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CTRI Number  CTRI/2024/12/078783 [Registered on: 31/12/2024] Trial Registered Prospectively
Last Modified On: 04/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Treatment for Tamaka shwasa(Bronchial asthma) by panchakarma in Ayurveda.  
Scientific Title of Study   A Clinical study to Evaluate the effect of Virechana karma on Interleukin(Inflammatory markers) in Tamaka shwasa(Bronchial asthma) A Single Arm Study. 
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 SHRIMANT G CHAVAN 
Designation  ASSOCIATE PROFESSOR 
Affiliation  Himalayiya Ayurvedic PG Medical College and Hospital Dehradun Uttarakhand 
Address  Out patient department Department of Panchakarma Room no 11 Himalayiya Ayurvedic PG Medical College and Hospital Dehradun Uttarakhand
GRAM FATEHPUR TANDA, MAJRI
Dehradun
UTTARANCHAL
248140
India 
Phone  09916863633  
Fax    
Email  drshrimantgc.bc@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR PRADEEP GRAMPUROHIT 
Designation  PROFESSOR  
Affiliation  KLEUs Shri B M K Ayurveda Mahavidhyalaya and Researchcentre Shahapur Belgaum Karnataka 
Address  Out patient department Department of Panchakarma KLEUs Shri B M K Ayurveda Mahavidhyalaya and Researchcentre Shahapur Belgaum Karnataka

Belgaum
KARNATAKA
590005
India 
Phone  09964144197  
Fax    
Email  pradeepgrampurohit@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR SHRIMANT G CHAVAN 
Designation  ASSOCIATE PROFESSOR 
Affiliation  Himalayiya Ayurvedic PG Medical College and Hospital Dehradun Uttarakhand 
Address  Out patient department Department of Panchakarma Room no 11 Himalayiya Ayurvedic PG Medical College and Hospital Dehradun Uttarakhand
GRAM FATEHPUR TANDA, MAJRI
Dehradun
UTTARANCHAL
248140
India 
Phone  09916863633  
Fax    
Email  drshrimantgc.bc@gmail.com  
 
Source of Monetary or Material Support  
Himalayiya Ayurvedic PG Medical College and Hospital Gram Fatehpur tanda Majri via Doiwala Dehradun District Dehradun State Uttarakhand Country India Pin code 248140 
 
Primary Sponsor  
Name  Dr Shrimant G Chavan 
Address  Out patient department Department of Panchakarma Room no 11 Himalayiya Ayurvedic PG Medical College and Hospital Gram Fatehpur tanda Majri Via Doiwala Dehradun Uttarakhand 
Type of Sponsor  Other [self] 
 
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 Shrimant G Chavan  Himalayiya Ayurvedic PG Medical College and Hospital   Himalayiya Ayurvedic PG Medical College & Hospital Gram- Fatehpur tanda, Via Doiwala, Dehradun, Uttarakhand 248140
Dehradun
UTTARANCHAL 
09916863633

drshrimantgc.bc@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KAHER ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:J22||Unspecified acute lower respiratory infection. Ayurveda Condition: TAMAKASVASAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Chitrakadi vati, Reference: Charaka Chikitsa stana 17th chapter 96 sloka, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: tds, Bhaishajya Kal: Abhakta, Duration: 5 Days, anupAna/sahapAna: Yes(details: -water), Additional Information: -
2Intervention ArmProcedure- स्नेहपान-कर्म (Procedure Reference: Snehapana, Procedure details: Ghrita paana In chronological dose )
(1) Medicine Name: Murchita Gritha, Reference: Bhishajya ratnavali Sneha kalpana, Route: Oral, Dosage Form: Ghrita, Dose: 60(ml), Frequency: sos, Duration: 7 Days
3Intervention ArmProcedure-virecana-karma, विरेचन-कर्म (Procedure Reference: Charaka kalpa stana, Procedure details: Virechana after Abhyanga & swedana)
(1) Medicine Name: Trivrut avaleha, Reference: Charaka kalpa stana 7 chapter, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 60(g), Frequency: od, Duration: 1 Days
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  • Chronicity less than 3-5 years.

• Mild to moderate grade of Bronchial asthma as per GINA.

• The patients having classical signs and symptoms of Tamakaswasa.

• PEFR 60% to 90% (Peak Expiratory flow rate).

• Patient who are fit for Virechana karma. 
 
ExclusionCriteria 
Details  The patient with chronic respiratory diseases includes history of Tuberculosis, Pneumonia, Pulmonary effusion.

History of cases of COPD.

Other complicated respiratory disease having any organic lesion or any anatomical defect in airways.

History of Cardiac troubles or any other Pathology.

Severe and disoriented asthmatic conditions.

Pregnant and lactating women.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Reduction in the levels of Interleukin 13  30days 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in the levels of Interleukin 13  30days 
Reduction in Symptoms   23days 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 
Date of First Enrollment (India)   16/01/2025 
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="2"
Months="6"
Days="1" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

A respiratory disorder, usually characterized by variable airflow limitation associated with airway inflammation and remodelling. Bronchial asthma is a chronic inflammatory disease of the airways. Tamaka Shwasa is nearer to bronchial asthma identified with airway obstruction, inflammation, producing extra mucus making it difficult to breath.The prevalence of bronchial asthma is increasingly alarming now a days due to increased air pollution, overcrowding, occupational conditions, stress and poor hygiene. Current Global Initiative for Asthma (GINA) guidelines reported that the prevalence is estimated to be 1 % to 18%. Studies have explored the potential role of indoor and outdoor allergens, microbial exposure, seasonal changes, diet, vitamins, breastfeeding, tobacco smoke, air pollution and obesity but no clear consensus has emerged. As per WHO 2019 health reports about 262 million people are suffering from bronchial asthma.  Annually 250000 deaths are attributed to asthma and its complications. It is estimated that there may be an additional 100 million persons with asthma, by 2025. It estimated that the prevalence of asthma in India is about 3% (30 million patients), with a prevalence of 2.4% in adults aged >15 years and between 4% and 20% in children. The current therapies used to treat Bronchial asthma are Corticosteroids, Anti-histamines and bronchodilators.These medications are similar in their adverse effect profile. Nervousness, Tachycardia, Palpitations, difficulty in sleeping are common adverse effects of all these agents. Long-term treatment with these drugs may produce serious adverse events. Cytokines are believed to have major role in inflammatory process of the airways of the lung. Interleukins play essential roles in the activation and differentiation of immune cells, as well as proliferation, maturation, migration, and adhesion. Interleukins also have pro-inflammatory and anti-inflammatory properties. Interleukins play important roles in the regulation of cytokines and signal transduction during the Ig-E synthesis and play a pivotal role in the pathobiology of asthma. The primary function of interleukins is, therefore, to modulate growth, differentiation, and activation during inflammatory and immune responses. The Interleukin-13 causes increased mucus production by epithelial cells, increased collagen synthesis by fibroblasts and inhibits pro-inflammatory cytokine production. Interleukin-13 works together with Interleukin-4 in producing biologic effects associated with allergic inflammation and in defence against parasites. Interleukins -13 is mostly responsible for airway hyper-responsiveness, mucus overproduction, and bronchial structural changes, Nitric oxide production, goblet cell metaplasia and fibroblast proliferation, as well as elicits contractile responses and hyperplasia of smooth muscle cells in the airways .The main Dosha involvement here is Kapha & Vata and the Gati of Vata is Pratiloma. The Pratiloma gati of Vayu must be brought to Anulomana. So, this pathogenesis is broken by Kapha Vataghna and Ushna guna Aushadha. And to achieve this, Virechana Karma is the process that does the Vata Anulomana and is Kapha-Vataghna. Secondly, Dusti of Pitta Sthana is the root cause of this disease and for removal of this Dushta Pitta Virechana Karma is said to the best procedure. Virechana Karma is indicated in Tamaka Shwasa. These cytokines exert key functions about inception, persistence and amplification of bronchial inflammation and remodeling. To test the hypothesis that serum IL-13 levels may be elevated in this cohort of patients, a property that could make them possible candidate biomarkers in determining asthma occurrence and severity. Serum Levels of IL-13, will be determined by an enzyme-linked immune-sorbent assay (ELISA). So, till now the studies to assess the effect of Virechana on inflammatory markers or on Interleukins has not been carried out in Tamaka shwasa (Bronchial asthma). Virechana karma as a prospective study. The study will be intendent to Evaluate the effect of Virechana karma on Interleukins (Inflammatory marker’s) in Tamaka shwasa (Bronchial Asthma)- Single arm Clinical study.

 

 
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