CTRI Number |
CTRI/2025/04/084547 [Registered on: 11/04/2025] Trial Registered Prospectively |
Last Modified On: |
11/04/2025 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Ayurveda Preventive |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
To Evaluate Efficacy of Ashwagandhadi Churna in the Management of Tamak Shwasa |
Scientific Title of Study
|
An Open Labelled Active-controlled Randomized Clinical Study To Evaluate The Efficacy Of Ashwagandhadi Churna In Tamak Shwasa With Special Reference to Bronchial 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 Stuti Parmar |
Designation |
PG Scholar |
Affiliation |
Parul Institute of Ayurved |
Address |
Opd No 116 Department of Kayachikitsa Parul Ayurved Hospital Parul university AP-Limda TAL-Waghodia Vadodara Gujarat
Vadodara GUJARAT 391760 India |
Phone |
9662665700 |
Fax |
|
Email |
parmarstuti05@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Manu R |
Designation |
Professor |
Affiliation |
Parul Institute of Ayurved |
Address |
Opd No 116 Department of Kayachikitsa Parul Ayurved Hospital Parul university AP-Limda TAL-Waghodia Vadodara Gujarat
Vadodara GUJARAT 391760 India |
Phone |
8160858967 |
Fax |
|
Email |
manu.r260022@paruluniversity.ac.in |
|
Details of Contact Person Public Query
|
Name |
Dr Manu R |
Designation |
Professor |
Affiliation |
Parul Institute of Ayurved |
Address |
Opd No 116 Department of Kayachikitsa Parul Ayurved Hospital Parul university AP-Limda TAL-Waghodia Vadodara Gujarat
Vadodara GUJARAT 391760 India |
Phone |
8160858967 |
Fax |
|
Email |
manu.r260022@paruluniversity.ac.in |
|
Source of Monetary or Material Support
|
Parul Institute of ayurved Parul university Ap-Limda Tal-Waghodia Dis-vadodara Gujarat India-391760 |
|
Primary Sponsor
|
Name |
Parul Institute of Ayurved |
Address |
Faculty of Ayurved Parul university Ap-Limda Tal-Waghodia Dis-vadodara Gujarat India-391760 |
Type of Sponsor |
Private medical college |
|
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 Stuti Parmar |
Parul Ayurved Hospital |
Opd No.116 Department of Kayachikitsa Parul Ayurved Hospital Parul university AP-Limda TAL-Waghodia Vadodara Gujarat Vadodara GUJARAT |
9662665700
parmarstuti05@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Parul Institute of Ayurved |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition:J459||Other and unspecified asthma. Ayurveda Condition: TAMAKASVASAH, |
|
Intervention / Comparator Agent
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Ashwagandhadi Churna, Reference: Sahsrayoga Churna Prakaran, Route: Oral, Dosage Form: Churna/ Powder, Dose: 12(g), Frequency: qid, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -warm water), Additional Information: - | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: talishadi Churna, Reference: Charaksamhita chikitsasthana chapter 8, Route: Oral, Dosage Form: Churna/ Powder, Dose: 12(g), Frequency: qid, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -warm water), Additional Information: - |
|
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
65.00 Year(s) |
Gender |
Both |
Details |
Patients diagnosed with well controlled and partly controlled Bronchial Asthma as per GINA 2024 Guideline of Bronchial Asthma
Patients with Prebronchodilator FEV1 of Greater than 60 Percentage of the predicted value
Patient willing to sign the informed consent and can participate in the study procedure
|
|
ExclusionCriteria |
Details |
Pregnant or lactating women
Known cases of Diabetes, uncontrolled hypertension, heart disease, secondary severe infections, Pleural effusion, pneumonia and pneumothorax, etc.
Uncontrolled Bronchial Asthma as per GINA Guidelines 2024
Severe Bronchial Asthma as per GINA Guidelines 2024
Patients with Prebronchodilator FEV1 Less than 60 Percentage of the predicted value
History of upper or lower respiratory tract infection, within the previous 30 days
History of lung resection of more than one full lobe
Have a known sensitivity to formoterol, ipratropium, and salbutamol etc medicine
Immunocompromised status such as HIV, tuberculosis, cancer, etc
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
Method of Concealment
|
Pre-numbered or coded identical Containers |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
To assess Immunomodulatory and Bronchodilator effect of Ashwagandhadi Churna in the managemnet of Bronchial Asthma on the basis of spirometry of GINA Guidelines 2024 |
Spirometry-On Screening visit and 60th day |
|
Secondary Outcome
|
Outcome |
TimePoints |
To assess Immunomodulatory and Bronchodilator effect of Ashwagandhadi Churna in the managemnet of Bronchial Asthma on the basis of IgE,WBC and Asthma Control Quiestionnaire |
IgE-On Screening visit and 60th day
WBC-On Screening visit and 60th day
Asthma Control Quiestionnaire-On Screening visit , 15TH days, 30TH days, 45TH days sand 60th day
|
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
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)
|
01/05/2025 |
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
|
N/A |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Bronchial Asthma is a chronic inflammatory disorder of the airways involving various cells and cellular components. This inflammation causes airway hyper-responsiveness, leading to repeated episodes of wheezing, breathlessness, chest tightness, and coughing, especially during the night or early morning. Over the past few decades, the prevalence of asthma has increased, affecting individuals of all age groups. It is now recognized as a major contributor to global disability. While genetics play a role in the development and progression of asthma, the rapid rise in its prevalence points to the significant influence of environmental factors. A key feature of asthma is airway hyper-reactivity, where the airways respond excessively to harmless triggers. The loss of immune tolerance to inhaled allergens is considered a leading cause of asthma, resulting in an abnormal immune response. In Ayurveda, Bronchial Asthma is correlated with Tamaka Shwasa, a chronic disorder of the pranavaha srotas that disturbs daily activities with symptoms like cough and difficulty in breathing. Tamaka Shwasa is identified as a Swatantra Vyadhi with distinct causes and treatments. Classical texts describe it as a palliative or difficult-to-cure disease, requiring proper management and lifestyle adaptations. Pathologically, Tamaka Shwasa occurs due to an imbalance of Kapha and Vata doshas, often triggered by cold, dry food or seasonal changes, leading to airway obstruction. Ayurvedic formulations like Ashwagandhadi churna help in managing the condition by pacifying Vata and removing Kapha-induced blockages in the airways. Globally, asthma affects around 300 million people, with numbers expected to rise to 400 million by 2025. It is more prevalent in males, with a 2 to 1 male to female ratio. Asthma remains a major health concern, particularly in low and middle income countries, contributing to high treatment costs and productivity losses. |