FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/07/090658 [Registered on: 10/07/2025] Trial Registered Prospectively
Last Modified On: 09/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   To assess the efficacy of Kalari Marma Chikitsa (an Ayurvedic procedure) for pain reduction in Sciatica cases 
Scientific Title of Study   Neurobiological and biochemical assessment of pain perception after Kalari Marma Chikitsa in Sciatica 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ipsita Panda 
Designation  PhD Scholar 
Affiliation  Institute of teaching and research in Ayurveda 
Address  O.P.D room no: 112 Shalya Tantra Dept. Panchakarma Bhavan ITRA, Jamnagar Gujarat India

Jamnagar
GUJARAT
361008
India 
Phone  8630205873  
Fax    
Email  pandaipsita82@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  T. S. Dudhamal 
Designation  H.O.D and Prfofessor Shalya Tantra Department 
Affiliation  Institute of teaching and research in Ayurveda 
Address  Room no.: 304 3rd floor Shalya Tantra Department Panchakarma Bhavan ITRA, Jamnagar Gujarat India

Jamnagar
GUJARAT
361008
India 
Phone  8849298620  
Fax    
Email  drtsdudhamal@gmail.com  
 
Details of Contact Person
Public Query  
Name  Ipsita Panda 
Designation  PhD Scholar 
Affiliation  Institute of teaching and research in Ayurveda 
Address  O.P.D Room No.: 112 Shalya Tantra department Panchakarma Bhavan ITRA, Jamnagar Gujarat India

Jamnagar
GUJARAT
361008
India 
Phone  8630205873  
Fax    
Email  pandaipsita82@gmail.com  
 
Source of Monetary or Material Support  
Institute of teaching and research in Ayurveda Jamnagar Gujarat 361008 
 
Primary Sponsor  
Name  ITRA, Jamnagar 
Address  Opp. B-Division Police Station, Gurudwara Road, Jamnagar, Gujarat 361008 
Type of Sponsor  Government medical college 
 
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 
Ipsita Panda  Institute of teaching and research in Ayurveda.  O.P.D and I.P.D of Shalya Tantra Department Room no.: 112 Panchakarma Bhavan ITRA, Jamnagar
Jamnagar
GUJARAT 		 8630205873

pandaipsita82@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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:G55||Nerve root and plexus compressionsin diseases classified elsewhere. Ayurveda Condition: GRUDHRASI,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-marmacikitsA, मर्मचिकित्सा (Procedure Reference: Marmacikitsa Basic Tenets in Ayurveda and Therapeutic Approaches, Procedure details: Kalari Marma Chikitsa of hip and lower limb for 1hour per day for 2 weeks. Purvakarma Marma massage, Pradhankarma Marma stimulation and manipulation. Paschatkarma Bandage or Bandhana of lumbosacral region.)
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients suffering from sign and symptoms of sciatica for more than 1month.
Patients within the age group 30-65 years, irrespective of gender, religion, occupation, and socioeconomic status will be included in the study.
Patients willing to undergo trial.
Patients with mild and moderate pain (upto grade 3) on a visual analogue scale.
Patients coming under the minimal and moderate disability gradation of Oswestry Low Back Pain Disability Questionnaire.
 
 
ExclusionCriteria 
Details  Patients with red flag conditions in sciatica (muscle wasting of one or both leg, bowel or bladder dysfunction, progressive neurological deficits, saddle anesthesia, sudden onset bilateral radiculopathy, incapacitating pain and unrelenting night pain).
Cauda equina syndrome.
Fractures related to spine and hip joint.
Tuberculosis, other infectious disease and malignancy of lumbosacral spine.
Sciatica patients with associated symptoms like fever, nausea, unexplained weight loss and considerable loss of appetite will be excluded.
Patients of controlled diabetes mellitus.
Patients of controlled hypertension.
Other diseases like cardiac diseases, renal diseases, endocrine disorders, severe anemia and malignancy.
Pregnant or lactating female.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The primary outcome is to evaluate the change of leg pain intensity on the basis of VAS from baseline to week 2.
To assess the change in pain perception by evaluating the changes in neurotransmitter levels before and after the treatment.

 		 0 day and 14 day

 
 
Secondary Outcome  
Outcome  TimePoints 
Changes in paresthesia, stiffness and muscle power grading of muscles of affected lower limb.
Changes in ROM.
Changes in straight leg raise test.
Changes in Sciatica Frequency and Bothersomeness Index (SFBI), it measures the frequency and symptom severity of sciatica with scores ranging from 0 to 24 respectively.
Changes in Oswestry Low Back Pain Disability Questionnaire to assess the relief in sciatica grades.
 		 0 day and 14 day. 
 
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)   30/07/2025 
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="2"
Months="0"
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  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 - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [pandaipsita82@gmail.com].

  6. For how long will this data be available start date provided 01-06-2025 and end date provided 30-06-2027?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Kalari Marma Chikitsa is an age old method used in southern regions of India especially the state of Kerala for various neuromuscular and arthrological disorders while clinical studies regarding its efficacy for pain management in sciatica is insufficient. This study aims to explore the feasibility and efficacy of Kalari Marma Chikitsa in pain perception of sciatica patients at both clinical and biochemical levels. 

 
Close