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CTRI Number  CTRI/2025/04/083863 [Registered on: 02/04/2025] Trial Registered Prospectively
Last Modified On: 27/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   A clinical study to evaluate the efficacy of medicated oil gauze in stiffness of low back. 
Scientific Title of Study   Open label single arm clinical study to evaluate the efficacy of Prishta Pichu with Prasarini Taila in Kati Graha. 
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 PrajnaRao G 
Designation  PG Scholar 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda & Hospital 
Address  Department of Panchakarma Sri Dharmasthala Manjunatheshwara College of Ayurveda & Hospital Thanniruhalla Hassan Karnataka India

Hassan
KARNATAKA
573201
India 
Phone  9945888328  
Fax    
Email  prajnaraog@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ashvini Kumar M 
Designation  Professor 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda & Hospital 
Address  Department of Panchakarma Sri Dharmasthala Manjunatheshwara College of Ayurveda & Hospital Thanniruhalla Hassan Karnataka India

Hassan
KARNATAKA
573201
India 
Phone  9448705660  
Fax    
Email  ashvinipanchakarma@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Ashvini Kumar M 
Designation  Professor 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda & Hospital 
Address  Department of Panchakarma Sri Dharmasthala Manjunatheshwara College of Ayurveda & Hospital Thanniruhalla Hassan Karnataka India

Hassan
KARNATAKA
573201
India 
Phone  9448705660  
Fax    
Email  ashvinipanchakarma@gmail.com  
 
Source of Monetary or Material Support  
Sri Dharmasthala Manjunatheshwara College of Ayurveda & Hospital Thanniruhalla Hassan Karnataka India 573201 
 
Primary Sponsor  
Name  Dr Prajnarao G 
Address  Department of Panchakarma Sri Dharmasthala Manjunatheshwara College of Ayurveda & Hospital Thanniruhalla Hassan Karnataka India 573201 
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 PrajnaRao G  Sri Dharmasthala Manjunatheshwara College of Ayurveda & Hospital   OPD and IPD under all departments of Sri Dharmasthala Manjunatheshwara Ayurveda College & Hospital, Thanirruhalla, Hassan, Karnataka, India 573201
Hassan
KARNATAKA 
9945888328

prajnaraog@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE 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:M519||Unspecified thoracic, thoracolumbar and lumbosacral intervertebral disc disorder. Ayurveda Condition: PRUSHTHA-GRAHAH (KEVALAVATA),  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-Pristha Pichu (Procedure Reference: Astanga Hridaya Sutrasthanam 22, Procedure details: Prasarini Taila is heated till 38-42 degree Celsius in double boil method. The prepared cotton pads are dipped into the heated oil and is placed over Prishta Pradesha, that is superiorly extending from atlas i.e first cervical vertebrae covering gluteal region inferiorly, laterally extending upto mid axillary line on either side. Once the heated oil cools down, the cotton pads are removed and then immersed in warm oil and are placed over prishta pradesha. This procedure is repeated for 30 minutes or till Samyak svinna lakshanas are attained with a replacement of oil when it gets cooled down.)
(1) Medicine Name: Prasarini Taila , Reference: Sharangdhara Samhita , Route: Topical, Dosage Form: Taila, Dose: 0(NA), Frequency: od, Duration: 7 Days
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Participants with low back pain, tenderness at kati pradesha, stiffness and reduced range of movements of kati pradesha.
2. Participants between the age of 20-60 years irrespective of gender.
3. Participants who are willing to participate and sign the informed consent form.  
 
ExclusionCriteria 
Details  1. Participants presenting with the history of traumatic, infective and neoplastic conditions
of spine.
2. Diagnosed cases of HIV, HBsAG, Tuberculosis,
3. Pregnant women.
4. Participants presenting with the history of major systemic disorders that may interfere
with the course of treatment. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Assessment will be based on Katishoola (Visual analogue scale 0-10), Stambha (Schober’s test), Kriyahani (flexion), Tenderness, Samyak svedana lakshana.  0th,7th and 22nd day  
 
Secondary Outcome  
Outcome  TimePoints 
To improve ease of life.  22nd 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   Phase 2 
Date of First Enrollment (India)   28/04/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  28/04/2025 
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 Yet Recruiting 
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  

In today’s fast-paced era of modernization, we are seeing lifestyle shifts like excessive mobile and computer usage, prolonged sitting with poor posture, long periods of uninterrupted work, and extensive travel. These habits can put undue pressure on the spine and increase the risk of injury. Low back pain is a common health issue that affects millions of people worldwide. The recent prevalence rates of low back pain show point prevalence is approximately 48%, annual prevalence is approximately 51%, lifetime prevalence is approximately 66%. Katigraha is an important clinical, social, economic and public health problem affecting the population. It falls within the spectrum of Vataja Nanatmaja Vyadhis, characterized by pain and stiffness in the Kati Pradesha. Spine is a single entity which is made up of 33 vertebrae, 23 intervertebral discs, various muscles, ligaments and connective tissues. The intrinsic muscles such as erector spinae group of muscles and ligaments such as anterior and posterior longitudinal ligaments run throughout the length of spine. The spine’s integrity depends significantly on the strength, flexibility, and coordination of the back muscles. The local kati basti or kati pichu treatments target only a small portion of the spine, covering approximately 10-15% of the back region. Whereas the proposed prishta pichu therapy offers an aid in comprehensive strengthening of the spine by addressing the entire spine and back area. Although Prishta pichu is practised, there is no sufficient research has been done on this procedure. Thus, for current study, Prishta pichu is taken in kati graha cases to know its clinical efficacy.

 
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