| CTRI Number |
CTRI/2025/04/084288 [Registered on: 07/04/2025] Trial Registered Prospectively |
| Last Modified On: |
02/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Use Of Marich Sharkara Churna in Vataj Kasa |
|
Scientific Title of Study
|
An Open Randomized Controlled Clinical Trial of Marich Sharkara Churna in Vataj Kasa |
| 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 Shubham Dilip Patil |
| Designation |
PG Scholar |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Center |
| Address |
OPD No 1 Kayachikitsa OPD Ground Floor Dhanvantari Ayurved Hospital Ashta
Tal Walwa Dist Sangli
Sangli MAHARASHTRA 416301 India |
| Phone |
9975536478 |
| Fax |
|
| Email |
shubhampatil199714@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Smita Vitthal Lokhande |
| Designation |
Associate Professor |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Center |
| Address |
Department Of Kayachikitsa 3rd Floor Hon Shri Annasaheb Dange Ayurved Medical College
Post Graduate & Research Center Ashta
Tal Walwa Dist Sangli
Sangli MAHARASHTRA 416301 India |
| Phone |
8149556591 |
| Fax |
|
| Email |
yoshitpriya@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Smita Vitthal Lokhande |
| Designation |
Associate Professor |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Center |
| Address |
Department Of Kayachikitsa 3rd Floor Hon Shri Annasaheb Dange Ayurved Medical College
Post Graduate & Research Center Ashta
Tal Walwa Dist Sangli
Sangli MAHARASHTRA 416301 India |
| Phone |
8149556591 |
| Fax |
|
| Email |
yoshitpriya@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center
Ashta tal walwa dist sangli maharashtra india 416301 |
|
|
Primary Sponsor
|
| Name |
Dr Shubham Dilip Patil |
| Address |
OPD No 1 Kayachikitsa OPD Ground Floor Dhanvantari Ayurved Hospital Ashta Tal Walwa Dist Sangli Maharashtra India 416301 |
| 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 Shubham Dilip Patil |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Center Ashta |
OPD no 1 Kayachikitsa OPD Ground Floor Dhanvantari Ayurved Hospital Ashta Tal Walwa Sangli Sangli MAHARASHTRA |
9975536478
shubhampatil199714@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Of Hon Shri Annasaheb Dange Ayurved Medical College And Post Graduate And Research Center Ashta Sangli |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J399||Disease of upper respiratory tract, unspecified. Ayurveda Condition: KASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Marich Sharkara Churna, Reference: Sushrut Samhita Uttartantra, Route: Oral, Dosage Form: Churna/ Powder, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: Ghrut and Madhu), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Vasabhavit Haridra Churna, Reference: Siddha Bheshaj Manimala, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: Dugdha Santanika), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Cases with confirmed diagnosis by signs symptoms of Vataj Kasa
2 Duration of illness not more than 1 week
3 Repeated attacks of Vataj Kasa
4 Patients of either sex with Age between 18 years to 60 years
5 Patients will be selected irrespective of age gender socioeconomic status |
|
| ExclusionCriteria |
| Details |
1 Patient with co-morbidities like Diabetes Mellitus Ischemic Heart Diseases and other serious cardiovascular disorders
2 Pregnancy and Lactating Mothers
3 Known case of Tuberculosis Pneumonia Bronchial asthma Bronchial carcinoma occupational lung disease Allergic Bronchopulmonary Aspergillosis etc
4 Patients giving history of Hematemesis Hemoptysis during cough |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Marich sharkara Churna Is Effective In the Management of Vataj Kasa |
7 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Vasabhavit Haridra Churna Is effective In the Management Of vataj kasa |
7 Days |
|
|
Target Sample Size
|
Total Sample Size="72" Sample Size from India="72"
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)
|
01/05/2025 |
| 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) |
Open to Recruitment |
|
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
|
Environmental changes constantly impact the human body. Pollution and urbanization deteriorating the quality of life on Earth. The purity of the air we breathe, the water we drink, and the food we consume doesn’t always promote health; instead, it burdens the body’s immune system and overall health. Kasa, a disease of pranvaha strotas, arises from an imbalance of the three doshas. The disturbed Pran vayu, along with Udan vayu aggravated, when combined with other doshas and is forcefully expelled with a coughing sound resembling a cracked bronze vessel, known as kasa. It represents the body’s attempt to eliminate excessive secretions, foreign matter, and other harmful substances from the Respiratory tract. Vataj kasa is one of the most frequent complaints encountered in general practice every day. It is one among the types of Kasa, where Shuska Kasa is prominent symptom. Vataj kasa characterized by Lakshanas like Shushka kantha, vaktra, Shushka kasa with Shushka alpakapha, Swarbheda, Parshvashool, Shriashool, Urashool, Dourbalya as explained in Ayurvedic texts. Prevalence of vataj kasa is 10%. Cough is foremost and enduring symptom of respiratory illnesses, prompted by the stimulation of sensory nerves within the mucosa of the respiratory tract. This reflex can become acutely sensitized in various conditions, typically by exposure to irritants like dust, cigarette smoke, pollens, or shifts in climate and atmospheric conditions. Which are also explained as hetu of vataj kasa. The Composition Marich sharkara churna explained as Kasahar in the Sushrut Samhita, Uttartantra is selected for trial of present study. which helps to decrease the symptoms of kasa. Also, the Vasa bhavit haridra churna as stated in siddha bhaishajya manimala is used for control study. |