| CTRI Number |
CTRI/2025/06/088379 [Registered on: 06/06/2025] Trial Registered Prospectively |
| Last Modified On: |
06/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To find causative factors for cervical spondylosis |
|
Scientific Title of Study
|
An Observational study on etiological factors of Manyastambh (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 Bharti Rede |
| Designation |
MD SCHOLAR ROGNIDAN EVUM VIKRUTI VIGYAN DEPARTMENT |
| Affiliation |
PT.KHUSHILAL SHARMA GOVT.AYURVED COLLEGE AND INSTITUTE BHOPAL |
| Address |
SCIENCE HILLS BEHIND MANIT,KOLAR NEHRU NAGAR BYPASS ROAD,BHOPAL MADHYA PRADESH 462003
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
8830695625 |
| Fax |
|
| Email |
bhartirede7788@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR RAJESH JAIN |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
PT.KHUSHILAL SHARMA GOVT.AYURVED COLLEGE AND INSTITUTE BHOPAL |
| Address |
ROOM NO 6 ROGNIDAN DEPARTMENT SCIENCE HILLS BEHIND MANIT,KOLAR NEHRU NAGAR BYPASS ROAD,BHOPAL MADHYA PRADESH 462003
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
9827730455 |
| Fax |
|
| Email |
rajeshjain1075@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr BHARTI REDE |
| Designation |
MD SCHOLAR ROG NIDAN EVUM VIKRTI VIGYAN |
| Affiliation |
PT.KHUSHILAL SHARMA GOVT.AYURVED COLLEGE AND INSTITUTE BHOPAL |
| Address |
ROOM NO 6 ROGNIDAN DEAPRTMENT SCIENCE HILLS BEHIND MANIT,KOLAR NEHRU NAGAR BYPASS ROAD,BHOPAL MADHYA PRADESH 462003
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
8830695625 |
| Fax |
|
| Email |
bhartirede7788@gmail.com |
|
|
Source of Monetary or Material Support
|
| ROOM NO 6 ROGNIDAN DEPARTMENT PT KHUSHILAL SHARMA GOVT AUTO AYURVEDA COLLEGE & INSTITuTE BHOPAL MADHYA PRADESH INDIA |
|
|
Primary Sponsor
|
| Name |
PT KHUSHILAL SHARMA GOVT AUTO AYURVEDA COLLEGE INSTITITE BHOPAL |
| Address |
ROOM NO 6 ROGNIDAN DEPARTMENT SCIENCE HILLS BEHIND MANIT KOLAR NEHRU NAGAR BYPASS
ROAD BHOPAL MADHYAPRADESH 462003 INDIA |
| 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 BHARTI REDE |
PT KHUSHILAL SHARMA GOVT AUTO AYURVEDA COLLEGE & INSTITITE BHOPAL MADHYA PRADESH INDIA |
ROOM NO 6 ROGNIDAN DEPARTMENT SCIENCE HILLS BEHIND MANIT,KOLAR NEHRU NAGAR BYPASS ROAD,BHOPAL MADHYA PRADESH 462003
Bhopal
MADHYA PRADESH |
8830695625
bhartirede7788@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M479||Spondylosis, unspecified. Ayurveda Condition: MANYASTAMBAH, (2) ICD-10 Condition:M472||Other spondylosis with radiculopathy. Ayurveda Condition: MANYASTAMBAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1Participants having signs and symptoms of Manyasatambh (Cervical Spondylosis).
2. Participants of either sex between the age group of 21 - 60 years.
3.Participants diagnosed with X ray findings.
4.Patients willing for participation in research activity with written informed consent.
|
|
| ExclusionCriteria |
| Details |
1.Participant not fulfilling the
inclusion criteria,
2, Pregnant and lactating women.
3. Patients who had given history of systemic complicated disease like
Tuberculosis,
HIV,
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| It is expected that at the end of the clinical observational study we would be able to explain probable etiological factors accountable for manifestation of Manyastambh (Cervical Spondylosis). |
It is further expected that this study will be helpful in clinical practice for the prevention as well as management of Manyastambh (Cervical Spondylosis). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
It is expected that at the end of the clinical observational study we would be
able to explain probable etiological factors accountable for manifestation of Manyastambh (Cervical Spondylosis). |
It is further expected that this study will be helpful in clinical practice for the prevention as well as management of Manyastambh (Cervical Spondylosis). |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
25/06/2025 |
| 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
|
It is expected that at the end of this study we would be able to explain probable etiological factors accountable for manifestation of Manyastambh ( cervical spondylosis). It is further expected that this study will be helpful in clinical practice for the prevention as well as management of Manyastambh ( Cervical spondylosis). |