CTRI

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CTRI Number

CTRI/2025/09/094754 [Registered on: 15/09/2025] Trial Registered Prospectively

Last Modified On:

12/09/2025

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Ayurveda

Study Design

Randomized, Parallel Group Trial

Public Title of Study

To compare the effect of Bala Tail Nasa Pichu And Shigru Tail Nasa Pichu In Nasanaha

Scientific Title of Study

Randomised Comparative Clinical Evaluation Of Bala Tail And Shigru Tail Nasa Pichu In Nasanaha

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

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

Name	Sachin Yadav
Designation	PG Scholar
Affiliation	Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Haridwar
Address	OPD- 3 Patanjali Ayurveda Hospital , Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Haridwar Hardwar UTTARANCHAL 249405 India
Phone	9027383681
Fax
Email	sachin38802@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Arun Kumar Pandey
Designation	Associate Professor
Affiliation	Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Haridwar
Address	OPD- 3 Patanjali Ayurveda Hospital , Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Haridwar Hardwar UTTARANCHAL 249405 India
Phone	8859761559
Fax
Email	arunpandey.pandey@gmail.com

Details of Contact Person
Public Query

Name	Sachin Yadav
Designation	PG Scholar
Affiliation	Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Haridwar
Address	OPD- 3 Patanjali Ayurveda Hospital, Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Haridwar Hardwar UTTARANCHAL 249405 India
Phone	9027383681
Fax
Email	Sachin38802@gmail.com

Source of Monetary or Material Support

Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Haridwar, Uttarakhand, India -249405

Primary Sponsor

Name	Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Haridwar
Address	Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan 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
Dr Sachin Yadav	Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan	O.P.D. 3, Department of Shalakya-Tantra, Patanjali ayurved hospital, Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Phase 1, Roorkee road Hardwar UTTARANCHAL	9027383681 sachin38802@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Ethical Committee, Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Haridwar Uttarakhand	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: NASAROGAH,

Intervention / Comparator Agent

sno	Intervention/Comparator	Type	Drug-Type	Procedure Name	Details
1	Intervention Arm	Procedure	-	picu, पिचु	(Procedure Reference: Charak Samhita Chapter 11 Shloka 55, Procedure details: A ribbon like gauze dipped in Tail, first few centimeters of gauze are folded upon itself and inserted along the floor, then the whole Nasal cavity is packed tightly by layering the gauze to the roof and from before backwards with the help of Tilley’s forceps . After 45 Minutes , gauze piece will be removed gently.) (1) Medicine Name: Bala Taila, Reference: Ashtang Hridyam Chikitsa Sthana 21/73-81, Route: Nasal, Dosage Form: Taila, Dose: 3(ml), Frequency: od, Duration: 14 Days
2	Comparator Arm	Procedure	-	picu, पिचु	(Procedure Reference: Charak Samhita Chapter 11 Shloka 55, Procedure details: A ribbon like gauze dipped in Tail, first few centimeters of gauze are folded upon itself and inserted along the floor, then the whole Nasal cavity is packed tightly by layering the gauze to the roof and from before backwards with the help of Tilley’s forceps. After 45 Minutes , gauze piece will be removed gently.) (1) Medicine Name: Shigru Taila, Reference: Vangsen Samhita chapter 35 Shloka 102, Route: Nasal, Dosage Form: Taila, Dose: 3(ml), Frequency: od, Duration: 14 Days

Inclusion Criteria

Age From	15.00 Year(s)
Age To	60.00 Year(s)
Gender	Both
Details	1) Patients suffering with clinical features of Nasanaha (Nasal obstruction) 2) Patient having complaints of Headache, Nasal discharge, Discomfort in nose, Congested Nasal mucosa and reduced perception of smell. 3) Patients yogya for Nasa pichu karma.

ExclusionCriteria

Details

I) Age group below 15 and above 60 years of either sex.
ii) Patients of Nasal obstruction other than DNS.
iii) Patients suffering from COPD, or any other severe systemic disease.
iv) Pregnant women and lactating mother.

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

On-site computer system

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
1) Nasal blockage (Nasaavrodha) 2) Nasal discharge 3) Discomfort in nose 4) Headache 5) Reduced smell perception	0, 30th, 45th, 60th day

Secondary Outcome

Outcome	TimePoints
1) X ray PNS view 2) Spatula test	0, 30th day

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

N/A

Date of First Enrollment (India)

25/09/2025

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="6"
Days="0"

Recruitment Status of Trial (Global)

Not Applicable

Recruitment Status of Trial (India)

Open to Recruitment

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 a randomized, open-labelled, parallel-group, clinical trial, to compare and evaluate effect of bala tail nasa pichu and shigru tail nasa pichu in nasanaha..

Patients suffering with symptoms of nasanaha attending the OPD/IPD of SHALAKYA TANTRA department of Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Haridwar will be selected randomly for this clinical study irrespective of sex, religion, occupation etc. A detailed Performa will be prepared on basis of Ayurvedic text and allied sciences. The patient fulfilling the inclusion and exclusion criteria will be registered on this Performa and scoring of different clinical features will be done on the assessment criteria.