FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/04/065609 [Registered on: 12/04/2024] Trial Registered Prospectively
Last Modified On: 15/04/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   A clinical Study to evaluate the safety and efficacy of Pankajakasthuri Breathe Eazy excel powder  
Scientific Title of Study   A single arm clinical study to evaluate the efficacy of Pankajakasthuri Breathe Eazy excel powder in managing various respiratory Disorders 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrJHareendran Nair  
Designation  Managing Director and Founder  
Affiliation  Pankajakasthuri Herbal research Foundation  
Address  Pankajakasthuri Herbal research Foundation Pankajakasthuri Ayurveda Medical college Kattakkada Trivandrum

Thiruvananthapuram
KERALA
695572
India 
Phone  9447096201  
Fax    
Email  hareendrannair@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Shan Sasidharan 
Designation  Director Research and Development 
Affiliation  Pankajakasthuri Herbal Research Foundation 
Address  Pankajakasthuri Ayurveda Medical College Campus, Killy, Kattakada, Kerala, India,

Thiruvananthapuram
KERALA
695572
India 
Phone  09188325339  
Fax    
Email  drshan@pkhil.com  
 
Details of Contact Person
Public Query
 
Name  Shan Sasidharan 
Designation  Director Research and Development 
Affiliation  Pankajakasthuri Herbal Research Foundation 
Address  Pankajakasthuri Ayurveda Medical College Campus, Killy, Kattakada, Kerala, India,


KERALA
695572
India 
Phone  09188325339  
Fax    
Email  drshan@pkhil.com  
 
Source of Monetary or Material Support  
Pankajakasthuri Herbals India Pvt. Ltd, Poovachal, Thiruvananthapuram, Kerala, India Pin 695575 
 
Primary Sponsor  
Name  Pankajakasthuri Herbals India Pvt Ltd P 
Address  Poovachal, Thiruvananthapuram, Kerala, India 69575 
Type of Sponsor  Pharmaceutical industry-Indian 
 
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 Hareendran Nair J  Pankajakasthuri Ayurveda Medical College & PG Centre   Department of kayachikitsa Room No.1 PankajakasthuriAyurveda MedicalCollege & PG Centre,Killy, Kattakada,Thiruvananthapuram, Thiruvananthapuram KERALA
Thiruvananthapuram
KERALA 
9447096201

hareendrannair@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Independent Ethics Committee of Pankajakasthuri Herbal Research Foundation   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:J40-J47||Chronic lower respiratory diseases. Ayurveda Condition: SVASAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: Pankajakasthuri Breathe Eazy excel, Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 6 Months, anupAna/sahapAna: Yes(details: Hot water or honey), Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Age 18 Years and above
Patients willing to take Breathe
Eazy Excel Powder in a dose of 1 Tea spoon twice daily after food
continuously for a minimum period of 3 months.
Subjects
willing to enroll in study by signing Informed consent.
Subjects presenting with Allergic bronchitis, Allergic rhinitis, COPD,
Sinusitis, Eosinophilia and other Respiratory tract infections.
 
 
ExclusionCriteria 
Details  1 Patients allergic to the any of the ingredients of Breathe Eazy
Excel Powder.
2. Pregnant and Lactating mother. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Any marked change in safety parameters
measured during the administration of the
product.
• Reporting the effectiveness of this product in
the management of Allergic bronchitis, Allergic
rhinitis, COPD, Sinusitis, Eosinophilia and other
Respiratory tract infections and associated
complaints. 
0th-baseline1st-first time blood investigations
and 2nd-Blood investigations the end of the
study. 
 
Secondary Outcome  
Outcome  TimePoints 
Additional therapeutic advantages of the product  0th-baseline1st-first time blood investigations and
2nd-Blood investigations the end of the study. 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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)   22/04/2024 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

 

Respiratory disorders impose a significant burden on individuals’ health and well-being globally. Herbal formulations have gained attention for their potential in managing such conditions. This single-arm clinical study aimed to evaluate the efficacy of Pankajakasthuri Breathe Eazy Excel Powder in managing various respiratory disorders. A total of 200 participants diagnosed with respiratory disorders, including asthma, chronic bronchitis, and allergic rhinitis, were enrolled in the study. Participants were administered Pankajakasthuri Breathe Eazy Excel Powder according to the recommended dosage for a duration of 6 months. Primary outcomes included improvements in respiratory symptoms, lung function parameters, and quality of life scores, assessed through standardized tools. Secondary outcomes comprised safety profiles and adverse events associated with the intervention. Statistical analyses were conducted to assess the significance of changes observed pre- and post-intervention. The results demonstrated statistically significant improvements in respiratory symptoms, lung function parameters, and quality of life scores following the administration of Pankajakasthuri Breathe Eazy Excel Powder. Moreover, the intervention exhibited a favorable safety profile with minimal adverse events reported. These findings suggest that Pankajakasthuri Breathe Eazy Excel Powder holds promise as an effective and safe adjunctive therapy for managing various respiratory disorders. Further randomized controlled trials with larger sample sizes are warranted to corroborate these findings and establish the clinical utility of this herbal formulation.

 
Close