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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  
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 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  
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 ArmDrugClassical(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: -
2Comparator ArmDrugClassical(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.

 
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