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CTRI Number  CTRI/2023/10/058923 [Registered on: 19/10/2023] Trial Registered Prospectively
Last Modified On: 09/10/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Management of Smoking induced Tamaka Shwasa through Ayurveda 
Scientific Title of Study   Clinical evaluation of Moorvadi Agad and Kalingadi Nasya in the management of Smoking induced Tamaka Shwasa 
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 Arti Vyas 
Designation  MD scholar 
Affiliation  Post Graduate Institute Of Ayurved Jodhpur Rajasthan 
Address  Pg Department Of Agad Tantra Post Graduate Institute Of Ayurved Dr S R Rajasthan Ayurved University Jodhpur Rajasthan

Jodhpur
RAJASTHAN
342037
India 
Phone  8107920415  
Fax    
Email  artivyas09@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ritu Kapoor 
Designation  Associate professor 
Affiliation  Post Graduate Institute Of Ayurved Jodhpur Rajasthan 
Address  Pg Department Of Agad Tantra Post Graduate Institute Of Ayurved Dr S R Rajasthan Ayurved University Jodhpur Rajasthan

Jodhpur
RAJASTHAN
342037
India 
Phone  9529831215  
Fax    
Email  drritukapoor4@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Ritu Kapoor 
Designation  Associate professor 
Affiliation  Post Graduate Institute Of Ayurved Jodhpur Rajasthan 
Address  Pg Department Of Agad Tantra Post Graduate Institute Of Ayurved Dr S R Rajasthan Ayurved University Jodhpur Rajasthan

Jodhpur
RAJASTHAN
342037
India 
Phone  9529831215  
Fax    
Email  drritukapoor4@gmail.com  
 
Source of Monetary or Material Support  
Post Graduate Institute Of Ayurved Jodhpur 
 
Primary Sponsor  
Name  Post Graduate Institute Of Ayurved Jodhpur Rajasthan 
Address  Post Graduate Institute Of Ayurved Jodhpur Dr S R Rajasthan Ayurved University Jodhpur 342037 
Type of Sponsor  Research institution and hospital 
 
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 Arti Vyas  Post Graduate Institute Of Ayurved Jodhpur  Post Graduate Institute Of Ayurved Jodhpur Dr S R Rajasthan Ayurved University Jodhpur 342037 Jodhpur RAJASTHAN
Jodhpur
RAJASTHAN 		 8107920415

artivyas09@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University, Jodhpur Post Graduate Institute of Ayurved Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:J705||Respiratory conditions due to smoke inhalation. Ayurveda Condition: TAMAKASVASAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Moorvadi agad, Reference: Ashtang sangraha uttar sthana 40/88, Route: Oral, Dosage Form: Churna/ Powder, Dose: 4(g), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: ushna jala), Additional Information: -
2Intervention ArmProcedure-nasyam/ nastam, नस्यम्/ नस्तम् (Procedure Reference: Sharangdhar samhita uttar khand 8/12, Procedure details: Kalka (paste) of required medicine should be prepared, placed in clean cloth & is squeezed directly into the nostril of the patient)
(1) Medicine Name: Kalingadi nasya, Reference: yogratnaakar nasaarogadhikar, Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 2(drops), Frequency: bd, Duration: 30 Days
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  a) Patient fulfilling the following general and diagnostic criteria was selected for the present study.
b) Patients diagnosed as Tamaka Shwasa based on clinical features mentioned in Ayurvedic texts.
c) Sex- either sex
d) Patients who are between 20-60 years will be selected.
e) Patient willing to sign the consent form.
f) Patient should be capable of obeying Pathya-apathya. 
 
ExclusionCriteria 
Details  a) Bronchial Carcinoma
b) COPD
c) Emphysema
d) Pleural Effusion
e) Tuberculosis Other Endocrine disorders like Diabetes, Thyroid dysfunction. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To assess the efficacy of Moorvadi Agad & Kalingadi Nasya in the management of smoking induced Tamaka Shwasa. The primary objective of the study is reducing objective criteria like Dyspnea, Constant Coughing, Comfort in sitting position Wheezing sound, Difficulty in speech, Comfort when sputum is expectorated, Common cold, Insomnia, Sweating on forehead, Discomfort in lying down position Unconsciousness, Dry mouth  30Days 
 
Secondary Outcome  
Outcome  TimePoints 
Improve quality of life  30 days 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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 3/ Phase 4 
Date of First Enrollment (India)   19/10/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  19/10/2023 
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)   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  
This study is single arm, an open label trial, with single group of 30 patients to assess the efficacy of Moorvadi Agad and Kalingadi Nasya in the management of smoking induced Tamaka Shwasa. The primary objective of the study is reducing subjective criteria like ï»¿ï»¿ï»¿ï»¿Dyspnea, Constant Coughing, Comfort in sitting position Wheezing sound, Difficulty in speech, Comfort when sputum is expectorated, Common cold, Insomnia, Sweating on forehead, Discomfort in lying down position Unconsciousness, Dry mouth. Moorvadi Agad will be administered with lukewarm water after meal in the dosage of 4gm orally thrice a day. Kalingadi Nasya will be administered in the form of nasal drops 1tsp powder form is soaked in lukewarm for one hour and squeeze out liquid through cloth in the dosage of 2-2 drops in each nostril twice a day.Total duration of the treatment is 30 days followed up once in a week regularly.
 
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