| CTRI Number |
CTRI/2025/04/085284 [Registered on: 21/04/2025] Trial Registered Prospectively |
| Last Modified On: |
08/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To study the effect of Maghadadyam churna in Tamak shwas with special reference to Bronchial asthma |
|
Scientific Title of Study
|
Randomised Open Controlled Clinical Study To Evaluate The Efficacy Of Maghadadyam Churna In Tamak Shwas 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 |
Dr Shashank Sukdatta Borkar |
| Designation |
PG Scholar |
| Affiliation |
Yashwant Ayuvedic College and Post graduate training and Research centre Kodoli |
| Address |
OPD No 17 kayachikitsa Department Second Floor
Yashwant Ayurvedic College Post Graduate Training and Research
Centre Kodoli
Tal Panhala Dist Kolhapur MAHARASHTRA
416114 India
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9075645686 |
| Fax |
|
| Email |
shashank101297@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vasundhara Borakhade |
| Designation |
MD Phd |
| Affiliation |
Yashwant Ayurvedic College and Post graduate training and Research centre kodoli |
| Address |
OPD No 17 kayachikitsa Department Second Floor
Yashwant Ayurvedic College Post Graduate Training and Research
Centre Kodoli
Tal Panhala Dist Kolhapur MAHARASHTRA
416114 India
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9860073109 |
| Fax |
|
| Email |
vasudha.borakhade@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shashank Sukdatta Borkar |
| Designation |
PG Scholar |
| Affiliation |
Yashwant Ayurvedic College and Post graduate training and Research centre kodoli |
| Address |
OPD No 17 kayachikitsa Department Second Floor
Yashwant Ayurvedic College Post Graduate Training and Research
Centre Kodoli
Tal Panhala Dist Kolhapur MAHARASHTRA
416114 India
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9075645686 |
| Fax |
|
| Email |
shashank101297@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yashwant Ayurvedic College Post Graduate Training and Research
Centre Kodoli
Tal Panhala Dist Kolhapur MAHARASHTRA
416114 India |
|
|
Primary Sponsor
|
| Name |
Dr Sashank Sukdatta Borkar |
| Address |
OPD No 17 kayachikitsa Department Second Floor
Yashwant Ayurvedic College Post Graduate Training and Research
Centre Kodoli
Tal Panhala Dist Kolhapur MAHARASHTRA
416114 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 Shashank Sukdatta Borkar |
Yashwant Dharmartha Rugnalaya |
OPD No 17 kayachikitsa Department Second Floor
Yashwant Ayurvedic College Post Graduate Training and Research
Centre Kodoli
Tal Panhala Dist Kolhapur MAHARASHTRA
416114 India
Kolhapur
MAHARASHTRA |
9075645686
shashank101297@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Yashwant Ayurved College PGT and RC Kodoli Taluka Panhala District Kolhapur Maharashtra India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J459||Other and unspecified asthma. Ayurveda Condition: TAMAKASVASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Maghadadyam Churna, Reference: Gadanigraha, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -madhu), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Talisadi churna, Reference: Bhaishajya Ratnavali, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -madhu), Additional Information: -consumption with pathya ahara vihara |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All the subjects of all gender between 18 to 60 years of age
All diagnosed with Tamak shwas as per Ayurveda Classical symptoms as shwas ghurghurakam vega
3. Patients having FEV1 greater than 80 percent of predicted |
|
| ExclusionCriteria |
| Details |
Having any major illness and known history of TB IHD CCF HTN DM HIV COVID
Asbestosis Silicosis
Severe asthamatic patients in avegavashtha |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Study the effect of Maghadadyam Churna with madhu internally in Tamak Shwasa by assesing Shwasa vega ghurghurakam FEV1 |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)To study Tamak shwasa in details from various Ayurvedic Texts
2)To study efficacy of Maghadadyam churna in signs of shwas,ghurghurakam,kasa in Tamak shwasa
3)To assess improvement by spirometry
4)To study modern view of Bronchial Asthma in detail
5)To achieve the outcome of study in 30 days
|
30 days |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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 3 |
|
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="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
|
This is Randomised open controlled clinical trial to evaluate the Efficacy of Maghadadyam Churna in Tamak Shwasa w.s.r to Bronchial Asthma The assesment of signs and symptoms will be done at regular follow ups Observations will be drawn from the outcomes achieved in 30 days |