| CTRI Number |
CTRI/2025/01/079752 [Registered on: 29/01/2025] Trial Registered Prospectively |
| Last Modified On: |
10/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Marma Chikitsa in cervical spondylosis |
|
Scientific Title of Study
|
Comparative study of efficacy of marma chikitsa and physiotherapy in the pain management 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 Niharika Vijayvergiya |
| Designation |
Md Scholar Rachna Sharir |
| Affiliation |
Pt Khushilal Sharma Govt (Auto) Ayurveda College And Institute Bhopal Madhya Pradesh |
| Address |
PG Department Of Rachna Sharir Pt Khushilal Sharma Govt (Auto) Ayurveda College And Institute Bhopal Madhya Pradesh
Bhopal MADHYA PRADESH 462003 India |
| Phone |
8871597475 |
| Fax |
|
| Email |
vijayvergiyaniharika@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Nisha Bhalerao |
| Designation |
Reader Department of Rachna Sharir |
| Affiliation |
Pt Khushilal Sharma Govt (Auto) Ayurveda College And Institute Bhopal Madhya Pradesh |
| Address |
PG Department Of Rachna Sharir Pt Khushilal Sharma Govt (Auto) Ayurveda College And Institute Bhopal Madhya Pradesh
Bhopal MADHYA PRADESH 462003 India |
| Phone |
9424542272 |
| Fax |
|
| Email |
nmandlik10@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Niharika Vijayvergiya |
| Designation |
Md Scholar Rachna Sharir |
| Affiliation |
Pt Khushilal Sharma Govt (Auto) Ayurveda College And Institute Bhopal Madhya Pradesh |
| Address |
PG Department Of Rachna Sharir Pt Khushilal Sharma Govt (Auto) Ayurveda College And Institute Bhopal Madhya Pradesh
Bhopal MADHYA PRADESH 462003 India |
| Phone |
8871597475 |
| Fax |
|
| Email |
vijayvergiyaniharika@gmail.com |
|
|
Source of Monetary or Material Support
|
| PG Department Of Rachna Sharir Pt Khushilal Sharma Govt (Auto) Ayurveda College And Institute Bhopal Madhya Pradesh 462003 Bhopal MADHYA PRADESH |
|
|
Primary Sponsor
|
| Name |
Pt Khushilal Sharma Govt (Auto) Ayurveda College And Institute Bhopal Madhya Pradesh |
| Address |
PG Department Of Rachna Sharir Pt Khushilal Sharma Govt (Auto) Ayurveda College And Institute Bhopal Madhya Pradesh 462003 Bhopal MADHYA PRADESH |
| Type of Sponsor |
Government funding agency |
|
|
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 Niharika Vijayvergiya |
Pt Khushilal Sharma Govt (Auto) Ayurveda College And Institute Bhopal Madhya Pradesh |
PG Department Of Rachna Sharir Bhopal Madhya Pradesh 462003 Bhopal MADHYA PRADESH Bhopal MADHYA PRADESH |
8871597475
vijayvergiyaniharika@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Pt Khushilal sharma govt(Auto) ayureda college and institute Bhopal Madhya Pradesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M959||Acquired deformity of musculoskeletal system, unspecified. Ayurveda Condition: GRIVASTAMBAH/GRIVAHUNDANAMÂ (KEVALAVATA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Physiotherapy | Ultrasound of cervical region is done for 5-6 min followed by cervical isometric exercises once a day | | 2 | Intervention Arm | Procedure | - | marmacikitsA, मर्मचिकित्सा | (Procedure Reference: Dr s k joshi, Procedure details: Marma sthana to be stimulated for 0.8 sec for 15-18 times once a day)
|
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Subject of age group 20-70 years
2.X-ray showing radiological sign of cervical spondylosis
3.Patients of either sex having clinical features like pain in neck region, stiffness, restricted movement of neck, tingling and numbness in upper extremities
4.Patient with written consent to participate in the study. |
|
| ExclusionCriteria |
| Details |
1.Fracture or dislocation in cervical spine.
2.Infectious disease of cervical spine.
3.Patient with trauma in neck region.
4.Pregnant and lactating women.
5.Patient with major systemic disorders like Tuberculosis, Malignancies etc. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| It is expected that at The End Of Study Scholar Wil Be Able To Evaluate The Effect Of Marma Chikitsa And physiotherapy in The pain Management Of cervical spondylosis |
15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| It is cost effective and give instant relief in pain. |
15 days |
|
|
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)
|
12/02/2025 |
| 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 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
|
Cervical spondylosis is the degenerative condition of cervical spine that causes pain, stiffness tingling sensation and restricted movement of neck .Affecting 75% of population of age group 20-70 year .In This Study The Assessment Has Done On The Basis Of Subjective And Objective Parameter Of Cervical spondylosis. The Overall Effect Of Marma Chikitsa Is Extremely Significant. |