CTRI

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CTRI Number

CTRI/2025/05/086610 [Registered on: 09/05/2025] Trial Registered Prospectively

Last Modified On:

08/05/2025

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug
Ayurveda

Study Design

Other

Public Title of Study

A Clinical Trial On Shatipushkaradi Tail Matra Basti In Katishool With Special Reference To Low Back Pain

Scientific Title of Study

A Randomized Controlled Clinical Trial On Shatipushkaradi Tail Matra Basti In Katishool With Special Reference To Low Back Pain

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 Kanchan Mohanrao Girade
Designation	PG Scholar
Affiliation	Government Ayurvedic Collage Nanded
Address	Department of Kayachikitsa Government Ayurvedic College Nanded Department of Kayachikitsa, Government Ayurvedic College Nanded Nanded MAHARASHTRA 431601 India
Phone	7517506409
Fax
Email	kanchangirade2016@gmail.com

Details of Contact Person
Scientific Query

Name	Dr P V Kulkarni
Designation	Assistant Professor, KC Department
Affiliation	Government Ayurvedic College, Nanded
Address	Department of Kayachikitsa,Government Ayurvedic College Nanded Vajirabad Department of Kayachikitsa, Government Ayurvedic College Nanded Vajirabad Nanded MAHARASHTRA 431601 India
Phone	9405365096
Fax
Email	kulk.prasad1@gmail.com

Details of Contact Person
Public Query

Name	Dr P V Kulkarni
Designation	Assistant Professor
Affiliation	Government Ayurvedic College, Nanded
Address	Department of Kayachikitsa, Government Ayurvedic College Nanded Vajirabad Department of Kayachikitsa,Government Ayurvedic College Nanded Vajirabad Nanded MAHARASHTRA 431601 India
Phone	9405365096
Fax
Email	kulk.prasad1@gmail.com

Source of Monetary or Material Support

Government Ayurvedic College and Hospital, Vajirabad Nanded Dist.Nanded-431601 India

Primary Sponsor

Name	Dr Kanchan Mohanrao Girade
Address	Department of Kayachikitsa, Government Ayurvedic College Vajirabad Nanded-431601 India
Type of Sponsor	Other [Self Sponser ]

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 Kanchan Mohanrao Girade	Government Ayurvedic College and Hospital,Nanded	Department of Kayachikitsa ,Government Ayurvedic College Nanded Nanded MAHARASHTRA	7517506409 kanchangirade2016@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Ethical Committee , Government Ayurvedic College and Hospital Nanded	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition:M47\|\|Spondylosis. Ayurveda Condition: VATAVYADHIH,

Intervention / Comparator Agent

sno	Intervention/Comparator	Type	Drug-Type	Procedure Name	Details
1	Intervention Arm	Drug	Classical		(1) Medicine Name: shatipushkaradi tail , Reference: sushrut chikitsa 37/8, Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: -
2	Comparator Arm	Drug	Classical		(1) Medicine Name: sahachara tail, Reference: ashtanghruday chikitsa 21/67, Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: -

Inclusion Criteria

Age From	18.00 Year(s)
Age To	60.00 Year(s)
Gender	Both
Details	1) Patient having complaints of back pain as per the diagnostic criteria. 2) Age of patient 18-60 years. 3) Patient with lumbar spondylosis 4) Irrespective of gender and socioeconomic status

ExclusionCriteria

Details

1) Patient on Analgesics
2) Patient having Recent lumbar surgery
3) Patients having anorectal complaints
4) Patients having any systemic severe illness
5) Pregnancy, Lactating mother

Method of Generating Random Sequence

Coin toss, Lottery, toss of dice, shuffling cards etc

Method of Concealment

Alternation

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
To study the effect of Shatipushkaradi tail matrabasti 60ml for 7 days in Katishool by VAS SCORE	7days

Secondary Outcome

Outcome	TimePoints
To compare effect of Shatipushkaradi tail matrabasti (60ml) & Sahachar tail matrabasti (60ml) In Katishool With Special Reference To Low Back Pain	7days

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 2/ Phase 3

Date of First Enrollment (India)

19/05/2025

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)

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

This study is randomized, controlled, clinical trial on shatipushkaradi tail matra basti in katishool with special reference to low back pain for 7 days. This study is conducted a Pg course at single centre. The primary outcome is to evaluate the effect of shatipushkaradi tail administration through basti of 60 ml for 7 days in katishool by VAS Score.