FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/03/082211 [Registered on: 12/03/2025] Trial Registered Prospectively
Last Modified On: 03/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Medical Device
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing preparation and effectiveness of Erandamuladi Niruha Basti given in Sciatica done by electrically powered Basti Sammelana Yantra and manual method 
Scientific Title of Study   A comparative pharmaceutico-analytical and clinical study to evaluate the efficacy of Erandamuladi Niruha Basti prepared by electrically powered Basti Sammelana Yantra and conventional method of Basti Sammelana in Gridrasi w.s.r to 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 Shubha Shree C N 
Designation  P.G Scholar 
Affiliation  K.V.G Ayurveda Medical College and Hospital 
Address  Room no 1,Department of Panchakarma K.V.G Ayurveda Medical College and Hospital, Ambateadka, Kurunjibhag, Jattipalla, Sullia.

Dakshina Kannada
KARNATAKA
574327
India 
Phone  7022464147  
Fax    
Email  shubha.cn1@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Smitha Thamban 
Designation  Associate Professor 
Affiliation  K.V.G Ayurveda Medical College and Hospital 
Address  Dr Smitha Thamban Associate Professor Room no 1,Department of Panchakarma K.V.G Ayurveda Medical College and Hospital, Ambateadka, Kurunjibhag, Jattipalla, Sullia.

Dakshina Kannada
KARNATAKA
574327
India 
Phone  8277402977  
Fax    
Email  smith.thmbn@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Smitha Thamban 
Designation  Associate Professor 
Affiliation  K.V.G Ayurveda Medical College and Hospital 
Address  Dr Smitha Thamban Associate Professor Room no 1,Department of Panchakarma K.V.G Ayurveda Medical College and Hospital, Ambateadka, Kurunjibhag, Jattipalla, Sullia.

Dakshina Kannada
KARNATAKA
574327
India 
Phone  8277402977  
Fax    
Email  smith.thmbn@gmail.com  
 
Source of Monetary or Material Support  
KVG Ayurveda Medical College and Hospital, Ambatedka, Kurunjibhag, Sullia-574327, Dakshina Kannada, Karnataka, India  
 
Primary Sponsor  
Name  Dr Shubha Shree C N 
Address  K.V.G Ayurveda Medical College and Hospital, Ambateadka, Kurunjibhag, Jattipalla, Sullia 574327 
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 Shubha Shree C N  KVG AYURVEDA MEDICAL COLLEGE AND HOSPITAL  Room no 01, PANCHAKARMA OPD, KVGAMCH, Ambatedka, Kurunjibhag, Sullia 574327
Dakshina Kannada
KARNATAKA 
7022464147

shubha.cn1@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KVG AYURVEDA MEDICAL COLLEGE INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M543||Sciatica. Ayurveda Condition: GRUDHRASI,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-yoga-bastiH, योग-बस्तिः (Procedure Reference: Charaka chikitsa sthana-28/101, Procedure details: Erandamuladi Niruha Basti will be administered in Gridrasi by preparing with Conventional method after organoleptic characteristics assessment.)
(1) Medicine Name: Erandamuladi niruha basti, Reference: Charaka Siddhisthana-3/38-42, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 650(ml), Frequency: od, Duration: 3 Days
(2) Medicine Name: Sahacharadi taila, Reference: Astanga Hridaya Chikitsasthana-21/67-69, Route: Rectal, Dosage Form: Taila, Dose: 150(ml), Frequency: od, Duration: 5 Days
2Intervention ArmProcedure-yoga-bastiH, योग-बस्तिः (Procedure Reference: Charaka Chikitsasthana-28/101, Procedure details: Erandamuladi Niruha Basti will be administered in Gridrasi by preparing in electrically powered Basti Sammelana Yantra after organoleptic characteristics assessment)
(1) Medicine Name: Erandamuladi Niruha Basti, Reference: Charaka siddhisthana-3/38-42, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 650(ml), Frequency: od, Duration: 3 Days
(2) Medicine Name: Sahacharadi Taila, Reference: Astanga Hridaya Chikitsasthana-21/67-69, Route: Rectal, Dosage Form: Taila, Dose: 150(ml), Frequency: od, Duration: 5 Days
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients with classical symptoms of Gridrasi will be selected.
2. Patients fit for Basti Karma.
 
 
ExclusionCriteria 
Details  1. Patients who are contraindicated for Basti Karma according to Ayurvedic classics.
2. Surgical conditions, congenital deformity.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Evaluating and comparing Pharmaceutico-analysis of Erandamuladi Niruha Basti dravya prepared by electrically powered Basti Sammelana Yantra and conventional method of Basti Sammelana  2nd day, 4th day and 6th day of Yoga basti 
 
Secondary Outcome  
Outcome  TimePoints 
Evaluating and comparing the efficacy of Erandamuladi Niruha Basti administered in Gridrasi by Electrically powered Basti Sammelana Yantra and by conventional method of Basti Sammelana  Before treatment(0th day), after treatment(8th day) and on Follow up(24th day) 
 
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)   18/03/2025 
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="1"
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  

Revamping Panchakarma therapy is crucial for global competitiveness. Updated methods and techniques improve treatment effectiveness, simplify procedures, and standardize practices. This saves time, manpower, and aids research and clinical refinement.

Basti karma is considered superior to all other therapeutic measures due to its various actions. The efficacy of Basti depends on the ingredients, Sammelana and its administration. According to Acharya Kashyapa, Samyak Mathita Basti, can only yield benefits. Sushruta Acharya asserted that relying solely on the study of a single Shastra makes it challenging to definitively conclude on concepts. Therefore, he advocated for the study of multiple Shastras to attain a more comprehensive understanding. The logic behind Niruha Basti formulation should be studied with the help of modern principles like emulsion, collision system, particle distribution, etc which makes understanding in a better way.

Gridrasi is a condition characterized by intense pain radiating from lower back to unilateral or bilateral lower limbs, significantly impairing the functional ability. Gridrasi can be correlated with Sciatica. Sciatica is characterized by excruciating pain and paraesthesia in the sciatic nerve distribution or associated lumbosacral nerve root and can severely impact the quality of life of those affected.

Among various treatment modalities, Basti Karma stands out as a unique procedure recommended for managing Gridrasi. As Erandamuladi Niruha Basti is indicated in Vataja Vyadhi associated with Kapha and Sahacharadi Taila in vatavyadhis, we have undertaken these for present study.

This research study aims to modernize the conventional approach of Niruha Basti Sammelana. In conventional method, Khalva Yantra is used for Sammelana which makes difficult to standardize the time, pressure and number of rotation required to mix each ingredient as these varies from person to person. Moreover, the conventional method is time-consuming compared to household kitchen blenders used as alternatives. But kitchen blenders have its own demerits like heat generated during the process may change the temperature of herbal mixtures and also causes depletion of nutrients and active compounds due to excessive blending. 

To address these challenges, an electrically powered Basti Sammelana Yantra was devised, aiming to ensure uniform pressure, speed, alleviate manual labor, automate the process and enhance clinical efficacy by integrating modern technology into the conventional method This study is an attempt to compare the analysis and effectiveness by administering the Erandamuladi Niruha Basti prepared with Electrically powered Basti Sammelana Yantra and conventional method. 
Close