CTRI

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CTRI Number

CTRI/2025/04/085601 [Registered on: 24/04/2025] Trial Registered Prospectively

Last Modified On:

24/04/2025

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug
Ayurveda

Study Design

Single Arm Study

Public Title of Study

A Clinical study on the effect of Kala Basti with Madhuyashtyadi enema and Balaguduchyadi oil in managing Gout

Scientific Title of Study

A Clinical study on the effect of Kala basti with Madhuyashtyadi niruha and Balaguduchyadi tailam anuvasana in the management of Vatarakta wsr 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 Pooja Bharti
Designation	MD (Ay) Scholar (Panchakarma)
Affiliation	Government Ayurvedic College and Hospital Patna
Address	Department of panchakarma Government Ayurvedic College and Hospital Kadamkuan Buddhamurti Patna Bihar Patna BIHAR 800003 India
Phone	6205251308
Fax	-
Email	pooh.210696@gmail.com

Details of Contact Person
Scientific Query

Name	DR POOJA BHARTI
Designation	MD (AY) SCHOLAR (PANCHAKARMA)
Affiliation	GOVERNMENT AYURVEDIC COLLEGE AND HOSPITAL,PATNA
Address	DEPARTMENT OF PANCHAKARMA GOVERNMENT AYURVEDIC COLLEGE AND HOSPITAL NEAR BUDDHAMURTI KADAMKUAN PATNA Patna BIHAR 800003 India
Phone	6205251308
Fax	-
Email	pooh.210696@gmail.com

Details of Contact Person
Public Query

Name	Dr Akhilesh Prasad Singh
Designation	Associate Professor Department of Panchakarma
Affiliation	Government Ayurvedic College and Hospital Patna
Address	Department of Panchakarma Government Ayurvedic College and Hospital near Buddhamurti Kadamkuan Patna Patna BIHAR 800003 India
Phone	8002680973
Fax	-
Email	drapsinghpatna@gmail.com

Source of Monetary or Material Support

Government Ayurvedic College and Hospital Patna Bihar

Primary Sponsor

Name	Dr Pooja Bharti
Address	Department of Panchakarma Government Ayurvedic College and Hospital near Buddhamurti Kadamkuan Patna
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 Pooja Bharti	Government Ayurvedic College and Hospital Patna Bihar	OPD No.11, Panchakarma Department, Near Buddhamurti Kadamkuan Patna Bihar Patna BIHAR	6205251308 - pooh.210696@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Ethical Committee (IEC)	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, (2) ICD-10 Condition:M109\|\|Gout, unspecified. Ayurveda Condition: VATARAKTAM,

Intervention / Comparator Agent

sno	Intervention/Comparator	Type	Drug-Type	Procedure Name	Details
1	Intervention Arm	Procedure	-	bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म	(Procedure Reference: charak samhita siddhistana(3/46) and sahashrayoga pancham prakarana tailyoga(5/80), Procedure details: The basti prepared will be administered as for 16 days i.e anuvasana on day 1 & then 6 anuvasana & 6 niruha basti alternatively for 12 days & final 3 anuvasana on last 3 days of the trial.)

Inclusion Criteria

Age From	18.00 Year(s)
Age To	70.00 Year(s)
Gender	Both
Details	Patients having Serum uric acid conc. more than 7.0mg/dl in male and more than 6.0 mg/dl female. Patients having their age between 18-70yrs Patients having sign & symptoms of vatarakta( Gout).

ExclusionCriteria

Details

Patients having complications of vatarakta( upadrava) like, moorcha, hikka etc.

Patients having secreting tophus..

Patients associated with HIV, Hepatitis and also pregnant women.

Patients below age 18 years and above 70 yrs of age

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
Relief in sign and symptoms of vatarakta i.e 1.sandhi shool(joint pain) 2. sparsha agyatwam(loss of tactile sensation) 3.ksate atiruk(tenderness) 4.vaivarnya(discolouration) 5.sandhi shoth(swelling)	60days

Secondary Outcome

Outcome	TimePoints
1.Normal range of uric acid in blood	60days

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

Date of First Enrollment (India)

10/05/2025

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="0"
Months="6"
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 an open label single arm prospective interventional clinical trial on the effectiveness of kala Basti with Madhuyashtyadi Niruha and Balaguduchyadi Anuvasana in the management of Vatarakta w.s.r to Gout, that will be conducted in the Government Ayurvedic College and Hospital at Patna, Bihar in the department of Panchakarma. A total of 30 patients will be taken who follow all inclusion criteria and will be given Basti for 16 days. The Basti prepared will be administered as Anuvasana on day 1 and then 6 anuvasana and 6 niruha basti alternatively for 12 days and final 3 Anuvasana on last 3 days of the trial. Post intervention follow up will be done every 8 days for total duration of study i.e of 48 days.