| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:R05||Cough. Ayurveda Condition: KASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | 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 | | 2 | Comparator Arm | Procedure | - | 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. |