| CTRI Number |
CTRI/2024/12/078031 [Registered on: 12/12/2024] Trial Registered Prospectively |
| Last Modified On: |
11/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare the effect of Lavangadisamsharkara churna and Kaphanashaka Yoga in the management of Kaphaja Kasa. |
|
Scientific Title of Study
|
A Randomized Clinical study to evaluate the efficacy of Lavangadisamsharkara churna and Kaphanashaka Yoga in the management of Kaphaja 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 Darshana Bahubali Patil |
| Designation |
PG Scholar |
| Affiliation |
Seth Govindaji Raoji Ayurved Mahavidyalaya Solapur |
| Address |
Seth Sakharam Nemchand Jain Ayurveda Rugnalaya, 118/119 shukrawar peth near juni faujdar chawdi Solapur MAHARASHTRA 413002 India
Solapur
MAHARASHTRA
413002
India |
| Phone |
8459536155 |
| Fax |
|
| Email |
darshanapatil835@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vivek S Chandurkar |
| Designation |
HOD Kayachikitsa Department |
| Affiliation |
Seth Govindaji Raoji Ayurved Mahavidyalaya Solapur |
| Address |
Seth Sakharam Nemchand Jain Ayurveda Rugnalaya, 118/119 shukrawar peth near juni faujdar chawdi Solapur MAHARASHTRA 413002 India
Solapur
MAHARASHTRA
413002
India |
| Phone |
9422788569 |
| Fax |
|
| Email |
vivek.chandurkar@sgrayurved.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Darshana Bahubali Patil |
| Designation |
PG Scholar |
| Affiliation |
Seth Govindaji Raoji Ayurved Mahavidyalaya Solapur |
| Address |
Seth Sakharam Nemchand Jain Ayurveda Rugnalaya, 118/119 shukrawar peth near juni faujdar chawdi Solapur MAHARASHTRA 413002 India
Solapur
MAHARASHTRA
413002
India |
| Phone |
8459536155 |
| Fax |
|
| Email |
darshanapatil835@gmail.com |
|
|
Source of Monetary or Material Support
|
| Seth Sakharam Nemchand Jain Ayurveda Rugnalaya 118/119 shukrawar peth near juni faujdar chawdi Solapur MAHARASHTRA 413002 India |
|
|
Primary Sponsor
|
| Name |
Dr Darshana Bahubali Patil |
| Address |
Seth Sakharam Nemchand Jain Ayurveda Rugnalaya 118/119 shukrawar peth near juni faujdar chawdi Solapur MAHARASHTRA 413002 India |
| 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 Darshana Bahubali Patil |
Seth Sakharam Nemchand Jain Ayurveda Rugnalaya |
Kayachikitsa OPD no 3 2 Seth Sakharam Nemchand Jain Ayurveda Rugnalaya 118/119 shukrawar peth near juni faujdar chawdi Solapur MAHARASHTRA 413002 India
Solapur
MAHARASHTRA |
8459536155
darshanapatil835@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Seth Govindaji Raoji Ayurved Mahavidyalaya ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J00-J06||Acute upper respiratory infections. Ayurveda Condition: KASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Lavangadisamsharkara churna, Reference: Vangasena Kasa Rogadhikara, Route: Oral, Dosage Form: Churna/ Powder, Dose: 4(g), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: -Madhu), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Kaphanashaka Yoga, Reference: Charaka Chikitasthana Kasa Chikitsa, Route: Oral, Dosage Form: Churna/ Powder, Dose: 4(g), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: -Madhu), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Participants with signs and symptoms of Kaphaja Kasa i.e. Kasa, Kapha Nishteevana, Aruchi, Mandagni and Peenasa.
2. Participants between age group of 18 to 70 years irrespective of religion, socio economic status and occupation will be selected.
3. Cough persisting for more than 5 days. |
|
| ExclusionCriteria |
| Details |
1.Cough persisting for more than 15 days.
2. Pregnant women and lactating mothers will be excluded.
3. Patients with the complication of Kasa like Tuberculosis, Emphysema, Pneumonia etc. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the efficacy of Lavangadisamsharkara churna in Kaphaja kasa |
15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the efficacy of Kaphanashaka Yoga in Kaphaja Kasa |
15 days |
| To study detailed samprapti of Kaphaja Kasa |
15 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
22/12/2024 |
| 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) |
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 essential disposition of living activity is said to be breathing which is a basic activity of Pranavaha Strotas. Unknowningly or because of natural disasters we are exposed to various types of stress, toxins, allergens in the atmosphere and pollution because of which our respiratory system gets affected first due to various inhaled toxic agents. These toxic agents act by direct toxicity on respiratory system or through immune mechanism. Such exposure can be either occupational or environmental. Due to this human being alleged with the disease condition Kasa. Forceful expulsion of vayu from throat is called Kasa. As Pranavaha Strotas conveys Prana, any disease affecting this strotas has to be treated with priority. Kaphaja Kasa may not be life threatening but increasingly annoying and irritating to the individual in his routine activity. Chronic bronchitis is a highly prevalent respiratory condition affecting nearly 4% to 22% of adult subjects globally and nearly 5% to 7% of subjects in India. Hence this topic is selected to study the comparison of lavangadisamsharkara churna and kaphanashaka yoga in the management of kaphaja kasa. Lavangadisamsharkara churna and Kaphanashaka yoga will be given for 15 days after food and follow up will be taken on 7th and 15th day. Assessment will be done before and after the treatment |