| CTRI Number |
CTRI/2025/03/081762 [Registered on: 06/03/2025] Trial Registered Prospectively |
| Last Modified On: |
04/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the Effect of Shrungyadi Churna and Sitopaladi Churna in Vataja Kasa with special reference to Simple Pulmonary Eosinophilia |
|
Scientific Title of Study
|
A Randomized Comparative Clinical Study to Evaluate the Effect of Shrungyadi Churna and Sitopaladi Churna in Vataja Kasa with special reference to Simple Pulmonary Eosinophilia. |
| 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 Bindu M N |
| Designation |
PG Scholar Kayachikitsa |
| Affiliation |
BVVS Ayurved Medical College and Hospital, |
| Address |
Department of PG Studies in Kayachikitsa BVVS Ayurved Medical College and Hospital, Bagalkot, Karnataka 587101
Bagalkot KARNATAKA 587101 India |
| Phone |
9686363503 |
| Fax |
|
| Email |
bindumnbindu4@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr sunil kumar M Chabanur |
| Designation |
Professor and HOD |
| Affiliation |
BVVS Ayurved Medical College and Hospital, |
| Address |
Department of PG Studies in Kayachikitsa BVVS Ayurved Medical College and Hospital, Bagalkot, Karnataka 587101
Bagalkot KARNATAKA 587101 India |
| Phone |
9740878703 |
| Fax |
|
| Email |
drsunilkumar09@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Sunil kumar M Chabanur |
| Designation |
Professor and HOD |
| Affiliation |
BVVS Ayurved Medical College and Hospital, |
| Address |
Department of PG Studies in Kayachikitsa BVVS Ayurved Medical College and Hospital, Bagalkot, Karnataka 587101
Bagalkot KARNATAKA 587101 India |
| Phone |
9740878703 |
| Fax |
|
| Email |
drsunilkumar09@gmail.com |
|
|
Source of Monetary or Material Support
|
| BVVS Ayurved Medical College and Hospital, Bagalkot, Karnataka 587101 |
|
|
Primary Sponsor
|
| Name |
BVVS Ayurved Medical College and Hospital |
| Address |
BVVS Ayurved Medical College and Hospital, Bagalkot, Karnataka 587101 |
| 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 |
| Dr Bindu M N |
BVVS Ayurved Medical College and Hospital |
Departmet of PG studied in Kayachikitsa BVVS Ayurved Medical College and Hospital, Bagalkot, Karnataka 587101 India Bagalkot KARNATAKA |
9686363503
bindumnbindu4@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IECBVVSAyurvedMedicalCollegeandHospital BagalkotKarnataka |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J069||Acute upper respiratory infection,unspecified. Ayurveda Condition: VATAJAKASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Shrungyadi Churna , Reference: Gadanigraha, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: -Ushna jala), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Sitopaladi Churna , Reference: Charaka samhita chikitsa sthana Rajayakshma chikitsa adhyaya, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: -Madhu), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion criteria :
1.Patients having classical signs and symptoms of Vataja Kasa with duration of 3 to 7 days.
2.Patients between age group 18 - 60 years of either sex.
3.Patients presenting with Absolute Eosinophilia Count more than 440 cells/cumm in the peripheral blood smear. |
|
| ExclusionCriteria |
| Details |
Exclusion criteria :
1.Patients with other disorders of Respiratory System.
2. Patients with DM and uncontrolled Hypertension.
3.Pregnant and lactating women. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To know the efficacy of Shrungyadi Churna and Sitopaladi Churna in Vataja Kasa with special reference to Simple Pulmonary Eosinophilia |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Aims and Objectives of the study :
1. To compare the efficacy of Shrungyadi Churna and Sitopaladi Churna in Vataja Kasa with special reference to Simpe Pulmonary Eosinophilia
2. To study the efficacy of Shrungyadi Churna in Vataja Kasa with special reference to Simple Pulmonary Eosinophilia
3. To study the efficacy of Sitopaladi Churna in Vataja Kasa with special reference to Simple Pulmonary Eosinophilia. |
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
10/04/2025 |
| 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="0" 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
|
Kasa is one of the disease mentioned in Pranavaha Srotovikara. Vataja Kasa is one among the 5 types of Kasa where Shushka Kasa is a prominent symptom. Prana and Udana Vayu are responsible for normal functioning of Pranavahasrotas which can be altered due to causative factors like Raja and Dhuma. When Adhogati of Vata is obstructed by Dushta Doshas it attains the Urdwa Gati and takes Sthanasamshraya in Urapradesha and produces Kasa. Incidence of Kasa has been increased due to continuous exposure of the respiratory system to the external environment affected by pollutants, allergens, smoke, dust, air pollution, occupational risks, industrialization and population explosion with an influence of modern life style. The prevalence of cough was found to be between 2.4 to 5.6 percent in the rural areas and 1.7 to 5.4 percent in urban areas in different centers of India.
Vataja Kasa presents with symptoms like Shushka Kasa, Hruth-Parshva-Shirashula,Ura-Kanta-Vaktra-Shushkata, Swarabheda, and Dourbalya .Based on similar signs and symptoms Vataja Kasa can be compared with ‘’Simple Pulmonary Eosinophilia.’’It is the most common form of Eosinophilic lung disease. Simple Pulmonary Eosinophilia affects males and females in equal number. It is characterized by chest pain, dry cough which may be associated with little amount of sputum, paroxysmal cough, headache, feeble voice and general weakness.
Management of non productive respiratory condition include antitussive alone or in combination of anti histamines, decongestants which have their own limitation and side effects. In classics Nidana Parivarjana, Shodana, Shamana, Rasayana with special importance for the use of Vata Anulomana Aushadi Prayoga in the management of Vataja Kasa has been explained.
Shrungyadi Churna is mentioned in Gadanigraha and Sitopaladi Churna is mentioned in Charaka Samhita, Chikitsa Sthana, Rajayakshma Chikitsa. Shrungyadi Churna contains Karkataka Shrungi, Vacha, Katphala, Katruna, Musta, Abhaya , Dhanyaka, Bringaraja, Devadaru, and Hingu. All are having Katu, Tikta, Kashaya Rasa, Laghu Ruksha Guna and Ushna Veerya acts as Vata Kaphahara, Deepana, Pachana, Vata Anulomana and Kasahara. Sitopaladi Churna contains Sitopala, Vamshalochana, Pippali, Ela, Twak. Among them Sitopala and Vamshalochana are having Madhura Rasa, Laghu Snigdha Guna and Sheeta Veerya which helps in Vata-Pitta Shamana. Pippali, Ela, Twak are having Katu Rasa, Laghu Ruksha Guna, Ushna Veerya acts as Vata Kaphahara and Vata Anulomana. Considering above points present study will be aimed to evaluate and compare the efficacy of Shrungyadi Churna and Sitopaladi Churna in Vataja Kasa with special reference to Simple Pulmonary Eosinophilia. |