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CTRI Number  CTRI/2024/03/064210 [Registered on: 15/03/2024] Trial Registered Prospectively
Last Modified On: 24/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Role of Panchakarma in low back pain 
Scientific Title of Study   Effect Of Rasnadi ghrita Anuvasana Basti In The Management Of Kati Graha (W.S.R. To Lumbar Spondylosis) – A Randomized Controlled Clinical Trial 
Trial Acronym  NOT APPLICABLE 
Secondary IDs if Any  
Secondary ID  Identifier 
NOT APPLICABLE  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Bagmibidbatta Ghadei 
Designation  PG Scholar 
Affiliation  KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya 
Address  Room No 04 and IPD Department of Panchakarma,KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya Shahapur Belagavi

Belgaum
KARNATAKA
590003
India 
Phone  7008671540  
Fax    
Email  bidbattabagmi@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rajashekhar V Sanapeti 
Designation  Professor & HoD 
Affiliation  Shri B M Kankanawadi Ayurveda Mahavidyalaya 
Address  Room No 04 and IPD Department of Panchakarma,KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya Shahapur Belagavi

Belgaum
KARNATAKA
590003
India 
Phone  9611442881  
Fax    
Email  rajashekharpk@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Rajashekhar V Sanapeti 
Designation  Professor & HoD 
Affiliation  Shri B M Kankanawadi Ayurveda Mahavidyalaya 
Address  Room No 04 and IPD Department of Panchakarma,KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya Shahapur Belagavi

Belgaum
KARNATAKA
590003
India 
Phone  9611442881  
Fax    
Email  rajashekharpk@gmail.com  
 
Source of Monetary or Material Support  
KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya 
 
Primary Sponsor  
Name  Shri B M Kankanawadi Ayurveda Mahavidyalaya 
Address  Room No 04 and IPD Department of Panchakarma,KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya Shahapur Belagavi 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NOT APPLICABLE  NOT APPLICABLE 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Bagmibidbatta Ghadei  KLE AYURVEDA HOSPITAL & MEDICAL RESEARCH CENTRE  Room No 04 and IPD Department of Panchakarma,KLE Ayurveda Hospital & Medical Research Centre Shahapur Belagavi
Belgaum
KARNATAKA 
7008671540

bidbattabagmi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee for Research on Human Subjects KAHERs Shri B M Kankanawadi Ayurved Mahavidyalaya & KLE Ayurved Hospital, Shahapur Belagavi  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: PRUSHTHA-GRAHAH (KEVALAVATA),  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म (Procedure Reference: Caraka Samhita, Procedure details: Anuvasna Basti with Sahacharadi Taila 75ml daily for 11 days through rectal route))
(1) Medicine Name: Sacharadi Taila, Reference: Astanga Hrudya, Route: Rectal, Dosage Form: Taila, Dose: 75(ml), Frequency: od, Duration: 11 Days
2Intervention ArmProcedure-anuvAsana-bastiH, अनुवासन-बस्तिः (Procedure Reference: Caraka Samhita, Procedure details: Anuvasna Basti with Rasnadi Ghrita 75ml daily for 11 days through rectal route))
(1) Medicine Name: Rasnadi Ghrita, Reference: Astanga Hrudya, Route: Rectal, Dosage Form: Ghrita, Dose: 75(ml), Frequency: od, Duration: 11 Days
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients with signs and symptoms of kati graha.
VAS Scale: 3-10.
Patient X-RAY showing degenerative changes.
Patient fit for Basti.
Patient ready to give consent for the study.
 
 
ExclusionCriteria 
Details  Patients with a recent history of Spinal Surgery
Patients with established Tumors or Malignancy
Patients with diagnosed T.B. of bone
Pregnant and lactating mother
Patients who are not fit for basti 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Changes in Range of Motion
Changes in Oswestry Low Back Disability Questionnaires
Changes in VAS Scale  
0th day and 11th day 
 
Secondary Outcome  
Outcome  TimePoints 
NOT APPLICABLE  NOT APPLICABLE 
 
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 1 
Date of First Enrollment (India)   01/04/2024 
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="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 - NO
Brief Summary  

As per the API, the incidence of low back pain (LBP) in the world is so severe that it is the 2nd most common reason why a patient visits the hospital. Although LBP has become more prominent in the case of young adults nowadays due to the current lifestyle, altered circadian rhythm along with the sedentary lifestyle and food intake: if we consider the older age group the incidence of the disease is so severe that around 85% of the population aged >40 suffer from LBA at any stage of their lives. [1]

 Among these ‘LUMBARSPONDYLOSIS’ comes under the congenital LBA, which covers degenerative diseases and osteoarthritic changes in the lumbar spine. Spondylosis occurs in 6-10% of the general population and has been found to be as high as 25-60% in athletes. The prevalence of radiographic spondylosis increases with age. It is present in only a small percentage of the population in the first few decades of life, but it is common by the age of 65yr. In those with low back pain, prevalence ranges from 7-75%, depending on the diagnostic criteria.[2]

In the contemporary medical system, the treatment protocol includes medications like muscle relaxants, NSAIDs, corticosteroids, and other pain relievers, which can provide quick but temporary relief to patients.

 On the other hand, for chronic cases, surgical treatments are advised, through which anatomical corrections are done for the management of the disease. For some patients, it acts like a boon by giving them permanent pain relief, but in another aspect, some patients even after the successful surgery could not recover. Even after performing such an invasive and expensive line of care, patients sometimes end their lives with a number of complications too.[3]

 

 

As the disease also involves the older age group i.e., patients aged >60 too, the surgical approach becomes a more tough choice for the surgeon; since it has to be performed under anesthetizing the patient for >5hr, which may lead to further complications. Patients with other neurological disorders are also avoided from the surgery and have to be unwillingly dependent on the used corticosteroids and the practiced NSAIDs for pain relief. [4]

Whereas, the Ayurvedic approach to the disease is holistic. Snehana Chikista is considered to be the Best Ayurvedic remedy for dhatukshyajanya vatavyadhi, as it reduces the vitiated vata dosha which further reduces the rukshsta, kharata, parushata by providing snigdhata, shlaksanata and mruduta to the affected body organs.[5]

Snehana can be given by different procedures like- Snehaana, Abhyanga, Shirobasti, And most importantly Anuvasan basti. For the purpose of Snehana as mentioned by the Acharya Charak chatuhsneha can be used i.e. Ghrita, Taila, Vasa, And Majja . But when we consider the vata; Taila is mentioned as the best due to its vatahara properties. That is the reason why in the previously conducted studies oils like Mahanarayn taila, Balaaswagandha taila, Brihat saindhavadya taila, and Sahacharadi taila are used the previously conducted studies. [6]

Since the taken disease is a degenerative and vata vitiated disorder as per Ayurveda the cause of the disease is due to the vitiation of vata and dhatu kshyaya, which can be managed by uttarotara dhatu poshana, Acharya Charak in the context of Ghrita explains it as “YOGAVAHI” having the properties like Pitta - Anilahara.

 

 

 

 

In the context of Anuvasan Basti; both Acharya Charak and Sushruta explained like it can be administrated daily in individuals, accustomed to daily exercise, have high digestive power, those who are Ruksha, and have Vata dominating disease in the inguinal, pelvis region, udawarta, and other Vatik disorders. In these individuals, the Sneha gets absorbed as rapidly as the water is absorbed when poured on the sand.[7]

 In the experimental group “RASNADI GHRITA” is taken which has mostly vatahara drugs which would do the actions of reducing vata along with nourishing the dhatus. As a result of which the degenerative changes can be dealt with by providing uttarotara dhatu poshana.

As the drug contains drugs like Rasna which is having Vata-kapha hara actions and drugs like dashamoola which acts as an anti-inflammatory as well as having vata kapha hara actions, the trial drug may show more efficacy in treating the disease.

In the phalashrurti of the drug, A.H. “KASA CHIKISTA” adhyaya Acharya Vagbhatta clearly explains the drug can be used for Vata-predominant diseases such as pana, navana, along with basti.[8]

 
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