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CTRI Number  CTRI/2022/09/045966 [Registered on: 27/09/2022] Trial Registered Prospectively
Last Modified On: 07/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical trial to study the effect of Kanakasava Nebulizer Solution in Patients with COPD 
Scientific Title of Study   An open labelled randomized active controlled evaluation of effect Of Kanakasava nebulizer solution in chronic obstructive pulmonary disease(COPD) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rashmi S Chojer  
Designation  P G Scholar  
Affiliation  Parul Institute of Ayurveda 
Address  OPD No 116 Department of Kayachikitsa Parul Ayurved Hospital Parul University AP Limda Tal Waghodia Vadodara Gujarat

Vadodara
GUJARAT
391760
India 
Phone  7973659766  
Fax    
Email  rashmi.chojer@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shailesh V Deshpande 
Designation  Professor 
Affiliation  Parul Institute of Ayurveda 
Address  OPD No 116 Department of Kayachikitsa Parul Ayurved Hospital Parul University AP Limda Tal Waghodia Vadodara Gujarat

Vadodara
GUJARAT
391760
India 
Phone  9763104451  
Fax    
Email  dr.shaileshd@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Vaishali S Deshpande 
Designation  Professor 
Affiliation  Parul Institute of Ayurveda and Research 
Address  OPD No 8 Khemdas Ayurved Hospital Parul Institue of Ayurveda and Research Limda Waghodia Vadodara

Vadodara
GUJARAT
391760
India 
Phone  9096082950  
Fax    
Email  dr.vaishalid@gmail.com  
 
Source of Monetary or Material Support  
Parul institute of ayurved, Parul university 
 
Primary Sponsor  
Name  Dean Faculty of Ayurved Parul University 
Address  Parul University AP Limda Tal Waghodia Vadodara Gujarat 
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 Rashmi S Chojer  Parul Institute of Ayurved   OPD No 116 Department of Kayachikitsa Parul Ayurved Hospital Parul University AP Limda Tal Waghodia Vadodara Gujarat
Vadodara
GUJARAT 		 7973659766

rashmi.chojer@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Parul Institute of Ayurved-Institutional Ethics Committee for Human Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:J449||Chronic obstructive pulmonary disease, unspecified. Ayurveda Condition: SVASAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator Arm (Non Ayurveda)-Asthalin Respirator Solution 2.5 mg Salbutamol Nebulization will be done at the baseline(0 hour),6 hour,18 hour and at the end of 24 hours.
2Intervention ArmDrugOther than Classical(1) Medicine Name: Kanakasava Nebulizer solution, Reference: NA, Route: Nasal, Dosage Form: Arka, Dose: 3(ml), Frequency: qid, Bhaishajya Kal: Muhurmuhu, Duration: 1 Days, anupAna/sahapAna: No, Additional Information: Kanakasava nebulizer solution will be given to the patients at baseline,6 hours, 18 hours and at the end of 24 hours.
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1 Patients between age group 18 to 60 years (both years inclusive) of either gender.
2 Patients diagnosed with Mild to Moderate COPD as per GOLD Guidelines 2020.
3 Patients with symptom of Shwaskashta (Dyspnea) even while resting.
4 Willing and able to give written informed consent.
 
 
ExclusionCriteria 
Details  1 Pregnant or Lactating women
2 History of any chronic respiratory disease other than COPD
3 Patients with known case of Systemic Diseases like Uncontrolled Diabetes and Hypertension.
4 Severe cases of COPD as per GOLD guidelines 2020.
5 History of upper or lower respiratory tract infection, within the previous 30 days.
6 History of lung resection of more than one full lobe.
7 Have a known sensitivity to formoterol, ipratropium, salbutamol.
8 Immunocompromised status such as HIV.
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Effect on COPD on the basis of FEV1( through spirometry)
Effect on COPD on the basis of Peak flow meter 		 Assessment at baseline(0 hour) and at the end of 24 hours
Assessment at baseline(0 hour), 6 hour, 18 hour and the end of 24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
Effect on COPD on the basis of CAT Score
Effect on COPD on the basis of symptom of Shwasakashta(dyspnea) 		 Assessment at baseline(0 hour), 6 hour, 18 hour and the end of 24 hours
Assessment at baseline(0 hour), 6 hour, 18 hour and the end of 24 hours 
 
Target Sample Size   Total Sample Size="72"
Sample Size from India="72" 
Final Enrollment numbers achieved (Total)= "73"
Final Enrollment numbers achieved (India)="73" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   01/10/2022 
Date of Study Completion (India) 11/09/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 11/09/2023 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Chronic obstructive pulmonary disease (COPD) is a common progressive disease that is characterized by persistent respiratory symptoms and airflow limitation that is due to airway and/or alveoli abnormalities usually caused by exposure to noxious particles or gases and influenced by host factors including abnormal lung development.
According to Ayurveda, respiratory diseases can be corelated with Pranavaha strotas vikara where cough, breathing difficulties, disturbed respiratory pattern etc. are the main clinical features. Though it is impossible to correlate COPD with any single disease of Pranavaha stroto dushti, but advanced conditions of diseases such as Kasa and Shwasa may result in the conditions which  resembles with COPD.
Kanakasava is a potent anti-asthmatic polyherbal formulation mentioned in Bhaishajya Ratnavali in Hikka/Shwasa Rogadhikara. Kanakasava aqueous solution will be made through simple distillation method of drug extraction. This solution will be administered with the help of nebulizer - a delivery device used to administer medication in the form of a mist inhaled directly in to the lungs and its effectiveness in the form of nebulizer solution will be seen in the management of COPD. 
 
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