| CTRI Number |
CTRI/2025/06/088585 [Registered on: 11/06/2025] Trial Registered Prospectively |
| Last Modified On: |
06/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Treatment for Kaphaja Kasa with Dadimadi Choorna. |
|
Scientific Title of Study
|
A Randomized controlled clinical study of Dadimadi Churna in the management of Kaphaja kasa chronic 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 Kadam Rutuja Dharmaraj |
| Designation |
PG Scholar |
| Affiliation |
Alvas Ayurveda Medical College and Hospital Vidyagiri Moodubidire Dakshina Kannada karnataka 574227 |
| Address |
3rd floor PG Department of Kayachikitsa Alvas Ayurveda Medical College and Hospital Vidyagiri Moodubidire Dakshina Kannada karnataka 574227
OPD no 5 PG Department of Kayachikitsa Alvas Ayurveda Medical College and Hospital Vidyagiri Moodubidire Dakshina Kannada karnataka 574227
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9403637262 |
| Fax |
|
| Email |
krutuja366@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Susheel Shetty |
| Designation |
Professor and HOD |
| Affiliation |
Alvas Ayurveda Medical College and Hospital Vidyagiri Moodubidire Dakshina Kannada karnataka 574227 |
| Address |
Opd no 5 PG DEPARTMENT OF KAYACHIKITSA Alvas Ayurveda Medical College and Hospital Vidyagiri Moodubidire Dakshina Kannada karnataka 574227
OPD no 5 PG Department of Kayachikitsa Alvas Ayurveda Medical College and Hospital Vidyagiri Moodubidire Dakshina Kannada karnataka 574227
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9980431676 |
| Fax |
|
| Email |
shettysusheel13@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kadam Rutuja Dharmaraj |
| Designation |
PG Scholar |
| Affiliation |
Alvas Ayurveda Medical College and Hospital Vidyagiri Moodubidire Dakshina Kannada karnataka 574227 |
| Address |
OPD No 5 PG DEPARTMENT OF KAYACHIKITSA Alvas Ayurveda Medical College and Hospital Vidyagiri Moodubidire Dakshina Kannada karnataka 574227
OPD no 5 PG Department of Kayachikitsa Alvas Ayurveda Medical College and Hospital Vidyagiri Moodubidire Dakshina Kannada karnataka 574227
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9403637262 |
| Fax |
|
| Email |
krutuja366@gmail.com |
|
|
Source of Monetary or Material Support
|
| Alvas Ayurveda Medical college and Hospital,Vidyagiri Moodubidire,Dakshina Kannada district,karnataka |
|
|
Primary Sponsor
|
| Name |
Dr Kadam Rutuja Dharmaraj |
| Address |
Alvas Ayurveda Medical College and Hospital Vidyagiri Moodubidire Dakshina Kannada karnataka 574227 |
| 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 Kadam Rutuja Dharmaraj |
Alvas Ayurveda Medical College Moodubidire |
OPD No : 06, POST GRADUATION DEPARTMENT OF KAYACHIKITSA, Alvas Ayurveda Medical College and Hospital Vidyagiri Moodubidire Dakshina Kannada karnataka 574227
Dakshina Kannada
KARNATAKA |
9403637262
krutuja366@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Alvas Ayurveda Medical College Moodubidire |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J418||Mixed simple and mucopurulent chronic bronchitis. Ayurveda Condition: KASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Dadimadi choorna, Reference: Asthanga Hridaya, Route: Oral, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: qid, Bhaishajya Kal: Muhurmuhu, Duration: 7 Days, anupAna/sahapAna: Yes(details: Madhu), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Bruhatsharkarasama churna, Reference: Vangasena Samhita, Route: Oral, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: qid, Bhaishajya Kal: Muhurmuhu, Duration: 7 Days, anupAna/sahapAna: Yes(details: Madhu), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients who fulfill diagnostic criteria.
Patients with age group between 16 to 60 years.
Patients willing to participate in the study and ready to sign informed consent form. |
|
| ExclusionCriteria |
| Details |
Patients having Productive cough with complications like: Tuberculosis, Emphysema or Pneumonia, Bronchial Asthma, Cystic fibrosis.
Patients with any other systemic and metabolic disorder which may interfere the study will be excluded.
Pregnant women and Lactating mothers will be excluded.
Patients undergoing steroid therapy. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
KASA (COUGH)
EXPECTORANT COUGH
SLIMY AND PRODUCTIVE,COUGH |
15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Peenasa (RUNNING NOSE)
Aasyamadhurya (DISSONANCE)
Aruchi (ANOREXIA)
Utklesha (AGITATION)
Gourava (HEAVYNESS) |
15 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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
18/06/2025 |
| 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="15" |
|
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
|
AIM OF THE STUDY To evaluate the efficacy of Dadimadi Churna in the management of Kaphaja Kasa.
OBJECTIVES OF STUDY 1.To prepare Dadimadi Churna as per classical method. 2.To compare the therapeutic effects of Dadimadi Churna with Bruhatsharkarasama Churna in the management of Kaphaja Kasa.
HYPOTHESIS H0 - There is neither statistically significant difference between Dadimadi Churna and Bruhatsharkarasama Churna nor Dadimadi Churna is better than Bruhatsharkarasama Churna in the management of Kaphaja Kasa. H1 - There is statistically significant difference in the effect of Dadimadi Churna and Bruhatsharkarasama Churna with Dadimadi Churna having better effect than Bruhatsharkarasama Churna in the management of Kaphaja Kasa. |