CTRI

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CTRI Number

CTRI/2024/06/068864 [Registered on: 13/06/2024] Trial Registered Prospectively

Last Modified On:

07/12/2024

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug
Ayurveda
Other (Specify) [curative]

Study Design

Randomized, Parallel Group, Multiple Arm Trial

Public Title of Study

A Clinical trial to study the effect of Varun and Indrayava in Vatarakta w.s.r to Gout

Scientific Title of Study

A Pharmaco-Therapeutic Study of Varun and Indrayava in Vatarakta w.s.r to Gout

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 Raj Kishor Verma
Designation	MD Ay. Scholar ( Dravyaguna )
Affiliation	Government Ayurvedic College and Hospital Patna
Address	Department of Dravyaguna Government Ayurvedic College and Hospital Patna. Patna BIHAR 800003 India
Phone	8873781475
Fax
Email	rajkishorverma144@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Mahendra Prasad Singh
Designation	Professor
Affiliation	Government Ayurvedic College and Hospital Patna
Address	Department of Dravyaguna Government Ayurvedic College and Hospital Patna. Patna BIHAR 800003 India
Phone	9431040125
Fax
Email	mahendrakiran1959@gmail.com

Details of Contact Person
Public Query

Name	Dr Mahendra Prasad Singh
Designation	Professor
Affiliation	Government Ayurvedic College and Hospital Patna
Address	Department of Dravyaguna Government Ayurvedic College and Hospital Patna. Patna BIHAR 800003 India
Phone	9431040125
Fax
Email	mahendrakiran1959@gmail.com

Source of Monetary or Material Support

Government Ayurvedic College and Hospital Patna

Primary Sponsor

Name	Government Ayurvedic College and Hospital Patna Aryabhatta Knowledge University Patna Bihar
Address	Department of Dravyaguna, Government Ayurvedic College and Hospital Patna, Aryabhatta Knowledge University Patna Bihar 800003
Type of Sponsor	Research institution and hospital

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 Raj Kishor Verma	Government Ayurvedic College and Hospital	Department of Dravyaguna, OPD Room No-10, Patna BIHAR	8873781475 rajkishorverma144@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional ethical committee	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	Comparator Arm	Drug	Classical		(1) Medicine Name: Indrayava, Reference: Bhavprakash Nighantu (Haritakyadi Varga) 1/159, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: No, Additional Information: -
2	Intervention Arm	Drug	Classical		(1) Medicine Name: Varuna, Reference: Bhavprakash Nighantu (Vatadi Varga) 5/66, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: No, Additional Information: -

Inclusion Criteria

Age From	20.00 Year(s)
Age To	60.00 Year(s)
Gender	Both
Details	Patient willing for Trial. Patient having symptoms of Vatarakta vyadhi as per ayurvedic classic and Gout w.s.r to modern view have include under the study. Patient having age between 20-60 year who can present their sign and symptoms of Vatarakta.

ExclusionCriteria

Details

Patients who have HIV HCV CKD etc
Patients suffering from serious systemic disorder like Diabetes Renal Calculus Hepatic Disorder are
excluded
Cardiac patients Cancer patient On Chemotherapy patient On Dialysis patient are excluded
Patient who have suffering from serious lungs disorders Asthmaticus Bronchogenic Carcinoma or
other types of malignancy
Pregnant and Lactating Women
Anemia- less than hemoglobin 9mgdl

Method of Generating Random Sequence

Method of Concealment

Blinding/Masking

Primary Outcome

Outcome	TimePoints
Improvement in the patient will be assessed mainly on the basis of relief in cardinal symptoms of disease. To access the effect of drug therapy subjectively, all sign & symptoms will be relief in 1. pain in affected joint. 2. swelling in the affected joint. 3. law of tactile sensation. upon their severity.	60 Days (8 weeks)

Secondary Outcome

Outcome	TimePoints
chaneges in serum uric acid and blood urea	60 days

Target Sample Size

Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60"

Phase of Trial

Phase 2/ Phase 3

Date of First Enrollment (India)

24/06/2024

Date of Study Completion (India)

23/10/2024

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Date Missing

Estimated Duration of Trial

Years="0"
Months="6"
Days="0"

Recruitment Status of Trial (Global)
Modification(s)

Not Yet Recruiting

Recruitment Status of Trial (India)

Completed

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
Modification(s)

Vatarakta is a chronic is a chronic and complex metabolic disorder of musculoskeletal system and characterised by severe pain, tenderness, inflammation and burning sensation in the affected joints. Vatarakta is a Vatapradhana Vyadhi where Rakta is main Dushya. The drug used in this trial is Varun churna and Indrayava churna mentioned in Ayurveda text with hope that they will prove more efficacious, less toxic and easy to use. This drug is easily available and effective in Vatarakta. Patient will be taken from OPD and IPD of Government Ayurvedic College and Hospital Patna. Duration of trial is 30 days.