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CTRI Number  CTRI/2024/09/074153 [Registered on: 23/09/2024] Trial Registered Prospectively
Last Modified On: 28/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Role of Ayurveda in Low back pain 
Scientific Title of Study   Efficacy of Prasaranyadi Taila Anuvasana Basti in the Management Of Gridhrasi (W.S.R. to Sciatica) – A Randomized Controlled Clinical Trial  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NOT APPLICABLE  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Yashraj Y Doshi 
Designation  PG Scholar 
Affiliation  KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya 
Address  OPD no 04 and IPD Department of Panchakarma KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya Shahapur Belagavi

Belgaum
KARNATAKA
590003
India 
Phone  7720903993  
Fax    
Email  yashrajd15@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rajashekhar V Sanapeti 
Designation  Professor 
Affiliation  KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya 
Address  OPD 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 
Affiliation  KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya 
Address  OPD no 04 and IPD Department of Panchakarma KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya Shahapur Belagavi


KARNATAKA
590003
India 
Phone  9611442881  
Fax    
Email  rajashekharpk@gmail.com  
 
Source of Monetary or Material Support  
KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya Shahapur Belagavi 590003 
 
Primary Sponsor  
Name  Dr Yashraj Y Doshi 
Address  OPD no 04 and IPD Department of Panchakarma KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya Shahapur Belagavi 590003 
Type of Sponsor  Other [SELF] 
 
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 Yashraj Y Doshi  KLE Ayurveda Hospital and Medical Research Centre  OPD no 04 and IPD Department of Panchakarma Shahapur Belagavi Karnataka India 590003
Belgaum
KARNATAKA 
7720903993

yashrajd15@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Insitutional Ethics Committee for Research on Human Subjects KAHERs Shri B. M. Kankanawadi Ayurveda 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:M489||Spondylopathy, unspecified. Ayurveda Condition: GRUDHRASI,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म (Procedure Reference: Caraka SAmhita, Procedure details: Anuvasana Basti 75ml rectal route For 7 days)
(1) Medicine Name: Prasaranyadi Taila, Reference: Bhaishajya Ratnawali, Route: Rectal, Dosage Form: Taila, Dose: 75(ml), Frequency: od, Duration: 7 Days
2Comparator ArmProcedure-bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म (Procedure Reference: Caraka Samhita, Procedure details: Anuvasana Basti Sahacharadi Taila 75 ml Rectal route For 7 days)
(1) Medicine Name: Sahacharadi Taila, Reference: Astanga Hrudaya, Route: Rectal, Dosage Form: Taila, Dose: 75(ml), Frequency: od, Duration: 7 Days
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1 Patient fulfilling the diagnostic criteria
2 Patient who is fit for Basti.
3 Patients who are indicated for Anuvasana Basti
 
 
ExclusionCriteria 
Details  1. History of spinal surgery and vertebral fracture.
2. Evidence of systemic diseases like uncontrolled diabetes, Hypertension, Ischemic heart disease, etc
3. Established tumors/malignancy.
4. Pregnant and lactation women.

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Pain, Stiffness, Twitching, Tastelessness, Stupor, Heaviness, Pain -VAS (Visual Analogue Scale), Tenderness, Schober’s Test, SLR Test- Grading, FABER’s Test  0th day, 8th day and 23rd day 
 
Secondary Outcome  
Outcome  TimePoints 
NOT APPLICABLE  NOT APPLICABLE 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   01/10/2024 
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  

The most common musculoskeletal disorder affecting the movement of leg is low back pain. Among the affected patients, 40% have radicular pain and these cases can be classified under the umbrella term of sciatic syndrome. Low back pain is extraordinarily common, second only to the common cold.[1] The prevalence of Sciatica varies from 1.2% to 43% in different studies, and about 50% of working adults experience a back injury each year. Lifetime incidence is reported to be between 10% to 40% and an annual incidence of sciatica ranges from 1 to 5%. [2]

 

Sciatica is characterized by excruciating pain and paresthesias in sciatic nerve distribution associated lumbosacral nerve root which severely affects the quality of life of those affected.[3]

 

Physical activity during work and occupational workload, such as lifting heavy objects twisting the trunk while working, or being exposed to whole-body vibration (for example, machine operators or motor vehicle drivers), are all potential risk factors for Sciatica. These factors can create pressure on the spinal cord, leading to lower back pain and radiating pain.[4] In modern medicine, muscle relaxants, NSAIDs, corticosteroids, and other medications are often used to provide temporary pain relief. However, surgery may be required as a last resort, which can result in various complications and even permanent loss of working capabilities.[5]

 

In Ayurveda, sciatica seems to similar in signs and symptoms with Gridhrasi. Gridhrasi is a condition where the pain starts in the sphik pradesh area and radiates


downwards to kati, prusta, uru, janu, jangha, and pada. Sciatica is a common cause of pain and disability and is more severe and persistent than low back pain

In this disease, mainly Vyana Vayu vitiation is observed, but Kapha is usually associated with Dosha.[6] So for the treatment of Gridhrasi, the drug of choice should have Vatashamaka, Kaphashamaka, Vatanulomaka, Dipana-Pachana(digestive- carminative), and Shulaprashamana properties.

Vasti is recommended as the best treatment for Vata because of how closely the Vata dosha and neurological system operate. It again validates the efficacy of Vasti karma on the nervous system. Charaka mentions that the administration of Anuvasana Vasti results in the nourishment of all pathways once it reaches Nabhipradesh, which is the central location of Sira(vessels) and Dhamani(channels).[7]

According to Bhaishyajya Ratnavali, in the Phalashruthi of Kubja Prasaranyadi Taila, Gridhrasi has been mentioned, Because it balances the vata and kapha doshas, Pratisarini taila is a useful taila for Anuvasna basti. The quality of Prasaranyadi taila is described as "Vatashleshmabhayan jayet" in Bhaishjya Ratnavali.[8]

The components of prasaranyadi taila consist of kaphavatahara, katu tikta, kashaya, rastmak dravya.

 
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