CTRI Number |
CTRI/2023/08/056522 [Registered on: 16/08/2023] Trial Registered Prospectively |
Last Modified On: |
15/08/2023 |
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
|
A study on efficacy of Ardraka Arka along with standard care in the management of Bronchial Asthma(Tamaka shwasa) |
Scientific Title of Study
|
A Clinical Study on the add-on effect of the
Ardraka arka along with standard care in the
management of Tamaka Shwasa vis-a-vis 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 |
Dr Puja M S |
Designation |
PG Scholar,Department of PG studies in Kaumarabhritya |
Affiliation |
JSS Ayurveda Medical College, |
Address |
JSS Ayurveda Medical College,
Lalithadripura road, Alanahalli, Mysore, Karnataka. Department of pediatrics OPD 1088
JSS hospital
Mahatmagandhi road
Fort mohalla
Mysuru
570004 Mysore KARNATAKA 570028 India |
Phone |
6360657093 |
Fax |
|
Email |
pujams89@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Srihari S |
Designation |
Professor |
Affiliation |
JSS Ayurveda Medical College |
Address |
Department of PG studies in Kaumarabhritya, OPD 11
JSS Ayurveda Medical College,
Lalithadripura road, Alanahalli, Mysore, Karnataka.
Mysore KARNATAKA 570028 India |
Phone |
7776077626 |
Fax |
570028 |
Email |
dr.srihari@rediffmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Prashanth S N |
Designation |
Proffessor |
Affiliation |
JSS Medical College |
Address |
Department of Pediatrics OPD No 1088
JSS Medical college and Hospital,Mysore,Karnataka.
Mysore KARNATAKA 570028 India |
Phone |
9886553398 |
Fax |
|
Email |
prashanthsnped@yahoo.co.in |
|
Source of Monetary or Material Support
|
JSS Ayurveda Medical College and Hospital |
|
Primary Sponsor
|
Name |
DrPuja MS |
Address |
H.NO - 1-4-1493/13 IDSMT LAYOUT,
RAICHUR, KARNATAKA 584101
|
Type of Sponsor |
Other [] |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 2 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr Srihari S |
JSS Ayurveda Medical College And Hospital |
Department of PG studies in Kaumarabhritya
OPD 11
JSS Ayurveda Medical College and Hospital
Mysuru
570028
Mysore KARNATAKA |
7776077626
dr.srihari@rediffmail.com |
Dr Prashanth S N |
JSS Medical College and Hospital |
Department of Pediatrics OPD No 1088 JSS Medical College and Hospital Mahatma Gandhi Road Mysuru Karnataka. Mysore KARNATAKA |
9886553398
prashanthsnped@yahoo.co.in |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
JSS Ayurveda Medical College |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition:J452||Mild intermittent asthma. Ayurveda Condition: Tamaka shwasa, (2) ICD-10 Condition:J453||Mild persistent asthma. Ayurveda Condition: TAMAKA SHWASA, (3) ICD-10 Condition:J453||Mild persistent asthma. Ayurveda Condition: PRANAVAHASROTOVIKARAH, |
|
Intervention / Comparator Agent
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Comparator Arm (Non Ayurveda) | | - | Salbutamol ,Levosalbutamol, Terbutaline , Formoterol ,Salmeterol | The following group of standard drugs either used singularly or in a combination will be considered as standard drug intervention as per the reference of IAP.(Quick relievers,Controller,Long term symptom relievers)like
Salbutamol (5-11 years): Nebulizer, 2.5 mg every 4-6 hours with subsequent doses.
(12 years or more): Nebulizer, 2.5 mg every 6 hours as needed;
Levosalbutamol: half dose of salbutamol
Terbutaline (<12 years) : Nebulization, 0.01-0.03 mg/kg/dose with the minimum dose of 0.1 | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Ardraka Arka, Reference: Arka Prakasha, Route: Oral, Dosage Form: Arka, Dose: 12(ml), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: -honey), Additional Information: --Given along with standard care mentioned in IAP |
|
|
Inclusion Criteria
|
Age From |
6.00 Year(s) |
Age To |
15.00 Year(s) |
Gender |
Both |
Details |
1. Subjects who are known cases of Bronchial Asthma /Tamaka Shwasa and
are already on the treatment of modern medications.
2. Subjects of age group 6-15 years irrespective of gender, religion, caste and
socio-economic status.
3. Subjects having clinical symptoms of Tamaka Shwasa/ Bronchial Asthma:
4. Subjects falling under the mild persistent, mild intermittent and moderate
persistent types of bronchial asthma as per Nelson. |
|
ExclusionCriteria |
Details |
1.Subjects admitted to the hospital due to Asthma exacerbation within 4
weeks prior to the visit.
2.Any known uncontrolled systemic disease.
3.Severe persistent type of asthma will be excluded.
4.Patients with a history of any other diagnosed lung pathology.
5.Subjects incompatible for Spirometry evaluation. |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Alternation |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
To evaluate and compare the effect of Ardraka Arka as an Add-on therapy
along with standard care on the subjective parameters of Tamaka Shwasa |
84 days |
|
Secondary Outcome
|
Outcome |
TimePoints |
To evaluate & compare the changes in spirometry values before & after
treatment of Ardraka Arka along with the Standard care in Tamaka Shwasa. |
84 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 2 |
Date of First Enrollment (India)
|
28/08/2023 |
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="5" 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
|
Tamaka Shwasa is an illness of Pranavaha Srotas, originating in the
Pittasthana, caused due to the vitiation of Vata and Kapha Doshas and
afflicting the Rasa Dhatu. It is characterized by Shwasa Kruchrata, Kasa,
Ghurghuraka. Ayurveda describes Tamaka Shwasa as Yapya Vyadhi.
1 The
clinical symptomatology of Tamaka Shwasa is similar to that of Bronchial
asthma in contemporary science, which is one among the commonest
chronic illnesses in childhood period.
2
Bronchial asthma is defined as heterogenous disease characterized by the
symptoms of recurrent episodes of wheezing, breathlessness, chest
tightness and cough which vary over time intensity. The airways show
chronic inflammation, hyperresponsiveness, and airflow limitation which
is reversible, recurrent and variable.
3
Among the 1.3 billion people in India, about 6 % of children and 2% of
adults are affected with Bronchial asthma.
4 The prevalence of asthma is
increasing with time and additional 100 million people are expected to
develop asthma by the year 2025.
5
In a recent study (2021), overall
prevalence of Asthma, in the rural areas of North Karnataka was 4% among
5-16 years aged children.
6. Study from Mysore has reported a prevalence of
17.14% Asthma in children in the age group of 6–14 years also.
7 This
alarming raise in the prevalence of Bronchial Asthma can be accounted to
factors such as Atmospheric pollution (Rajodhuma), rapid environmental
6
changes, an adaptation of newer dietic preparations, excessive exercise
(Vyayama Karma), and tremendous psychological stress.8
Childhood Asthma is responsible for school absenteeism, restricted
activities, and psychological impact on the family also, there is impact on
socio-economic status, since there is increased unscheduled hospital visits.
Some of the common complications of bronchial asthma if left unattended,
are sinusitis, allergic rhinitis, urinary incontinence and psychological
problems like anxiety, depression and panic attacks.
9
In contemporary science, current challenges in pediatric asthma
management include Inhaled corticosteroids which may result in Growth
delay, irritable or difficult behavior and oral candidiasis.10
From 18th century A.D. onwards Arka Kalpana, the method of extracting
essence from medicinal plants, was extensively adopted in Ayurveda
medicine.11 The text Arka Prakasha has mentioned that, Ardraka Arka if
consumed cures Shwasa Roga.
12 Since Ardraka has Ushna Virya,
Vataanulomana properties and works on Kapha Dosha in Tamaka Shwasa
it removes the obstruction present in the Pranavaha Srotas caused by
Kapha. It is also proved to have Anti-Asthmatic13 property. Arka is
Shighrakari, does not vitiate Dosha and is devoid of all the Dosha.
14
Asthma is a condition where invasive interventions are necessary, and if
not, it might result in emergency condition. Hence, it may require the
continuation of consuming standard medications for children, devoiding
them of standard medications would be unethical. With this backdrop, this
7
study is designed to evaluate the add-on efficacy of Ardraka Arka in
Tamaka Shwasa along with standard care of management |