| CTRI Number |
CTRI/2025/03/082352 [Registered on: 17/03/2025] Trial Registered Prospectively |
| Last Modified On: |
13/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Use of Kantakaryadi arka in allergic bronchitis |
|
Scientific Title of Study
|
A randomized controlled clinical trial to evaluate the efficacy of kantakaryadi arka in allergic bronchitis (Vataja 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 |
Dr Digvijay Singh |
| Designation |
PG Scholar |
| Affiliation |
Parul Institute of Ayurved |
| Address |
Room 204 Department of Kaumarbhritya Parul Institute of Ayurved Parul University Vadodara Gujarat 391760 India
Vadodara
GUJARAT
391760
India |
| Phone |
8708267035 |
| Fax |
|
| Email |
sdigvijay942@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kavya Mohan |
| Designation |
Associate Professor |
| Affiliation |
Parul Institute of Ayurved |
| Address |
Room 204 Department of Kaumarbhritya Parul Institute of Ayurved Parul University Vadodara Gujarat 391760 India
Vadodara
GUJARAT
391760
India |
| Phone |
9745727376 |
| Fax |
|
| Email |
kavya.thannickel@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kavya Mohan |
| Designation |
Associate Professor |
| Affiliation |
Parul Institute of Ayurved |
| Address |
Room 204 Department of Kaumarbhritya Parul Institute of Ayurved Parul University Vadodara Gujarat 391760 India
Vadodara
GUJARAT
391760
India |
| Phone |
9745727376 |
| Fax |
|
| Email |
kavya.thannickel@gmail.com |
|
|
Source of Monetary or Material Support
|
| Parul University Limda Vadodara Gujarat India 391760 |
|
|
Primary Sponsor
|
| Name |
Parul Institute of Ayurved |
| Address |
Parul Institute of Ayurved Parul University At post Limda Waghodia Vadodara Gujarat India 391760 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Digvijay Singh |
PARUL AYURVED HOSPITAL |
OPD No.103, Department of Kaumarbhritya,Parul University, Limda, Tal. waghodia, Vadodara, 391760
Vadodara
GUJARAT |
8708267035
sdigvijay942@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J393||Upper respiratory tract hypersensitivity reaction, site unspecified. Ayurveda Condition: Kasah, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Kantakaryadi Arka, Reference: Arka Prakasha, Route: Oral, Dosage Form: Arka, Dose: 12(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: Warm Water), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Cetrizine Syrup | 10 mg in 2 divided doses after food |
|
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Age group between 5yrs to 12yrs.
Patients of either gender will be included.
Patients of Vataja kasa with symptoms like Shushka Kasa (dry cough), Swarbheda (hoarseness of voice), Shirashool (headache), Parshvashool and Urashool (pain in flank and chest region), Shushka mukha and gala (dryness of mouth and throat irritation)
|
|
| ExclusionCriteria |
| Details |
All types of Kasa except Vataja Kasa lakshana will be excluded.
Pneumonia, Juvenile DM, Tuberculosis, Asthma should be excluded.
Cough with expectoration along with fever
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in episodes of cough dry |
Day 1 Day 7 Day 14 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in cough Symptom Score |
Day 1 Day 7 Day 14 |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 |
|
Date of First Enrollment (India)
|
18/03/2025 |
| 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 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
|
Allergic Bronchitis is prevailed childhood illness need to be handle with active combination of immunemodulators and antitussive agents, in present trial kantakari Arka is the similar combination used for childhood allergic bronchitis |