CTRI

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CTRI Number

CTRI/2025/06/088095 [Registered on: 02/06/2025] Trial Registered Prospectively

Last Modified On:

06/05/2025

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug
Ayurveda

Study Design

Single Arm Study

Public Title of Study

Clinical study of hapushadi yapana basti procedure for pain and stiffness in sciatica

Scientific Title of Study

Single arm open label clinical trial of hapushadi yapana basti in grudhrasi 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 Mayuri Mangesh Dange
Designation	Post Graduate Scholar
Affiliation	Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Center
Address	OPD no 9 Panchakarma OPD ground floor Dhanvantari Ayurved Hospital Ashta Tal Walwa Dist Sangli Sangli 416301 Maharashtra india Sangli MAHARASHTRA 416301 India
Phone	9403382492
Fax
Email	dangemayuri9@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Archana Suhas Wadkar
Designation	Professor
Affiliation	Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Center
Address	4th floor Department of Panchakarma Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta Tal Walwa Dist Sangli 416301 Maharashtra India Sangli MAHARASHTRA 416301 India
Phone	8888817891
Fax
Email	archanaswadkar@gmail.com

Details of Contact Person
Public Query

Name	Dr Archana Suhas Wadkar
Designation	Professor
Affiliation	Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Center
Address	4th floor Department of Panchakarma Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta Tal Walwa Dist Sangli Sangli MAHARASHTRA 416301 India
Phone	08888817891
Fax
Email	archanaswadkar@gmail.com

Source of Monetary or Material Support

Hon Shri Annasaheb Dange Ayurved Medical Collage Post Graduate and Research center Ashta Tal Walwa Dist Sangli 416301 Maharashtra India

Primary Sponsor

Name	Dr Mayuri Mangesh Dange
Address	OPD no 9 Panchakarma OPD ground floor Dhanvantari Ayurved Hospital Ashta Tal Walwa Dist Sangli Sangli 416301 Maharashtra india
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 Mayuri Mangesh Dange	Hon Shri Annasaheb Dange Ayurved Medical COllege Post Graduate And Research Center Ashta	4th floor Department of Panchakarma Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta Tal Walwa Dist Sangli 416301 Maharashtra India Sangli MAHARASHTRA	9403382492 dangemayuri9@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Hon Shri Annasaheb Dange Ayurved Medical Collage Post Graduate and Research center Ashta Tal Walwa Dist Sangli 416301 Maharashtra India	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 (KEVALAVATA),

Intervention / Comparator Agent

sno	Intervention/Comparator	Type	Drug-Type	Procedure Name	Details
1	Intervention Arm	Procedure	-	yApana-bastiH, यापन-बस्तिः	(Procedure Reference: Charak samhita Siddhisthana, Procedure details: Reference : Charak samhita siddhisthana adhyaya 12 shlok no.31 Purvakarma : 1.Sambhar sangraha : Enema can,Rubber catheter,Hand gloves,prescribed medicine,cloth for drapin,Khalva yantra,Nadi Swedana yantra etc. should be collected. Madhu, Saindhav, Sneha, Kwatha dravya will be collected in adequate quantity for basti. 2.Take consent of patient and explain karma to the patient. 3.Preparation of basti should be done. 4.Patient will be advised to pass his/her natural urges before Basti. 5.Sthanik Abhyanga with tila taila and Nadi Svedana with dashamoola kwatha over abdomen, thighs, gluteal, and back. Pradhanakarma : 1.Patient will be advised to come in empty stomach before Basti Pranidhana. 2.Then advise patient to lie down in left lateral position. 3.A small amount of Sneha will be apply over tip of catheter and anal region and catheter will be gently introduced into the anal opening and basti dravya will be administered slowly into the patients rectum. 4.Patient will asked to take deep breath during the procedure and catheter will be removed slowly. 5.Then advised the patient to lie down in the supine position. Paschatkarma : 1.After giving Basti Anti-clockwise massage should be done on the abdomen. 2.Basti pratyagaman : 1 Muhurta ( 48 min.) 3.Advised to take hot water bath, Light diet ( like mudga yusha ) 4.Observe the samyaka yoga, ayoga, atiyoga lakshana. Duration of Treatment- 8 Days Follow up - 9th day and 25th day ) (1) Medicine Name: Hapushadi yapana basti, Reference: Charak samhita Siddhisthana adhyaya 12, Route: Rectal, Dosage Form: Not Applicable, Dose: 400(ml), Frequency: od, Duration: 8 Days

Inclusion Criteria

Age From	20.00 Year(s)
Age To	60.00 Year(s)
Gender	Both
Details	The patient having sign and symptoms of Grudhrasi Patient age group between 20 to 60 yrs Patient irrespective of gender Patient indicated for yapana basti Patient in niram avastha

ExclusionCriteria

Details

patient unfit for basti karma
Lactating, pragnant women
Patient of diagnosed with any other systemic illness which are fatal and chronic in nature like pots disease

Method of Generating Random Sequence

Other

Method of Concealment

Case Record Numbers

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
To evaluate the efficacy of hapushadi yapana basti in management of grudhrasi	4 weeks

Secondary Outcome

Outcome	TimePoints
To review grudhrasi in detail to review sciatica in detail to review hapushadi yapana basti in detail to observe the adverse effect of hapushadi yapana basti	4 weeks to 6 weeks

Target Sample Size

Total Sample Size="60"
Sample Size from India="60"
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 2/ Phase 3

Date of First Enrollment (India)

01/08/2025

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="8"
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 present era, no. of patient of grudhrasi increases due to change in their lifestyle, nature of work, improper and continuous sitting postures, over exertion, jerking movements during travelling and sports etc. all leads to vitiation of vata. Vata take place in

lumber region and produce certain symptoms which are nothing but radiating pain to lower limbs restricted movement of lower limb and in Ayurveda Gridhrasi includes Stambha Ruka Toda and Spandan in Sphika KatiPrushtha Uru Janu Jangha & Pada in order and Sakthikshepa Nigraha. Has prevalence ranging from 5% to 10% population.Study is clinical trial to check effectiveness of hapushadi yapana Basti in Ghridhrasi. Its having hapushadi yapana basti as trial group for 8 days. On 9th day follow up of patient is taken. After 9 days patient is advice to come on 16th day for follow up. 60 patients in group will be studied. Study will be conducted in India.Outcome of study will be asses on reduction of signs and symptoms of Gridhrasi.