| CTRI Number |
CTRI/2026/02/103127 [Registered on: 05/02/2026] Trial Registered Prospectively |
| Last Modified On: |
04/02/2026 |
| 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 check the effect of medicated enema named Vaitarana Basti given through self dispensing Basti Yantra in comparison with existing putaka method in patients with sciatica pain |
|
Scientific Title of Study
|
A Comparative Clinical Study To Evaluate The Efficacy Of Vaitarana Basti Administered Through Self Dispensing Basti Yantra And Basti Putaka In Gridhrasi with special reference 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 Shrividya Ravindra bhat |
| Designation |
Post graduate scholar |
| Affiliation |
KVG Ayurveda Medical College and Hospital, Sullia |
| Address |
Room No-1, Panchakarma OPD, KVG Ayurveda Medical college and hospital, Ambatedka Kurunjibhag, Jatti palla, Sullia, Dakshina Kannada,
Karnataka
Dakshina Kannada
KARNATAKA
574327
India |
| Phone |
9148962184 |
| Fax |
|
| Email |
9692shri@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Soumya S V |
| Designation |
Professor |
| Affiliation |
KVG Ayurveda Medical College and Hospital, Sullia |
| Address |
Room No-1,Panchakarma OPD, KVG Ayurveda Medical College and
Hospital, Ambatedka, Kurunjibhag, Jattipalla, Sullia, Dakshina
Kannada, Karnataka
Dakshina Kannada
KARNATAKA
574327
India |
| Phone |
9620283474 |
| Fax |
|
| Email |
drsoumyasv@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Soumya S V |
| Designation |
Professor |
| Affiliation |
KVG Ayurveda Medical College and Hospital, Sullia |
| Address |
Room No-1,Panchakarma OPD, KVG Ayurveda Medical College and
Hospital, Ambatedka, Kurunjibhag, Jattipalla, Sullia, Dakshina
Kannada, Karnataka
Dakshina Kannada
KARNATAKA
574327
India |
| Phone |
9620283474 |
| Fax |
|
| Email |
drsoumyasv@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr. Shrividya Ravindra Bhat |
| Address |
KVG Ayurveda Medical College and Hospital, Ambatedka,
Kurunjibhag, Jattipalla, Sullia, Dakshina Kannada, India- 574327 |
| Type of Sponsor |
Other [Self] |
|
|
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 Shrividya Ravindra Bhat |
KVG Ayurveda Medical college and hospital, ambatedka, Sullia |
Room No-1,
Panchakarma OPD,
KVG Ayurveda Medical
College and
Hospital,Ambatedka,
Kurunjibhag, Jattipalla,
Sullia, Dakshina
Kannada- 574327
Dakshina Kannada
Dakshina Kannada
KARNATAKA |
9148962184
9692shri@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KVG Ayurvdea Medical College Ethical Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | Vaitarana Basti | (Procedure Reference: Chikitasa sara sangraha, Basti vidhi adhikara, Procedure details: Vaitarana Basti with Ksheera as an ingredient will be administered through Self dispensing Basti Yantra for 15 patients of Group A for 8 days )
| | 2 | Comparator Arm | Procedure | - | Vaitarana Basti | (Procedure Reference: Chikitsa sara sangraha, Procedure details: Vaitarana Basti with Ksheera will be administered through Basti Putaka for 15 patients of Group B for 8 days)
|
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Day(s) |
| Age To |
70.00 Day(s) |
| Gender |
Both |
| Details |
1.Patients with classical symptoms of Gridhrasi will be selected.
2.Patients of age group 20 to 70 years irrespective of sex, occupation, socio
economic status.
3.Patients fit for Basti karma |
|
| ExclusionCriteria |
| Details |
1.Patients who are contraindicated for basti according to Ayurvedic classics .
2.Patients below 20 years of age and above 70 years.
3.Patients with congenital spinal deformities and other
comorbidities interfering with the treatment plan of study. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To determine the efficacy of Vaitarana Basti administered through self dispensing Basti Yantra
2. Determine the speed of effective Basti administration |
1. To determine the efficacy of Vaitarana Basti administered through self dispensing Basti Yantra
2. Determine the speed of effective Basti administration |
|
|
Secondary Outcome
|
|
|
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)
|
16/02/2026 |
| 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="0"
Months="0"
Days="7" |
|
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
|
Panchakarma is one of the branch of ayurveda which has seen many revolutionary changes. Basti is one among the Panchakarma which is considered even Sarva Chikitsa. This is the choice of treatment in case of any Vata vyadhi. Most common now a days is sciatica. Sciatica refers to radiating pain along the course of the sciatic nerve from the lower back or buttock to one or both legs or an associated lumbosacral nerve root. For the effective treatment of sciatica attempt has been made to administer Vaitarana Basti having ingredients such as Guda (25g), Sanidhava Lavana(12g), Murchita Tila Taila( 20ml), Chincha( 50g) and Ksheera(200ml). This will be administered through self dispensing Basti Yantra in comparison with Basti putaka for group of 15 patients each. Now a days, traditional Basti putaka has been replaced by enema pot , syringe etc.but for these existing modifications of Basti Putaka, medicine could not be administered with uniform pressure and proper quantity. However, The efficacy of Basti vary according to many reasons like method of administration, skill of the person who is administering the Basti, features of Bastinetra and Bastiputaka etc. Hence self-dispensing basti yantra has been designed as a modification of basti putaka to bring the benefits of Ardha Chikitsa as well as Poorna Chikitsa Basti at the ease of home. This yantra could overcome the drawbacks of other modifications of Basti putaka with uniform pressure and flow rate which can be controlled by patients themselves. The effectiveness of Basti will be measured with Pratyagamana Kala along with speed of administration and relief of symptoms of sciatica after completion of course of treatment of Vaitarana Basti. |