| CTRI Number |
CTRI/2025/04/084060 [Registered on: 03/04/2025] Trial Registered Prospectively |
| Last Modified On: |
03/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To See The Effect Of Sitopaladi Churna And Its Modified Dosage Form Lozenges On Kasa (Dry Cough) |
|
Scientific Title of Study
|
DEVELOPMENT OF A NEW DOSAGE FORM "LOZENGES" FROM THE CONTENTS OF THE SITOPALADI CHURNA BY DIFFERENT METHODS AND ITS COMPARATIVE PHARMACEUTICAL, ANALYTICAL, STABILITY AND PILOT STUDY OF BOTH DOSAGE FORMS ON KASA (DRY COUGH) |
| 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 POOJA |
| Designation |
MD Scholar Rasa Shastra Evum Bhaishajya Kalpana |
| Affiliation |
Institute For Ayurved Studies And Research |
| Address |
OPD No 58 Department of Rasa Shastra Evum Bhaishjya Kalpana Institute For Ayurved Studies And Research Umri Road Sector-8 Kurukshetra Haryana
Kurukshetra
HARYANA
136118
India |
| Phone |
09891195282 |
| Fax |
|
| Email |
narwatpooja1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR RAVI RAJ |
| Designation |
Professor Department Of Rasa Shastra Evum Bhaishajya Kalpana |
| Affiliation |
Institute For Ayurved Studies And Research |
| Address |
Room No. 37 PG Department Of Rasa Shastra Evum Bhaishajya Kalpana Institute For Ayurved Studies And Research Umri Road Sector 8 Kurukshetra Haryana
Kurukshetra
HARYANA
136118
India |
| Phone |
7988499972 |
| Fax |
|
| Email |
raviraz@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR POOJA |
| Designation |
MD Scholar Rasa Shastra Evum Bhaishajya Kalpana |
| Affiliation |
Institute For Ayurved Studies And Research |
| Address |
OPD NO 58 Department Of Rasa Shastra Evum Bhaishajya Kalpana Institute For Ayurved Studies And Research Umri Road Sector 8 Kurukshetra Haryana
Kurukshetra
HARYANA
136118
India |
| Phone |
09891195282 |
| Fax |
|
| Email |
narwatpooja1997@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute For Ayurved Studies And Research Umri Road Sector 8 Kurukshetra Haryana Pin Code-136118 India |
|
|
Primary Sponsor
|
| Name |
Institute For Ayurved Studies And Research |
| Address |
Umri Road Sector 8 Kurukshetra Haryana Pin Code-136118 India |
| Type of Sponsor |
Other [Government Ayurvedic 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 POOJA |
Institute For Ayurved Studies And Research |
OPD No. 58 Department Of Rasa Shastra Evum Bhaishajya Kalpana Institute For Ayurved Studies And Research Umri Road Sector 8 Kurukshetra
Kurukshetra
HARYANA |
09891195282
narwatpooja1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SHRI KRISHNA AYUSH UNIVERSITY INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:R05||Cough. Ayurveda Condition: KASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: sitopaladi churna, Reference: Charak Samhita, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Muhurmuhu, Duration: 14 Days, anupAna/sahapAna: Yes(details: madhu), Additional Information: - | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Sitopaladi Churna, Reference: NA, Route: Oral, Dosage Form: Lozenges, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Muhurmuhu, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients having classical features of kasa. Patients having cough without sputum. |
|
| ExclusionCriteria |
| Details |
Patients below the age of 20 years and above the age of 50 years. Patients having kasa as a complication of other systemic disease. Patients suffering from any lower respiratory tract infection like pneumonia, bronchial asthma etc. Patients suffering from tuberculosis, HIV, SLE, respiratory failure, CHF. Patients having Kasa associated with chest injuries, hemoptysis and bronchial carcinoma. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To develop the lozenges which is of good consistency with good stability and efficacy.
|
The patient will be assessed at 7th and 14th day of the treatment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess whether the lozenges are equally, more or less effective than the sitopaladi churna in the patients of kasa. |
The patient will be assessed at 7th & 14th day of the treatment. |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
06/05/2025 |
| 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="2"
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
|
Ayurveda, the science of life, focuses on both the prevention and cure of diseases by following specific guidelines. Cough is a common symptom experienced by many, often triggered by environmental pollutants like dust, smoke, and chemicals. It is categorized into acute (less than 3 weeks), sub-acute (3-8 weeks), and chronic (more than 8 weeks) forms. In Ayurveda, cough is referred to as "Kasa," a condition caused by imbalances in the Vata and Kapha doshas, affecting the Pranavaha Strotas. It can appear as an independent disease, symptom, or complication. Sitopaladi Churna is a popular Ayurvedic remedy for respiratory issues, known for its anti-tussive, anti-microbial, anti-inflammatory, and anti-expectorant properties. However, its taste and texture can make it difficult to take. To address this, Ayurveda has adapted such formulations into lozenges, which are easier to use, pleasant-tasting, and do not require a vehicle (anupan) for administration, making them more appealing in the modern world. |