CTRI

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CTRI Number

CTRI/2022/11/047309 [Registered on: 15/11/2022] Trial Registered Prospectively

Last Modified On:

14/11/2022

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Ayurveda

Study Design

Randomized, Parallel Group Trial

Public Title of Study

TO STUDY THE EFFECT OF CLASSICAL DHUMA NASYA AND MODIFIED DHUMA NASYA (IN THE FORM OF NEBULIZATION) IN TAMAKA SWASA(BRONCHIAL ASTHMA)

Scientific Title of Study

A COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF CLASSICAL DHUMA NASYA AND MODIFIED DHUMA NASYA (IN THE FORM OF NEBULIZATION)IN TAMAKA SWASA (BRONCHIAL ASTHMA)

Trial Acronym

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

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

Name	DrShrimant G Chavan
Designation	Associate Professor
Affiliation	Himalayiya ayurvedic PG Medical College and hospital
Address	OPD No.11,Department of Panchakarma,Himalayiya Ayurvedic Medical college and Hospital,Fatehpur Tanda,Majri grant via Doiwala,Dehradun Dehradun UTTARANCHAL 248140 India
Phone	7204863633
Fax
Email	drsgc.hamc@gmail.com

Details of Contact Person
Scientific Query

Name	DrVibha Chauhan
Designation	PG Scholar
Affiliation	Himalayiya ayurvedic PG Medical College and hospital
Address	OPD no.11 Department of Panchakarma,Himalayiya Ayurvedic PG Medical College and Hospital,Fatehpur Tanda,Majri grant via Doiwala,Dehradun Dehradun UTTARANCHAL 248140 India
Phone	8219195028
Fax
Email	ranavibha9@gmail.com

Details of Contact Person
Public Query

Name	DrVibha chauhan
Designation	PG Scholar
Affiliation	Himalayiya ayurvedic PG Medical College and hospital
Address	OPD No.11 Department of Panchakarma,Himalayiya Ayurvedic Medical College and Hospital,Fatehpur Tanda,Majri grant via Doiwala,Dehradun Dehradun UTTARANCHAL 248140 India
Phone	8219195028
Fax
Email	ranavibha9@gmail.com

Source of Monetary or Material Support

Himalayiya campus,UAU Haridwar

Primary Sponsor

Name	Dr Vibha Chauhan
Address	PG Department of Panchakarma,Himalayiya Ayurvedic PG Medical College and Hospital,Fatehpur Tanda,Majri grant via Doiwala,Dehradun
Type of Sponsor	Other [Self]

Details of Secondary Sponsor

Name	Address
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 Vibha Chauhan	Himalayiya Ayurvedic PG Medical College and Hospital	OPD No.11,Department of Panchakarma,Fatehpur Tanda,Majri grant via Doiwala,Dehradun Dehradun UTTARANCHAL	8219195028 ranavibha9@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
institutal ethical comittee	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition:J22\|\|Unspecified acute lower respiratory infection. Ayurveda Condition: swasaroga, (2) ICD-10 Condition:J069\|\|Acute upper respiratory infection,unspecified. Ayurveda Condition: SANTAMAKASVASAH,

Intervention / Comparator Agent

sno	Intervention/Comparator	Type	Drug-Type	Procedure Name	Details
1	Comparator Arm	Drug	Classical		(1) Medicine Name: Satyadi Dravyas, Reference: Charak Sutrasthan chapter 4,Sloka37, Route: Nasal, Dosage Form: Arka, Dose: 4(ml), Frequency: tds, Bhaishajya Kal: Muhurmuhu, Duration: 7 Days, anupAna/sahapAna: Yes(details: -), Additional Information: -

Inclusion Criteria

Age From	20.00 Year(s)
Age To	50.00 Year(s)
Gender	Both
Details	1.patients age between 20-50 years irrespective of caste, race gender . 2.The patient having classical signs and symptoms of tamakaswasa. 3.PEFR 60%-90% (PEAK EXPIRATORY FLOW RATE )

ExclusionCriteria

Details

1.The patient with chronic respiratory disease like history of tuberculosis, emphysema,pulmonary effusion COPD other complicated respiratory disease such as tumor or any anatomical defect in airways.
2. pregnant and lactating woman.
3. severe and systemic diseases like uncontrolled hypertention uncontrolled diaebets
4. CKD (chronic kidney disease ) severe chronic metabolic disorders.

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Case Record Numbers

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
25% unchanged 25-50% mild improvement 50-75% moderate improvement 75% marked improvement	10th 20th 30th days

Secondary Outcome

Outcome	TimePoints
exacerbation in sign and symptoms	2 months

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)

17/11/2022

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="0"

Recruitment Status of Trial (Global)

Not Applicable

Recruitment Status of Trial (India)

Not Yet Recruiting

Publication Details

nil

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

Brief Summary

Bronchial Asthma is defined as a chronic inflammatory disease of airways that is characterized by increased responsiveness of the trachea- bronchial tree to a multiplycity of stimuli. Tamakaswasa is a kind of swasa roga , distressing the pranavaha srotas , which is ominously distressing and a fatal disorder of the present day life . study is conducted to achive an immediate action by incorporating the process of nebulization where the medication is directly administered in to the respiratory system . in ayurveda proper nebulization therapy has been not explained but the process of classical dhuma nasaya may be analogous in some extend.