FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/03/083219 [Registered on: 24/03/2025] Trial Registered Prospectively
Last Modified On: 19/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To Study the Efficacy of Trijata gutika in the Management of Kasa w.s.r Bronchitis  
Scientific Title of Study   A Randomized Open Labelled Controlled Clinical Study to evaluate the Efficacy of Trijata gutika in the Management of Kasa w.s.r Bronchitis 
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 SAKSHI BALI 
Designation  PG SCHOLAR 
Affiliation  JAMMU INSTITUTE OF AYURVEDA AND RESEARCH JAMMU  
Address  P.G. DEPARTMENT OF KAYACHIKITSA,JAMMU INSTITUTE OF AYURVEDA AND RESEARCH,NARDNI,JAMMU,JAMMU AND KASHMIR Jammu JAMMU & KASHMIR 181123 India

Jammu
JAMMU & KASHMIR
181123
India 
Phone  09419886857  
Fax    
Email  bali.sakshi1997@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR NITIN MAHAJAN 
Designation  PRINCIPAL 
Affiliation  JAMMU INSTITUTE OF AYURVEDA AND RESEARCH JAMMU  
Address  P.G. DEPARTMENT OF KAYACHIKITSA,JAMMU INSTITUTE OF AYURVEDA AND RESEARCH,NARDNI,JAMMU,JAMMU AND KASHMIR Jammu JAMMU & KASHMIR 181123 India

Jammu
JAMMU & KASHMIR
181123
India 
Phone  9419119123  
Fax    
Email  drnitinmahajan1608@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR NITIN MAHAJAN 
Designation  PRINCIPAL 
Affiliation  JAMMU INSTITUTE OF AYURVEDA AND RESEARCH JAMMU  
Address  P.G. DEPARTMENT OF KAYACHIKITSA,JAMMU INSTITUTE OF AYURVEDA AND RESEARCH,NARDNI,JAMMU,JAMMU AND KASHMIR Jammu JAMMU & KASHMIR 181123 India

Jammu
JAMMU & KASHMIR
181123
India 
Phone  9419119123  
Fax    
Email  drnitinmahajan1608@gmail.com  
 
Source of Monetary or Material Support  
JAMMU INSTITUTE OF AYURVEDA AND RESEARCH,NARDNI ,JAMMU,JAMMU AND KASHMIR 181123 INDIA 
 
Primary Sponsor  
Name  JAMMU INSTITUTE OF AYURVEDA AND RESEARCH JAMMU 
Address  JAMMU INSTITUTE OF AYURVEDA AND RESEARCH,NARDNI ,JAMMU,JAMMU AND KASHMIR 181123  
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 NITIN MAHAJAN  JAMMU INSTITUTE OF AYURVEDA AND RESEARCH JAMMU  P.G. DEPARTMENT OF KAYACHIKITSA, OPD and IPD of hospital,NARDNI, JAMMU, JAMMU AND KASHMIR- 181123 Jammu JAMMU & KASHMIR
Jammu
JAMMU & KASHMIR 
09419886857

bali.sakshi1997@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE JAMMU INSTITUTE OF AYURVEDA AND RESEARCH, JAMMU   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:R05||Cough. Ayurveda Condition: KASAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-gutika (Procedure Reference: yogratnakar vidhyotani hindi tika kasa chikitsa p.no.411, Procedure details: Patient will be advised to take this gutika 4 times a day with water after meal)
(1) Medicine Name: Trijata gutika, Reference: yogratnakar, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 250(mg), Frequency: qid, Duration: 15 Days
2Comparator ArmProcedure-churna (Procedure Reference: charak samhita chikitsa sthana, Procedure details: initially patient was advised to take 3gms churna and mix it with honey to form a paste twice a day after meal)
(1) Medicine Name: sitopladi churna, Reference: charak samhita chikitsa sthana , Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Duration: 15 Days
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1.Subjects aged between 20 to 50 years.
2.Patient representing signs and symptoms of Kasa who will be willing to participate in the study.
3.Subjects willing to participate with written informed consent, which is conveyed in the language which the subject can understand.
 
 
ExclusionCriteria 
Details  1.subjects who do not fullfill inclusion criteria will be excluded
2.subjects with systemic disorders like CHD, Diabetes, Pneumonia, Hepatorenal complications, Bronchial Asthma, Allergic Bronchitis, Pulmonary Tuberculosis and other Respiratory illness.
3.Cough associated with severe malnutrition.
4.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 
Patients of both sexes and age group 20 to 50 years of Kasa will be selected for relieving sign and symptoms.   Patients of both sexes and age group 20 to 50 years of Kasa will be selected for relieving sign and symptoms  
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
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   N/A 
Date of First Enrollment (India)   01/06/2025 
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="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  

Ayurveda is the first and foremost spiritual science that offers a scientific approach to live in harmony with nature. Ayurveda is the most ancient healing science and ideal approach for an appropriate life style. According to this science, proper choice of Ahara and Vihara helps to achieve healthy life by maintaining and / or restoring equilibrium of the body and mind.

Prana and Udana Vayu play a role in maintaining the proper functioning of the respiratory channels (Pranavaha Strotas). Kasa occurs when imbalanced Kapha obstructs the smooth flow of Prana Vayu in the throat and chest. This imbalance causes Kasa, where disturbed Prana Vayu and Udana Vayu create sounds reminiscent of striking broken pieces of bronze1. Kasa can be an independent ailment or a symptom of various other diseases.

 

Acharya Charak, identified five types of Kasa: Vataja, Pittaja, Kaphaja, Kshataja, and Kshayaja.2

Acute bronchitis (AB) is an upper respiratory illness characterized by inflammation of small and largeairways and their lining (1-5). It is usually a self-limiting disease with symptoms lasting about 2 to 3 weeks (6). It

is one of the most commonly presenting illnesses among outpatients and frequent reasons of visit to primary caremphysicians (2, 3, 6)

 

Kasa is often triggered by factors like exposure to dust, smoke, strenuous exercise, consuming excessively dry food, inhalation of food particles, and suppressing natural urges like coughing and sneezing.3Kasa has been described under various categories in the classics of Ayurveda as an independent disease, symptom, complication and sequel. Due to the various similarities in clinical presentation, Kasa is correlated with cough (Bronchitis).4Acute bronchitis (AB) is an upper respiratory illness characterized by inflammation of small and large airways and their lining. It is usually a self-limiting disease with symptoms lasting about 2 to 3 weeks. It is one of the most commonly presenting illnesses among outpatients and frequent reasons of visit to primary care physicians

Bronchitis is an upper respiratory illness characterized by inflammation of small and large airways and their lining. It is usually a self-limiting disease with symptoms lasting about 2 to 3 weeks. It is one of the most commonly presenting illnesses among outpatients and frequent reasons of visit to primary care physicians.5

 

Acute Bronchitis is most often caused by infectious agents of which most common are viruses; however, bacterial pathogens have been identified in up to 10% of cases of bronchitis.6 Some of the common viruses causing Acute Bronchitis are influenza virus A and B, respiratory syncytial virus, adenovirus and adenovirus, while some of the common bacterial pathogens identified are Mycoplasma pneumoniae, Streptococcus pneumonia.7 Besides known etiological factors, commonly identified triggers and risk factors for Acute Bronchitis are dust, allergens, polluted air, and irritants such as smoke. Furthermore, seasons such as winter and fall also lead to a higher incidence of bronchitis as compared to spring and summer seasons, with 82% of cases occurring in autumn and winter.8

The primary symptom of bronchitis is cough which manifests within 2 days of infection in 85% of patients, among whom coughing subsides within two weeks for most of the patients, and 26% are still coughing after 2 weeks, whereas in some coughing does not subside for up to 8 weeks.9

Chronic   bronchitis   is   characterized   by   cough associated with sputum on most days for atleast 3 consecutive months for more than 2 successive years. The initial symptoms are repeated attacks of productive cough which shows steady increase in severity during the winter months and present all the year round with recurrent respiratory infection.10 Chronic bronchitis is a pathological condition followed by chronic cough and mucous secretion.  The causes of chronic bronchitis are long term exposure to irritants that damage the lungs and kidneys.  Cigarette smoking is one of the main causes. Exposure to other inhales irritants   can contribute to chronic bronchitis. Air pollution and chemical fumes or dusts from the environment or workplace.

 
Close