| CTRI Number |
CTRI/2024/05/067896 [Registered on: 27/05/2024] Trial Registered Prospectively |
| Last Modified On: |
23/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical trial to study the combined effect of Ayurvedic formulations in Bronchial Asthma. |
|
Scientific Title of Study
|
An Open label, Single arm, Interventional trial to study the Efficacy and Safety of Shwasakuthara rasa and Kasahara kashaya in Tamaka Shwasa W.S.R. to Bronchial Asthma. |
| 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 Deval Kevadiya |
| Designation |
MD Scholar |
| Affiliation |
National Institute of Ayurveda, Deemed to be University, Jaipur |
| Address |
Department of Kayachikitsa, National Institute of Ayurveda, Jorawar Singh Gate,Jaipur Rajasthan 302002
Jaipur
RAJASTHAN
302002
India
Jaipur
RAJASTHAN
302002
India |
| Phone |
9723904588 |
| Fax |
|
| Email |
devalkevadiya14@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abhishek Upadhyay |
| Designation |
Assistant Professor |
| Affiliation |
National Institute of Ayurveda, Deemed to be University, Jaipur |
| Address |
Department of Kayachikitsa, National Institute of Ayurveda, Jorawar Singh Gate,Jaipur Rajasthan 302002
Jaipur
RAJASTHAN
302002
India
Jaipur
RAJASTHAN
302002
India |
| Phone |
9915613039 |
| Fax |
|
| Email |
dr.abhishek82@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deval Kevadiya |
| Designation |
MD Scholar |
| Affiliation |
National Institute of Ayurveda, Deemed to be University, Jaipur |
| Address |
Department of Kayachikitsa, National Institute of Ayurveda, Jorawar Singh Gate,Jaipur Rajasthan 302002
Jaipur
RAJASTHAN
302002
India
Jaipur
RAJASTHAN
302002
India |
| Phone |
9723904588 |
| Fax |
|
| Email |
devalkevadiya14@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda ,Deemed to be university, Madhav Vilas Palace, Amer road, Jaipur, Rajasthan 302002, India |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda Deemed to be University |
| Address |
Madhav Vilas Palace, Amer road, Jaipur, Rajasthan 302002, India |
| 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 Deval Kevadiya |
National Institute of Ayurveda(De-novo) |
OPD No 1,18,22(Kayachikitsa) at Hospital of
National Institute of Ayurveda, Deemed to be university, Madhav Vilas Palace, Amer road, Jaipur 302002
Jaipur
RAJASTHAN |
9723904588
devalkevadiya14@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, National Institute of Ayurveda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J452||Mild intermittent asthma. Ayurveda Condition: TAMAKASVASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Shwasakuthara rasa , Reference: Yogatarangini , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: Kwath), Additional Information: -(2) Medicine Name: Kasahara Kashaya , Reference: Charaka Samhita , Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 12(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 28 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients of either sex in age group of 18-60 years.
2. patients with intermittent, mild- persistent and moderate persistent asthma according to GINA classification.
3.Patients presenting with symptoms of allergic rhinitis and having associated asthma symptoms as per GINA classification.
4.Patients who have not received any AYUSH intervention in last 15 days for related symptoms.
|
|
| ExclusionCriteria |
| Details |
1.Patients having acute exacerbation of asthma at the time of recruitment.
2.Patients having severe persistent asthma as per GINA classification.
3.Patient having any acute respiratory infection or have received any modern medication for such illness in last 15 days.
4.Patients having past or recent diagnosis/treatment of tuberculosis, pneumonia, COPD, bronchiectasis.
5.Patient having history of any hypersensitivity to any of the ingredient/s of the trial drugs.
6.Patients having history or diagnosis of any type of malignancy.
7.Patients on regular anti allergic medications.
8.Patients receiving aspirin, oral corticosteroids or are on regular inhaled corticosteroids.
9.Patients on immunotherapy for allergy.
10.Patients with Hemoglobin less than 9.0 g/dl.
11.Patients having concomitant systemic illness like uncontrolled hypertension, poorly controlled diabetes, renal failure, and severe acute or chronic liver disease.
12.Pregnant and lactating mothers
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in Asthma control questionnaire (ACQ) score from baseline value at the end of 4th week. |
0,2 week,4 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Changes in Peak expiratory flow rate (PEFR) and FEV1 and FVC; in Fractional exhaled Nitric Oxide (FeNO) value; in Absolute Eosinophil count, IgE value from baseline value at the end of 4th weeks.
Changes in Asthma Quality of Life (AQLQ) score from baseline value at the end of 4th week.
Average reduction in use of rescue medication from baseline score at the end of 4th week.
|
0,2 week,4 week |
|
|
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 |
|
Date of First Enrollment (India)
|
01/08/2024 |
| 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="1"
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
|
Ayurvedic literature has vast references of formulations indicated for clinical conditions similar to asthma. On the basis of those references, “Shwasakuthara Rasa†and “Kasahara Kashaya†have been selected for the present clinical study. Shwasakuthara Rasa is a herbo-mineral formulation mentioned for the management of Shwasa whereas Kasahara Kashaya is described by Acharya Charaka as Mahakashaya having ten herbal ingredients for the treatment of cough. Previous studies have reported beneficial effects of Shwasakuthara Rasa in management of asthma. Present trial will focus on assessment of combined efficacy and safety of Shwasakuthara Rasa and Kasahara Kashaya in asthma. |