| CTRI Number |
CTRI/2025/11/097557 [Registered on: 17/11/2025] Trial Registered Prospectively |
| Last Modified On: |
16/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To study the efficacy of kshudradi kwath in the management of kaphaja kasa with special reference to acute bronchitis |
|
Scientific Title of Study
|
Open Randamized Controlled Clinical Trails Of Efficacy Of
OF Kshudradi Kwath In The Management Of Kaphaja Kasa With Special Reference 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 Yashavant sambhaji patil |
| Designation |
PG Scholar |
| Affiliation |
Late Kedari Rederkar Ayurvedic Mahavidyalaya, Gadhinglaj Kolhapur. 416502 |
| Address |
Late kedari Rederkar ayurvedic Mahavidyalaya Room no.1 kayachikitsa Department,Gadhinglaj,Kolhapur,India pin code 416502
Kolhapur
MAHARASHTRA
416502
India |
| Phone |
8605495307 |
| Fax |
|
| Email |
yashavantpatil1586@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Viraj Vinayak Shukla |
| Designation |
HOD of Kayachikitsa Department |
| Affiliation |
Late Kedari Rederkar Ayurvedic Mahavidyalaya, Gadhinglaj,Kolhapur. 416502 |
| Address |
Late Kedari Rederkar Ayurvedic Mahavidyalaya Room no.1 Kayachikitsa Department, gadhinglaj,Kolhapur,India pin code 416502
Kolhapur
MAHARASHTRA
416502
India |
| Phone |
9822936193 |
| Fax |
|
| Email |
rajvishukla@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Viraj Vinayak Shukla |
| Designation |
HOD of Kayachikitsa Department |
| Affiliation |
Late kedari rederkar ayurvedic Mahavidyalaya Gadhinglaj 416502 |
| Address |
Late kedari Rederkar Ayurvedic Mahavidyalaya Room no.1 Kayachikitsa Department,Gadhinglaj Kolhapur,India pin code 416502
Kolhapur
MAHARASHTRA
416502
India |
| Phone |
9822936193 |
| Fax |
|
| Email |
rajvishukla@gmail.com |
|
|
Source of Monetary or Material Support
|
| Daily OPD patients at Late Kedari Redekar Ayurvedic Mahavidyalaya Gadhinglaj Kolhapur India Pincode 416502 |
|
|
Primary Sponsor
|
| Name |
Dr Yashavant Sambhaji patil |
| Address |
Late Kedari Rederkar Ayurvedic Mahavidyalaya Room no.1 Kayachikitsa Department,Gadhinglaj,Kolhapur,India pin code 416502 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Yashavant Sambhaji patil |
Late Kedari Rederkar Dharmadaa ruganalya gadhinglaj ,Kolhapur |
Late Kedari Rederkar Ayurvedic Mahavidyalaya Room no.1 Kayachikitsa Department Gadhinglaj,Kolhapur India pin code 416502
Kolhapur
MAHARASHTRA |
8605495307
yashavantpatil1586@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical comittee late kedari rederkar ayurvedic Mahavidyalaya |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Kshudradi kwath , Reference: Bhav Prakash nighntu, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 30(ml), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -koshna jal), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Bhruhatpanchamool kwath , Reference: Bhav Prakash nighntu , Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 30(ml), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -koshna jal), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient with sign and symptoms of kaphaja kasa.Patient age group between 20-60 yrs. Patients selected irrespective of age, Sex, socio economic
status.Patients who are willing to give consent for this study. |
|
| ExclusionCriteria |
| Details |
1.Pregnancy and lactating women.
2.History of allergic to medicine
3.Patient with other co morbidity like copd chronic productive cough pleural effusion pneumonia asthma etc.
|
|
|
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 |
| Kshudradi kwath is effective in management of kaphaja kasa |
Initial assessment at 0 day
Follow up at 10th ,20th day.
Final assessment at 30th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Kshudradi kwath is More effective than bhruhatpanchamool kwath in the management of kaphaja kasa. |
Initial assessment at 0 day
Follow up at 10th 20th day
Final assessment at 30th 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)
|
17/12/2025 |
| 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) |
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 an open randamised controlled clinical trial to evaluate the efficacy of kshudradi kwath in the management of kaphaja kasa w.s.r to acute bronchitis.study will be carried out at opd of kayachikista department of late kedari redekar ayurvedic mahavidyalaya and hospital gadhinglaj kolhapur.The observation would be drawn on the basis of Symptoms after treatment is given. |