| CTRI Number |
CTRI/2024/12/078550 [Registered on: 24/12/2024] Trial Registered Prospectively |
| Last Modified On: |
20/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To see effect of Bharangyadi Churna in Vataj Kasa |
|
Scientific Title of Study
|
Randomized Control Clinical Trial Of Bharangyadi Churna In Vataj Kasa |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shantanu suryakant mali |
| Designation |
PG schoolar |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta |
| Address |
OPD no 1 Kayachikitsa OPD Ground Floor Dhanvantari Ayurved
Hospital Ashta Tal Walwa
Dist.Sangli
OPD no 1 Kayachikitsa OPD Ground Floor Dhanvantari Ayurved
Hospital Ashta Tal Walwa
Dist. Sangli
Sangli
MAHARASHTRA
416301
India |
| Phone |
7414979737 |
| Fax |
|
| Email |
shantanumali440@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr parag deshmukhe |
| Designation |
Professor and HOD |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta |
| Address |
OPD no 1 Kayachikitsa OPD Ground Floor Dhanvantari Ayurved
Hospital Ashta Tal Walwa
Dist Sangli
OPD no 1 Kayachikitsa OPD Ground Floor Dhanvantari Ayurved
Hospital Ashta Tal Walwa Dist. Sangli
Sangli
MAHARASHTRA
416301
India |
| Phone |
7719954457 |
| Fax |
|
| Email |
pdeshmukhe@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr parag deshmukhe |
| Designation |
Professor and HOD |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta |
| Address |
OPD no 1 Kayachikitsa OPD Ground Floor Dhanvantari Ayurved
Hospital Ashta Tal Walwa Dist Sangli
OPD no 1 Kayachikitsa OPD Ground Floor Dhanvantari Ayurved
Hospital Ashta Tal Walwa Dist Sangli
Sangli
MAHARASHTRA
416301
India |
| Phone |
7719954457 |
| Fax |
|
| Email |
pdeshmukhe@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center
Ashta
Tal.walwa
Dist. Sangli
Maharashtra
416301
India |
|
|
Primary Sponsor
|
| Name |
Dr Shantanu Suryakant mali |
| Address |
OPD no 1 Kayachikitsa OPD Ground Floor Dhanvantari Ayurved Hospital Ashta Tal Walwa Dist Sangli MAHARASHTRA 416301
India |
| Type of Sponsor |
Private medical college |
|
|
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 shantanu suryakant mali |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta |
OPD no 1 Kayachikitsa
OPD Ground Floor
Dhanvantari Ayurved
Hospital Ashta Tal
Walwa Dist Sangli
Sangli
MAHARASHTRA
Sangli
MAHARASHTRA |
7414979737
shantanumali440@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Hon.shri Annasaheb Dange Ayurved medical college post graduate and research center Ashta |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J069||Acute upper respiratory infection,unspecified. Ayurveda Condition: KASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Bharangyadi Churna , Reference: Ashtang sangraha 4/ 19, Route: Oral, Dosage Form: Churna/ Powder, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: Gud ), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Pippali churna , Reference: Ashtang sangraha 4/ 19, Route: Oral, Dosage Form: Churna/ Powder, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: Koshana jala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Patient with sign and symptoms of vataj kasa Shushka kasa Swarabhed
Hrita pradeshi shool Shira shool Parshwa shool Will be included in study
2 Patient age group between 20 to 60 years
3 Patients selected irrespective of age gender socio economic status |
|
| ExclusionCriteria |
| Details |
1 Pregnancy and Lactating Mother
2 Patient with co-morbidities likel DM
IHD COPD
3 Patient having history of Hematemesis Haemoptysis |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare effect of Bharangyadi churn and pippali churn in vataj kaas |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 To evaluate efficacy of Bharangyadi churn in vataj kasa
2 To compare efficacy of Bharangyadi churn and pippali churn in vataj kasa
3 To review clinical textual of vataj kasa
4 To observe adverse effect of Bharangyadi churn in vataj kasa |
7 days |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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)
|
10/01/2025 |
| 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
|
Kasa is pranavaha strotas vyadhi Kasa couse due to vitiation of Tridoshas The vitiated pranavaha vayu along with udan vayu witch further gets aggravated in association with other doshas and expelled out abruptly with a coughing sound like the broken bronze vessel call as kasa In pranavaha strotas origin is hrudaya as well as maha strotas Vataj kas is one of the commonest complaints in day to day general practice and it is also a symptoms of various disease of respiratory system Prevalence of vataj kasa is 10%
vataj kasa main symptoms are hruta shoola, shankha shoola murdha shool udar shoola parshwa shoola kshama anan kshina bala swara oja shushka kasa |