| CTRI Number |
CTRI/2025/03/083271 [Registered on: 24/03/2025] Trial Registered Prospectively |
| Last Modified On: |
27/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical trial to determine the effect of lashunadi yoga in the management of kaphaja pratishyaya thai is chronic rhinitis |
|
Scientific Title of Study
|
A single arm clinical trial to evaluate the efficacy of lashunadi yoga in the management of kaphaja pratishyaya w s.r to chronic rhinitis |
| 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 Kiran Ramchandra Dudhuke |
| Designation |
Post graduate resident |
| Affiliation |
Sangam sevabhavi trust ayurved mahavidyalaya, sangamner, Ahmadnagar, Maharashtra |
| Address |
OPD no 2 shalakya tantra department,SST Ayurved mahavidyalaya,front of Prasad hotel,Pune - nashik highway,sangamner,Ahmadnagar
OPD no 2,Shalakya tantra department,SST Ayurved mahavidyalaya,Front of Prasad hotel,Pune nashik highway, sangamner, Ahmadnagar, Maharashtra
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
8329920149 |
| Fax |
|
| Email |
kirandudhuke@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rekha Jori |
| Designation |
Professor |
| Affiliation |
Sangam sevabhavi trust ayurved mahavidyalaya, sangamner, Ahmadnagar, Maharashtra |
| Address |
OPD no 2,Shalakya tantra department, SST Ayurved mahavidyalaya,Front of Prasad hotel, pune-nashik highway,sangamner,Ahmadnagar
OPD no 2,Shalakya tantra department, SST Ayurved mahavidyalaya,Front of Prasad hotel, pune-nashik highway, sangamner ,Ahmadnagar, Maharashtra
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
9503197787 |
| Fax |
|
| Email |
drrekhamatkar1912@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kiran Ramchandra Dudhuke |
| Designation |
Post graduate resident |
| Affiliation |
Sangam sevabhavi trust ayurved Mahavidyalaya, sangamner, Ahmadnagar,Sangamner |
| Address |
OPD no 2 , Shalakya tantra department,SST Ayurved mahavidyalaya,Front of Prasad hotel, pune-nashik highway,sangamner,Ahmadnagar
OPD no 2 , Shalakya tantra department,SST Ayurved mahavidyalaya,Front of Prasad hotel pune-nashik highway sangamner Ahmadnagar Maharashtra
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
8329920149 |
| Fax |
|
| Email |
kirandudhuke@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Kiran Dudhuke |
| Address |
OPD no 2,Shalakya tantra department, SST Ayurved mahavidyalaya,Front of Prasad hotel, Sangamner,Ahmadnagar, Maharashtra,India pin - 422605 |
| 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 Kiran Dudhuke |
Sangam sevabhavi trust ayurved mahavidyalaya sangamner |
OPD no 2, Shalakya tantra department,sangam sevabhavi trust ayurved mahavidyalaya,Front of Prasad hotel,Pune nashik highway sangamner Ahmadnagar Maharashtra
Ahmadnagar
MAHARASHTRA |
8329920149
kirandudhuke@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SST Ayurved mahavidyalaya Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:B97||Viral agents as the cause of diseases classified elsewhere. Ayurveda Condition: PRATISYAYAH/PINASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Lashunadi yoga, Reference: Charak samhita , chikitsa sthan,adhyaya 26,shloka 150, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: Goghrita), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1)Patient fulfilling clinical features of KaphajPratishyaya i.e GhanaKaphaStrava [Rhinorrhea] Kasa[Cough] Aruchi[Loss of taste] Nasakandu[Itchinginnose] 3. 2)Selection of patient will be irrespective of their sex, religion, socioeconomic status. |
|
| ExclusionCriteria |
| Details |
1)Patient K/C/O any nasal congenital deformity.
2) Patient K/C/O nasal polyp, sinusitis, those having rhinorrhea due to foreign body or trauma,deviated nasal septum requiring any surgical interventions.
3)Patient K/C/O lower respiratory tract infections.
4) K/C/O–DM,HTN,Malignancy of Oral cavity. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the efficacy of lashunadi yoga in the management of kaphaja pratishyaya with special reference to chronic rhinitis |
0 day,1week,2 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Relief of symptoms severity will be observed |
0 day,1 week ,2 week |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
05/04/2025 |
| 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="1"
Days="6" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Kaphaja pratishyaya is a considerable health problem for a common public and has a definite effect on quality of life and if it is left untreated can lead to serious complications like sinusitis, nasal polyps,sleep disturbances.Thus, to overcome above raised problems in present dissertation study the lashunadi yoga is taken in the management of kaphaja pratishyaya w.s.r to chronic rhinitis. Lashunadi yoga is easily available, cost effective and affordable for patient. This study is a “A SINGLE ARM CLINICAL TRIAL TO EVALUATE THE EFFICACY OF LASHUNADI YOGA IN THE MANAGEMENT OF KAPHAJA PRATISHYAYA W.S.R. TO CHRONIC RHINITIS”. In this study Randomly 60 patients having signs and symptoms of kaphaja pratishyaya will be selected from OPD and IPD of sst Ayurved Rugnalaya. study will be conducted in India. Outcome of study will be asses on reducing symptoms of kaphaja pratishyaya like Ghana kapha strava, kasa, aruchi, nasa kandu. |