| 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
|
|
|
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
|
|
|
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. |
|
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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. |