
| Email |
drminiktr@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurveda College Pariyaram Kannur |
|
|
Primary Sponsor
|
| Name |
Government Ayurveda College PariyaramKannurKeralaIndia |
| Address |
Government Ayurveda College Pariyaram kannur 670503 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Amritha K |
Government Ayurveda College Pariyaram Kannur |
Department of Roganidana
Kannur
KERALA |
9497702754
Amritha.k.unni@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTE GOVERNMENT AYURVEDA COLLEGE KANNUR PARIYARAM |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M472||Other spondylosis with radiculopathy. Ayurveda Condition: VATAVYADHIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Individuals of diagnosed cases of Cervical Spondylosis of age 30 to 70 irrespective of gender |
|
| ExclusionCriteria |
| Details |
Individuals with serious systemic illness& mental illness are excluded from the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To understand the pathological factors involved in cervical spondylosis like Dosha , dushya , stoats ,Agni ,Prakriti |
24 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the main etiological and pathological factors so it can help to avoid the causes and other factors involved in this condition |
24 weeks |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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)
|
13/03/2025 |
| 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="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 is to assess the etiopathogenesis of cervical Spondylosis.The main focus is to assess the ayurvedic factors such as dosha dushya, Agni ,srotas , Prakriti involved in this condition. By this study after assessment of these factors it is easier to treat the condition and also the prevention |