| CTRI Number |
CTRI/2025/08/093469 [Registered on: 22/08/2025] Trial Registered Prospectively |
| Last Modified On: |
21/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Rajarasayan in treatment of Pratishyay in children |
|
Scientific Title of Study
|
Evaluation of efficacy of Rajrasayan verses Vachadi Avaleha in the
Management of Pratishyaya (Rhinitis) in School going Children : A
Randomized Controlled Trial |
| 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 PRIYANKA PRASHANT MUNJEWAR |
| Designation |
PG SCHOLAR |
| Affiliation |
Mahatma Gandhi Ayurved College, Hospital and Research Centre Salod(H) Wardha |
| Address |
Room No 41, Department of Kaumarbhritya, Mahatma Gandhi Ayurved College, Hospital and Research Centre Salod Hirapur Wardha.
MAHARASHTRA 442001 India
Wardha
MAHARASHTRA
442001
India
Wardha
MAHARASHTRA
442001
India |
| Phone |
8390963886 |
| Fax |
|
| Email |
dr.priyankamunjewar12@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rahul M Jumle |
| Designation |
PROFESSOR |
| Affiliation |
Mahatma Gandhi Ayurved College, Hospital and Research Centre Salod(H) Wardha |
| Address |
Room No 41, Department of Kaumarbhritya, Mahatma Gandhi Ayurved College, Hospital and Research Centre Salod Hirapur Wardha.
MAHARASHTRA 442001 India
Wardha
MAHARASHTRA
442001
India
Wardha
MAHARASHTRA
442001
India |
| Phone |
9766643990 |
| Fax |
|
| Email |
rahul.kaumarbhritya@dmiher.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
DR PRIYANKA PRASHANT MUNJEWAR |
| Designation |
PG SCHOLAR |
| Affiliation |
Mahatma Gandhi Ayurved College, Hospital and Research Centre Salod(H) Wardha |
| Address |
Room No 41, Department of Kaumarbhritya, Mahatma Gandhi Ayurved College, Hospital and Research Centre Salod Hirapur Wardha.
MAHARASHTRA 442001 India
Wardha
MAHARASHTRA
442001
India
Wardha
MAHARASHTRA
442001
India |
| Phone |
8390963886 |
| Fax |
|
| Email |
dr.priyankamunjewar12@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Ayurved College, Hospital and Research Centre Salod(H), Wardha Dist
Wardha Maharashtra, India 442001 |
|
|
Primary Sponsor
|
| Name |
Mahatma Gandhi Ayurved College, Hospital and Research Centre |
| Address |
Mahatma Gandhi Ayurved College, Hospital and Research Centre Salod(H) Wardha, MAHARASHTRA 442001 India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 PRIYANKA PRASHANT MUNJEWAR |
Mahatma Gandhi Ayurved College, Hospital and Research Centre, Salod(H) Wardha |
Room No 41, Department of Kaumarbhritya, Mahatma Gandhi Ayurved College, Hospital and Research Centre Salod(H) Wardha.
MAHARASHTRA
442001 India
Wardha
MAHARASHTRA
Wardha
MAHARASHTRA |
8390963886
dr.priyankamunjewar12@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Mahatma Gandhi Ayurved College, Hospital and Research Centre Institutional Committee, Salod(H) Wardha, Maharashtra 442001 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J300||Vasomotor rhinitis. Ayurveda Condition: PRATISYAYAH/PINASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Vachadi Avaleha, Reference: Harita Samhita 3rd sthana 2/49, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 10(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: Koshna Jal), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Rajarasayan, Reference: Vangasen Samhita Part 1 Nasaroga Adhyay 35-37, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 10(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: koshna jal), Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Patients suffering from Pratishaya less than 3-4 days
Patients in the age group of 4 year to 18 years will be selected irrespective of sex, socio-economic status and religion
Children whose parents are giving written consent for their child to participate in the study |
|
| ExclusionCriteria |
| Details |
Mucoid and purulent or blood-stained nasal discharge
Patient suffering from nasal polyps, Deviated nasal septum
Any other systemic illness for eg. Fever
Rhinitis associated with immunodeficiency like HIV |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the reduction in the symptoms of pratishyaya on the basis of subjective and objective criteria. |
Treatment for 7 days and post treatment follow up on 14th and 21st day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assses the recurrence of pratishyaya in school going children. |
Follow up on 14th & 21st day. |
|
|
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
10/10/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
The volunteers will be informed about the study protocol. Willing participants will be randomly selected as per computer-generated table. The clinical research format will be prepared and validated.Before the study approval will be taken from IEC, MGACHRC, Salod (H) Wardha, and CTRI registration will be done. After selection, each participant will be tested individually and selected according to selection criteria. They are divided into two groups. The trial is a Randomized Single blind clinical control trial. |