CTRI

FULL DETAILS (Read-only) -> Click Here to Create PDF for Current Dataset of Trial

CTRI Number

CTRI/2025/02/080611 [Registered on: 14/02/2025] Trial Registered Prospectively

Last Modified On:

05/02/2025

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Ayurveda

Study Design

Single Arm Study

Public Title of Study

Clinical trial on Karkatashringi syrup in the management of diffrent types of coughs in children

Scientific Title of Study

A single arm clinical trial on Karkatashringi Kwatha (syrup)in the management of diffrent types of kasa in chidren

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 Apoorva Sharma
Designation	MD scholar
Affiliation	State Ayurvedic college and hospital Lucknow
Address	P.G. Dept. of Kaumarabhritya OPD NO.G13 State Ayurvedic college and hospital, Lucknow UTTAR PRADESH 226003 India Lucknow UTTAR PRADESH 226003 India
Phone	7310848367
Fax
Email	drapoorva1711@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Ramesh Kumar Gautam
Designation	Reader
Affiliation	State Ayurvedic college and hospital Lucknow
Address	PG Department of Kaumarabhritya State Ayurvedic College and Hospital Tulsidas Marg, Lucknow Uttar Pradesh Lucknow UTTAR PRADESH 226003 India PG Department of Kaumarabhritya State Ayurvedic College and Hospital Tulsidas Marg, Lucknow Uttar Pradesh Lucknow UTTAR PRADESH 226003 India Lucknow UTTAR PRADESH 226003 India
Phone	9450361310
Fax
Email	gautamramesh09@gmail.com

Details of Contact Person
Public Query

Name	Dr Ramesh Kumar Gautam
Designation	Reader
Affiliation	State Ayurvedic college and hospital Lucknow
Address	PG Department of Kaumarabhritya State Ayurvedic College and Hospital Tulsidas Marg, Lucknow Uttar Pradesh Lucknow UTTAR PRADESH 226003 India PG Department of Kaumarabhritya State Ayurvedic College and Hospital Tulsidas Marg, Lucknow Uttar Pradesh Lucknow UTTAR PRADESH 226003 India Lucknow UTTAR PRADESH 226003 India
Phone	9450361310
Fax
Email	gautamramesh09@gmail.com

Source of Monetary or Material Support

State ayurvedic college and hospital, turiyaganj, Lucknow, Pincode 226003

Primary Sponsor

Name	state ayurvedic college and hospital, Turiyaganj, Lucknow
Address	PG Department of Kaumarabhritya State Ayurvedic College and Hospital Tulsidas Marg, Lucknow Uttar Pradesh 226003
Type of Sponsor	Government 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 Apoorva Sharma	State Ayurvedic College and Hospital	P.G. Dept. of Kaumarabhritya OPD NO.G13 State Ayurvedic college and hospital, Lucknow UTTAR PRADESH 226003 India Lucknow UTTAR PRADESH	07310848367 drapoorva1711@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Office of Institutional Ethics Committee, State Ayurvedic College and Hospital, Lucknow	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition:J069\|\|Acute upper respiratory infection,unspecified. Ayurveda Condition: KASAH,

Intervention / Comparator Agent

sno	Intervention/Comparator	Type	Drug-Type	Procedure Name	Details
1	Intervention Arm	Drug	Classical		(1) Medicine Name: Karkatashringi Kwatha, Reference: Charak Samhita Sutra Sthana chapter 4, Route: Oral, Dosage Form: Sharkara/ Syrup, Dose: 5(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: -

Inclusion Criteria

Age From	3.00 Year(s)
Age To	15.00 Year(s)
Gender	Both
Details	1. Subjects presenting with the sign & symptoms of Kasa (acute). 2. Children of both sex . 3. Cough less than two weeks. 4. Parents who have given written consent

ExclusionCriteria

Details

1.Kshataja and Kshayaja Kasa.
2. Subjects presenting with Pneumonia, COPD (Emphysema,
Bronchiectasis).
3. Subjects with tamaka shwas (bronchial asthma).
4. Cough more than 2 weeks.

Method of Generating Random Sequence

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

Method of Concealment

Not Applicable

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
To evaluate and observe the effect of KARKATSHRINGI KWATHA(SYRUP) in the management of kasa roga.	3rd, 7th, 15th and 21st day

Secondary Outcome

Outcome	TimePoints
To observe clinical improvement/prognosis / recurrence or any side effect during and after treatment period	Before trial and at 21st 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

N/A

Date of First Enrollment (India)

25/02/2025

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="0"
Days="21"

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

Kasa is one of the most common disease in children which affect Pranavaha Srotas. Kapha and Vata are the elements dominated in kasa. Kasa is not life threatening but it disturbs the normal life style of children and if neglected without following proper treatment may hamper the growth and development of children. The present study has been undertaken with an objective of â€œA single arm clinical trial on the management of kasa in children with an ayurvedic formulation of KARKATASHRINGI KWATHA(SYRUP)â€. It contains karkatashringi kwath with Madhu (Honey).