| CTRI Number |
CTRI/2025/04/085568 [Registered on: 24/04/2025] Trial Registered Prospectively |
| Last Modified On: |
04/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
An interventional trial to evaluate the effect of an
Ayurveda treatment protocol in Allergic rhinitis |
|
Scientific Title of Study
|
A pre and post-trial to evaluate the effect of an
Ayurveda treatment protocol in 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 |
Drpreethi Mohan |
| Designation |
Professor |
| Affiliation |
amrita school of ayurveda |
| Address |
Dept.of Agadatantra
Amrita school of ayurveda
Clappana Po
vallikkavu
karunagappalli
vallikkavu
Kollam
KERALA
690525
India |
| Phone |
09447320363 |
| Fax |
|
| Email |
drpreeti94@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Ramwsh N.V(Guide) |
| Designation |
professor |
| Affiliation |
amrita school of ayurveda |
| Address |
dept of Rasasatra
amrita school of ayurveda Clappana Po
vallikkavu
karunagappalli
vallikkavu
KERALA
690525
India |
| Phone |
09447320363 |
| Fax |
|
| Email |
rameshnv@ay.amrita.edu |
|
Details of Contact Person
Public Query
|
| Name |
Drpreethi Mohan |
| Designation |
professor |
| Affiliation |
amrita school of ayurveda |
| Address |
dept of agadatantra
amrita school of ayurveda
Clappana Po
vallikkavu
karunagappalli
vallikkavu
KERALA
690525
India |
| Phone |
09447320363 |
| Fax |
|
| Email |
drpreeti94@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
DrPreethi Mohan |
| Address |
professor
dept of agadatantra
amrita school of ayurveda
clappana.p.o
karunagappally |
| 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 |
| DrPreethi Mohan |
Amrita school of ayurveda |
professor
dept of agadatantra
clappana.p.o..vallikkavu
room no -09-Agadatantatra opd
Kollam
KERALA |
09447320363
drpreeti94@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional ethics committee,Amrita school of Ayurveda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J350||Chronic tonsillitis and adenoiditis. Ayurveda Condition: PRATISYAYAH/PINASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: surasadi gana kashayam, Reference: ashtanga hridaya, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 48(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: -nil |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Those had recurrence of allergic rhinitis
History of exposure to allergens
Active age group of 20-40 years prone to exposure
Clinical symptoms of mild allergic rhinitis and prathisyaya like rhinorrhoea, obstructed nose and sneezing.
Positive skin prick test for aeroallergens
Mild to moderate allergic rhinitis
|
|
| ExclusionCriteria |
| Details |
• Asthma
• DNS
• ENT disorders
• Food allergy
• Persistent severe allergic rhinitis
• Patients less than 20yrs and above 40 yrs
• Pregnant ladies & lactating mothers
• Patients who failed to give consent and who failed to follow –up
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
SUBJECTIVE PARAMETER
1. Total Nasal Symptom Scores (TNSS) Each symptom (sneezing, congestion, itching, and rhinorrhea) is graded from 0-3 by the participants during the screening and subsequent visits
OBJECTIVE PARAMETER
Total IgE assessment
|
baseline,2weeks,6week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="41"
Sample Size from India="41"
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)
|
03/05/2025 |
| 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="25"
Months="11"
Days="25" |
|
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
|
This study is a pre and post trial comprised od 41 samples.The treatment protocol consists of surasadi gana kashayam ,vishavilwady gutika for 14 days and amrita ghritham for 1 month.Patient will be assessed based on Total IgE,T5SS and SNOT 20 questionnaire of allergic rhinitis.The data statistically analysed by Pired t. |