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CTRI Number  CTRI/2025/08/092903 [Registered on: 12/08/2025] Trial Registered Prospectively
Last Modified On: 12/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Diagnostic
Preventive 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Study Conducted to see the Effect of Oriladi Kashaya(Saliparnyadi kashaya) and Vyaghradi Kashaya in cough and breathing difficulties. 
Scientific Title of Study   A Randomized Controlled Clinical Study to Evaluate the Efficacy of Oriladi Kashaya(Saliparnyadi Kashaya) and Vyaghradi Kashaya in Tamaka Swasa W.S.R to 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  Pooja Patil 
Designation  M.D 2nd year  
Affiliation  Rajarajeshwari Ayurvedic Medical College Hospital and P.G Centre , Humnabad 585330, District- Bidar. 
Address  19-6-337 , Vaishnavi colony Shivnagar North Bidar. Karnataka.
Dept. Of Kayachikitsa , Room no.:-03, first floor Rajarajeshwari Ayurvedic Medical College Hospital and P.G Centre , Humnabad 585330, District- Bidar.
Bidar
KARNATAKA
585401
India 
Phone  7259917212  
Fax    
Email  poojaprakashpatil1998@gmail.com   
 
Details of Contact Person
Scientific Query
 
Name  Pooja Patil 
Designation  M.D 2nd year  
Affiliation  Rajarajeshwari Ayurvedic Medical College Hospital and P.G Centre , Humnabad 585330, District- Bidar. 
Address  19-6-337 , Vaishnavi colony Shivnagar North Bidar. Karnataka.
Dept. Of Kayachikitsa, Room no.:- 03 , first floor Rajarajeshwari Ayurvedic Medical College Hospital and P.G Centre , Humnabad 585330, District- Bidar.
Bidar
KARNATAKA
585401
India 
Phone  7259917212  
Fax    
Email  poojaprakashpatil1998@gmail.com   
 
Details of Contact Person
Public Query
 
Name  DrKKarunakar Rao 
Designation  H.O.D  
Affiliation  Rajarajeshwari Ayurvedic Medical College Hospital and P.G Centre, Humnabad  
Address  Rajarajeshwari Ayurvedic Medical College Hospital and P.G Centre, Humnabad - 585330 District-Bidar
Dept. Of Kayachikitsa, Room no.:-03 , First floor , Rajarajeshwari Ayurvedic Medical College Hospital and P.G Centre, Humnabad 585330 District-Bidar
Bidar
KARNATAKA
585330
India 
Phone  8008402007  
Fax    
Email  karunakarrao040@gmail.com   
 
Source of Monetary or Material Support  
Rajarajeshwari Ayurvedic Medical College Hospital and P.G Centre, Humnabad  
 
Primary Sponsor  
Name  Rajarajeshwari Ayurvedic Medical College Hospital and P.G Centre, Humnabad . 
Address  Rajarajeshwari Ayurvedic Medical College Hospital and P.G Centre, Humnabad ,585330 District- Bidar. 
Type of Sponsor  Private 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 
DrPooja Patil   Rajarajeshwari Ayurvedic Hospital Humnabad -585330  Dept. Of Kayachikitsa First floor Room no.:-03 Humnabad - 585330
Bidar
KARNATAKA 
7259917212

poojaprakashpatil1998@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC Rajarajeshwari Ayurvedic Medical College Hospital And P G Centre , Humnabad -585330  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:J453||Mild persistent asthma. Ayurveda Condition: TAMAKASVASAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Oriladi Kashaya (Saliparnyadi kashaya), Reference: Sahasrayogam , Kashaya Prakarana- Shloka no.-53, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 24(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: -Ushnajala), Additional Information: -
2Comparator ArmDrugClassical(1) Medicine Name: Vyaghradi Kashaya , Reference: Ashtanga HridayaChikitsaSthana Chapter:-IvaraChikitsa Adhyaya, Shloka No. 61, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 24(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: -Ushna Jala), Additional Information: -
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients between 16-60 yrs of age fulfilling the diagnostic criteria
Patients with mild and moderate symptoms of Tamakaswasa
Fresh cases of Bronchial Asthma.
Previously treated cases of Bronchial Asthma with no active medication.

Patients willing to participate in the study. 
 
ExclusionCriteria 
Details  Patients below age of 16.
Patients with other systemic disorders
Lung carcinoma and other lung pathology.
Bronchial asthma having severe attack who requires nebulization support and oxygen.
Other complicated respiratory disorders like TB, Pneumonia, COPD etc.
Patients under steroid therapy
Pregnant and Lactating women.
Patients addicted to smoking. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
A Randomized Controlled Clinical Study to Evaluate the Efficacy of Oriladi Kashaya (Saliparnyadi Kashaya) and Vyaghradi Kashaya in Tamaka Swasa W.S.R to Bronchial Asthma  7 days 
 
Secondary Outcome  
Outcome  TimePoints 
Aims and objectives of study
1. To evaluate the efficacy of Oriladi Kashaya(Saliparnyadi Kashaya) in the treatment of TamakaShwasa

2. To evaluate the efficacy of Vyaghradi Kashaya in the treatment of TamakaShwasa.

3. To compare the efficacy of Oriladikashaya(Saliparnyodi Kashayajand VyaghradiKashaya in the treatment of Tamakashwasa 
7 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   N/A 
Date of First Enrollment (India)   25/08/2025 
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 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   The word Shwasa indicates both Physiological and Pathological state of Respiration. Breathing is a task of Pranavahasrotas, which is an unavoidable factor for the continued existence of human being. The exclusive sign of life. Respiration is affected in the disease Tamaka swasa, causing an impediment to the function of Respiratory system

According to Acharya Charaka, Vayu, located in the chest afflicting the pranavahasrotas, gets aggravated and stimulates Kapha, which leads to the deadly disease called swasa roga. At the same time, Acharya Vagbhata explains the involvement of prana, udaka and annavahasrotases in the pathogenesis of swasa roga. Vayu moving in the pratilomagati (the reverse direction) spreads through the respective channels, afflicts the neck and head, and then stimulates the Kapha (phlegm) to cause peenasa(rhinitis) which then shows the symptoms of Tamakaswasa. Acharyas have mentioned the laxana of Tamaka swasasuch as ghurghurakam (wheeze), TeevravegaSwasa(deep velocity), kasa (cough)etc.

Among the various respiratory ailments, Tamaka shwasa has been selected here. Tamakashwasa is one of the five shwasarogas explained in ayurvedic classics. It is VataKaphaja Vyadhi originating from Amashaya due to vitiation of pranavaha srotas.

The presentation of Tamaka shwasa is peculiar, it is pittasthanasamudbhava pranovahasrotovikara in which avarudhamarga of Pranvayu due to morbid kapha is principle pathology involved. Vitiated doshus afflicts Rasadhatu involves the Pranavahasrotas and produces the illness. In contemporary Science, it seems identical to Bronchial Asthma

Asthma is defined as a disorder characterised by chronic airway inflammation and increased airway responsiveness resulting in the cardinal symptoms of wheeze, cough, chest tightness and dyspnoea- It is characterised functionally by airflow obstruction, which is variable over short time intervals or reversible with treatment

Both Ayurveda and Modern science agree regarding the nidana of the disease as host factor (Nija hetu-doshajadushti, ama etc) and environmental factors (Agantujahetu- Dhumaetc). Nidanaparivarjanam hence plays key role in management strategy in both sciences.

The management of respiratory disorders is becoming a challenge to the medical world. Ayurveda the ancient system of medicine provides a lot of hope in assuring better results in the field of prevention and management of respiratory disorders.

Respiratory disorders are the leading cause of morbidity and mortality that includes an economic and social burden world wide. According to Global Asthma Report prepared by Global Asthma Network, shows that 35 million people suffering from Asthma in India and around 300 million people world wide suffer from Asthma and this no. has increased by 50% in the last decade".

Research in Respiratory disease is necessity in todays era because of air pollution, dietary habits, crowd, low immunity of people etc. Asthmatic problem is increasing day by day due to all the factors resulting from urbanization..

In todays world finding Preventive methods and cure from these enormous challenges should be one of the priorities in Global Health Sector. The development of an effective oral therapy for mild and moderate asthma without any side effects, thus, studies are needed to be carried out in this field to find out a better remedy with no or least side effects.

While explaining the treatment of Shwasaroga, Acharyas have mentioned the importance of Shamana and Brimhana chikitsa over shodhana chikitsa. Shamana chikitsa is applicable for even in patients of mild and moderate strength and can also be done in OPD basis.

Considering all these aspects, the present study has been framed to evaluate the efficacy of two Ayurvedic formulations namely Oriladikashaya(Saliparnyadi Kashaya) mentioned in Sahasrayogam and Vyaghradikashaya mentioned in Ashtanga Hridayam chikitsasthana. Oriladikashaya(Saliparnyadi Kashaya) having ingredients Salaparni, Prisniparni, Brihati, Satavari, Vira(kasamarda), Ardraka, Jivanti, Vasa, Water etc and Vyaghradi Kashaya having ingredients Vyaghri(kantakari), Shunti, Amruta(Guduchi), Pippali ete indicated in Tamaka shwasa. Both having Vatakapha hara, Shwasahara, Deepana, Pachanaproperty has been selected.

Therefore, a humble attempt will be made in this regard to evaluate and compare the efficacy of trial drug Oriladikashaya(Saliparnyadi Kashaya and standard drug Vyaghradi Kashaya in Tamaka Shwasa.
 
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