| CTRI Number |
CTRI/2024/03/064783 [Registered on: 27/03/2024] Trial Registered Prospectively |
| Last Modified On: |
26/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Diagnostic |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Assessing the effectiveness of Vasa Kantakari Kwatha a Kalpita yog in managing Swasha rog (Bronchial asthma) in children. |
|
Scientific Title of Study
|
Clinical study on Vasa Kantkari Kwath in the management of Shwasa (Bronchial Asthma) in children |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Darshana Jain |
| Designation |
UG Scholar |
| Affiliation |
Post Graduate Institute Of Ayurved DSRRAU Jodhpur |
| Address |
PG Department of Kaumarbhritya
Post Graduate Institute Of Ayurved DSRRAU Jodhpur
Nagaur Road Karwar Jodhpur Rajasthan
Jodhpur
RAJASTHAN
342037
India |
| Phone |
8302911283 |
| Fax |
|
| Email |
jaindarshi22@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Harish Kumar Singhal |
| Designation |
Associate Professor |
| Affiliation |
Post Graduate Institute Of Ayurved DSRRAU Jodhpur |
| Address |
PG Department of Kaumarbhritya
Post Graduate Institute Of Ayurved DSRRAU Jodhpur
Nagaur Road Karwar Jodhpur Rajasthan
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9636622206 |
| Fax |
|
| Email |
drharish_md@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Harish Kumar Singhal |
| Designation |
Associate Professor |
| Affiliation |
Post Graduate Institute Of Ayurved DSRRAU Jodhpur |
| Address |
PG Department of Kaumarbhritya
Post Graduate Institute Of Ayurved DSRRAU Jodhpur
Nagaur Road Karwar Jodhpur Rajasthan
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9636622206 |
| Fax |
|
| Email |
drharish_md@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Post Graduate Institute Of Ayurved DSRRAU Jodhpur
Nagaur Road Karwar Jodhpur Rajasthan India
342037 |
|
|
Primary Sponsor
|
| Name |
Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University PGIA Jodhpur |
| Address |
PG Department of Kaumarbhritya Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University PGIA Jodhpur |
| Type of Sponsor |
Government 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 Harish Kumar Singhal |
Post Graduate Institute of Ayurved DSRRAU Jodhpur |
OPD NO-4 PG Department of Kaumarbhritya
Post Graduate Institute Of Ayurved DSRRAU Jodhpur
Nagaur Road Karwar 342037 Rajasthan
Jodhpur
RAJASTHAN |
9636622206
drharish_md@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Post Graduate Institute of Ayurved |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J454||Moderate persistent asthma. Ayurveda Condition: TAMAKASVASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Vasa Kantakari Kwath, Reference: Kalpita Yoga, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: This Kwath preparation is a Kalpita yoga |
|
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1.Individual between age group of 5 to 12 years of both sexes.
2.All the case of both sexes, cast, and religion will be included in the study.
3.Children diagnosed as shwasa as per contemporary medical sciences as per clinical features mentioned in Ayurvedic texts.
4.Children with no family history of bronchial asthma.
|
|
| ExclusionCriteria |
| Details |
1.Children below 5 and above 12 years of age.
2.Patients suffering from chronic respiratory disorders like pulmonary tuberculosis, chronic lung disease, pulmonary edema, lung carcinoma will be excluded from present study.
3. Patient suffering from cardiac disease, chronic pulmonary disorders like tuberculosis, bronchiectasis, chronic lung disease, bronchogenic carcinoma etc will be excluded from study.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Primarily the improvement in the patient will be assessed mainly based on certain symptoms of the disease- Kasa (Cough), Shwasakrichchhata (Dyspnea), Ghurghuraka (Wheezing), Use of Accessory Muscles (Sternomastoid Activity), Nidralpata (Disturbance in Sleep),Bhasana kricchthta (Difficulty in Speaking), Nasal Discharge, Colour of Face will be assessed before treatment and after treatment on subsequent 7th day, 15th day, 30th day. |
7th, 15th, 30th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To investigate the impact of Vasa Kantakari Kwath on the frequency & severity of recurrent shwasa episodes in children.
To assess the effect of therapy, certain symptoms will be given scoring depending upon their severity.
A special scoring pattern will be adopted for the symptoms. Symptom Rating scale- For assessment of improvement in the clinical manifestation this will be used.
It is divided into four grades on the basis of severity of symptoms present as-0,1,2,3
Symptoms assessed will be-
Coughing, Wheezing, Dyspnoea, Use of accessory muscles (sternomastoid activity), Sleep disturbance, Difficulty in speaking, Nasal discharge, Colour of face.
|
30 days |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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)
|
03/04/2024 |
| 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="30" |
|
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
|
To explore clinical effectiveness of Vasa kantakari kwath in alleviating symptoms associated with shwasa in children . Study design is Single Arm Open Label. Duration of study will be 30 days for eligible 10 patients on the basis of inclusion criteria and symptoms will be assessed before and after treatment.
It will be given through oral route, and dosage will be decided on the basis of Young’s formula according to age of child. |