CTRI

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CTRI Number

CTRI/2025/06/088466 [Registered on: 10/06/2025] Trial Registered Prospectively

Last Modified On:

04/06/2025

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug
Ayurveda

Study Design

Randomized, Parallel Group Trial

Public Title of Study

A Clinical Trial To Study The Effect Of Guggulu Vati In Vatarakta (Gouty Arthritis)

Scientific Title of Study

An Open Label Randomised Controlled Clinical Trial To Evaluate The Effect Of Guggulu Vati In The Management Of Vatarakta w.s.r. To Gouty Arthritis.

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 Amritha P
Designation	Pg Scholar
Affiliation	Sdm Ayurveda College ,Hospital And Research Center,Laxminagar,Kuthpady,Udupi
Address	Department Of Kayachikitsa Sdm Ayurveda College,Hospital And Research Center,Laxminagar,Kuthpady, Udupi,Karnataka,India - Udupi KARNATAKA 574118 India
Phone	8848908793
Fax
Email	amrithapmenon@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Veerakumara K
Designation	Professor
Affiliation	Sdm Ayurveda College,Hospital And Research Center,Laxminagar,Kuthpady,
Address	Department Of Kayachikitsa Sdm Ayurveda College,Hospital And Research Center,Laxminagar,Kuthpady, Udupi,Karnataka,India Udupi KARNATAKA 574118 India
Phone	9743490753
Fax
Email	khadiravana@gmail.com

Details of Contact Person
Public Query

Name	Dr Veerakumara K
Designation	Professor
Affiliation	Sdm Ayurveda College,Hospital And Research Center,Laxminagar,Kuthpady, Udupi
Address	Department Of Kayachikitsa Sdm Ayurveda College,Hospital And Research Center,Laxminagar,Kuthpady, Udupi,Karnataka,India - Udupi KARNATAKA 574118 India
Phone	9743490753
Fax
Email	khadiravana@gmail.com

Source of Monetary or Material Support

Sdm Ayurveda College,Hospital And Research Center,Laxminagar,Kuthpady, Udupi,Karnataka,India

Primary Sponsor

Name	Sdm Ayurveda College Hospital And Research Center
Address	Laxminagar,Kuthpady, Udupi,Karnataka,India
Type of Sponsor	Private medical college

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 Amritha P	Sdm Ayurveda College,Hospital And Research Center	Laxminagar,Kuthpady, Udupi,Karnataka,574118 Udupi KARNATAKA	8848908793 amrithapmenon@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional ethical clearance committee-Human,SDM Colloege of Ayurveda,Udupi	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition:M109\|\|Gout, unspecified. Ayurveda Condition: VATARAKTAM,

Intervention / Comparator Agent

sno	Intervention/Comparator	Type	Drug-Type	Procedure Name	Details
1	Intervention Arm	Drug	Classical		(1) Medicine Name: GUGGULU VATI, Reference: Bhavaprakash of Bhavamisra .Madyamakhanda ; Vatarakthadhyaya-29/46, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 2(g), Frequency: tds, Bhaishajya Kal: Antarabhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -MADHU), Additional Information: -
2	Comparator Arm	Drug	Classical		(1) Medicine Name: KAISHORA GUGGULU, Reference: Bhaishajya Ratnavali ,Vatarakta Chikitsaprakaranam 27/98, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1(g), Frequency: tds, Bhaishajya Kal: Antarabhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -

Inclusion Criteria

Age From	18.00 Year(s)
Age To	70.00 Year(s)
Gender	Both
Details	1.Serum uric acid level 7 mg/dL -30 mg/dL in male and 5.7 - 30 mg/dL in female. 2.Clinical features of Vatarakta such as Sandhi soola and Sandhi shotha ,pertaining to smaller joints especially joints of toe and digits of hand

ExclusionCriteria

Details

Pregnancy and lactation period

Method of Generating Random Sequence

Permuted block randomization, fixed

Method of Concealment

Case Record Numbers

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
Serum uric acid	0 th and 30 th day

Secondary Outcome

Outcome	TimePoints
1.Sandhi shoola.(Pain in joints) 2.Sandhi shotha (Swelling in joints) 3. Sparsha asahyata(tenderness) 4.Raga(discolouration) 5.Disease specific Quality of life Measurement (SF 36)	1 st and 30 th day

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)

25/07/2025

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 is an open label randomised controlled clinical trial to evaluate the effect of Guggulu vati in the management of Gouty Arthritis w.s.r to Gouty Arthritis and also compare it with the standard drug,kaishora guggulu for a period of intervention of 30 days with primary outcomes as Serum uric acid and secondary outcome as Sandhi shoola (pain in joints) ,Sandhi shotha(swelling in joints) , Sparsha asahyata(tenderness) ,Raga(discolouration).