FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/05/086276 [Registered on: 05/05/2025] Trial Registered Prospectively
Last Modified On: 03/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Treatment of breathing difficulty 
Scientific Title of Study   An open labelled RCT study to assess the combined efficacy of virechanottara agnimukha churna over sapta balaadhanita maricha vati alone in the management of tamaka shwasa (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  Afrin M 
Designation  Kayachikitsa post graduate scholar 
Affiliation  Taranath Government Ayurvedic Medical College and Hospital,Bellary,Karnataka 
Address  Department of Pg studies in Kayachikitsa, Taranath Government Ayurvedic Medical College and Hospital,DR Rajkumar Road,Bellary

Bellary
KARNATAKA
583101
India 
Phone  9353137150  
Fax    
Email  moratlaafrin@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Fareeda Begum Shaikh 
Designation  Professor  
Affiliation  Taranath Government Ayurvedic Medical College and Hospital,Bellary,Karnataka 
Address  Department of Pg studies in Kayachikitsa,Taranath Government Ayurvedic Medical College and Hospital, DR Rajkumar Road Bellary

Bellary
KARNATAKA
583101
India 
Phone  9886478611  
Fax    
Email  drfareedabegumshaikh@gmail.com  
 
Details of Contact Person
Public Query  
Name  Afrin M 
Designation  Kayachikitsa post graduate scholar 
Affiliation  Taranath Government Ayurvedic Medical College and Hospital,Bellary,Karnataka 
Address  Department of Pg studies in Kayachikitsa,Taranath Government Ayurvedic Medical College and Hospital, DR Rajkumar Road Bellary

Bellary
KARNATAKA
583101
India 
Phone  9353137150  
Fax    
Email  moratlaafrin@gmail.com  
 
Source of Monetary or Material Support  
Department of PG studies in kayachikitsa ,room no 1, Taranath Government Ayurvedic Medical College and hospital,DR.Rajkumar road,Ballari 583101, karnataka  
 
Primary Sponsor  
Name  Taranath Government Ayurvedic Medical College and Hospital Bellary 
Address  Taranath Government Ayurvedic Medical College and hospital,DR.Rajkumar road,Ballari-583101, Karnataka  
Type of Sponsor  Government 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 Afrin M  Taranath Government Ayurvedic Medical College and Hospital   Department of Pg studies in Kayachikitsa, Taranath Government Ayurvedic Medical College and Hospital,DR Rajkumar Road,bellary
Bellary
KARNATAKA 		 09353137150

moratlaafrin@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee of Taranath Government Ayurvedic Medical college, Ballari   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:J454||Moderate persistent asthma. Ayurveda Condition: TAMAKASVASAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: agnimukachoorna, Reference: yogartnakara ajirna chitkistsa shloka no -73-78, Route: Oral, Dosage Form: Churna/ Powder, Dose: 500(mg), Frequency: qid, Bhaishajya Kal: Adhobhakta, Duration: 20 Days, anupAna/sahapAna: Yes(details: sukhoshna jala), Additional Information: -
2Comparator ArmDrugClassical(1) Medicine Name: sapta balaadhanita maricha vati, Reference: charaka ,kalpa stana 12th , 47th shloka, bhavaprakasha , haritakyadi varga , 55-56 , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: qid, Bhaishajya Kal: Adhobhakta, Duration: 34 Days, anupAna/sahapAna: Yes(details: -madhu,ghrita,sharkara), Additional Information: -
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Subjects with breathlessness(shwasa krichrata),cough (kasa), wheezing( ghurghuraka) kapha nishtivana
 
 
ExclusionCriteria 
Details  Pregnant and lactating women
Subjects suffering from chronic systemic illness 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Improvement in shwasa krichrata,kasa,kapha nishtivana,ghur ghuraka  34 days 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in spirometry
AEC
Eosinophill percentage
IgE
 		 34 days  
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   24/05/2025 
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="0"
Months="1"
Days="11" 
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  
Bronchial asthma1 is a major disorder interrupting the lifestyle of an individual. Chronic recurrent airway diseases are increasingly seen all over the world due to atmospheric pollution, rapid environmental change, diet and lifestyle changes which has complex pathology, involving airway inflammation, intermittent obstruction, bronchial hyperresponsiveness, varying degrees of mononuclear cell and eosinophilic infiltration, mucus hyper secretion, desquamation of epithelium, along with smooth muscle hyperplasia, partially reversible due to airway remodeling. Anti-inflammatory, Antibiotic, Bronchodilation, Mucolytic and Anti-tussive medications are effective in the management of Bronchial asthma.
Tamaka shwasa mentioned in ayurvedic texts simulates with Bronchial asthma mentioned in western science, of Pranavaha srotas, predominantly Kapha vataja vyadhi originating from Pitta sthana, Kasta sadhya and Yapya vyadi. It is estimated with the of prevalence of 2.4 % adults in India2. Inspite of enormous development in modern science, a cost effective, Detoxification, Rejuvenation, Metabolic Improvement, Anti-inflammatory, Anti-viral, Immunomodulatory, Spirometry evidence-based regime is needed.
The research question is whether Kapha vatahara and pitta sthana pratyanika Virechana karma followed by oral admistration of Rasayana kalpa over Sapta balaadhanita Maricha vati alone is effective or not. In one group verticle research on Shodhana and Rasayana will be studied and compared with an Ekamoolika which will help in the general practice.
Virechana karma indicated in Tamaka shwasa3 which is Vata anulomaka, Kaphahara and removes mainly Kapha pitta doshas. Deepana pachana with Nayopayam kashaya4 as it does Amapachana and is Shwasa kasaharam param. Shodhananga Snehapana with Kantakari ghrita5 is kapha vatahara which acts as expectorant and clears the airways. Vishramakaleena abhyanga with Murchita tila taila6 helps to resolve Bronchospasm also. Virechana will be administered with Murchita eranda taila7 which is Vatanulomaka and Balya.
Agnimukha churna8 is polyherbal formulation having Hingu, Vacha, Pippali, Sringavera, Yavani, Haritaki, Chitraka, Kusta possesses properties like kapha vataghna, Kasa Shwasa nihanti ashu, Kshaya nashanam, Shula hara, Gulma hara.
Alone Sapta balaadhanita Maricha vati9,10 has kapha hara property, which acts as Mucolytic agent and helps to liquify the accumulated mucous in the airways. Piperine which is phytoconstituent of maricha helps to reduce Th2 cytokines (interleukin 4 and 5) and Histamine production. Its anupana are Ghrita, Kshoudra and Sharkara11. Maricha has Anti-bacterial, Anti-inflammatory, Anti-oxidant, Anti-cancer effect, Anti-obesity and Hepatoprotective properties.
Hence to know the efficacy of Shodhana and Rasayana in one arm and alone Ekamoolika prayoga is one of the extended branch of Kayachikitsa to promote Ayurveda contribution in general practice, hence the current title
‘‘AN OPEN LABELLED RCT STUDY TO ASSESS THE COMBINED EFFICACY OF VIRECHANOTTARA AGNIMUKHA CHURNA OVER SAPTA BALAADHANITA MARICHA VATI ALONE IN THE MANAGEMENT OF TAMAKA SHWASA (BRONCHIAL ASTHMA)’’ is undertaken.

OBJECTIVES OF THE STUDY :

To assess the efficacy of Virechanottara Agnimukha churna in Tamaka shwasa (Bronchial asthma)
To assess the efficacy of Sapta balaadhanita Maricha vati alone in Tamak shwasa (Bronchial asthma)
To compare the effect of Virechanottara Agnimukha churna over Sapta balaadhanita Maricha vati alone in Tamaka shwasa (Bronchial asthma)

STUDY DESIGN

Study type

Prospective, Add-on, Open labelled, Interventional RCT study

 

Estimated enrollment

40 subjects (20 in each group)

 

Intervention model

  Comparative

  INTERVENTION

Group A

Virechana followed by Agnimukha churna

Group B

Sapta balaadhanita Maricha vati

Masking

Open

Primary purpose

Treatment

STUDY DURATION

Treatment duration

34 days

Follow up

7 days

Total duration

41 days

Assessment on

Subjective -0th day, 13th day, 34th day and 41st day

Objective -Before and after intervention

OUTCOME MEASURES

Primary

Improvement in sign and symptoms of Tamaka Shwasa

Secondary

Improvement in Objective 


DIAGNOSTIC CRITERIA

SUBJECTIVE PARAMETERS

Signs and symptoms of Tamaka Shwasa - Shwasa krichrata, Kasa, Kapha nishtivana, Ghur ghuraka.


INCLUSION CRITERIA

· Subjects with classical symptoms of Tamaka shwasa (Bronchial asthma).

· Subjects age between 20 to70 years.

· Subjects fit for Virechana.

· Subjects irrespective of Religion, gender, socio economic status, occupation.

· Subjects who signed for informed consent form.

EXCLUSION CRITERIA

· Pregnant and lactating women.

· Subjects suffering from chronic systemic complex diseases which interferes with the course of intervention will be excluded.


 GRADING FOR SUBJECTIVE PARAMETER:

1. SHWASA KRICHRATA

2. KASA

3. KAPHA NISHTIVANAM

4. GHUR GHURAKA

1. Shwasa krichrata (Breathlessness)

 

SEVERITY

GRADE

No symptoms

CD0

Breathless with activity, frequency-1 to 2times/week.

CD1

  Breathless with talking, frequency 2 to 4 times/week

CD2

Breathless at rest, frequency 4 to 6 times/week, with limited activity.

CD3

 

 

2. Kasa (Cough)

 

SEVERITY

GRADE

No cough

CD0

Cough with mild pain

and slight expectoration.

CD1

Cough with severe pain & feelings of Restlessness because of difficulty in

expectoration.

CD2

Frequent coughing due to which patient becomes

faint.

CD3

 

3. Kapha Nishtivanam (expectoration)

 

SEVERITY

GRADE

No kapha nistivanam.

CD0

Kapha nistivanam only in the early morning.

CD1

2-3 times Kapha nistivanam /day

CD2

kapha nistivanam always

CD3

 

4. Ghur ghuraka (Wheezing)

 

SEVERITY

GRADE

No wheezing

CD0

Mild wheezing at mid to end respiration

CD1

Moderate wheezing at mid to end respiration

CD2

Loud wheeze throughout expiration

CD3

Loud inspiration and expiration wheeze

CD4

 

OBJECTIVE CRITERIA

• SPIROMETRY

• AEC

• IgE 

  EOSINOPHIL %


  OVERALL ASSESSMENT

· VERY GOOD IMPROVEMENT    -  >75%

· GOOD IMPROVEMENT                -  51% TO 74%

· MODERATE IMPROVEMENT     -  26-50%

· MILD IMPROVEMENT                 -  <25%

· NO IMPROVEMENT                     -  0

      

 
Close