CTRI

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CTRI Number

CTRI/2022/04/041972 [Registered on: 20/04/2022] Trial Registered Prospectively

Last Modified On:

19/04/2022

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug
Ayurveda

Study Design

Randomized, Parallel Group Trial

Public Title of Study

A study of comparison of effect of Prasarani tail matra basti versus sahachar tail matra basti in Grudhrasi

Scientific Title of Study

A comparative clinical study of efficacy of Prasarani tail matra basti and Sahachar tail matra basti in management of Grudhrasi w.s.r. sciatica

Trial Acronym

Secondary IDs if Any

Secondary ID	Identifier
Nil	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Abhinandan Shital Dhotare
Designation	PG Student
Affiliation	Yashwant Ayurvedic College post graduate training & research centre Kodoli
Address	Panchkarma Department, Yashwant Ayurvedic college and post graduate training center, kodoli Yashwant Ayurvedic College postgraduate training and research centre AP Kodoli Tal Panhala Kolhapur MAHARASHTRA 416115 India
Phone	9527374114
Fax
Email	drabhidhotare@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Ravikumar Patil
Designation	PG Guide
Affiliation	Yashwant Ayurvedic College post graduate training and research centre Kodoli
Address	Panchkarma Department, Yashwant Ayurvedic College postgraduate training and research centre Kodoli Tal Panhala Dist Kolhapur Kolhapur MAHARASHTRA 416114 India
Phone	9822010316
Fax
Email	vaidyaravipatil@gmail.com

Details of Contact Person
Public Query

Name	Dr Ravikumar Patil
Designation	PG Guide
Affiliation	Yashwant Ayurvedic College post graduate training and research centre Kodoli
Address	Panchkarma Department, Yashwant Ayurvedic College postgraduate training and research centre Kodoli Tal Panhala Dist Kolhapur Kolhapur MAHARASHTRA 416114 India
Phone	9822010316
Fax
Email	vaidyaravipatil@gmail.com

Source of Monetary or Material Support

Yashwant Ayurvedic college post graduate training and research center kodoli

Primary Sponsor

Name	Dr Abhinandan Shital Dhotare
Address	Yashwant Ayurvedic college post graduate training and research center kodoli
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 Abhinandan Shital Dhotare	Panchkarma Department, Yashwant Ayurvedic Hospital	AP Kodoli Tal Panhala Dist Kolhapur Kolhapur MAHARASHTRA	9527374114 drabhidhotare@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Ethics Committee	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition:M472\|\|Other spondylosis with radiculopathy. Ayurveda Condition: GRUDHRASI,

Intervention / Comparator Agent

sno	Intervention/Comparator	Type	Drug-Type	Procedure Name	Details
1	Intervention Arm	Procedure	-	Matra basti	(Procedure Reference: Charak Sanhita Siddhi sthan, Procedure details: Matra basti 72 ml for 7 days per rectum) (1) Medicine Name: Prasarani Tail, Reference: Sharangdhar Sanhita, Route: Rectal, Dosage Form: Taila, Dose: 72(ml), Frequency: od, Duration: 7 Days (2) Medicine Name: Rasnadi Guggul, Reference: Bhaishjya Ratnavali, Route: Oral, Dosage Form: Guggulu, Dose: 500(mg), Frequency: bd, Duration: 30 Days
2	Comparator Arm	Procedure	-	Matra basti	(Procedure Reference: Charak sanhita Siddhi sthan, Procedure details: Matra basti 72 ml , Od, for 7 days) (1) Medicine Name: Sahchar Tail, Reference: Ashtang Hriday Chikitsa sthan, Route: Rectal, Dosage Form: Taila, Dose: 72(ml), Frequency: od, Duration: 7 Days (2) Medicine Name: Rasnadi Guggul, Reference: Bhaishjya Ratnavali, Route: Oral, Dosage Form: Guggulu, Dose: 500(mg), Frequency: bd, Duration: 30 Days

Inclusion Criteria

Age From	30.00 Year(s)
Age To	60.00 Year(s)
Gender	Both
Details	1. Patient having sign and symptoms of Grudhrasi acc to Charak sanhita like Ruk, Tod, Stambha etc 2. SLR test,3. Patient having mild to moderate pain

ExclusionCriteria

Details

1. Patient with known case of CA spine,
2. Tuberculosis of spine,
3. Congenital abnormalities of spine,
4. surgical indications like
spondylolisthesis,
5. Pregnant and Lactating mother,
6. Systemic diseases like HTN, DM,
7.structural deformities and trauma to
lumbar spine

Method of Generating Random Sequence

Random Number Table

Method of Concealment

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
Parameters such as Ruk, Tod, Stambha, Spandan, Aruchi, Tandra, Gaurav is symptomatically reduces.	4 week

Secondary Outcome

Outcome	TimePoints
SLR test will be negative	18 months

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 2/ Phase 3

Date of First Enrollment (India)

25/04/2022

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="6"
Days="0"

Recruitment Status of Trial (Global)

Not Applicable

Recruitment Status of Trial (India)

Not Yet Recruiting

Publication Details

Nil

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

Brief Summary

This is a simple , randomized, parallel group comparing the efficacy of Prasarani Tail Matra Basti and Sahachar Tail Matra Basti in 100 patients of Grudhrasi that will be conducted in one center in India.