CTRI

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CTRI Number

CTRI/2025/09/094665 [Registered on: 12/09/2025] Trial Registered Prospectively

Last Modified On:

12/09/2025

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

Clinical Evaluation Of Ayurvedic Arka Nebulization In Tamak Shwasa

Scientific Title of Study

Comparative Clinical Evaluation Of Vasa Kantakari And Pushkarmoola Arka Nebulization In Tamak Shwasa

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
nil	NIL

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

Name	Prince Singla
Designation	Pg Scholar
Affiliation	Patanjali Bhartiya Ayurvigyan Evan Anusandhan Sansthan Haridwar
Address	Balroga Opd No.5, Patanjali Bhartiya Ayurvigyan Evan Anusandhan Sansthan Haridwar Uttrakhand Room No. 402 , Balroga Department , Patanjali Bhartiya Ayurvigyan Evan Anusandhan Sansthan Haridwar Uttrakhand Hardwar UTTARANCHAL 249405 India
Phone	9729903162
Fax
Email	princesngl4@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Priyanka Wadhwa
Designation	Associate professor, Deptt. of Kaumarbhritya
Affiliation	Patanjali Bhartiya Ayurvigyan Evan Anusandhan Sansthan Haridwar
Address	Balroga Opd No.5, Patanjali Bhartiya Ayurvigyan Evan Anusandhan Sansthan Haridwar Uttrakhand Room No. 402, Balroga Department ,Patanjali Bhartiya Ayurvigyan Evan Anusandhan Sansthan Haridwar Uttrakhand Hardwar UTTARANCHAL 249405 India
Phone	8105938269
Fax
Email	pwadhwa13@gmail.com

Details of Contact Person
Public Query

Name	Dr Rahul Sharma
Designation	Associate professor, Deptt of Ras shastra and bhaisjya kalpana
Affiliation	Patanjali Bhartiya Ayurvigyan Evan Anusandhan Sansthan Haridwar
Address	Ras Shastra and Bhaisjya Kalpna Opd no. 31, Patanjali Bhartiya Ayurvigyan Evan Anusandhan Sansthan Haridwar Uttrakhand Room No.213,Ras Shastra and Bhaisjya Kalpna Department, Patanjali Bhartiya Ayurvigyan Evan Anusandhan Sansthan Haridwar Uttrakhand Hardwar UTTARANCHAL 249405 India
Phone	9806009806
Fax
Email	rasayurved@gmail.com

Source of Monetary or Material Support

Patanjali Bhartiya Ayurvigyan Evan Anusandhan Sansthan Phase 1, Roorkee Road, Haridwar, Uttarakhand 24940,5Haridwar

Primary Sponsor

Name	Patanjali Bhartiya Ayurvigyan Evan Anusandhan Sansthan Haridwar
Address	Patanjali Bhartiya Ayurvigyan Evan Anusandhan Sansthan Phase 1, Roorkee Road, Haridwar, Uttarakhand 249405
Type of Sponsor	Private 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
Prince Singla	Patanjali Bhartiya Ayurvigyan Evan Anusandhan Sansthan Haridwar	Opd no.5 Patanjali Bhartiya Ayurvigyan Evan Anusandhan Sansthan Haridwar Uttrakhand Hardwar UTTARANCHAL	9729903162 princesngl4@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Ethics Committee Patanjali Bhartiya Ayurvigyan Evan Anusandhan Sansthan Haridwar	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition:J452\|\|Mild intermittent asthma. Ayurveda Condition: TAMAKASVASAH,

Intervention / Comparator Agent

sno	Intervention/Comparator	Type	Drug-Type	Procedure Name	Details
1	Comparator Arm	Drug	Classical		(1) Medicine Name: vasa kantakari arka, Reference: arka prakash, Route: Nasal, Dosage Form: Arka, Dose: 3(ml), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: Vasa Kantakari Arka Nebulization
2	Intervention Arm	Drug	Classical		(1) Medicine Name: Pushkarmoola Arka, Reference: Arka Parkash, Route: Nasal, Dosage Form: Arka, Dose: 3(ml), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: Pushkarmoola Arka Nebulization

Inclusion Criteria

Age From	5.00 Year(s)
Age To	15.00 Year(s)
Gender	Both
Details	Age between 5 year to 15 years. Sex both male and female. Diagnosed cases of bronchial asthma. Mild to moderate case of bronchial asthma. Case of productive and unproductive cough. Case of acute or chronic cough. Occasionally vomiting present

ExclusionCriteria

Details

Severe case of bronchial asthma.
Severe pneumonia
Status asthamaticus
Any associated bleeding disorder or sign of any severe illness.
Child suffering from life threatening conditions.
Cardiac asthma
Case of pleural effusion, pneumothorax and pulmonary tuberculosis etc.
Cough which is associated with blood
Children less then 5 years and more than 15 years

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
changes in clinical symptoms of asthma like breathlessness cough wheezing etc per week frequency of asthmatic attacks before and after treatment PEFR AEC other laboratory investigation will be observed before and after treatment.	1st follow up day 1, 2nd follow up day 7, 3rd follow up day 15

Secondary Outcome

Outcome	TimePoints
To evaluate whether the drug works as bronchodilator or not

Target Sample Size

Total Sample Size="60"
Sample Size from India="60"
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)

27/09/2025

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 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 is an open label Randomized, Parallel group, active controlled trial to evaluate the effect of VASA KANTAKARI AND PUSHKARMOOLA ARKA NEBULIZATION IN TAMAK SHWASA. A total of 60 patients fulfilling the diagnostic criteria will be divided into two groups. 30 patients will be receiving vasakantakari arka nebulization and 30 patients will be receiving pushkarmoola arka nebulization 3 time a day for 7 days. The efficacy will be accessed on the bases of subjective parameter like breathlessness, cough, PEFR. Follow up will be done on day 1, day 7 & day 15. The AIM is to compare both regimens and provide cost effective safe and efficient ayurvedic intervention for tamak shwasa.