| CTRI Number |
CTRI/2025/12/099489 [Registered on: 19/12/2025] Trial Registered Prospectively |
| Last Modified On: |
13/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to find out how effective Maricha Arka is in treating allergic cold (allergic rhinitis) in children aged 6 to 12 years. |
|
Scientific Title of Study
|
Single arm clinical study to evaluate efficacy of maricha arka in the management of vataj pratishyaya with special reference to allergic rhinitis in children of age 6 to 12 years. |
| 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 Neeta Prakash Suryawanshi |
| Designation |
PG Scholar |
| Affiliation |
LRP Ayurvedic medical college and hospital, PG Institute and research centre urun Islampur |
| Address |
Pediatric department 2 nd floor LRP Ayurvedic medical college and
hospital PG Institute and Research center Urun Islampur Sangli
LRP Ayurvedic medical college and hospital, PG Institute and
research centre urun Islampur
Sangli
MAHARASHTRA
415409
India |
| Phone |
7057488290 |
| Fax |
|
| Email |
neetasuryawanshi41@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Masaudaalam Mujawar |
| Designation |
professor |
| Affiliation |
LRP Ayurvedic medical college and hospital, PG Institute and research centre urun Islampur |
| Address |
Pediatric department 2 nd floor LRP Ayurvedic medical college and
hospital PG Institute and Research center Urun Islampur Sangli
OPD 2 Pediatric Opd
Ground Floor LRP
Ayurvedic Hospital
Urun
Sangli
MAHARASHTRA
Sangli
MAHARASHTRA
415409
India |
| Phone |
9823645588 |
| Fax |
|
| Email |
dr.masudaalam10@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Masaudaalam Mujawar |
| Designation |
professor |
| Affiliation |
LRP Ayurvedic medical college and hospital, PG Institute and research centre urun Islampur |
| Address |
Pediatric department 2 nd floor LRP Ayurvedic medical college and
hospital PG Institute and Research center Urun Islampur Sangli
OPD 2 Pediatric Opd
Ground Floor LRP
Ayurvedic Hospital
Urun
Sangli
MAHARASHTRA
Sangli
MAHARASHTRA
415409
India |
| Phone |
9823645588 |
| Fax |
|
| Email |
dr.masudaalam10@gmail.com |
|
|
Source of Monetary or Material Support
|
| LRP Ayurvedic medical college and hospital, PG Institute and
research centre urun Islampur Maharashtra 415409 |
|
|
Primary Sponsor
|
| Name |
Dr Neeta Prakash Suryawanshi |
| Address |
LRP Ayurvedic medical college and hospital, PG Institute and
research centre urun Islampur Maharashtra 415409 |
| Type of Sponsor |
Other [other ( self )] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
NIL |
| NIL |
NIL |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Neeta Prakash Suryawanshi |
LRP Ayurvedic medical college and hospital, PG Institute and research centre urun Islampur |
OPD No -2 Pediatric OPD
Ground Floor LRP
Ayurvedic Hospital
Urun
Sangli
MAHARASHTRA
Sangli
MAHARASHTRA |
07057488290
neetasuryawanshi41@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC LRP |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J308||Other allergic rhinitis. Ayurveda Condition: VATAJAPRATISYAYAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Maricha arka, Reference: NA, Route: Oral, Dosage Form: Arka, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: -Madhu), Additional Information: -doses will be calculated by clarks rule,according to weight.
doses will be adminiatered by oral as well as nebulization |
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient in age group of 6 to 12 years will be selected irrespective of
sex, socioeconomic status and Religion.
2.Patient who fulfill subjective and objective criterias.
3.Parents who were consciously willing to participate their children in
the study and ready to sign the informed consent form. |
|
| ExclusionCriteria |
| Details |
1.Rhinitis caused by infection and associated with nasal polyp, asthma,
sinusitis, congenital anomalies and fever.
2.Patients who need surgical and other intervention (nasal polyp, DNS)
3.Dusht, raktaj, pitttaj, sannipataj, kaphaj Pratishyay |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate efficacy of Nebulization and Oral administration of Maricha arka in
Vataj Pratishyaya with special reference to Allergic rhinitis. |
7days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To Study the clinical textual review of Vataj Pratishyay in children according to Ayurveda & Allergic rhinitis according to modern text. |
7 Days |
|
|
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)
|
24/12/2025 |
| 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="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
|
Aim-To evaluate efficacy of Nebulization and Oral administration of Maricha arka in Vataj Pratishyaya with special reference to Allergic rhinitis.
Primary objectives – To evaluate efficacy of Nebulization and Oral administration of Maricha arka in Vataj Pratishyaya with special reference to Allergic rhinitis. Secondary objectives-
1. To study the clinical textual review of Vataj Pratishyaya in children according to ayurveda and Allergic rhinitis according to modern text. 2. To study efficacy of Maricha arka in Vataj Pratishyaya. 3. To prepare Maricha arka according to arkaprakasha (Simple distillation process).
Methodology a) Study design – Single arm study. b) Study setting- patient will be selected randomly from OPD of Kaumarbhritya department in our hospital. c) Duration of study- 18 months. d) Duration of treatment -7days e) Follow up -3rd,5th7th day
Assessment phase
Subjective Criteria- Nasavrodha Kshavathu Nasasrava Shirashool
Objective Criteria: Absolute Eosinophil Count
6) Discussion- After analyzing, data will be discussed in detail. 7) Conclusion- Conclusion will be drawn on the basis of data obtained and observation during study. 8) Summary – Data will be summarized on the basis of observation and results.
|