CTRI

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CTRI Number

CTRI/2025/02/080990 [Registered on: 20/02/2025] Trial Registered Prospectively

Last Modified On:

17/02/2025

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Ayurveda

Study Design

Randomized, Parallel Group, Active Controlled Trial

Public Title of Study

A study to assess the efficacy of Tilsaptak Churna in treatment of Kaphaj kasa , with a focus on acute bronchitis.

Scientific Title of Study

A randomized controlled clinical trial to evaluate the efficacy of Tilasaptak Churna in Kaphaj Kasa w.s.r. to Acute Bronchitis.

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 Sakshi Shrikant Jadhav
Designation	PG scholar
Affiliation	LATE KEDARI REDEKAR AYURVEDIC MAHAVIDYALA KAYACHIKITSA DEP.GADHINGLAJ KOLHAPUR
Address	Late Kedari Redekar Ayurvedic Mahavidyalaya and hospital kayachikitsa department room no. 1 kayachikitsa OPD Gadhinglaj Kolhapur Pin 416502 Late Kedari Redekar Ayurvedic Mahavidyalaya and hospital kayachikitsa department room no. 1 kayachikitsa OPD Gadhinglaj Kolhapur Pin 416502 Kolhapur MAHARASHTRA 416502 India
Phone	9175703225
Fax
Email	sakshisj2123@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Vibhavari Tukaram Kokane
Designation	Professor at Kayachikitsa department
Affiliation	Late Kedari Redekar Ayurvedic Mahavidyalaya and hospital kayachikitsa department room no. 1 kayachikitsa OPD Gadhinglaj Kolhapur Pin 416502
Address	Late Kedari Redekar Ayurvedic Mahavidyalaya and hospital kayachikitsa department room no. 1 kayachikitsa OPD Gadhinglaj Kolhapur Pin 416502 Late Kedari Redekar Ayurvedic Mahavidyalaya and hospital kayachikitsa department room no. 1 kayachikitsa OPD Gadhinglaj Kolhapur Pin 416502 Kolhapur MAHARASHTRA 416502 India
Phone	99420326846
Fax
Email	vibhavari.kokane@gmail.com

Details of Contact Person
Public Query

Name	Dr Vibhavari Tukaram Kokane
Designation	Professor at Kayachikitsa department
Affiliation	Late Kedari Redekar Ayurvedic Mahavidyalaya and hospital kayachikitsa department room no. 1 kayachikitsa OPD Gadhinglaj Kolhapur
Address	Late Kedari Redekar Ayurvedic Mahavidyalaya and hospital kayachikitsa department room no. 1 kayachikitsa OPD Gadhinglaj Kolhapur Pin 416502 Late Kedari Redekar Ayurvedic Mahavidyalaya and hospital kayachikitsa department room no. 1 kayachikitsa OPD Gadhinglaj Kolhapur Pin 416502 Kolhapur MAHARASHTRA 416502 India
Phone	99420326846
Fax
Email	vibhavari.kokane@gmail.com

Source of Monetary or Material Support

Daily OPD patients at Late Kedari Redekar Ayurvedic Mahavidyalaya Gadhinglaj Kolhapur India Pin code -416502

Primary Sponsor

Name	Dr Sakshi Shrikant Jadhav
Address	Late Kedari Redekar Ayurvedic Mahavidyalaya, Gadhinglaj, Kolhapur India Pin code 416502
Type of Sponsor	Other []

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 Sakshi Shrikant Jadhav	Late Kedari Redekar dharmaday rugnalay, Gadhinglaj,Kolhapur	Late Kedari Redekar Ayurvedic Mahavidyalaya and hospital kayachikitsa department room no. 1 kayachikitsa OPD Gadhinglaj Kolhapur Pin 416502 Kolhapur MAHARASHTRA	9175703225 sakshisj2123@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Ethical committee Ltae Kedari Redekar Ayurvedic Mahavidyalaya, Gadhinglaj, Kolhapur	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition:J209\|\|Acute bronchitis, unspecified. Ayurveda Condition: KASAH,

Intervention / Comparator Agent

sno	Intervention/Comparator	Type	Drug-Type	Procedure Name	Details
1	Comparator Arm	Drug	Classical		(1) Medicine Name: BHADRA MUSTADI CHURNA, Reference: NIGHANTU RATNAKAR KASAH , Route: Oral, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: MADHU AND KOSHNA JAL ), Additional Information: -
2	Intervention Arm	Drug	Classical		(1) Medicine Name: TILASAPTAK CHURNA , Reference: BHARAT BHAISHAJYA RATNAKAR DWITIYA BHAG , Route: Oral, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: GUD AND KOSHNA JAL), Additional Information: -

Inclusion Criteria

Age From	18.00 Year(s)
Age To	50.00 Year(s)
Gender	Both
Details	1) Patients with complaints of kasa, bahul ghan kapha nishtivan, mandangni, aruchi, pinasa, aasyamadhurya 2)Age group-18 years to 50years 3) Irrespective of Gender and Religion and socio economic status, 4) patients from OPD and IPD of our hospital. 5) Patients willing to give consent.

ExclusionCriteria

Details

1. Patients less than 18 yrs age and more than 50 yrs age.
2. k/c/o-Tuberculosis, COPD, DM, smokers cough, Asthma, malignant HTN, pneumonia, pleural effusion, HIV, cor-pulmonale, any systemic condition causing cough
3. Patients having complaints more than 6 months.
4. Pregnancy and lactating mother.
5. Not willing to undertake consent.

Method of Generating Random Sequence

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

Method of Concealment

Alternation

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
Tilasaptak churna is effective in management of Kaphaj kasa	Initial assessment at 0 day Follow up 7th and 14th day Final assessment at 14th day

Secondary Outcome

Outcome	TimePoints
Tilasaptak churna is more effective than Bhadra Mustadi churna in management of Kaphaj kasa	Initial assessment at 0 day Follow up 7th & 14th day Final assessment at 14th day

Target Sample Size

Total Sample Size="70"
Sample Size from India="70"
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)

01/03/2025

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 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

The study is a randomized controlled clinical trial to evaluate the efficacy of Tilasaptak churna in Kaphaj kasa w.s.r. to acute bronchitis. Study will be carried out at the OPD of kayachikitsa department of Late Kedari Redekar Ayurvedic Mahavidyalaya and hospital Gadhinglaj Kolhapur. The observation would be drawn on the basis of relief of symptoms after treatment given.