CTRI

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CTRI Number

CTRI/2026/02/105065 [Registered on: 27/02/2026] Trial Registered Prospectively

Last Modified On:

27/02/2026

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug
Ayurveda

Study Design

Non-randomized, Active Controlled Trial

Public Title of Study

COMPARATIVE CLINICAL STUDY TO REDUCE THE SYMPTOMS OF TAMAKA SHWASA IN CHILDREN WITH BHARANGI GUDA AND DRAKSHADI LEHA.

Scientific Title of Study

COMPARATIVE CLINICAL STUDY ON TAMAKA SHWASA IN CHILDREN WITH BHARANGI GUDA AND DRAKSHADI LEHA.

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 Baishali Dani
Designation	3rd year PG Scholar
Affiliation	Gopabandhu Ayurveda Mahavidyalaya Puri
Address	Post graduate Department of OPD and IPD of Kaumarabhritya Gopabandhu Ayurveda Mahavidyalaya Puri VIP Road Puri ORISSA 752002 India
Phone	9337758184
Fax
Email	baishalidani@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Sangita Prusty
Designation	Reader and H.O.D Department of Kaumarabhritya
Affiliation	Gopabandhu Ayurveda Mahavidyalaya Puri
Address	Post graduate Department of OPD and IPD of Kaumarabhritya Gopabandhu Ayurveda Mahavidyalaya Puri VIP Road Puri ORISSA 752002 India
Phone	7008329522
Fax
Email	prustydrsangita@gmail.com

Details of Contact Person
Public Query

Name	Dr Sangita Prusty
Designation	Reader and H.O.D Department of Kaumarabhritya
Affiliation	Gopabandhu Ayurveda Mahavidyalaya Puri
Address	Post graduate Department of OPD and IPD of Kaumarabhritya Gopabandhu Ayurveda Mahavidyalaya Puri VIP Road Puri ORISSA 752002 India
Phone	07008329522
Fax
Email	prustydrsangita@gmail.com

Source of Monetary or Material Support

NIL

Primary Sponsor

Name	Dr. Baishali Dani
Address	Post graduate Department of Kaumarabhritya, Gopabandhu Ayurveda Mahavidyalaya, Puri, Odisha Pin-752002
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 Baishali Dani	Gopabandhu Ayurveda Mahavidyalaya, Puri	Post graduate Department of Kaumarabhritya, Gopabandhu Ayurveda Mahavidyalaya, Puri, VIP road, ODISHA Pin-752002 Puri ORISSA	09337758184 baishalidani@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Ethics Committee Gopabandhu Ayurveda Mahavidyalaya, VIP Road, Puri, 752002	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition:J453\|\|Mild persistent asthma. Ayurveda Condition: TAMAKASVASAH,

Intervention / Comparator Agent

sno	Intervention/Comparator	Type	Drug-Type	Procedure Name	Details
1	Intervention Arm	Drug	Classical		(1) Medicine Name: Bharangi Guda, Reference: Bhaisajya Ratnavali, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Usnajala), Additional Information: -
2	Comparator Arm	Drug	Classical		(1) Medicine Name: Drakshadi Leha, Reference: Bhaisajya Ratnavali, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Usnajala), Additional Information: -

Inclusion Criteria

Age From	5.00 Year(s)
Age To	16.00 Year(s)
Gender	Both
Details	1. Patients with age group of 5 to 16 years will be taken for study. 2. Patients suffering from symptoms of Tamaka shwasa i.e. breathlesssness, cough, running nose, restlessness, wheeze, crepitation. 3. Oxygen saturation more than 90 percent.

ExclusionCriteria

Details

1. Oxygen saturation less than 90 percent.
2. Tamaka Shwasa patients suffering from other diseases will be excluded.
3. Patient having anomaly and lesions in lungs.
4. Breathlessness due to severe anemia.
5. Any other physical & surgically ill patient will be excluded.

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
To reduce the episode of attack of Tamaka Shwasa	30 days

Secondary Outcome

Outcome	TimePoints
to compare the efficacy of Bharangi Guda with the efficacy of Drakshadi Leha	30 days

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

N/A

Date of First Enrollment (India)

25/03/2026

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="30"

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

Lower respiratory tract infections are reported more in children now a days and Bronchial asthma (Tamaka Shwasa) is most common complain among them. Tamaka Shwasa is crucial due to its high prevalence, impact on quality of life and potential severity. Therefore, there is need for the study in this field. At present study Bharangi Guda and Drakshadi Leha has taken for understanding the effectiveness of traditional treatment which can offer safer and more accessible options for managing asthma as both have Shwasahara properties. Additionally, comparative studies help to identify the most effective intervention.