FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/12/078665 [Registered on: 27/12/2024] Trial Registered Prospectively
Last Modified On: 25/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda
Physiotherapy (Not Including YOGA)
Other (Specify) [MARMA THERAPY AND TENS THERAPY]  
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Comparing Two Treatments for Back Pain: Traditional Healing Methods vs. Electric Nerve Stimulation for Lumbar Spine Issues 
Scientific Title of Study   A comparative clinical study of marmachikithsa and transcutaneous electrical nerve stimulation in management of katigraha with special reference to lumbar 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.PURUSHOTHAMAN M P 
Designation  M.Sc scholar 
Affiliation  National Institute of Ayurveda jaipur 
Address  The Department of Marmalogy and Sports Medicine, National Institute of Ayurveda (Deemed to be University, De Novo), is located at Jorawar Singh Gate, Amer Road, Jaipur, Rajasthan.

Jaipur
RAJASTHAN
302002
India 
Phone  9495516028  
Fax    
Email  mallisserypurushothaman@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR P HEMANTHA KUMAR  
Designation  PROFESSOR AND HOD 
Affiliation  National Institute of Ayurveda jaipur 
Address  The Department of Marmalogy and Sports Medicine, National Institute of Ayurveda (Deemed to be University, De Novo), is located at Jorawar Singh Gate, Amer Road, Jaipur, Rajasthan.

Jaipur
RAJASTHAN
302002
India 
Phone  9414056362  
Fax    
Email  profphknia@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR P HEMANTHA KUMAR  
Designation  PROFESSOR AND HOD 
Affiliation  National Institute of Ayurveda jaipur 
Address  The Department of Marmalogy and Sports Medicine, National Institute of Ayurveda (Deemed to be University, De Novo), is located at Jorawar Singh Gate, Amer Road, Jaipur, Rajasthan.

Jaipur
RAJASTHAN
302002
India 
Phone  9414056362  
Fax    
Email  profphknia@gmail.com  
 
Source of Monetary or Material Support  
National institute of Ayurveda, jorawar singh gate,amer road,jaipur,302002,rajasthan ,india 
 
Primary Sponsor  
Name  Self 
Address  Dr Purushothaman M P National institute of Ayurveda Madhav villa palace Amer road jaipur 302002 Rajasthan India Jaipur Rajasthan  
Type of Sponsor  Other [national institute of ayurveda, deemed university] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrPurushothaman m p  National institute of Ayurveda   OPDnumber 32 National institute of Ayurveda Madhav villa palace Amar road Jaipur Rajasthan
Jaipur
RAJASTHAN 		 9495516028

mallisserypurushothaman@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
National Instute of Ayurveda  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M478||Other spondylosis. Ayurveda Condition: ASTHIVAHASROTADUSHTIH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-marmacikitsA, मर्मचिकित्सा (Procedure Reference: Marmachikitha, Procedure details: Marmachikitsa will be administered by stimulating the Pada Kshipra Marma, Gulpha Marma, Indravasti Marma, Katikataruna Marma, & Kukundara Marma, with each Marma stimulated at a frequency synchronized with the rhythm of respiration, approximately 18 times per minute. The treatment will be conducted once daily for 15 days, with stretching & strengthening exercises introduced only after the initial 7 days & continued for the remaining duration)
2Intervention ArmProcedure-marmacikitsA, मर्मचिकित्सा (Procedure Reference: marmachikithsa, Procedure details: Marmachikitsa will be administered by stimulating the Pada Kshipra Marma, Gulpha Marma, Indravasti Marma, Katikataruna Marma, & Kukundara Marma, with each Marma stimulated at a frequency synchronized with the rhythm of respiration, approximately 18 times per minute. The treatment will be conducted once daily for 15 days, with stretching & strengthening exercises introduced only after the initial 7 days & continued for the remaining duration)
3Intervention ArmProcedure-vyAyAmaH, व्यायामः (Procedure Reference: physiotherapy, Procedure details: Procedure Reference: , Procedure details: TENS therapy will be administered for 10 minutes at 100 Hz once daily for 15 days. Stretching & strengthening exercises will begin after the first 7 days of TENS therapy & continue for the remaining duration.))
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients will be diagnosed on the basis of signs and symptoms of lumbar spondylosis
Patients having chronic non radiating low back pain that is persistent and worsens with activity.
Radiological degenerative changes such as disc space narrowing, osteophyte formation, and facet joint degeneration.
Patients having reduced range of motion and stiffness, particularly in the lower back.
Age - 40 to 70 years, of either sex.
Patients willing to undergo trial.
Patients free from systemic illness. 
 
ExclusionCriteria 
Details  Not willing to undergo trial.
Age below 40 years and above 70 years.
Patients having any previous surgical procedure of lumbo-sacral spine and pelvic cavity.
HIV, HBsAg positive patients.
Pregnancy.
Uncontrolled Diabetes Mellitus and any bleeding disorders.
Patients having any history of Malignancy, Hypertension, Tuberculosis, Epilepsy or Seizure disorders.
Cases of Spondylolisthesis, Sacroiliac arthritis, Herpes simplex infection causing radiating pain.
Potts spine, bamboo spine, PIVD
Patients affected with multiple wounds, cases with destructed vertebral bodies & fractures of the vertebra & lower limb.
Patient having low back pain radiating to legs.
Patients having pacemakers or any implanted electronic devices.
Fever or any infection.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
reduction in symptoms of lumbar spondylosis Change in ODI scale  Reduction in symptoms of lumbar spondylosis. day 15 
 
Secondary Outcome  
Outcome  TimePoints 
change in quality of life of patient  : Improvement in the quality of life of patients with lumbar spondylosis. day30 
 
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   Phase 3 
Date of First Enrollment (India)   16/01/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  16/01/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [drmallissery@yahoo.com].

  6. For how long will this data be available start date provided 28-02-2025 and end date provided 31-12-2025?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary  
Dr. Purushothaman’s MSc dissertation focuses on a comparative clinical study of Marmachikitsa (a traditional Ayurvedic therapy targeting vital energy points or Marma) and Transcutaneous Electrical Nerve Stimulation (TENS) for managing Katigraha, a condition identified with lumbar spondylosis in Ayurveda, involving pain and stiffness in the lower back due to Vata dosha imbalance.

The study, conducted at the National Institute of Ayurveda, Jaipur, involves 30 patients divided into three groups:

1. Group A receives only Marmachikitsa.


2. Group B receives only TENS therapy.


3. Group C receives a combined treatment of Marmachikitsa and TENS.


Each treatment lasts for 15 days, with daily sessions and a final evaluation based on subjective criteria (such as pain and stiffness) and objective criteria (range of motion). Primary goals include assessing pain reduction and functional improvement using tools like the Oswestry Disability Index (ODI). By comparing these therapies, the study aims to fill research gaps, establish evidence-based practices, and optimize treatment strategies for lumbar spondylosis.
 
Close