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CTRI Number  CTRI/2025/08/092648 [Registered on: 08/08/2025] Trial Registered Prospectively
Last Modified On: 23/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparision of Kulaththadi vaitarana basti and Madanaphala vaitarana basti in sciatica 
Scientific Title of Study   A Randomized controlled trail to evaluate the effect of Kulaththa kwatha vaitarana Basti and Madanaphala Vaitarana Basti in the management of Vata-Kaphaja Gridrasi (Sciatica) 
Trial Acronym  RKMB  
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Smitha C Kanavi 
Designation  Assistant Proffessor 
Affiliation  Shree Jagadguru Gavisisddeshwar Ayurvedic Medical College and Hospital 
Address  Shree Jagadguru Gavisisddeshwar Ayurvedic Medical College and Hospital -Koppal

Koppal
KARNATAKA
583231
India 
Phone  9986813246  
Fax    
Email  drsmitha26@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Suresh Hakkandi 
Designation  Proffessor 
Affiliation  Shree Jagadguru Gavisisddeshwar Ayurvedic Medical College and Hospital 
Address  Department of panchakarma Shree Jagadguru Gavisisddeshwar Ayurvedic Medical College and Hospital -Koppal

Koppal
KARNATAKA
583231
India 
Phone  9986813246  
Fax    
Email  drsmitha26@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Smitha C Kanavi 
Designation  Assistant Proffessor 
Affiliation  Shree Jagadguru Gavisisddeshwar Ayurvedic Medical College and Hospital 
Address  Shree Jagadguru Gavisisddeshwar Ayurvedic Medical College and Hospital -Koppal
Shree Jagadguru Gavisisddeshwar Ayurvedic Medical College and Hospital -Koppal
Koppal
KARNATAKA
583231
India 
Phone  9986813246  
Fax    
Email  drsmitha26@gmail.com  
 
Source of Monetary or Material Support  
Shree Jagadguru Gavisisddeshwar Ayurvedic Medical College and Hospital 
 
Primary Sponsor  
Name  Dr Smitha C Kanavi 
Address  Dept of Panchakarma Shree Jagadguru Gavisisddeshwar Ayurvedic Medical College and Hospital koppal 583231 karnatka 
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 Smitha c kanavi  Dept of Panchakarma,Shree Jagadguru Gavsiddeshwar Ayurvedic Medical College and Hospital  Gavimath,Koppal 583231 karnataka
Koppal
KARNATAKA 
9986813246

drsmithak26@gmail.com 
 
Details of Ethics Committee  
 
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,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म (Procedure Reference: Indradev Tripathi edited by Prof Ramanath Dwivedi Chakradatta o Chakrapanidatta Vaidyaprabha Hindi Commentary Reprint edition 2015 Chaukamba Sanskrit Bhawan Varanasi Chapter 73, Procedure details: Basti karma with Kulattha kwatha and Madanaphala kwatha)
(1) Medicine Name: Kulattha kwatha and Madanaphala kwatha, Reference: Indradev Tripathi edited by Prof Ramanath Dwivedi Chakradatta o Chakrapanidatta Vaidyaprabha Hindi Commentary Reprint edition 2015 Chaukamba Sanskrit Bhawan Varanasi Chapter 73, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 350(ml), Frequency: od, Duration: 7 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  • Subjects with lakshana’s of Vatakaphaja Gridhrasi

• Subjects with chronicity less than 3 years.
• Subjects fit for Basti karma
 
 
ExclusionCriteria 
Details  • Subjects with infective neoplastic congenital traumatic conditions of spine.
• Subjects with Deep vein thrombosis varicose vein and other inflammatory conditions
• Pregnant Women Lactating women and uncontrolled Hypertension and Diabetes Mellitus Myxoedema Ischemic heart disease RHD Ankylosing spondylosis Subjects with anorectal disorders and any Systemic disorders that interferes the course of treatment
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To cure the Grudrasi vyadhi
Controlls vata dosha and makes its proper anulomana 
24th day 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
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 1/ Phase 2 
Date of First Enrollment (India)   01/10/2025 
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)
Modification(s)  
Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details
Modification(s)  
N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Panchakarma is a unique approach of Ayurveda which is especially designed for internal purification of body via nearest possible route  Vamana Virechana Basti  Nasya and Raktamokshana are the Panchakarma

Changing Lifestyle of modern human being has created several disharmonies in the biological system of the body as the advancement of busy professional and social life improper sitting posture in office factories continuous and over exertion jerky movements during travelling and sports which are major cause for creating undue pressure over spinal cord by postural impairments which in turn leads to many pathological conditions like lower backache sciatica etc Now a days most common disorders which effects the movements of leg particular in middle age is low backache out of which 40 percent are radiating pain which comes under sciatica syndrome effecting greatly in day today routine work Exact data on the incidence and prevalence of sciatica are lacking In general an estimated 5 percent to10 percent of patients with low back pain have sciatica whereas the reported lifetime prevalence of low back pain ranges from 49 percent to 70 percent  The annual prevalence of disc related sciatica in the general population is estimated at 2.2 percentage

Gridhrasi is enumerated as one among the Vataja Nanatmaja and Samanyaja VataVikaras It is pain dominant lifestyle disorders in which the pain starts from spik Pradesh and radiates downwards to Kati Prusta Uru Janu Jangha and Pada Here piercing type of pain which restricts the movements of the affected leg make his or her gait like bird vulture and put them in disgraceful condition  Ayurveda categorized Gridrasi as one of the disease caused by vitiation of vata which is responsible for the movement and functions of the body Even Kapha vitiation along with Vata also causes Vata-Kaphaja Gridrasi This vyadi is characterised by sthamba Toda Ruk and spandana These lakshana in sphik and kati gradually involves jaanu janga uru and pada The classification of Vyadhi is done based on involvement of dosha either vata or kapha Acharyas have mentioned the lakshana based on these dosha pradhanata They are shoola supti stamba in vatapradhanja and in kapha pradhanaja tandra,gourava and arochaka The treatment is based on dosha involvement Acharyas have explained that the chikitsa depends on vatavyadhi samprapti ie kevala vata and avaranajanaya   vata Vyadhi. Considering this as samprapti they had mentioned about the basti karma.

 Basti is one among the Panchashodhana and is considered as half of all treatment modalities ArdhaChikitsa It is most important constituent of Panchakarma due to its multifocal effects It eliminates Vata dosha along with other doshas by entering Mulasthana  Basti is the Ardha chikitsa for Vata dosha Niruha basti helps to eliminate Pitta and Kapha dosha and thereby brings down Vata to prime sthana and helps to attain Vatanulomana  By proper modulation Basti can perform multidimensional tasks It can act as Shodhana and Shamana as well as Brimhana based on different combination of drugs

Vaitaranabasti is a type of Niruha basti which is mentioned in Chakradatta Vangasena Samhita and Vrunda Madhava It is Shodhaka and Kaphavata Shamaka in nature  Vaitarana basti can be administered in such patients in initial stage itself to relieve pain and inflammation immediately compared to other external therapies and internal oral medications

Saindhava lavana guda chinchakalka taila and gomutra are the ingredients of Vaitarana basti Guda is having sara guna and Sristha vinmutra Chincha kalka is anti-inflammatory and analgesic Since it is having Amla rasa it acts as a mudha vatanulomaka also Vaitarana basti acts as Anti-inflammatory and analgesic There are many treatment protocols for Gridrasi in its initial phase to reduce Aamavastha or anti-inflammatory phase like internal medication ruksha basti, ruksha sweda  application of lepa etc Among these Vaitarana basti deserves the most important place

In present study Madanaphala kashaya   is replaced in the Vaitarana basti  It is intended to take Madanaphala kashaya in place of gomutra as due to fear of unhygienic chances of infection from leptospirosis etc and also due to reduced availability of hygienic Gomutra Also the religious aspects binds the limitations in usage of Gomutra  Madanaphala kashaya being Tikta Madura rasa laghu ruksha guna kapha vatahara and Laghu ushna in nature and does the aamanirharana In the Vatakaphaja Gridrasi   the above said properties are helpful

Kulattha is one of the drugs in Niruha gana mentioned in Astanga HridayaSutrasthana 15thchapter Shodhanadi gana sangrahaniyamadhyaya The peculiarity of this gana is that we can pick a single drug from gana and it is not mandatory that all the drugs of gana should be used as a whole Among the drugs in Niruha gana, Kulattha is the one which acts subsequently like gomutra due to its similarities in their properties  Kulatha kwatha yukta Vaitarana basti acts as Anti-inflammatory and analgesic Where Vaitarana is said to be Shodhaka and Kaphashamaka and amahara It is less expensive needs minimum man power as the route of administration is rectal route and there is no question of palatability So an attempt was made to evaluate the efficacy of Madanaphalakashaya Vaitarana basti in Gridrasi and to document it for future use this present study has been selected

 
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