| CTRI Number |
CTRI/2025/08/092177 [Registered on: 01/08/2025] Trial Registered Prospectively |
| Last Modified On: |
31/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Marma Chikitsa In Lumbar Spondylosis |
|
Scientific Title of Study
|
A Comparative Study On The Efficacy Of Marma Chikitsa And Physiotherapy In The Pain Management Of Lumbar Spondylosis |
| Trial Acronym |
RCT |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mohini Rajoriya |
| 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 |
7440958987 |
| Fax |
|
| Email |
kopalsharma1996@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Nisha Bhalerao |
| Designation |
Associate professor Rachna Sharir Department |
| 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 |
nmandalik10@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Mohini Rajoriya |
| 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 |
7440958987 |
| Fax |
|
| Email |
kopalsharma1996@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 |
|
|
Primary Sponsor
|
| Name |
Pt khushilal Sharma Govt (Auto) Ayurveda College And Institute Bhopal Madhya Pradesh 462003 |
| Address |
PG Department Of Rachna Sharir Pt khushilal Sharma Govt (Auto) Ayurveda College And Institute 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 Mohini Rajoriya |
Pt khushilal Sharma Govt (Auto) Ayurveda College And Institute Bhopal Madhya Pradesh |
PG Department Of Rachna Sharir Pt khushilal Sharma Govt (Auto) Ayurveda College And Institute Bhopal Madhya Pradesh Bhopal MADHYA PRADESH |
7440958987
kopalsharma1996@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Pt khushilal Sharma Govt (Auto) Ayurveda College And Institute Bhopal Madhya Pradesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M498||Spondylopathy in diseases classified elsewhere. Ayurveda Condition: Lumbr, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | marmacikitsA, मर्मचिकित्सा | (Procedure Reference: , Procedure details: Marma Chikitsa And Physiotherapy Once A Day / For 15 Days)
| | 2 | Comparator Arm | Procedure | - | marmacikitsA, मर्मचिकित्सा | (Procedure Reference: , Procedure details: Marama Chikitsa And Physiotherapy Once A Day For 15 Days)
|
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients of either sex between 30 to 60 years of age
2.Duration of illness up to 2 years
3.Patients willing to sign the consent for participation in study |
|
| ExclusionCriteria |
| Details |
1.Subject having Spinal tumor, Tuberculosis, Malignant disease of the pelvis, fracture of
spine, Congenital or acquired skeletal deformity.
2.Any traumatic condition of spine.
3.Recent lumbar surgery or implanted instrumentation or prosthesis.
4.Pregnant and lactating women.
5.Having Chronic pathologies e.g. ankylosing spondylosis, rheumatoid arthritis, psoriatic
arthritis, gouty arthritis or any other systemic illness. |
|
|
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
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
It is expected that at the end of study, scholar will be able to evaluate the effect of Marma
Chikitsa in the pain management of Lumbar Spondylosis (Katigraha). |
15 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Marma Chikitsa Is Non Pharmaceutical Approach To Treat Lumbar Spondylosis (Katigraha) |
15 Days |
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
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)
|
10/09/2025 |
| 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
|
Lumbar spondylosis is a degenerative condition of the lower spine that can cause chronic pain, stiffness, and reduced mobility. Effective management options include Marma Chikitsa and Physiotherapy. Marma Chikitsa, with its holistic approach, may offer added benefits by relieving pain, reducing inflammation, and supporting natural healing. Patients receiving Marma Chikitsa often experience improved spinal flexibility, reduced symptoms, and enhanced quality of life. As a safe and integrative therapy, Marma Chikitsa shows promising potential in the management of lumbar spondylosis and is worth considering for those seeking alternative or supportive treatment options. |