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CTRI Number  CTRI/2024/12/078234 [Registered on: 17/12/2024] Trial Registered Prospectively
Last Modified On: 11/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical trial to evaluate the effectiveness of Tamak Shwashar leha and role of Pranayam yoga in management of childhood Asthma  
Scientific Title of Study   A randomised Comparative Clinical Trial on Tamaka Shwas har leha and Anulom-Vilom Pranayam in the management of Tamak Shwas WSR to Childhood Asthma 
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 Sonam Angial 
Designation  M D Scholar 
Affiliation  state ayurvedic college and hospital Lucknow 
Address  Department of Kaumarabhritya OPD G13 State Ayurvedic College and Hospital Tulsidas Marg, Lucknow Uttar Pradesh

Lucknow
UTTAR PRADESH
226004
India 
Phone  8219791613  
Fax    
Email  angialsonam29@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mahesh Narayan Gupta 
Designation  Head of Department and Reader 
Affiliation  state ayurvedic college and hospital Lucknow 
Address  Department of Kaumarabhritya OPD G13 State Ayurvedic College and Hospital Tulsidas Marg, Lucknow Uttar Pradesh

Lucknow
UTTAR PRADESH
226004
India 
Phone  9415447523  
Fax    
Email  mngupta75@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Mahesh Narayan Gupta 
Designation  Head of Department and Reader 
Affiliation  state ayurvedic college and hospital Lucknow 
Address  Department of Kaumarabhritya OPD G13 State Ayurvedic College and Hospital Tulsidas Marg, Lucknow Uttar Pradesh

Lucknow
UTTAR PRADESH
226004
India 
Phone  9415447523  
Fax    
Email  mngupta75@yahoo.com  
 
Source of Monetary or Material Support  
State Ayurvedic college and Hospital, Lucknow 
 
Primary Sponsor  
Name  State Ayurvedic College and Hospital, Lucknow 
Address  State Ayurvedic College and Hospital, Tulsidas marg, Turiyaganj, Lucknow, U.P. Pincode 226004 
Type of Sponsor  Government medical college 
 
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 Sonam Angial  State Ayurvedic College and Hospital  Department of Kaumarabhritya OPD G13
Lucknow
UTTAR PRADESH 		 08219791613

angialsonam29@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Office of Institutional Ethics Committee, State Ayurvedic College and Hospital, Lucknow  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:J459||Other and unspecified asthma. Ayurveda Condition: TAMAKASVASAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: Tamak Shwas har leha, Reference: NA, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 3(g), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: -Rasna, Pippli, Draksha, Maricha, Haridra, Manjishtha, Guda, Tila Taila
2Comparator ArmDrugOther than Classical(1) Medicine Name: Tamak Shwas har leha, Reference: NA, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 3(g), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: -with Yoga intervention (Anulom-vilom pranayam)
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  10.00 Year(s)
Gender  Both 
Details  1. Cardinal features of childhood asthma
2. History of at least 3 attacks in last year  
 
ExclusionCriteria 
Details  1. Age less than 5 year and greater than 10 year
2. More than four short cases of oral corticosteriod with in the year preceding the screening visit
3. Shwas rog associated with complication i.e. Pneumothorax, Pnemonia 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Reduction in the severity of the and frequency of attack in childhood Asthma  Three months 
 
Secondary Outcome  
Outcome  TimePoints 
Effective reduced attack of asthma  2 months 
 
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   N/A 
Date of First Enrollment (India)   26/12/2024 
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="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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   The word Shwas means " difficulty in breathing" normally Shwas word represent to Tamak Shwas described in Ayurvedic text. Bronchial Asthma mentioned in modern medicine closely resembles with Tmak Shwas, is a major chronic airway disorder. In this clinical trial, we evaluate the effectiveness of Tamak Shwas har leh (Rasna, Pippli, Maricha, Haridra, Manjistha, Guda, Tila Taila) and role of Anulom- Vilom Pranayam in childhood asthma. 
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