CTRI

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CTRI Number

CTRI/2025/04/085869 [Registered on: 29/04/2025] Trial Registered Prospectively

Last Modified On:

28/04/2025

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug

Study Design

Randomized, Parallel Group, Active Controlled Trial

Public Title of Study

A clinical study to evaluate the efficacy of the Sinhasyadi Avaleha in Doshika Kasa with special refference to cough in children of age group 3-12 years.

Scientific Title of Study

Randomised Open Controlled Clinical Study to evaluate the efficacy of Sinhasyadi Avaleha in Doshik Kasa with special refference to Cough in Children of age group 3 to12 years

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

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

Name	DrGitanjali Radheshyam Pawar
Designation	PG SCHOLAR
Affiliation	Yashwant Ayurvedic College and Research Centre Kodoli
Address	Yashwant Ayurvedic College Post graduate Training And Research Centre Kodoli Kolhapur OPD No.7 Department of Kaumarbhritya Yashwant charitable hospital Kodoli Tal Panhala, District Kolhapur Maharashtra Kolhapur MAHARASHTRA 416114 India
Phone	8411949455
Fax
Email	pawargitanjali64@gmail.com

Details of Contact Person
Scientific Query

Name	DrPravat Kumar Dash
Designation	PG Guide
Affiliation	Yashwant Ayurvedic College ,Kodoli
Address	Yashwant Ayurvedic College Post graduate Training and Research Centre Kodoli Kolhapur OPD No.7 Department of Kaumarbhritya Yashwant charitable hospital Kodoli Tal Panhala, District Kolhapur Maharashtra Kolhapur MAHARASHTRA 416114 India
Phone	9423277590
Fax
Email	drpkdash25@gmail.com

Details of Contact Person
Public Query

Name	DrGitanjali Radheshyam Pawar
Designation	PG SCHOLAR
Affiliation	Yashwant Ayurvedic College ,Kodoli
Address	Yashwant Ayurvedic College Post graduate Training and Research Centre Kodoli Kolhapur OPD No.7 Department of Kaumarbhritya Yashwant charitable hospital Kodoli Tal Panhala District Kolhapur Maharashtra MAHARASHTRA 416114 India
Phone	8411949455
Fax
Email	pawargitanjali64@gmail.com

Source of Monetary or Material Support

Daily OPD patients of department of f Kaumarbhritya Yashwant Ayurvedic College and hospital Kodoli Kophapur 416114

Primary Sponsor

Name	Yashwant Charitable Hospital
Address	Yashwant Charitable Hospital OPD No.7 Department Of Kaumarbhritya Kodoli Kolhapur 416114
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 Gitanjali Radheshyam Pawar	Yashwant Ayurvedic Collect Post Graduate Training And Research Centre	Yashwant Charitable Hospital OPD No.7 Department Of Kaumarbhritya Kodoli Kolhapur 416114 Kolhapur MAHARASHTRA	8411949455 pawargitanjali64@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:J418\|\|Mixed simple and mucopurulent chronic bronchitis. Ayurveda Condition: KASAH,

Intervention / Comparator Agent

sno	Intervention/Comparator	Type	Drug-Type	Procedure Name	Details
1	Intervention Arm	Drug	Classical		(1) Medicine Name: SINHASYADI AVALEHA , Reference: CHAKRADATTA 52/19, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 20(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 4 Weeks, anupAna/sahapAna: Yes(details: -LEUKWARM WATER ), Additional Information: PATHYAPATHYA
2	Comparator Arm	Drug	Classical		(1) Medicine Name: VYAGHRI HARITAKI , Reference: BHAISHAJYA RATNAVALI KASA ROGADHIKARA 15/169-172, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 20(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 4 Weeks, anupAna/sahapAna: Yes(details: -LEUKWARM WATER ), Additional Information: -PATHYAPATHYA

Inclusion Criteria

Age From	3.00 Year(s)
Age To	12.00 Year(s)
Gender	Both
Details	1.Age 3year to 12year 2.Patient presenting with classical symptoms of Kasa as per their Dosha variety Vataj Pittaja Kaphaja since 2 weeks 3.Patient with low grade fever 4.Patient fit for adopted treatment 5.Patient will be selected irrespective of sex and socioeconomic status

ExclusionCriteria

Details

1.Patient presenting with symptoms of Tamaka Shwasa Kshayaja and Kshataj Kasa.
2.Patient presenting with complication like viral croup Laryngitis etc
3.Patient presenting with complication like Pneumonia COPD Emphysema TB Diptheria Pertusis etc
4. Patient associated with systemic illness presenting with cough
5.Patients with congenital anatomical abnormalities of chest and respiratory system

Method of Generating Random Sequence

Coin toss, Lottery, toss of dice, shuffling cards etc

Method of Concealment

An Open list of random numbers

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
To evaluate the efficacy Of Sinhasyadi Avaleha in Doshika Kasa in children of age group 3 to 12 Years by assessing nature of cough frequency of bouts fever nasal discharge loss of appetite disturbance of sleep	8 weeks

Secondary Outcome

Outcome	TimePoints
1)Literature Study of Doshika Kasa 2) To study the probable mode of action of Sinhasyadi Avaleha 3)Standard procedure for preparation of Sinhasyadi Avaleha 4)Raw drug will be authentified & standardized 5)Clinical trial & data collection 6)Statistical analysis & conclusion 7)To observe adverse effect if any	8 weeks

Target Sample Size

Total Sample Size="90"
Sample Size from India="90"
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)

15/05/2025

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="1"
Months="2"
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 open randomised controlled clinical trial to evaluate the efficacy of Sinhasyadi Avaleha in Doshik Kasa in children of age group 3 to 12 years with special refference to cough.

This study will be carry in OPD of Kaumarbhritya department of Yashwant Ayurvedic College and hospital Kodoli.

Observation would be drawn on the basis of symptoms after treatment given.