| CTRI Number |
CTRI/2025/07/089972 [Registered on: 02/07/2025] Trial Registered Prospectively |
| Last Modified On: |
30/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Does Eating Abhishyandi Aahar Increase the Risk of Tamaka Shwasa A Case Control Study |
|
Scientific Title of Study
|
A Case Control study to find the Association of Abhishyandi Aahar seven in diagnosed Tamaka Shwasa patients. |
| Trial Acronym |
Nill |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Akash Nandu Thoke |
| Designation |
PG SCHOLAR |
| Affiliation |
PDEAs College of Ayurveda And Research Centre Nigdi Pune. |
| Address |
PDEAs College of Ayurved And Research Centre Ayurved Rugnalay and sterling multispeciality hospital Pathology lab Room no. 115 sector no.27 Pradhikaran Nigdi, Pune.
Pune
MAHARASHTRA
411044
India
Pune
MAHARASHTRA
411044
India |
| Phone |
8308274717 |
| Fax |
|
| Email |
akashthoke912@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Satyendra Kumar Singh |
| Designation |
Associate Professor |
| Affiliation |
PDEAs College of Ayurveda And Research Centre Nigdi Pune. |
| Address |
PDEAs College of Ayurved And Research Centre Ayurved Rugnalay and sterling multispeciality hospital Pathology lab Room no. 115 sector no.27 Pradhikaran Nigdi, Pune.
Pune
MAHARASHTRA
411044
India
Pune
MAHARASHTRA
411044
India |
| Phone |
9890741683 |
| Fax |
|
| Email |
drsatyendra1981@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Satyendra Kumar Singh |
| Designation |
Associate Professor |
| Affiliation |
PDEAs College of Ayurveda And Research Centre Nigdi Pune. |
| Address |
PDEAs College of Ayurved And Research Centre Ayurved Rugnalay and sterling multispeciality hospital Pathology lab Room no. 115 sector no.27 Pradhikaran Nigdi, Pune.
Pune
MAHARASHTRA
411044
India
Pune
MAHARASHTRA
411044
India |
| Phone |
9890741683 |
| Fax |
|
| Email |
drsatyendra1981@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAs College of Ayurveda and Research Centre Nigdi Pune Maharashtra 411044 |
|
|
Primary Sponsor
|
| Name |
Not Applicable |
| Address |
Not Applicable |
| Type of Sponsor |
Other [] |
|
|
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 Akash Nandu Thoke |
PDEAs Ayurveda Rugnalay and Multispeciality Hospital |
Pathology lab, Room No.115. Department of Rog nidan,Pune
Pune
MAHARASHTRA
Pune
MAHARASHTRA |
8308274714
akashthoke912@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee,PDEAS College of Ayurveda and Research Centre, Sector No.25 Pradhikaran Nigdi, Pune. |
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 |
|
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Case group Diagnosed Tamaka Shwasa Patients
Control group Heathy individual
Cases & Control group both having age group between 20-50 years of patients will be selected
Cases & Control groups patients will be selected Irrespective of their gender religion socio economic class and material status |
|
| ExclusionCriteria |
| Details |
Patients having history of communicable disease like Tuberculosis Influenza flu
Patients with complicated or advanced stages of Chronic obstructive pulmonary disease like emphysema bronchiectasis bronchitis
Patient with any other systemic disorder like Uncontrolled diabetes mellitus hypertension chronic kidney disease
Post Covid-19 patients Pneumonia Cancer of lungs will be excluded |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To find the Association of Abhishyandi Aahar seven in diagnosed Tamaka Shwasa patients |
24 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
|
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)
|
15/07/2025 |
| 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="5" |
|
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 study investigates the association between Abhishyandi Aahar (dietary habits promoting excessive moisture and heaviness) and Tamaka Shwasa (bronchial asthma) in diagnosed patients. According to Ayurveda, Abhishyandi Aahar can lead to digestive issues, accumulation of toxins, and respiratory disorders. The study aims to understand the relationship between Abhishyandi Aahar and Tamaka Shwasa, which can help reduce disease prognosis and promote overall well-being by avoiding causative factors and making dietary and lifestyle changes. The findings may contribute to the development of preventive and therapeutic strategies for managing Tamaka Shwasa. |