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CTRI Number  CTRI/2024/03/063917 [Registered on: 11/03/2024] Trial Registered Prospectively
Last Modified On: 08/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Other (Specify) [PANCHAKARMA BASTI KARMA]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To Evaluate Effectiveness of Erandamooladi Niruha Basti and Shampakadi Niruha Basti Karma in management of Gridrasi(Sciatica) 
Scientific Title of Study   A Comparative Clinical Study to Evaluate the Effectiveness of Erandamooladi Niruha Basti and Shampakadi Niruha Basti in the Management of Gridrasi 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  CHANDU METRI 
Designation  PhD Scholar 
Affiliation  Government Ayurvedic Medical College BAngalore 
Address  OPD 6 Ground floor Department of Panchakarma Government Ayurveda Medical college,Bangalore

Bangalore
KARNATAKA
560009
India 
Phone  9739317110  
Fax    
Email  akrmchandu@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Ananta Desai 
Designation  Professor & HOD 
Affiliation  Government Ayurvedic Medical College Bangalore 
Address  OPD 6 Department of Panchakarma Government Ayurveda Medical college Bangalore KARNATAKA

Bangalore
KARNATAKA
560009
India 
Phone  9448185896  
Fax    
Email  anantdesai30@gmail.com  
 
Details of Contact Person
Public Query
 
Name  CHANDU METRI 
Designation  PhD Scholar 
Affiliation  Government Ayurvedic Medical College BAngalore 
Address  OPD 6 Ground Floor Department of Panchakarma Government Ayurveda Medical college Bangalore

Bangalore
KARNATAKA
560009
India 
Phone  9739317110  
Fax    
Email  akrmchandu@gmail.com  
 
Source of Monetary or Material Support  
GAMC Hospital Bangalore & Krishna Ayurveda College Sankeshwar 
 
Primary Sponsor  
Name  Chandu Metri 
Address  department of Panchakarma, Krishna AYurvedic Medical College  
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 Chandu Metri  GOVERNMENT AYURVEDA MEDICAL COLLEGE BANGALORE  OPD 6 Panchakarma Division Department of Panchakarma Government Ayurveda Medical college Bangalore,KARNATAKA
Bangalore
KARNATAKA 
9739317110

akrmchandu@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
GOVERNMENT AYURVEDA COLLEGE DHANWANTARI ROAD BANGALORE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M898||Other specified disorders of bone. Ayurveda Condition: GRUDHRASI, (2) ICD-10 Condition:M498||Spondylopathy in diseases classified elsewhere. Ayurveda Condition: GRUDHRASI,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-yoga-bastiH, योग-बस्तिः (Procedure Reference: susruta samhita chiktsa sthana 38/43-45, Procedure details: Procedure Purvakarma sambarasangraha of all the medicine & equipments and advised to pateient regrading basti pradhana karma bastipratidana basti pratyagamana lakshana of yoga ayoga and atiyoga paschaatkarma )
(1) Medicine Name: Sampakadi niruha basti, Reference: Susruta samhita chiktsa sthana, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 480(ml), Frequency: od, Duration: 8 Days
2Comparator ArmProcedure-yoga-bastiH, योग-बस्तिः (Procedure Reference: Charaka samhita siddhisthana , Procedure details: Procedure Purvakarma sambarasangraha of all the medicine & equipments and advised to pateient regrading basti pradhana karma bastipratidana basti pratyagamana lakshana of yoga ayoga and atiyoga paschaatkarma )
(1) Medicine Name: Erandamooladi niruha basti, Reference: Charaka samhita , Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 480(ml), Frequency: od, Duration: 8 Days
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Subjects yogya for Basti karma,Subjects Presenting with classical signs and symptoms of Gridrasi,Sign like Sakthi nikshepa nigraha (SLR, i.e., straight leg rising test positive),Subjects of age group between 20 and 70 years either sex.
 
 
ExclusionCriteria 
Details  1.Ayogya for Niruha Basti.
2.Uncontrolled diabetes mellitus, hypertension, tuberculosis of spine and hip joint, malignancy of spine or other organs
3.Fracture related to spine
4.Anemia (hemoglobin % <07.00 mg/dl)
5.Pregnancy.
6.Patients who have completed participation in any other clinical trial during the past six (06) months
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Pain,Radiating pain from lumbar to lower linmbs,difficulty in walking  1st day ,8th day and 24th day  
 
Secondary Outcome  
Outcome  TimePoints 
Pratyatmalaksana of gá¹›idhrasi
CRP 
Baseline & 24th day 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   18/03/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  18/03/2024 
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  

The disease Gridhrasi is commonly seen in the society as a prominent problem. Gridhrasi listed among the Nanatmaja vatavyadhi is characterized by Stambha, Ruka, Toda and Spandana, initially affect Sphika (buttock) as well as posterior aspect of kati (waist) and then gradually radiates to posterior aspect of uru (thigh), janu (knee), Jangha (calf) and Pada (foot)  Acharya Susruta has also mentioned Sakthishepana Nigrahanti (restricted movement of lower limb) as one additional symptom of Gridhrasi. In Vata-Kaphaj Gridhrasi; Tandra (drowsiness), Gaurav (heaviness) and Aruchi (anorexia) may also be present. This condition causes great discomfort to the patient and affects his daily routine as it is directly related to the locomotors system. Improper seating posture, irregular food habits, lack of proper sleep, travelling in jerky vehicles etc. are responsible for Sciatica.

            On the basis of symptoms of Gridhrasi; it can be equated with the disease sciatica in modern science. It occurs due to spinal nerve irritation and is characterized by pain in distribution of sciatic nerve. Low back pain and radiating pain due to lumbar disc prolapse are the major cause of morbidity throughout the world. Lifetime incidence of low back pain is 50-70% with incidence of sciatica more than 40%. However sciatica due to lumbar disc prolapse occurs only in 4-6% of the population. Despite the staggering annual costs of back pain to society there is paucity of well controlled clinical trials in the area of low back pain.

              In today’s era quick pain relief is of prime importance to resume normal activities. Basti is considered as prime line of treatment in the Vataja disorders and deferent shodhana basti is mentioned in the classics for Vataja and Vata-kaphaja disorders. Keeping this as background, present comparative integrated study is proposed to see the  effectiveness of Erandamooladi Niruha Basti  and Shampakadi Niruha Basti  in the management of  Gridrasi” 
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