| CTRI Number |
CTRI/2025/03/081556 [Registered on: 03/03/2025] Trial Registered Prospectively |
| Last Modified On: |
01/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical study to evaluate the efficacy of Aparajita Avaleha in Vatja kasa vis-a-vis Bronchitis |
|
Scientific Title of Study
|
An open labelled clinical study to evaluate the efficacy of Aparajita Avaleha in Vataja Kasa Vis-A-Vis 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 J Kaveriabinaya |
| Designation |
PG Scholar |
| Affiliation |
Sushrutha Ayurveda Medical college and Hospital |
| Address |
Room No 5, Department of Kayachikitsa,Department of PG studies Division,Sushrutha Ayurveda Medical college and Hospital Prashanthi Kuteera,Jodi Bingipura,Jigani,Anekal Taluk Bangalore
Room No 5, Department of Kayachikitsa,Department of PG studies Division,Sushrutha Ayurveda Medical college and Hospital Prashanthi Kuteera,Jodi Bingipura,Jigani,Anekal Taluk Bangalore
Bangalore
KARNATAKA
560105
India |
| Phone |
9014025351 |
| Fax |
|
| Email |
kaveriabinaya0697@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sowmya S B |
| Designation |
Proffesor |
| Affiliation |
Sushrutha Ayurveda Medical college and Hospital |
| Address |
Room No 5, Department of Kayachikitsa,Department of PG studies Division,Sushrutha Ayurveda Medical college and Hospital Prashanthi Kuteera,Jodi Bingipura,Jigani,Anekal Taluk Bangalore
Room No 5, Department of Kayachikitsa,Department of PG studies Division,Sushrutha Ayurveda Medical college and Hospital Prashanthi Kuteera,Jodi Bingipura,Jigani,Anekal Taluk Bangalore
Bangalore
KARNATAKA
560105
India |
| Phone |
9916149850 |
| Fax |
|
| Email |
drsbsowmya.ayu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr J Kaveriabinaya |
| Designation |
PG Scholar |
| Affiliation |
Sushrutha Ayurveda Medical college and Hospital |
| Address |
Room No 5, Department of Kayachikitsa,Department of PG studies Division,Sushrutha Ayurveda Medical college and Hospital Prashanthi Kuteera,Jodi Bingipura,Jigani,Anekal Taluk Bangalore
Room No 5, Department of Kayachikitsa,Department of PG studies Division,Sushrutha Ayurveda Medical college and Hospital Prashanthi Kuteera,Jodi Bingipura,Jigani,Anekal Taluk Bangalore
Bangalore
KARNATAKA
560105
India |
| Phone |
9014025351 |
| Fax |
|
| Email |
kaveriabinaya0697@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of kayachikitsa,Department of PG studies Division,Sushrutha Ayurvedic medical college and hospital,prashanthi kuteera jodi bingipura ,Jigani anekal Taluk Bengaluru,Karnataka India -560105 |
|
|
Primary Sponsor
|
| Name |
Dr J Kaveriabinaya |
| Address |
Sushrutha Ayurvedic medical college and hospital,prashanthi kuteera jodi bingipura ,Jigani anekal Taluk Bengaluru,Karnataka India -560105 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Sushrutha Ayurvedic Medical college and Hospital |
Prashanthi Kuteera,Jodi Bingipura Jigani Anekal Taluk,Bengaluru 560105 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrJKaveriabinaya |
Sushrutha Ayurvedic Medical College and Hospital |
Room No 4,
Department of
Kayachikitsa, Out
Patient Department,
Prashanthi Kuteera,
Jodi Bingipura, Jigani,
Anekal Taluk
Bangalore
KARNATAKA
Bangalore
KARNATAKA |
9014025351
kaveriabinaya0697@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee SAMC and H |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J980||Diseases of bronchus, not elsewhere classified. Ayurveda Condition: VATAJAKASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Aparajita avaleha, Reference: Bhaisajya Ratnavali, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 12(g), Frequency: qid, Bhaishajya Kal: Muhurmuhu, Duration: 7 Days, anupAna/sahapAna: Yes(details: -Warm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Subject not taking any other medication for cough
Subject who have discontinued the previous medication atleast 1 week prior to the study
Subjects who are willing to provide informed consent will be included |
|
| ExclusionCriteria |
| Details |
Subject with Plumonary tuberculosis, Chronic obstructive pulmonary disorder, Pertussis, or any other serious respiratory illness
Immune-compromised subjects like cancer, HIV, etc,
Subject on any other medications for kasa or other systemic disorders that interfere with the current study.
Physiological conditions like pregnancy, and lactation will be excluded
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduce the symptoms of kasa is assessed using kasa Visual analog scale |
0 and 7th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| improvement in patient symptomatic condition |
0 and 7th day |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
29/03/2025 |
| 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="2"
Months="0"
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
|
This study is An open labelled clinical trial to evaluate the efficacy of Aparajita avaleha 12gms 4 times a day in divided doses with lukewarm water in a group of 30 subjects in the management of Vataja kasa vis-a vis Bronchitis for a period of 7 days .The primary outcome is reducing the symptomatic condition of the patient and the secondary outcome is improving the quality of life . |