| CTRI Number |
CTRI/2025/08/092694 [Registered on: 08/08/2025] Trial Registered Prospectively |
| Last Modified On: |
11/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to test the effectiveness of Amrutprabha Gutika in treating allergic rhinitis. |
|
Scientific Title of Study
|
Randomized controlled clinical trial to evaluate efficacy of Amrutprabha gutika in the management of Pratishayay with special reference to allergic 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 Vaishnavi Ranganath Patil |
| Designation |
PG scholar |
| Affiliation |
Late Kedari Redekar Ayurvedic Mahavidyalaya Gadhinglaj Kolhapur |
| Address |
Late Kedari Redekar Ayurvedic Mahavidyalaya Ground floor Room No2 Kaumarbhritya department Gadhinglaj Kolhapur pin 416502, Maharashtra India
Kolhapur
MAHARASHTRA
416502
India |
| Phone |
7709249216 |
| Fax |
|
| Email |
vaishnavipatil956@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Asmita Sudhir Yesane |
| Designation |
Reader at Kaumarbhritya department |
| Affiliation |
Late Kedari Redekar Ayurvedic Mahavidyalaya Gadhinglaj |
| Address |
Late Kedari Redekar Ayurvedic Mahavidyalaya Ground floor Room No2 Kaumarbhritya department Gadhinglaj Kolhapur pin 416502, Maharashtra India
Kolhapur
MAHARASHTRA
416502
India |
| Phone |
9552635237 |
| Fax |
|
| Email |
shindeasmita1982@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Asmita Sudhir Yesane |
| Designation |
Reader at Kaumarbhritya department |
| Affiliation |
Late Kedari Redekar Ayurvedic Mahavidyalaya Gadhinglaj |
| Address |
Late Kedari Redekar Ayurvedic Mahavidyalaya ground floor Room No2 Kaumarbhritya department Gadhinglaj Kolhapur pin 416502, Maharashtra India
Kolhapur
MAHARASHTRA
416502
India |
| Phone |
9552635237 |
| Fax |
|
| Email |
shindeasmita1982@gmail.com |
|
|
Source of Monetary or Material Support
|
| Daily OPD patients at Late Kedari Redekar Ayurvedic Mahavidyalaya and hospital Ground floor Room No2 Gadhinglaj Kolhapur pin code 416502 maharashtra India |
|
|
Primary Sponsor
|
| Name |
Dr Vaishnavi Ranganath Patil |
| Address |
Late Kedari Redekar Ayurvedic Mahavidyalaya ground floor Room No2 Gadhinglaj 416502 Kolhapur Maharashtra 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 Vaishnavi Ranganath Patil |
Late Kedari Redekar Dharmaday Rugnalaya Gadhinglaj Kolhapur |
Ground floor Room No2 Kaumarbhritya department Gadhinglaj Kolhapur pin 416502Maharastra India
Kolhapur
MAHARASHTRA |
7709249216
vaishnavipatil956@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committe Late Kedari Redekar Ayurvedic Mahavidyalaya Gadhinglaj Kolhapur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J309||Allergic rhinitis, unspecified. Ayurveda Condition: PRATISYAYAH/PINASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Amrutprabha gutika , Reference: Bharat bhaishajya ratnakar 8836, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: Sukoshna jal), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Levocetirizine | Tb levocetirizine
Dose- 2.5 mg
Frequency - HS
Duration - 7 days
Route of administration - oral
After meal |
|
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients fulfilling clinical features of Pratishayay
2.selection of patients will be irrespective of their sex, religion, socioeconomic status |
|
| ExclusionCriteria |
| Details |
1. Patients having any congenital deformity
2. Patients having nasal polyp, sinusitis, rhinorrhea due to foreign body or trauma, DNS
3. Patients having lower respiratory tract infection |
|
|
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 |
| Amrutprabha gutika is effective in the management of Pratishayay |
Initial assessment at 0 day
Follow up at 3rd day and 5th day
Final assessment at 7th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Amrutprabha gutika is effective than tablet levocetirizine in the management of Pratishayay |
Initial assessment at 0 day
Follow up at 3rd day and 5th day
Final assessment at 7th 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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
11/08/2025 |
| 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="1"
Months="6"
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
|
This study is an open randomized controlled clinical trial to evaluate efficacy of Amrutprabha gutika in the management of Pratishayay w.s.r. allergic rhinitis. The study will be carried at OPD of Kaumarbhritya department of Late Kedari Redekar Ayurvedic Mahavidyalaya and hospital Gadhinglaj Kolhapur. The observation would be drawn on the basis of symptoms after treatment is given. |