| CTRI Number |
CTRI/2023/06/053838 [Registered on: 13/06/2023] Trial Registered Prospectively |
| Last Modified On: |
12/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effectiveness of Chaturabhadravaleha on clinical features of Tamakaswasa in children |
|
Scientific Title of Study
|
To study the effectiveness of Chaturabhadravaleha on clinical features of Tamakaswasa in children - An open label randomized controlled clinical trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Murtujali Makanadar |
| Designation |
PG Scholar |
| Affiliation |
Rajiv Gandhi University of Health Sciences Bengaluru |
| Address |
OPD 7,8,9
Department of Kaumarabhritya
Shree Dharmasthala Manjunatheswara institute of Ayurveda and hospital Anchepalya Bengaluru
Bangalore
KARNATAKA
560074
India |
| Phone |
8105753013 |
| Fax |
|
| Email |
murtujaliim@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Girish Kumar SV |
| Designation |
Associate professor |
| Affiliation |
Rajiv Gandhi University of Health Sciences Bengaluru |
| Address |
OPD 7,8,9
Department of Kaumarabhritya
Shree Dharmasthala Manjunatheswara institute of Ayurveda and hospital Anchepalya Bengaluru
Bangalore
KARNATAKA
560074
India |
| Phone |
9449577136 |
| Fax |
|
| Email |
drgirishkumargowda@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Murtujali Makanadar |
| Designation |
PG Scholar |
| Affiliation |
Rajiv Gandhi University of Health Sciences Bengaluru |
| Address |
OPD 7,8,9
Department of Kaumarabhritya
Shree Dharmasthala Manjunatheswara institute of Ayurveda and hospital Anchepalya Bengaluru
Bangalore
KARNATAKA
560074
India |
| Phone |
8105753013 |
| Fax |
|
| Email |
murtujaliim@gmail.com |
|
|
Source of Monetary or Material Support
|
| SDM institute of Ayurveda and hopsital Anchepalya ,Bengaluru |
|
|
Primary Sponsor
|
| Name |
Dr Murtujali Makanadar |
| Address |
SDM institute of Ayurveda and hopsital Anchepalya Bengaluru |
| Type of Sponsor |
Other [self ] |
|
|
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 Murtujali Makanadar |
SDM ayurveda Hospital Bengaluru |
Anchepalya Kumabalgudu post
OPD 7,8,9
Department of Kaumarabhritya
Bangalore
KARNATAKA |
08105753013
murtujaliim@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Istitutional ethics committee, Sri Dharmasthala Manjunatheshwara institute of Ayurveda and hopsital Anchepalya Bnegaluru |
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: Chaturabhadravleha , Reference: Saxena Nirmal, editor, (2nd ed.). Vangasena Samhita, Nidanadhikar; Jvarachikista: chapter 4, verse 276.Varanasi: Chowkhambha Sanskrit series office, 2014; 36., Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 15(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -warm water), Additional Information: | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Kantakari avaleha , Reference: Sharangdhara madhyama khanda , Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 15(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -with warm water ), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
Children of age group 5 – 15 years fulfilling the diagnostic criteria, irrespective of gender, religion and socioeconomic status |
|
| ExclusionCriteria |
| Details |
1.Children of age below 5 years and above 15 years.
2.All other variety of Swasa apart from Tamakaswasa; Swasa an Anubhandha lakshana of any other condition
3. Acute or Severe persistent Asthma which required usage of Nebulisation / inhalation of nasal spray / any other immediate intervention.
4.Diagnosed cases of sever COPD, respiratory distress syndrome (RDS), Pneumonia, Pulmonary TB, and Status Asthmaticus
5.Any other systemic disorder which may interfere with trail |
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Grading Scale of asthama - swasakruchrata,pinasa ,kaphanistevana,ghurghuraka,muhrmuhrswasa,kasa ,kantadwamsa |
baseline, 30th day ,60th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of Peak exploratory flow rate |
Assessment will be done on every 15 days of the study |
|
|
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/ Phase 3 |
|
Date of First Enrollment (India)
|
27/06/2023 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Tamak swasa is one among the five varieties of Swasa roga explained in Ayurvedic literature under the broad spectrum of Pranavahasrotovikara. The clinical features of Tamakaswasa are more similar to that of Bronchial asthma, which is considered as 3rd leading cause of hospitalization under the age of 15 years. In India the prevalence rate of asthma in school going children has been reported between 5 to 11 % with peak incidence in 5 to 10 years of age group,Hence the study is planned to study the effectiveness of Chaturbhadravaleha on clinical features of Tamaka swasa in children of 5-15 years of age group a randomised controlled clinical trial Total 30 subjects fulfilling the diagnostic criteria ,attending Kaumarabhritya out patient department, SDMIAH, Anchepalya ,Bengaluru 1.study group -15 subjcet / Chaturabhadravelaha /5-15gm /BD/ Before food/Warm watre /30day. 2. control group -15subject /Kantakariavaleha /5-15gm /BD/Before food /Warm water /30days |