| CTRI Number |
CTRI/2024/11/076360 [Registered on: 07/11/2024] Trial Registered Prospectively |
| Last Modified On: |
29/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of milk processed with krishnadi drug and nasal drops of kshavaka tailam in allegic rhinitis |
|
Scientific Title of Study
|
Effect of krishnadi ksheera pana and kshavaka taila as pratimarsha nasya 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 |
Anjana Rajan |
| Designation |
PG scholar , department of shalakyatantra |
| Affiliation |
Government Ayurveda College , Tripunithura, Ernakulam |
| Address |
Department of shalakyatantra, Government Ayurveda College , Tripunithura, Ernakulam
Ernakulam
KERALA
682301
India |
| Phone |
7034265355 |
| Fax |
|
| Email |
anjanask386@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sreeja Sukesan |
| Designation |
Professor and HOD Department of Shalakyatantra |
| Affiliation |
Government Ayurveda College , Tripunithura, Ernakulam |
| Address |
Department of shalakyatantra, Government Ayurveda College , Tripunithura, Ernakulam
Ernakulam
KERALA
682301
India |
| Phone |
7034115701 |
| Fax |
|
| Email |
doctorsreejamd@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sreeja Sukesan |
| Designation |
Government Ayurveda College , Tripunithura, Ernakulam |
| Affiliation |
Government Ayurveda College , Tripunithura, Ernakulam |
| Address |
Department of shalakyatantra,Government Ayurveda College , Tripunithura, Ernakulam
Ernakulam
KERALA
682301
India |
| Phone |
7034115701 |
| Fax |
|
| Email |
doctorsreejamd@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurveda College , Tripunithura, Ernakulam 682301 |
|
|
Primary Sponsor
|
| Name |
Government Ayurveda College , Tripunithura, Ernakulam |
| Address |
Government Ayurveda College , Tripunithura, Ernakulam 682301 |
| Type of Sponsor |
Other [Government Ayurveda College , Tripunithura, Ernakulam] |
|
|
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 |
| ANJANA RAJAN |
Goverment ayurveda hospital, tripunithura |
Department of shalakyatantra, Government Ayurveda College , Tripunithura, Ernakulam
Ernakulam
KERALA |
07034265355
anjanask386@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Committee For Ethics In Research Government Ayurveda College Tripunithura 682301 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J00-J99||Diseases of the respiratory system. Ayurveda Condition: PRATISYAYAH/PINASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: krishnadi ksheera pana, Reference: Astanga sangraha uthara sthana nasa roga prathisheda, Route: Oral, Dosage Form: Ksheerpaka, Dose: 48(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: -(2) Medicine Name: Kshavaka taila, Reference: Astanga sangraha uthara sthana nasa roga prathisheda, Route: Nasal, Dosage Form: Taila, Dose: 1(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
sneezing, clear rhinnorrhea, nasal blockage as chief complaint |
|
| ExclusionCriteria |
| Details |
subjects with congenital nose anomalies, pre existing nasal polyp,tumours, subjects requiring surgical intervention
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| In a sample size of 32 change in the total nasal symptom score |
Assessment done on 0th day,15th day and follow up after 7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in other associated symptoms like headache in the sample size of 32 |
Assessment done on 0th day,15th day & follow up after 7 days |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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 |
|
Date of First Enrollment (India)
|
20/11/2024 |
| 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
|
A clinical trial with 32 subjects will be selected from the OPD of salakyatantra department Govt. Ayurveda college Tripunithura based on inclusion criteria and exclusion criteria TNS scoring will be done before intervention. The subjects will be given Ayurvedic medicine for 14 days Assessment will be done on 0th day, 15th day and a follow up assessment will be done on 21st day. A case proforma is created and data will be collected . Outcome of the study will be graded as per the parameters results will be statistically analysed |