| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J453||Mild persistent asthma. Ayurveda Condition: TAMAKASVASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (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: - | | 2 | Comparator Arm | Drug | Classical | | (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. |