CTRI

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CTRI Number

CTRI/2023/07/054625 [Registered on: 03/07/2023] Trial Registered Prospectively

Last Modified On:

29/06/2023

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Ayurveda

Study Design

Randomized, Parallel Group Trial

Public Title of Study

Vatari guggul and Agnikarma in Sciatica

Scientific Title of Study

RANDOMIZED OPEN CONTROLLED CLINICAL STUDY TO EVALUATE THE EFFICACY OF VATARI GUGGUL WITH AGNIKARMA IN GRIDHARASI WITH SPECIAL REFERENCE TO SCIATICA

Trial Acronym

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

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

Name	Shivani Dadaso Gawade
Designation	PG scholar
Affiliation	Yashwant ayurvedic Medical College PGT and RC kodoli
Address	Yashwant Ayurvedic Medical College PGT and RC kodoli shalyatantra department opd no 4 Yashwant Ayurvedic Medical College PGT and RC kodoli Kolhapur MAHARASHTRA Yashwant Ayurvedic Medical College PGT and RC kodoli shalyatantra department opd no 4 Yashwant Ayurvedic Medical College PGT and RC kodoli Kolhapur MAHARASHTRA Kolhapur MAHARASHTRA 416012 India
Phone	9373985240
Fax
Email	shivanigawade19@gmail.com

Details of Contact Person
Scientific Query

Name	DR T SRINIVAS
Designation	PG GUIDE / HOD shalyatantra department
Affiliation	Yashwant ayurvedic Medical College PGT and RC kodoli
Address	Yashwant Ayurvedic Medical College PGT and RC kodoli shalyatantra department opd no 4 Yashwant Ayurvedic Medical College PGT and RC kodoli Kolhapur MAHARASHTRA Yashwant Ayurvedic Medical College PGT and RC kodoli shalyatantra department opd no 4 Yashwant Ayurvedic Medical College PGT and RC kodoli Kolhapur MAHARASHTRA Kolhapur MAHARASHTRA 416012 India
Phone	9503147698
Fax
Email	drsrinivast@gmail.com

Details of Contact Person
Public Query

Name	Shivani Dadaso Gawade
Designation	PG scholar
Affiliation	Yashwant Ayurvedic Medical College PGT and RC kodoli
Address	Yashwant Ayurvedic Medical College PGT and RC kodoli Yashwant Ayurvedic Medical College PGT and RC kodoli Kolhapur MAHARASHTRA Yashwant Ayurvedic Medical College PGT and RC kodoli Yashwant Ayurvedic Medical College PGT and RC kodoli Kolhapur MAHARASHTRA Kolhapur MAHARASHTRA 416012 India
Phone	9373985240
Fax
Email	shivanigawade19@gmail.com

Source of Monetary or Material Support

Yashwant Ayurvedic medical college and PGT and RC kodoli Dist Kolhapur Maharashtra

Primary Sponsor

Name	DR SHIVANI DADASO GAWADE
Address	Yashwant Ayurvedic Hospital Kodoli Kolhapur
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
Shivani Dadaso Gawade	Yashwant dharmartha rugnalaya	Yashwant Ayurvedic Medical College PGT and RC kodoli shalya tantra department opd no 4 Yashwant Ayurvedic Medical College PGT and RC kodoli Kolhapur MAHARASHTRA Kolhapur MAHARASHTRA	9373985240 shivanigawade19@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional ethics committee Yashwant Ayurvedic college PGT and RC kodoli	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition:G00-G99\|\|Diseases of the nervous system. Ayurveda Condition: GRUDHRASI,

Intervention / Comparator Agent

sno	Intervention/Comparator	Type	Drug-Type	Procedure Name	Details
1	Comparator Arm	Drug	-
2	Comparator Arm	Drug	Classical		(1) Medicine Name: Vatari guggul, Reference: Bhaishajya Ratnavali Amavata 152 155, Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: Koshnajala), Additional Information:
3	Intervention Arm	Drug	Classical		(1) Medicine Name: Vatari guggul, Reference: Bhaishajya Ratnavali Amavata 152 155, Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: Koshnajala), Additional Information:

Inclusion Criteria

Age From	18.00 Year(s)
Age To	60.00 Year(s)
Gender	Both
Details	1 Patient with lakshana like gridhrasi that is suptata stambha aruchi tandra gaurav spandana in sphik kati uru janu Jangha Pada 2 Patients in the age group of 18 to 60 yrs 3 Irrespective of Caste Gender Socioeconomic status

ExclusionCriteria

Details

1 K C O Uncontrolled diabetes mellitus
hypertension
tuberculosis of spine and hip joint
malignancy of spine or other organs
2 Fracture related to spine
3 Cardiac diseases ischemic heart disease
coronary artery disease
myocardial infarction
etc
4 Anemia hemoglobin Percentage Less then 07 mg dl
5 Pregnancy

Method of Generating Random Sequence

Adaptive randomization, such as minimization

Method of Concealment

An Open list of random numbers

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
Decrease stambha	18 months

Secondary Outcome

Outcome	TimePoints
Decrease stambha suptata spandana aruchi tandra gaurava	18 months

Target Sample Size

Total Sample Size="80"
Sample Size from India="80"
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)

15/07/2023

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

none yet

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 OPEN CONTROLLED CLINICAL STUDY TO EVALUATE THE EFFICACY OF VATARI GUGGUL WITH AGNIKARMA IN GRIDHARASI WITH SPECIAL REFERENCE TO SCIATICA. STUDY WILL BE CARRIED IN O.P.D. OF SHALYATANTRA DEPARTMENT OF YASHWANT AYURVEDIC COLLEGE AND HOSPITAL KODOLI.THE OBSERVATION WOULD BE DRAWN ON THE BESIS OF SYMTOMPS AFTER TREATMENT GIVEN .