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CTRI Number  CTRI/2017/07/008986 [Registered on: 06/07/2017] Trial Registered Retrospectively
Last Modified On: 29/01/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda
Other (Specify) [Nebulization]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To compare the effect of Bharangimoola arka and Tamboolapatra arka when given as nebulization and understand which one is more effecient in the attack of Tamaka swasa in children 
Scientific Title of Study   A comparative clinical study on the efficacy of Bharangimoola arka and Tamboola patra arka nebulization in the management of Tamaka swasa 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 Greeshma Purushothaman 
Designation  Post Graduate Scholar 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital  
Address  Dept Of Kaumarabhritya, Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan 573201 Karnataka India

Hassan
KARNATAKA
573201
India 
Phone  9035751871  
Fax  918172256464  
Email  greeshma.p309@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vijayalaxmi Mallannavar 
Designation  ASSOCIATE PROFESSOR 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital  
Address  Dept Of Kaumarabhritya, Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan

Hassan
KARNATAKA
573201
India 
Phone  9480624829  
Fax  918172256464  
Email  drvijayalaxmim@sdmcahhassan.org  
 
Details of Contact Person
Public Query
 
Name  Dr Vijayalaxmi Mallannavar 
Designation  ASSOCIATE PROFESSOR 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital  
Address  Dept Of Kaumarabhritya, Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan


KARNATAKA
573201
India 
Phone  9480624829  
Fax  918172256464  
Email  drvijayalaxmim@sdmcahhassan.org  
 
Source of Monetary or Material Support  
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan 573201 Karnataka India 
 
Primary Sponsor  
Name  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital  
Address  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan 573201 Karnataka India 
Type of Sponsor  Other [Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Greeshma Purushothaman  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital  Department of Kaumarabhritya, Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, BM Road, Thanniruhalla, Hassan-573201, Karnataka, India
Hassan
KARNATAKA 
9035751871

greeshma.p309@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan 573201 Karnataka India  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Tamaka Swasa (Bronchial Asthama),  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Bharangimoola Arka  Bharangimoola Arka 3ml Nebulization 8th hourly, for 2 days  
Intervention  Tamboolapatra Arka  Tamboolapatra Arka 3ml Nebulization 8th hourly, for 2 days  
 
Inclusion Criteria  
Age From  8.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  1. Children of age group 8-12 years, irrespective of gender, religion and socio-economic status.
2. Children with mild to moderate exacerbation of asthma.
3. Parents who are consciously willing to participate their children in the study and ready to sign the informed assent form.
 
 
ExclusionCriteria 
Details  1. Children with H/o or presenting with tuberculosis, emphysema, chronic airway limitation, severe upper airway obstruction or any anatomical defect in airway.  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Subjective parameter as per GINA assessment criteria(2015) in which alertness, respiratory rate, pulse, wheeze, breathlessness, position, sputum, talk and tightness of chest are assessed as mild, moderate and severe.
Objective Parameters: Spirometry and Peak Expiratory Flow Rate  
2 days 
 
Secondary Outcome  
Outcome  TimePoints 
Overall health improvement
 
2 days 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   01/01/2017 
Date of Study Completion (India) 07/01/2018 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None Yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

The prevelance of respiratory disorders like Tamaka swasa is observed to be predominant in the early childhood. Tamaka swasa can be closely related to asthma owing to the similarity in the presenting features which includes wheezing, cough, chest tightnesss, difficulty in breathing and in severe cases disturbance to the day-to-day activities. Children are more prone to the respiratory disorders owing to the reduced immunity, hereditary factors or other external environmental factors like dust, pollen, pollution etc.

Nebulization is a method which has been in use for relieving the symptoms of the asthma attack. It involves suspension of fine vaporised liquid directly into the respiratory system and hence relieving the bronchospasm involved. Regular use of the modern medicines for nebulisation is found to have some adverse reactions. Hence, this study involves the suspension of the liquid extract of the drugs Bharangi (Clerodendrum serratum) and Tamboola (Piper betel) for the management of Tamaka swasa.

References of the drugs in possessing swasahara property have been explained widely in our classics. Both the drugs possesses katu tikta rasa, laghu ruksha guna and ushna virya which effectively alleviates and clears the vitiated kapha lodged in the pranavaha srotas, and channelizing the normal gati of vata. Thus, the symptoms of swasa is relieved.

This study involves the administration of Bharangi moola arka and Tamboola patra arka for children affected with the lakshanas of Tamaka swasa in the age group of 8-12 years. One group, consisting of 15 patients will be administered with Bharangi moola arka and the other group with Tamboola arka. 3ml of the medicine will be used 8th hourly for 2 days in the patients. Assessment of the treatment will be based on GINA assessment criteria and the spirometry and PEFR done before and after the administration of the medicine.

Statistical analysis of the study data will be performed using statistical software SPSS 20.0, unpaired t test and Wilcoxon test will be carried out for within the group analysis, paired t test and Mann Whitney for between the group analysis along with Repeated Measure ANOVA test.

The present study taken aims to provide an insight into the concept of Tamaka swasa based on the classical references and allied modern literature to study and document the comparative efficacy of the drug Bharangi and Tamboola in the form of arka for nebulization during the vegavastha of Tamaka swasa in children.

 
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