| CTRI Number |
CTRI/2026/02/103255 [Registered on: 06/02/2026] Trial Registered Prospectively |
| Last Modified On: |
04/02/2026 |
| 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 an Ayurvedic formulation (Simhyadi Choorna Vati) and standard modern medicine in the management of Peenas Vyadhi(Chronic Rhinitis)in School going children. |
|
Scientific Title of Study
|
A randomized comparative clinical trial to evaluate the efficacy of Simhyadi
Choorna Vati and Montelukast + Levocetrizine combination in the management of
Peenas Vyadhi( Chronic Rhinitis)in school-going children. |
| 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 Rutuja Sanjay Abak |
| Designation |
PG Scholar |
| Affiliation |
PDEAs College of Ayurved and Research Centre ,nigdi ,Pune |
| Address |
PDEAs College of Ayurved and Research Centre,third floor Balrog department,Nigdi Pune
MAHARASHTRA
411044
India
Pune
MAHARASHTRA
411044
India |
| Phone |
9421987166 |
| Fax |
|
| Email |
rutujaabak14@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sudha Singh |
| Designation |
Associate Professor |
| Affiliation |
PDEAs college of Ayurved and Research centre, Nigdi |
| Address |
PDEAs College of Ayurved and Research Centre,3rd floor Balrog department,Nigdi Pune
MAHARASHTRA
411044
India
Pune
MAHARASHTRA
411044
India |
| Phone |
9975404439 |
| Fax |
|
| Email |
drsudha2010@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sudha Singh |
| Designation |
Associate Professor |
| Affiliation |
PDEAs college of Ayurved and Research centre, Nigdi |
| Address |
PDEAs College of Ayurved and Research Centre,3rd floor Balrog department,Nigdi Pune
MAHARASHTRA
411044
India
MAHARASHTRA
411044
India |
| Phone |
9975404439 |
| Fax |
|
| Email |
drsudha2010@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAs College of Ayurved and Research Centre sector 25 pradhikaran nigdi Pune 411044 |
|
|
Primary Sponsor
|
| Name |
PDEAs college of Ayurved And Research centre Nigdi pune |
| Address |
PDEAs College of Ayurved and Research Centre Sector 25
Pradhikaran Nigdi Pune Maharashtra 411044 |
| 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 Rutuja Abak |
Ayurved Rugnalaya and Sterling Multispeciality Hospital Nigdi Pradhikaran Pune |
Ayurved Rugnalay And
Sterling Multispeciality
Hospital Nigdi
Pradhikaran Pune
Sector 27 Balrog
Department OPD No
118 Pune
MAHARASHTRA
Pune
MAHARASHTRA |
9421987166
rutujaabak14@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PDEAS College Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J310||Chronic rhinitis. Ayurveda Condition: PRATISYAYAH/PINASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Simhyadi Choorna Vati, Reference: Yogaratnakar, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: -Dose-15mg/kg/day | | 2 | Comparator Arm (Non Ayurveda) | | - | Montair LC Kid Tab | Dose-1 Tab
Route of Administration -Oral
Time of Administration -Evening once a day
Duration-14days
|
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1.Children diagnosed with case of Peenas (Chronic Rhinitis)
having Nasavrodha(Nasal Congestion) with two or more
presenting symptoms like Nasastrava(Rhinorrhea),
Kshavathu(Sneezing),Nasakandu (Nasal
Itching),Shirashoola(Headache) for atleast 4 weeks.(AAP
guidelines)
2. Children between the ages of 6 to 12 years, irrespective
of gender, socioeconomic status. |
|
| ExclusionCriteria |
| Details |
1. Known case of Acute Sinusitis with fever more than 100oF..
2. Nasal polyps or any other clinically significant nasal anomaly.
3. Patient having rhinitis but associated with known case of
Asthma.
4. Patient who have received surgical procedure in the nasal
cavity within 3 months prior to visit.
5. Those who have started immunosuppressive therapy like
inhaled corticosteroids. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the efficacy of Simhyadi Choorna Vati and
Montelukast + Levocetrizine combination in the management of nasal symptoms
such as rhinorrhea, nasal congestion, and nasal itching in school-going children
diagnosed with Peenas Vyadhi( Chronic Rhinitis) over 2 weeks. |
14 Days study with Follow up on 5th,10th and 14th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To observe the adverse effects of the drug, if any. |
14 Days study with Follow up on 5th,10th and 14th day. |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
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)
|
15/02/2026 |
| 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
|
Brief CTRI Summary (Lay + Scientific, concise): Peenas (Chronic Rhinitis) is a common pediatric respiratory disorder caused by repeated exposure to environmental allergens, pollution, and climatic variations. In Ayurveda, Peenas is described as a Vata-Kapha predominant disorder characterized by chronic nasal obstruction, discharge, sneezing, and impaired nasal function, closely resembling features of chronic/allergic rhinitis described in modern medicine. The prevalence of chronic rhinitis in children is rising and significantly affects school attendance and quality of life. Conventional management with antihistamines, leukotriene antagonists, and nasal steroids often provides only symptomatic relief and may be associated with adverse effects on long-term use. Ayurveda offers time-tested formulations with potential disease-modifying action and better safety profiles. Simhyadi Choorna Vati, mentioned in Yogratnakar, is traditionally indicated in Peenas due to its Vata-Kapha shamaka properties. Montelukast + Levocetirizine is a commonly used standard modern therapy for chronic/allergic rhinitis. This randomized comparative clinical trial aims to evaluate and compare the efficacy and safety of Simhyadi Choorna Vati versus Montelukast + Levocetirizine in the management of Peenas (Chronic Rhinitis) in school-going children, thereby generating evidence for integrative and rational pediatric respiratory care. |