| CTRI Number |
CTRI/2025/05/087304 [Registered on: 21/05/2025] Trial Registered Prospectively |
| Last Modified On: |
20/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To know the efficacy between Vasaghruta and Kulattadi Kashaya in Asthma |
|
Scientific Title of Study
|
A Controlled Double Arm Open Labelled Clinical Trial to Evaluate the Efficacy of Vrusha Ghruta and Kulatthadi Kashaya in the Management of Tamaka Shwasa vis a vis Bronchial Asthma |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR NAYANA D R |
| Designation |
PG SCHOLOR |
| Affiliation |
Government Ayurveda Medical College and Hospital, Mysuru |
| Address |
Post Graduate Department of Kayachiktsa Government Ayurveda Medical College and Hospital, Mysuru Visvesvaraya Cir, Devaraja Mohalla, Mandi Mohalla, Mysuru, Karnataka 570001
Post Graduate Department of Kayachikitsa Government Ayurveda
Medical College and Hospital Mysuru Vishweshwaraiah circle
Devraja Mohalla Mysuru Karnataka 570001 India
Mysore
KARNATAKA
570001
India
Mysore
KARNATAKA
570001
India |
| Phone |
9113853433 |
| Fax |
|
| Email |
nayanadrbaby@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Sanjay Kumar M D |
| Designation |
Professor |
| Affiliation |
Government Ayurveda Medical College and Hospital, Mysuru |
| Address |
Post Graduate Department of Kayachikitsa Government Ayurveda Medical College and Hospital, Mysuru Visvesvaraya Cir, Devaraja Mohalla, Mandi Mohalla, Mysuru, Karnataka 570001
Post Graduate Department of Kayachikitsa Government Ayurveda
Medical College and Hospital Mysuru Vishweshwaraiah circle
Devraja Mohalla Mysuru Karnataka 570001 India
Mysore
KARNATAKA
570001
India
Mysore
KARNATAKA
570001
India |
| Phone |
9986083244 |
| Fax |
|
| Email |
drsanjaygowda@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR Nayana D R |
| Designation |
PG Scholar |
| Affiliation |
Government Ayurveda Medical College and Hospital, Mysuru |
| Address |
Post Graduate Department of Kayachikitsa Government Ayurveda Medical College and Hospital, Mysuru Visvesvaraya Cir, Devaraja Mohalla, Mandi Mohalla, Mysuru, Karnataka 570001
Post Graduate Department of Kayachikitsa, Government Ayurveda Medical College and Hospital, Mysuru Visvesvaraya Cir, Devaraja Mohalla, Mandi Mohalla, Mysuru, Karnataka 570001
Mysore
KARNATAKA
570001
India |
| Phone |
9113853433 |
| Fax |
|
| Email |
nayanadrbaby@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurveda Medical College and Hospital, Mysuru Visvesvaraya Cir, Devaraja Mohalla, Mandi Mohalla, Mysuru, Karnataka 570001 |
|
|
Primary Sponsor
|
| Name |
DR NAYANA D R |
| Address |
Government Ayurveda Medical College and Hospital, Mysuru
Visvesvaraya Cir, Devaraja Mohalla, Mandi Mohalla, Mysuru, Karnataka 570001 |
| Type of Sponsor |
Other [SELF] |
|
|
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 Nayana D R |
Government Ayurveda Medical College,Mysuru |
Department of Kayachikitsa,opd no 10, Government Ayurveda Medical College, 8M72+VJ5, Visvesvaraya Cir, Devaraja Mohalla, Mandi Mohalla, Mysuru, Karnataka 570001
Mysore
KARNATAKA |
9113853433
nayanadrbaby@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The institutional Ethics committee of GAMC, Mysuru |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J452||Mild intermittent asthma. Ayurveda Condition: TAMAKASVASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Vrusha Ghruta for Group A, Reference: Sahasra yoga , Route: Oral, Dosage Form: Ghrita, Dose: 12(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 23 Days, anupAna/sahapAna: No, Additional Information: For group A for the first 7 days (1st day to 7th)
• Sthanika abhyanga with lavana yukta Vishagarbha taila followed by Nadisweda, Nithya mrudu virechana
with Gandarva hasthadi eranda taila 10 ml before food in empty stomach at 7pm with ushnodaka for first
consecutive 7days (1st –7thday) | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Kulattadi Kashaya for Group B, Reference: Chakradatta, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 15(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 23 Days, anupAna/sahapAna: No, Additional Information: -For group B for the first 7 days (1st day to 7th)
• Sthanika abhyanga with lavana yukta Vishagarbha taila followed by Nadisweda, Nithya mrudu virechana
with Gandarva hasthadi eranda taila 10 ml before food in empty stomach at 7pm with ushnodaka for first
consecutive 7days (1st –7thday)
As a prakskepaka dravya Pushkara moola churna 1.5gm is added in Kulattadi Kashaya |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Subjects fulfilling the diagnostic criteria of Tamaka Swasa.
2)Subjects having peak expiratory flow rate of greter than 50percent of predicted value of Peak Expiratory Flow Rate chart.
3)Subjects within the age group of 18 to 60 years.
4) Both fresh and treated cases |
|
| ExclusionCriteria |
| Details |
1) Acute condition of Bronchial Asthma, Status Asthmaticus.
2) Subjects suffering from associated diseases like Tuberculosis, pneumonia,Cardiac asthma,Uncontrolled Diabetes mellitus FBS 180ml by dl,Uncontrolled Hypertension BP 160by100mmhg
3) Subjects having peak expiratory flow rate of lessthan 50percent of predicted value of Peak Expiratory Flow
Rate chart.
4)Subjects who are on corticosteroids.
5)Pregnant and lactating women. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)Asthma control questionaire value less than 1.5
|
0th day, 8th day, 31st day.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Symptomatically relief to the patient |
0th day 8th day and 31st day |
|
|
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)
|
15/06/2025 |
| 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="1"
Months="6"
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
|
Tamaka Shwasa is one among the five varieties of Shwasa roga manifested due to vitiation of kapha-vata
dosha and rasa dhatu in pranavaha srotas, originating from pittastana. Shwasa krichrata, kasa, ghurghuraka
and prana peedana are the pradhana lakshana Asthma is defined as a chronic inflammatory disorder of the airways which is associated with airway hyper
responsiveness. It leads to recurrent episodes of wheezing, breathlessness, chest tightness and coughing
particularly at night and in early morning .
According to WHO, Globally, Asthma has affected an estimated 262 million people in 2019. The overall
burden of asthma in India is estimated to be more than 15 million . Asthma, owing to its chronic nature, has
a significant impact on quality of life in patients due to the decreased capacity of physical exertion, constant
dependence on medications, decreased quality of sleep, low performance at work and constant fear of
trigger factors.
The current management of Bronchial Asthma in modern medicine is only providing short term
symptomatic relief but does not provide any long-term relief to the patient. On the other hand, prolonged use
of these drugs are not safe, as it has many adverse effect with systemic manifestation and as the chronicity
increases drug dose dependency increases. Ayurveda is the best way to effectively & safely manage the
condition without inducing any drug dependency. Various shodhana procedures and internal medications are
advised. They detoxify the body, provides nutrition to tissues, increases the elasticity of lung tissue and
develops natural immunity. Thus, decreasing episodic recurrence of the disease and providing long term
relief to the patient .
Kapha is the sthanika dosha involved in Tamaka shwasa and it will cause obstruction to vata leading to a
Pratiloma gati of vata.kaphavruta vata samprapti is observed in tamaka shwasa and it is important to remove
the obstruction and clearing the vata marga. The management protocol for kaphavruta vata includes usage of
kaphahara dravya and achieving vatanulomana, lavana taila abhyanga and nadi sweda told as primary
treatment in shwasa. Hence Sthanika abhyanga with samudra lavana yukta Vishagarbha taila followed by nadi
sweda and Nithya mrudu virechana with Gandharva hastadi eranda taila are selected in the study. Vasa is
present in Vrusha ghruta which is kasa shwasahara,hence Vrusha ghruta has been selected for the study. kulatta is also having the property of kasa shwasahara. Hence the present study is designed to compare the efficacy
and internally vrusha ghrutha and kulattadi Kashaya in patients of Tamaka Shwasa keeping Nithyavirechana, Lavanataila abhyanga followed by Nadisweda as control in both the groups. |