| CTRI Number |
CTRI/2025/03/081846 [Registered on: 06/03/2025] Trial Registered Prospectively |
| Last Modified On: |
10/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Marma chikitsa in lumbar spondylosis(katigraha) |
|
Scientific Title of Study
|
A comparative study of marma chikitsa and kati basti in pain management of lumbar spondylosis Katigraha |
| Trial Acronym |
nill |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vishal Verma |
| Designation |
PG Scholar |
| 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 462003
Bhopal
MADHYA PRADESH
462003
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
8085680679 |
| Fax |
|
| Email |
vermatjvishal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pankaj Gupta |
| 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 462003
Bhopal
MADHYA PRADESH
462003
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
9425647011 |
| Fax |
|
| Email |
drpankaj35@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vishal Verma |
| Designation |
PG Scholar |
| 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 462003
Bhopal
MADHYA PRADESH
462003
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
8085680679 |
| Fax |
|
| Email |
vermatjvishal@gmail.com |
|
|
Source of Monetary or Material Support
|
| PG Department Of Rachna Sharir Pandit 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 |
| 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 Vishal Verma |
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
Bhopal
MADHYA PRADESH |
08085680679
vermatjvishal@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:M958||Other specified acquired deformities of musculoskeletal system. Ayurveda Condition: PRUSHTHA-GRAHAH (KEVALAVATA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | marmacikitsA, मर्मचिकित्सा | (Procedure Reference: dr S k joshi, Procedure details: A steady & moderate pressure will be applied slowly & gently. Pressure will be increased gradually depending upon patient’s strength & tolerance.)
| | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: sahacharadi tail, Reference: ashtang hrudayam, Route: Topical, Dosage Form: Taila, Dose: 30(ml), Frequency: od, Bhaishajya Kal: Sabhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: -katibasti |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Duration of illness up to 2 years.
2.Pain in the lumbar region with or without radiating.
3.Stiffness of the lumbar region.
4.Patients fulfilling the diagnostic criteria.
5.Patients willing to sign the consent for participation in study. |
|
| ExclusionCriteria |
| Details |
Age below 20 years & above 60 years.
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
|
Participant Blinded |
|
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 Katigraha (lumbar spondylosis) |
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)
|
20/03/2025 |
| 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="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(Katigraha) is an age related and work related painful condition, sometimes many patients are unable to do their normal routine work. Though a lot of potent Analgesic Drugs Are Available Today But None Of Them Is Free From Adverse Effects. Thats Why Marma Chikitsa Has Been Taken. In This Study The Assessment Has Done On The Basis Of Subjective And Objective Parameter Of Lumbar spondylosis(katigraha). The Overall Effect Of Marma Chikitsa Is Extremely Significant. |