| CTRI Number |
CTRI/2025/01/079142 [Registered on: 21/01/2025] Trial Registered Prospectively |
| Last Modified On: |
20/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Compare the effect of Kantakari arka and Talisadi churna in kaphaja kasa (acute cough) in children |
|
Scientific Title of Study
|
A comparative clinical study on the efficacy of Kantakari arka and Talisadi churna in the management of kaphaja kasa (acute cough) in children of the age group 5-15 years |
| 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 Harikrishnan M |
| Designation |
Associate Professor |
| Affiliation |
Amrita School of Ayurveda |
| Address |
Associate Professor, Department of Kaumarabhritya, Amrita School of Ayurveda, Clappana PO, Vallikavu, Kollam , Kerala, India
Kollam
KERALA
690525
India |
| Phone |
9446262733 |
| Fax |
|
| Email |
drharikrishnan.m@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ajith Kumar R |
| Designation |
Professor |
| Affiliation |
Shri Jagdishprasad Jhabarmal Tibrewala University |
| Address |
Department of Ayurveda, First Floor Shri Jagdishprasad Jhabarmal Tibrewala University, Vidyanagari, Jhunjhunu, Churu Road, Chudela , Jhunjhunu, Rajasthan,India
Jhunjhunun
RAJASTHAN
333010
India |
| Phone |
8848384191 |
| Fax |
|
| Email |
ayudrajith@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Harikrishnan M |
| Designation |
Associate Professor |
| Affiliation |
Amrita School of Ayurveda |
| Address |
Associate Professor, Department of Kaumarabhritya, Amrita School of Ayurveda, Clappana PO, Vallikavu, Kollam , Kerala, India
Kollam
KERALA
690525
India |
| Phone |
9446262733 |
| Fax |
|
| Email |
drharikrishnan.m@gmail.com |
|
|
Source of Monetary or Material Support
|
| Amrita School of Ayurveda, Clappana PO, Vallikavu, Kollam , Kerala, India 690525 |
|
|
Primary Sponsor
|
| Name |
Amrita School of Ayurveda |
| Address |
Amrita School of Ayurveda, Clappana PO, Vallikavu, Kollam , Kerala, India 690525 |
| Type of Sponsor |
Other [Private Ayurveda 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 Harikrishnan M |
Amrita School of Ayurveda |
Department of Kaumarabhritya, Amrita School of Ayurveda, Clappana PO, Vallikavu, Kollam , Kerala, India 690525
Kollam
KERALA |
9446262733
drharikrishnan.m@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Committee Amrita School of Ayurveda |
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: KAPAJAKASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Kantakari Arka , Reference: Arka Prakasha , Route: Oral, Dosage Form: Arka, Dose: 5(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: -Water), Additional Information: -Nil | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Talisadi Churna , Reference: Charaka Chikitsa Sthana , Route: Oral, Dosage Form: Churna/ Powder, Dose: 1.75(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: -Honey), Additional Information: -Nil |
|
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
Subjects between the age group of 5-15 years
Children presenting with clinical features of Kaphaja Kasa as per classics will be selected.
Cough with chronicity less than seven days duration will be selected.
Parents who are ready to give written consent
|
|
| ExclusionCriteria |
| Details |
Subjects with Brochial Asthma, Pneumonia, Bronchiectasis, Lung abscess, Foreign body, Pertussis, Pulmonary Tuberculosis ,Respiratory distress , Cough associated with congenital anomalies and associated with infections
Kaphaja Kasa associated with Jwara
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To study the effect of Kantakari Arka in the management of Kaphaja Kasa
as compared to Talisadi Churna |
on 8th day and 21st day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To achieve an alternative treatment for Kaphaja Kasa
To Study literature of Kaphaja Kasa from Ayurvedic and modern point of view |
on 8th day and 21st day |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "120"
Final Enrollment numbers achieved (India)="120" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/02/2025 |
| Date of Study Completion (India) |
28/11/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 one of the commonest symptoms of respiratory diseases noticed during pediatric practice. Children with a predominance of Kaphadosha who indulge in Kaphakara Ahara and Vihara give rise to Kaphaja Kasa (one among the Pancha Kasa)—cough, which is productive in nature. Arkas are Laghupaki, Vyavayi, and Vikasi & thus assimilate quickly in the body. This Kalpana is easy to administer to the patients of Mridu Prakriti and those who hesitate to take medicines like Churna and Kwatha. Kantakari (Solanum xanthocarpum) is said to have Tikta and Katu rasa, Deepana pachana, and Laghu ruksha ushna sara guna. It has a good expectorant property and is considered an agraoushadhi for the conditions of Kasa. In this study, keeping in mind the palatability, longer preservation time, and quick assimilation in the body, Arka has been taken into consideration for the treatment. Talisadi is a churna combination of Talisapatra, Shunti, Maricha, Pippali, Twak, and Ela, where it possesses kaphavatahara property. This is taken as the comparator drug because of the other constituents’ mucolytic, expectorant, and antitussive properties |