| CTRI Number |
CTRI/2025/07/089977 [Registered on: 02/07/2025] Trial Registered Prospectively |
| Last Modified On: |
30/06/2025 |
| 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
|
Ayurvedic trial for treatment of kaphaja kasa in children |
|
Scientific Title of Study
|
A RANDOMIZED COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFECT OF KARMARANGADI LEHA AND KANTAKARI AVALEHA IN UPPER RESPIRATORY TRACT INFECTION WSR TO KAPHAJA KASA IN CHILDREN |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Raksha Bhat H |
| Designation |
BAMS PG SCHOLAR |
| Affiliation |
SDM College of Ayurveda Kuthpady udupi |
| Address |
Sri Dharmasthala Manjunatheshwara College of Ayurveda Hospital and Research Centre Kuthpady Udupi 574118
Udupi
KARNATAKA
574118
India |
| Phone |
8660187387 |
| Fax |
|
| Email |
rakshabhathebri@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nagaratna S Jartarghar |
| Designation |
Associate Professor Kaumarabhritya |
| Affiliation |
SDM College of Ayurveda Kuthpady udupi |
| Address |
Sri Dharmasthala Manjunatheshwara College of Ayurveda Hospital and Research Centre Kuthpady Udupi 574118
Udupi
KARNATAKA
574118
India |
| Phone |
8971518695 |
| Fax |
|
| Email |
nagaratnar@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Raksha Bhat H |
| Designation |
BAMS PG SCHOLAR |
| Affiliation |
SDM College of Ayurveda Kuthpady udupi |
| Address |
Sri Dharmasthala Manjunatheshwara College of Ayurveda Hospital and Research Centre Kuthpady Udupi 574118
Udupi
KARNATAKA
574118
India |
| Phone |
8660187387 |
| Fax |
|
| Email |
rakshabhathebri@gmail.com |
|
|
Source of Monetary or Material Support
|
| KAUMARABHRITYA OPD NUMBER 11 SDM AYURVEDA HOSPITAL KUTHPADY UDUPI 574118
Karnataka India |
|
|
Primary Sponsor
|
| Name |
SDM COLLEGE OF AYURVEDA HOSPITAL AND RESEARCH CENTRE KUTHPADY UDUPI |
| Address |
Sri Dharmasthala Manjunatheshwara College of Ayurveda Hospital and Research Centre Kuthpady Udupi India 574118 |
| 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 Raksha Bhat H |
SDM AYURVEDA HOSPITAL KUTHPADY UDUPI |
Kaumarabhritya OPD Number 11 Sri Dharmasthala Manjunatheshwara College of Ayurveda Hospital and Research Centre Kuthpady
Udupi
KARNATAKA |
08660187387
rakshabhathebri@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL CLEARANCE COMMITTEE HUMAN |
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, (2) 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 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Karmarangadi leha, Reference: NA, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 3(g), Frequency: qid, Bhaishajya Kal: Abhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: Sukoshna jala), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Kantakari avaleha, Reference: Sharangadhara samhita, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 3(g), Frequency: qid, Bhaishajya Kal: Abhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: Sukoshna jala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
1 Children of either gender aged between 2 to 6 years presenting with signs and symptoms of upper respiratory tract infection Kaphaja kasa with 2 or more symptoms mentioned under the diagnostic criteria |
|
| ExclusionCriteria |
| Details |
Children suffering from lower respiratory tract infections
Kasa as a complication of other systemic illness which interferes with treatment
Children with peritonsillar abscess Parapharyngeal abscessIntratonsillar abscess
Tonsilloliths tonsillar cyst
Children suffering from other acute and chronic systemic illness and undergoing other interventions |
|
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Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Karmarangadi leha may show better results in management of kaphaja kasa in comparison to Kantakari avaleha in children |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Karmarangadi leha may have better results on cough enlarged tonsils and headache |
30 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 3 |
|
Date of First Enrollment (India)
|
17/07/2025 |
| 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="0"
Months="0"
Days="6" |
|
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
|
Acute respiratory infections are a major cause of morbidity and mortality in children significantly in developing countries The overall incidence of acute respiratory infection under five may be three to eight episodes for a child every year kasa is one of the commonly seen disease in pediatric practice As childhood period is predominant of kapha dosha child adhered to madhura snigdha ahara and diwaswapna vihara will further vitiate kapha and obstruct vata and cause kaphaja kasa recurrent use of antibiotics may destroy gut microbiota there are many herbal drugs which alone or in combination is used to treat the kaphaja kasa especially in children hence one among the formulation practiced by folklore practitioner since ages are taken for present study after the acute oral toxicity study has been finished to evaluate effect of karmarangadi leha in treating kaphaja kasa I children in comparison with kantakari avaleha |