| CTRI Number |
CTRI/2025/06/088159 [Registered on: 03/06/2025] Trial Registered Prospectively |
| Last Modified On: |
03/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare the effect of shatyadi yoga and panchkarma procedure (virechan ) in the managment of tamak shwasa (bronchial asthma) |
|
Scientific Title of Study
|
A Comparative Clinical Study of Effect of Shatyadi Yoga Shaman And Samshodhana in the Management of Tamak Shwasa With Special Reference 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 Piyush Thukral |
| Designation |
PG SCHLOR |
| Affiliation |
Desh Bhagat Ayurvedic College and Hospital |
| Address |
Department of kayachikitsa
Desh Bhagat Ayurvedic College and Hospital Mandi Gobindgarh
Fatehgarh Sahib
PUNJAB
147301
India |
| Phone |
9815072376 |
| Fax |
|
| Email |
piyushthukral005@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Satya Deo Pandey |
| Designation |
Director Clinical Research |
| Affiliation |
Desh Bhagat Ayurvedic College and Hospital Mandi Gobindgarh |
| Address |
Department of kayachikitsa
Desh Bhagat Ayurvedic College and Hospital Mandi Gobindgarh
Fatehgarh Sahib
PUNJAB
147301
India |
| Phone |
9872583155 |
| Fax |
|
| Email |
sdkayachikitsa@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Piyush Thukral |
| Designation |
PG SCHLOR |
| Affiliation |
Desh Bhagat Ayurvedic College and Hospital Mandi Gobindgarh |
| Address |
Department of kayachikitsa
Desh Bhagat Ayurvedic College and Hospital Mandi Gobindgarh
Fatehgarh Sahib
PUNJAB
147301
India |
| Phone |
9815072376 |
| Fax |
|
| Email |
piyushthukral005@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Desh Bhagat Ayurvedic College and Hospital Mandi Gobindgarh |
| Address |
Depatment of kayachikitsa Desh Bhagat Ayurvedic College and Hospital Mandi Gobindgarh |
| 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 Piyush Thukral |
Desh Bhagat Ayurvedic College and Hospital Mandi Gobindgarh |
opd no. 24 department of Kayachikitsa
Fatehgarh Sahib
PUNJAB |
9815072376
piyushthukral005@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Desh Bhagat Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J452||Mild intermittent asthma. Ayurveda Condition: TAMAKASVASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: shatyadi yoga, Reference: charak samhita chikitsa sthan 17/121-124, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: honey), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Shatyadi yoga , Reference: charak samhita chikitsa sthan , Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: honey), Additional Information: -(2) Medicine Name: Trivrit avleha, Reference: charak samhita sutrasthan 25, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 25(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: ushan jala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients with classical features of Tamak Shwasa as mentioned in classical texts.
Patients of any socio-economic status,both sexes and all ethnic origins.
Patients with age above 15 years and below 65 years.
history of diseseas at least one year duration.
Non smokers and absence of long term remission of Asthma.
Both fresh and treated cases were selected.
Lean and thin patients of average physic and patients of Tamak Shwasa eligible for samshodhana karma (virechana). |
|
| ExclusionCriteria |
| Details |
Below the age of 16 and above the age of 65 years.
Patients with uncontrolled metabolic and other systemic disorders like Renal failure,hypertension,diabetes mellitus etc.
Dyspnea resulting from other diseases such as left ventricular failure , chronic obstructive pulmonary dieseas , tuberculosis , pleural effusion, emphysemma ,status asthamaticus , upper respiratory tract obstruction , lung cancer and abscess.
Patients who had long term history of smoking .
Abnormal baseline hematology and blood chemistry.
Lactating mothers and pregnent womens. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Conclusion will be made on the basis of observation which will be done on subjective and objective parameters. This result will be discussed and will be analyzed statistically.
From the clinical study it is expected that the ayurvedic line of treatment is better , cost effective and it will show improvement in the managment of Tamak Shwasa. |
0 day - Enrolment day
15th day - 1st visit
30th day - 2nd visit
60th day - follow up (1month after completion of treatment) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
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)
|
16/06/2025 |
| 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="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
|
in this trial we will see the effects of shatyadi yoga Shaman and samshodhana in the management of tamak shwasa as mentioned in the classical texts with special refrence to bronchial asthma . Conclusions will be made on observations which will be done on subjective and objective parameters. Results will be analyzed statistically. |