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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator Arm (Non Ayurveda)-Salbutamol ,Levosalbutamol, Terbutaline , Formoterol ,SalmeterolThe 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
2Intervention ArmDrugClassical(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 
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