| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J40-J47||Chronic lower respiratory diseases. Ayurveda Condition: SVASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other 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. |