| 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 |
|
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Details of Secondary Sponsor
|
|
|
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 |
|
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Details of Ethics Committee
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G55||Nerve root and plexus compressionsin diseases classified elsewhere. Ayurveda Condition: GRUDHRASI, |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | 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 |
|
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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
|
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Method of Generating Random Sequence
|
Other |
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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 |
|
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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
|
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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 |