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CTRI Number  CTRI/2024/08/072565 [Registered on: 16/08/2024] Trial Registered Prospectively
Last Modified On: 14/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study to know the Efficacy of Patrapinda Sweda in the management of katigraha(lumbar spondylosis) 
Scientific Title of Study   To Study The Efficacy Of Patrapinda Sweda In The Management Of Katigraha (Lumbar Spondylosis)-A Controlled Clinical Study 
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 Poojashree NK 
Designation  2nd Year PG Scholar 
Affiliation  Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital Bengaluru 
Address  Department of Panchakarma Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital OPD 13 and OPD 26 Anchepalya Bengaluru

Bangalore
KARNATAKA
560074
India 
Phone  8660732371  
Fax    
Email  poojashree2504@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr ARUN B JAINER  
Designation  Associate professor  
Affiliation  Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital Bengaluru 
Address  Department of Panchakarma Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital OPD 13 and OPD 26 Anchepalya Bengaluru


KARNATAKA
560074
India 
Phone  8660732371  
Fax    
Email  draruns@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Arun B Jainer 
Designation  Associate Professor 
Affiliation  Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital Bengaluru 
Address  Department of Panchakarma Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital OPD 13 Anchepalya Bengaluru

Bangalore
KARNATAKA
560074
India 
Phone  9900940333  
Fax    
Email  draruns@gmail.com  
 
Source of Monetary or Material Support  
Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital Anchepalya Bengaluru  
 
Primary Sponsor  
Name  Dr Poojashree NK 
Address  Department of Panchakarma Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital OPD 13 and OPD 26 Anchepalya Bengaluru Karnataka 560074  
Type of Sponsor  Other [Self ] 
 
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 
Dr Poojashree NK  Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital   OPD 13 AND OPD 26 Department of Panchakarma
Bangalore
KARNATAKA 		 8660732371

poojashree2504@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M479||Spondylosis, unspecified. Ayurveda Condition: VATAVYADHIH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-piNDasvedaH, पिण्डस्वेदः (Procedure Reference: charaka sutra 14th chapter, Procedure details: kolakulattadi churnapinda sweda for 7 days)
(1) Medicine Name: kolakulattadi churna, Reference: charaka sutra 2nd chapter, Route: Topical, Dosage Form: Churna/ Powder, Dose: 350(g), Frequency: od, Duration: 7 Days
2Intervention ArmProcedure-piNDasvedaH, पिण्डस्वेदः (Procedure Reference: Charaka sutra 14th , Procedure details: Patrapinda sweda for 7 days )
(1) Medicine Name: fresh leaves like shigru,arka,nirgundi,agnimantha , Reference: charaka sutra 14th chapter, Route: Topical, Dosage Form: Kalka/ Paste, Dose: 350(g), Frequency: od, Duration: 7 Days
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1 Patients of either gender and of age between 30 – 50 years
2 Fulfilling the diagnostic criteria with the presentation of signs and symptoms of katigraha
3 Radiologically early degenerative changes
4 Patients suitable for the Swedana procedure
5 Patients who are voluntarily willing to sign informed consent.  
 
ExclusionCriteria 
Details  1 Patients having spinal tumor, malignant diseases of the pelvis, tuberculosis of vertebral bodies
2 Lumbar region surgery or implanted instrumentation
3 Chronic metabolic pathologies like ankylosing spondylosis, rheumatoid arthritis, psoriatic arthritis, gouty
arthritis, pelvic inflammatory disease, and infective arthritis
4 Pregnancy
5 Patients with major systemic disorders that may interfere with the course of treatment 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. Significant Reduction in Pain measured using VAS scale
2. Significant Reduction in stiffness assessed through Gradings
3. Significant Improvement in Range of movements (Schober’s test) 		 1st assessment 0th day
(Before treatment)
2nd assessment
8th day (after
treatment) 
 
Secondary Outcome  
Outcome  TimePoints 
Improved Quality of life-related to the lumbar spine by reducing the pain, and dependency & improving
functionality through the Oswestry disability index (questionaries method) 		 1st assessment 0th day
(Before treatment)
2nd assessment
8th day (after
treatment) 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" 
Phase of Trial   N/A 
Date of First Enrollment (India)   26/08/2024 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 02/07/2025 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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   Katigraha is considered as the most common complaint in the present era, due to sedentary lifestyle, lack of exercise, trauma, and aging causes vitiation of the Vata dosha which leads to the diseases like Katigraha, it is explained in the context of Vatavyadhi characterized by Kati Shula (low back pain) and sthambha (stiffness) in the low back region especially in the lumbar region, which bears the whole-body weight of the individual, hence lumbar vertebra and its attachments plays an important role in maintaining the good locomotive activity of each individual. Katigraha can be correlated with lumbar spondylosis by its similar clinical presentation, with a prevalence rate of more than 61.5 % of Indian population affected by lumbar spondylosis. Swedana is one among the procedures explained in the classics for all kinds of Vata and Vatakaphaja vyadhi, it induces sweating, relieves pain, stiffness, heaviness, and brings softness in the body, it also helps in achieving improvement in mobility of the joints. to attain Samyak swinna lakshana’s various methods of procedures were explained, among them Sankara sweda is prime, Pinda prepared with various leaves and powders are explained in Sankara sweda, Patrapinda sweda in one which contains various vatahara drug leaves like Eranda, Arka, Nirgundi, Agnimantha, Shigru used in the form of pottali acts as vatahara, shoolahara, stambhahara. Hence an attempt is made to know the effect of Patrapinda sweda and Churnapinda sweda in the management of Katigraha (Lumbar spondylosis). 
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