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CTRI Number  CTRI/2023/08/056604 [Registered on: 17/08/2023] Trial Registered Prospectively
Last Modified On: 14/08/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to compare the efficacy of Kashyapokta Kala Basti and Vagbhatokta Kala Basti in the management of Vataja Gridhrasi or Sciatica. 
Scientific Title of Study   A comparative clinical study to evaluate the efficacy of Kashyapokta Kala Basti and Vagbhatokta Kala Basti in the management of Vataja Gridhrasi vis-a-vis Sciatica. 
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 Sreejith R 
Designation  PG Scholar 
Affiliation  Sri Sri College Of Ayurvedic Science And Research, Bangalore. 
Address  Room No-8,Panchakarma OPD, Sri Sri College of Ayurvedic Science and Research Hospital,21st K.M Kanakapura Road Udayapura, Bangalore.

Bangalore
KARNATAKA
560082
India 
Phone  09895715110  
Fax    
Email  sreerejit@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ganesh Puttur 
Designation  Principal and HOD 
Affiliation  Sri Sri College Of Ayurvedic Science And Research, Bangalore. 
Address  Room No-8,Panchakarma OPD, Sri Sri College of Ayurvedic Science and Research Hospital,21st K.M Kanakapura Road Udayapura, Bangalore.

Bangalore
KARNATAKA
560082
India 
Phone  9538176059  
Fax    
Email  drganeshputtur@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Ganesh Puttur 
Designation  Principal and HOD 
Affiliation  Sri Sri College Of Ayurvedic Science And Research, Bangalore. 
Address  Room No-8,Panchakarma OPD, Sri Sri College of Ayurvedic Science and Research Hospital,21st K.M Kanakapura Road Udayapura, Bangalore.

Bangalore
KARNATAKA
560082
India 
Phone  9538176059  
Fax    
Email  drganeshputtur@gmail.com  
 
Source of Monetary or Material Support  
Sri Sri College Of Ayurvedic Science And Research Hospital, Bangalore. 
 
Primary Sponsor  
Name  Dr Sreejith R 
Address  Sri Sri College Of Ayurvedic Science And Research, Bangalore. 
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 Sreejith R  Sri Sri College Of Ayurvedic Science And Research Hospital, Bangalore.  Room No-8,Panchakarma OPD
Bangalore
KARNATAKA 
9895715110

sreerejit@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SRI SRI INSTITUTIONAL ETHICAL COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:G55||Nerve root and plexus compressionsin diseases classified elsewhere. Ayurveda Condition: GRUDHRASI (KEVALAVATA),  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म (Procedure Reference: Ashtanga Hrudaya Sutra Sthana 19, Procedure details: GROUP A- KASHYAPOKTA KALA BASTI Niruha basti – Ardhamatrika basti-596 ml Anuvasana basti – Sahacharadi taila-72ml Day 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 Type of Basti A A A N A A A N A A A N A A A I. ANUVASANA BASTI POORVAKARMA Preparation of Basti Yanta & Basti Netra – 100ml syringe along with the rubber catheter fitted to the free end of the syringe will be used for Anuvasana Basti. The mentioned quantity of medicine is indirectly warmed and is filled inside the sterile syringe)
(1) Medicine Name: Ardhamatrika Basti, Reference: Vangasena Samhita,Bastikarmaadhikara, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 596(ml), Frequency: od, Duration: 3 Days
(2) Medicine Name: Sahacharadi taila, Reference: Ashtanaga Hrudaya Chikitsa Sthana 21, Route: Rectal, Dosage Form: Taila, Dose: 72(ml), Frequency: od, Duration: 12 Days
2Intervention ArmProcedure-bastikarma, बस्तिकर्म (Procedure Reference: Ashtanga Hrudaya Sutra 19, Procedure details: GROUP B- VAGBHATOKTA KALA BASTI Niruha basti - Ardhamatrika basti-596 ml Anuvasana basti – Sahacharadi taila-72ml Day 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 Type of Basti A N A N A N A N A N A N A A A I. ANUVASANA BASTI POORVAKARMA Preparation of Basti Yanta & Basti Netra – 100ml syringe along with the rubber catheter fitted to the free end of the syringe will be used for Anuvasana Basti. The mentioned quantity of medicine is indirectly warmed and is filled inside the sterile syringe. )
(1) Medicine Name: Ardhamatrika Basti, Reference: Vangasena samhita Bastikarmadhikara, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 596(ml), Frequency: od, Duration: 6 Days
(2) Medicine Name: Sahacharadi Taila, Reference: Ashtanga Hrudaya Chikitsa Sthana 21, Route: Rectal, Dosage Form: Taila, Dose: 72(ml), Frequency: od, Duration: 9 Days
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  -Subjects between the age group of 21 - 60 years irrespective of gender, religion, occupation and socioeconomic status.
-Subjects fit for Basti Karma.
-Subjects presenting with clinical signs and symptoms of Vataja Gridhrasi.
-Subjects who are willing to give a written consent for the treatment.
 
 
ExclusionCriteria 
Details  -Subjects below 21 years and above 60 years of age.
-Subjects unfit for Basti Karma.
-Subjects presenting with signs and symptoms of Vata-Kaphaja Gridhrasi.
-Systemic diseases which interfere with the course of treatment will be excluded.
-Subjects with spinal deformity, severe traumatic injury, tuberculosis of the spine, benign or malignant tumors of spine.
-Pregnant and lactating women.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
SLR Test, VAS scale for pain assessment, Oswestery low back disability index  0th day,15th day,45th day 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
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 3 
Date of First Enrollment (India)   28/08/2023 
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="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 the present era, there is considerable increase in disorders related to the locomotory system which has affected both social and professional life of human, impairing the quality of living. ‘Gridhrasi’ is one among such disorders described in Ayurvedic classics. It is a Ruja Pradhana Vatavyadhi and the name ‘Gridhrasi’ itself indicates the impaired gait of the patient i.e., “Gridhravath”. In Gridhrasi, there is intense shooting pain characteristically radiating from Sphik (gluteal region) to Prishtha Bhaga of Kati (lumbo-sacral region), Uru, Janu, Jangha and Pada in the same sequential order. The symptoms of Gridhrasi are Ruk, Toda, Spandana and Stambha. In modern view the above condition is described as pain or paresthesia which is experienced along the course and distribution of the sciatic nerve or an associated lumbosacral nerve root. It is well known even among the laymen as “Sciatica”. Lifetime incidence of sciatica reported between 10% to 40% with an annual incidence of 1% to 5% of the population. The prevalence of sciatica varies considerably ranging from1.6% in the general population to 43% in the working population.

The change in lifestyle including busy professional and social life, improper sitting posture in offices, factories, overexertion, jerking movements during travelling and sports– are few factors creating undue pressure to the spine. Also, other factors like irregular & improper food habits, suppression of natural urges, lack of proper sleep or sleeping during day time and over exerting day to day work has led to an increased incidence of low backache and sciatica. Likewise, progressive disorders affecting the pelvis and nearer structures are also precipitating this condition. In this way, this disease is now becoming a significant threat to the working population.

In reference to sciatica treatment, contemporary medical science has only symptomatic management with analgesics and anti-inflammatory drugs which causes serious side effects on prolonged usage. In some cases, if nerve compression is more, then steroid injections, peri-radicular infiltration and surgical interventions like laminectomy, discectomy are indicated but these procedures are expensive with their own limitations. All these factors show a gravity of the disease and have compelled to go for a better remedial search or alternate choice of treatment which can be achieved through Ayurveda.

            In Ayurveda, Basti Chikitsa is considered as the most effective form of treatment in the management of various ailments especially in diseases occurring due to Vata Dosha due to its multi- dimensional action. Acharya Charaka and Acharya Vagbhata have described Basti as Ardha Chikitsa which itself is self-explanatory about its importance. It is also considered as one among the important treatment procedures in Gridhrasi.

             There are different patterns of Basti explained in our classics like Yoga Basti, Kala Basti and Karma Basti , but Acharya Kashyapa has mentioned special pattern for Kala Basti  where, 12 Anuvasana Basti’s and 3 Niruha Basti’s are mentioned which would be more beneficial in Vataja Rogas including Gridhrasi.

              Considering the above factors, an attempt has been made to clinically evaluate the comparative efficacy of Kashyapokta Kala Basti and Vagbhatokta Kala Basti in Vataja Gridhrasi (Sciatica)

 
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