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CTRI Number  CTRI/2024/11/076620 [Registered on: 11/11/2024] Trial Registered Prospectively
Last Modified On: 11/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To access the role of medication through rectal route and taila dhara in lumbar spondylosis 
Scientific Title of Study   Comparative clinical evaulation of sahacharadi yapana basti and sahacharadi taila katidhara in katigraha (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 Arvind K Gupta 
Designation  professor 
Affiliation  Himalayiya Ayurvedic PG Medical College & Hospital 
Address  OPD No.11 Department of Panchakarma, Himalayiya Ayurvedic P.G. Medical College and Hospital, Fatehpur Tanda, Majri grant via Doiwala, Dehradun

Dehradun
UTTARANCHAL
248140
India 
Phone  7895624474  
Fax    
Email  arvindguptapk@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Drishti Kotiyal 
Designation  pg scholar 
Affiliation  Himalayiya Ayurvedic PG Medical College & Hospital 
Address  OPD No.11 Department of Panchakarma, Himalayiya Ayurvedic P.G. Medical College and Hospital, Fatehpur Tanda, Majri grant via Doiwala, Dehradun

Dehradun
UTTARANCHAL
248140
India 
Phone  8976995442  
Fax    
Email  yashraj.dun@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Drishti Kotiyal 
Designation  pg scholar 
Affiliation  Himalayiya Ayurvedic PG Medical College & Hospital 
Address  OPD No.11 Department of Panchakarma, Himalayiya Ayurvedic P.G. Medical College and Hospital, Fatehpur Tanda, Majri grant via Doiwala, Dehradun

Dehradun
UTTARANCHAL
248140
India 
Phone  8976995442  
Fax    
Email  yashraj.dun@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Dr Drishti Kotiyal 
Address  Himalayiya Ayurvedic PG Medical college and hospital, dehradun 
Type of Sponsor  Private 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 
Dr Drishti Kotiyal  Himalayiya Ayurvedic PG Medical College And Hospital  OPD No 11 department of panchakarma, himalayiya ayurvedic pg medical college and hospital dehradun
Dehradun
UTTARANCHAL 		 8976995442

yashraj.dun@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Minutes of Institutional Ethical Committee  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: VATAVYADHIH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म (Procedure Reference: ch. si.12/15, Procedure details: Procedure- For Yapan Basti- Purva Karma-  Patient will be given Abhyanga & Swedana over Adhobhag, Kati, & Prishtha Pradesh.  Then patient will be lied on his left lateral position on the Basti table. Pradhan Karma-  Enema will be pushed into rectum after lubricating nozzle & Guda.  Then Sahacharadi Yapana Basti will be administered slowly in the dose of 480 ml. Paschat Karma-  When the administration will be over, buttocks of the patient will be patted with palms for 3 times & patient will be advised to relax in supine position.  Patient will be advised Pathya Ahara during the treatment. )
2Comparator ArmProcedure-pariSheka, परिषेक (Procedure Reference: ch. su. 20/13, Procedure details: For Katidhara- Purva Karma-  Patient should lie in the prone position with well exposed Katipradesh over Droni.  Local Abhyanga is done. Pradhan Karma-  Lukewarm oil is poured over the kati pradesh from a height of 9 inches(12 angula) in a uniform stream along with a gentle massage for 45 mins. Paschat Karma-  Body should be cleaned with soft towel.  Advice rest for for half an hour and take bath.)
(1) Medicine Name: sahacharadi taila, Reference: as. hr. chi. 21/67-71, Route: Topical, Dosage Form: Taila, Dose: 1.5(NA), Frequency: od, Duration: 16 Days
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Patient of either sex between 30-70 yrs of age
2. Patient fulfilling the assessment criteria such as suffering from lumbar
spondylosis
3. degenerative changes in the lumbosacral vertebrae
4. Willing to participate and give written consent for study.
5. Patient with low back ache
6. Patients who are Basti Yogya according to the classics  
 
ExclusionCriteria 
Details  1. Pregnant and lactating women, epilepsy or any other serious systemic illness.
2. Lumbar radiculopathy.
3. Patients who are Basti Ayogya according to the classics.
4.Any rectal disease  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
improvement in Visual analog scale for intensity of pain Grading
2. 0swestry disability index(ODI) 0-20 % 		 4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
relief in sign and symptoms  2 weeks 
 
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   Phase 2/ Phase 3 
Date of First Enrollment (India)   15/11/2024 
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   In modern medicine the treatment of lumbar spondylosis aims to relieve pain, improve functionality, and prevent further degeneration. It may include lifestyle modifications and medications i.e. non-steroidal anti-inflammatory drugs, muscle relaxants and pain relievers; corticosteroids injections and surgery in severe cases. The treatment outcomes may vary from patient to patient. Unfortunately, all these medicaments, may not always provide complete or lasting relief either and also has their own side effects particularly by longterm use. Despite considerable endeavors to explore conservative and invasive methods to manage symptoms and halt progressive degeneration, a universally accepted gold standard treatment for lumbar spondylosis (Katigraha) remains elusive. So the quest for a safer, cost effective, and minimally harmful treatment that offers both symptomatic relief and a cure is crucial. In Ayurveda lower back is termed as katipradesha, hence Katigraha is closest correlation to lumbar spondylosis as it shows similarity in symptoms. Katigraha is characterized predominantly by pain and restricted movement of Kati region. There are two main causative factors for vitiation of Vata i.e. Dhatukshaya (degenerative pathology) and Margavrodhjanya (obstructive pathology in channels).(4) In Katigraha or Katishool, Dhatukshaya plays an important role. Panchkarma has a multidisciplinary approach presented by each therapy. It not only means Shodhan but also Bruhman, Vrishya, Lekhan, Langhan properties. Vata is the main etiological factor in the pathogenesis of the diseases causing pain and for managaement of Vatavyadhi, Basti holds a prominent place as it is called as Ardhchikitsa.(5) Acharya Charaka has mentioned Sek (Dhara) and Bastikarma in Samanya Chikisa of Vatvyadhi. In this study, we will assess the efficacy of Sahacharadi Yapana Basti and Sahacharadi Taila Katidhara in the management of Katigraha. Yapana basti which is selected for present study is a mild type of Niruha Basti that has Balya, Rasayana, Vata-Kapha Shamaka and Bruhman effect which will help in preventing further degeneration in lumbar spondylosis (Katigraha). Sahacharadi Taila Katidhara serves the purpose of both Snehana and Swedana which will pacify Vata and Kapha and can also rectifies the Margaavarana and give Srotomukavishodhana. Considering the significant prevalence of disability during the productive span of life, the intensity of disease symptoms, the absence of effective treatments, we aim to incorporate Sahacharadi Yapan Basti and Sahacharadi Taila Katidhara for the management of Katigraha (lumbar spondylosis). The decision is rooted in classical references, where their efficacy has been substantiated. Total 40 patients will be randomly selected for the study and divided equally into 2 groups (Group A and Group B). Group A will receive 2 sittings of Sahacharadi Yapan Basti in Kaal basti schedule (16 days) with 8 days gap. Group B will receive 2 sittings of Sahacharadi Taila Katidhara for 16 days with 8 days gap. So here is an effort for the management of Katigraha. 4 
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