| CTRI Number |
CTRI/2025/07/092017 [Registered on: 30/07/2025] Trial Registered Prospectively |
| Last Modified On: |
28/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
comparative study to know the effect between Virechana with Kalyanaguda and Manibhadra Avaleha in Tamaka Shwasa |
|
Scientific Title of Study
|
A comparative clinical trial to study the effect between Virechana with Kalyanaguda and Manibhadra Avaleha in Tamaka Shwasa |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vishnu prasad V |
| Designation |
Associate professor |
| Affiliation |
Ph.D. scholar dept of panchakarma |
| Address |
Dept. o panchakarma
Nandha ayurveda medical college
Erode
Tamilnadu
Dept. of panchakarma
College of Ayurved and hospital,
Bharati Vidyapeeth deemed to be University,
Pune.43
Pune
MAHARASHTRA
411043
India |
| Phone |
9743919410 |
| Fax |
|
| Email |
vishnuprasadv@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Santosh E Chavan |
| Designation |
HOD & professor |
| Affiliation |
|
| Address |
Dept. of Panchakarma
College of Ayurved and hospital,
Bharati Vidyapeeth deemed to be University campus,
Pune.43
Pune
MAHARASHTRA
411043
India |
| Phone |
9822249807 |
| Fax |
|
| Email |
drsantoshchavan5@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Santosh E Chavan |
| Designation |
HOD & professor |
| Affiliation |
|
| Address |
Dept of panchakarma,
College of Ayurved and hospital,
Bharati Vidyapeeth deemed to be University campus,
Pune.43
Pune
MAHARASHTRA
411043
India |
| Phone |
9822249807 |
| Fax |
|
| Email |
drsantoshchavan5@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bharathi vidhyapeet ayurved college & hospital,
ollege of Ayurved and hospital,
Bharati Vidyapeeth deemed to be University campus,
Pune.43
Maharashtra,
India
|
| Nandha ayurveda college and hospital,
Pitchandanpalayam
Erode-638011
Tamilnadu
India |
|
|
Primary Sponsor
|
| Name |
Dr vishnu prasad V |
| Address |
Ph.D scholar
Bharathi vidhyapeet ayurved college,
Bharathi campus
Katraj, pune
katraj
pune
Maharastra
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 Santhosh E chavan Hod and professor dept of panchakarma |
bharathi vidhyapeeth ayurveda hospital. |
Dept. Of panchakarma
Bharati Ayurveda Hospital
bharathi campus
kathraj
pune
Maharastra
India
Pune
MAHARASHTRA |
9822249807
drsantoshchavan5@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional etics committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J989||Respiratory disorder, unspecified. Ayurveda Condition: TAMAKASVASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Manibhadram avaleham and kalayanakam avaleham, Reference: astangahrudhayam, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 80(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 1 Days, anupAna/sahapAna: Yes(details: -grape juice), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1) subjects with classical symptoms of thamaka swasa
2)thamaka swasa with chronicity ofless than three years |
|
| ExclusionCriteria |
| Details |
1)chronic copd cases
2)pregnant women and lactating mothers
3)participants contra indicated for virechana
4)known case of ano rectal disease
5)progressive bronchial deficit suggesting surgury,emphysema, interstitial lung disease, cystic fibrosis, pulmonary hypertension
6)patients on regular steroids, known case of hypertension, diabetics mellitus
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
changes found in subjects in sign and symptoms
subjective and objective
Laboratory investigations |
Day of completion-1day
First follow up-14-th day
Second follow up-42-nd day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
PEFR
AEC
IgE |
14th day of snehapana
28th day of snehapana
42nd day of snehapana |
|
|
Target Sample Size
|
Total Sample Size="104"
Sample Size from India="104"
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)
|
15/08/2025 |
| 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="0"
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
|
1)A study aiming to know the efficacy of virechana treatment with two different medicaments in tamaka swasa diseased patients of chronicity less than three years.
2)For comparing the same, pre procedure and post procedure is maintained same in both the study groups.
|