CTRI

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CTRI Number

CTRI/2025/04/084199 [Registered on: 07/04/2025] Trial Registered Prospectively

Last Modified On:

04/04/2025

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug
Ayurveda

Study Design

Randomized, Parallel Group, Active Controlled Trial

Public Title of Study

A comparative clinical study to evaluate the effect of Chinchadi masi and Jatyadi taila in Shuddha vrana W.S.R to Healing ulcer

Scientific Title of Study

A randomized clinical trial to evaluate the effect of Chinchadi masi (folkore medication) and Jatyadi taila in Shuddha vrana W.S.R to Healing ulcer

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 Niveditha S
Designation	PG Scholar
Affiliation	Sri Dharmasthala Manjunatheshwara college of Ayurveda Hospital and Research Centre, Kuthpady, Udupi
Address	Department of PG studies in Shalya Thantra Sri Dharmasthala Manjunatheshwara college of Ayurveda Hospital and Research Centre, Kuthpady, Udupi Karnataka 574118 Udupi KARNATAKA 574118 India
Phone	6238892368
Fax
Email	niveditha217@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Rajneesh V Giri
Designation	M.S.(Ayu),PhD
Affiliation	Sri Dharmasthala Manjunatheshwara college of Ayurveda Hospital and Research Centre, Kuthpady, Udupi
Address	Department of PG studies in Shalya Thantra Sri Dharmasthala Manjunatheshwara college of Ayurveda Hospital and Research Centre, Kuthpady, Udupi Udupi KARNATAKA 574118 India
Phone	9845407543
Fax
Email	drrajneeshgiri@gmail.com

Details of Contact Person
Public Query

Name	Dr Niveditha S
Designation	PG Scholar
Affiliation	Sri Dharmasthala Manjunatheshwara college of Ayurveda Hospital and Research Centre, Kuthpady, Udupi
Address	Department of PG studies in Shalya Thantra Sri Dharmasthala Manjunatheshwara college of Ayurveda Hospital and Research Centre, Kuthpady, Udupi Karnataka 574118 Udupi KARNATAKA 574118 India
Phone	6238892368
Fax
Email	niveditha217@gmail.com

Source of Monetary or Material Support

Sri Dharmasthala Manjunatheshwara college of Ayurveda Hospital and Research Centre, Kuthpady, Udupi,576101,Karnataka,India

Primary Sponsor

Name	Dr Niveditha S
Address	PG Scholar Department of PG studies in Shalya Thantra Sri Dharmasthala Manjunatheshwara college of Ayurveda Hospital and Research Centre, Kuthpady, Udupi
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 Niveditha S	Sri Dharmasthala Manjunatheshwara college of Ayurveda Hospital and Research Centre, Kuthpady, Udupi	OPD and IPD of Sri Dharmasthala Manjunatheshwara college of Ayurveda Hospital and Research Centre, Kuthpady, Udupi, Karnataka 574118 Udupi KARNATAKA	6238892368 niveditha217@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
INSTITUTIONAL ETHICAL CLEARANCE COMMITTEE - HUMAN Managed by SRI DHARMASTHALA MANJUNATHESHWARA EDUCATIONAL SOCIETY UJIRE	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition:S00-T88\|\|Injury, poisoning and certain other consequences of external causes. Ayurveda Condition: SUDDHAVRANAH,

Intervention / Comparator Agent

sno	Intervention/Comparator	Type	Drug-Type	Procedure Name	Details
1	Intervention Arm	Drug	Other than Classical		(1) Medicine Name: Chinchadi masi, Reference: NA, Route: Topical, Dosage Form: Kalka/ Paste, Dose: 30(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: coconut oil), Additional Information: powder of Chinchadi masi mixed with coconut oil as base is applied
2	Comparator Arm	Drug	Classical		(1) Medicine Name: Jatyadi taila, Reference: Sarangadhara samhita, Route: Topical, Dosage Form: Taila, Dose: 10(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: 10ml Jatyadi taila is applied topically

Inclusion Criteria

Age From	16.00 Year(s)
Age To	80.00 Year(s)
Gender	Both
Details	1.Patients presenting with signs and symptoms of Shuddha vrana 2.Patient between the age of 16-80 years 3.Vrana with features like avedana, nirasrava, syavoshta, pidaki sama, serous discharge, uniform distribution of granulation tissue

ExclusionCriteria

Details

1. Patients suffering from systemic illness like uncontrolled Diabetes Mellitus, Tuberculosis, and HIV.
2. Patients below 16 years and above 80 years.
3. Patients suffering from Malignant Ulcer, Syphilitic Ulcer, Soft sores.
4. Patients suffering from Gangrene, Sepsis.
5. Patients having features of Dushta Vrana

Method of Generating Random Sequence

Random Number Table

Method of Concealment

Not Applicable

Blinding/Masking

Participant Blinded

Primary Outcome

Outcome	TimePoints
1.To evaluate the Ropana Effect of Chinchadi masi in Shuddha Vrana. 2.To evaluate the Ropana Effect of Jatyadi taila in Shuddha Vrana. 3.To compare the Ropana Effect of Chinchadi masi versus Jatyadi taila in Shuddha Vrana.	Assessment will be done on 1st 7th 15th and 21st day

Secondary Outcome

Outcome	TimePoints
NIL	NIL

Target Sample Size

Total Sample Size="40"
Sample Size from India="40"
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)

16/04/2025

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="1"
Months="0"
Days="0"

Recruitment Status of Trial (Global)

Not Yet Recruiting

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 Randomized control clinical study to eveluate the effect of Chinchadi masi (folklore medication) and Jatyadi taila in Shuddha vrana W.S.R to Healing ulcer. Patients will be divided into 2 groups each group of 20 patients with total participant of 40. Group A recruited subjects will be administered with Chinchadi masi and Group B with Jatyadi taila. The study will be conducted from the OPD and IPD of Sri Dharmasthala Manjunatheshwara college of Ayurveda Hospital and Research centre, Kuthpady, Udupi, Karnataka. The inclusive subjects will be observed with Barber measuring tool on 1st 7th 15th and 21st day and is assessed. Hence this study is an effort to evaluate and compare the effect of Chinchadi masi (folklore medication) and Jatyadi taila in Shuddha vrana W.S.R to Healing ulcer.