| CTRI Number |
CTRI/2024/12/078697 [Registered on: 27/12/2024] Trial Registered Prospectively |
| Last Modified On: |
23/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
It is a study to see how much Effective Is ayurvedic Medicine Katutrikadi Churna in the treatment if disease Allergic Rhinitis |
|
Scientific Title of Study
|
Single arm clinical study to evaluate efficacy of Katutrikadi Churna in the
management of Vataj Pratishyaya 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 Shubhangi Ram Bhosale |
| 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
Sangli
MAHARASHTRA
415409
India |
| Phone |
9552771545 |
| Fax |
|
| Email |
shubhangi1121997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sandeep Patill |
| Designation |
Assistant professor |
| Affiliation |
LRP Ayurvedic medical college and hospital, PG Institute and Research center ,Urun Islampur |
| Address |
Pediatric Department
2 nd floor
LRP Ayurvedic medical college and hospital PG Institute and
Research center Urun Islampur
Sangli
Sangli
MAHARASHTRA
415109
India |
| Phone |
9860970379 |
| Fax |
|
| Email |
sandeep.patil76.sp@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sandeep Patill |
| Designation |
Assistant professor |
| Affiliation |
LRP Ayurvedic medical college and hospital, PG Institute and Research center, Urun Islampur |
| Address |
Pediatric Department
2 nd floor
LRP Ayurvedic medical college and hospitalPG Institute and
Research center Urun Islampur
Sangli
Sangli
MAHARASHTRA
415409
India |
| Phone |
9860970379 |
| Fax |
|
| Email |
sandeep.patil76.sp@gmail.com |
|
|
Source of Monetary or Material Support
|
| LRP Ayurvedic medical college and hospital, PG Institute and
Research center, Urun Islampur 415409 |
|
|
Primary Sponsor
|
| Name |
Dr Shubhangi Ram Bhosale |
| Address |
LRP Ayurvedic medical college and hospital, PG Institute and
Research center, Urun Islampur 415409 |
| 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 Sandeep Patil |
LRP Ayurvedic medical college and hospital, PG Institute and Research center Urun Islampur |
OPD 2 Pediatric Opd Ground Floor
LRP Ayurvedic Hospital Urun
Sangli
MAHARASHTRA |
9552771545
shubhangi1121997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC- LRP Ayurvedic Medical College And Hospital Post Graduate Institute And Research Centre, Islampur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J309||Allergic rhinitis, unspecified. Ayurveda Condition: VATAJAPRATISYAYAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Katutrikadi churna, Reference: Tripathi Hariprasad - Vangsen Samhita, Nasarog 35/18 1st edition, Varanasi, Chaukhamba series office,2009; 892, Route: Oral, Dosage Form: Churna/ Powder, Dose: 4(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: -gud), Additional Information: -Ingredients - Trikatu, chitrak, Tintidik, tailspatra, chavya, amlvetas
Jeerak, ela, twak. |
|
|
|
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 Allergic Rhinitis signs and symptoms.
3 patient suffering from Vataj Pratishyaya. |
|
| 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, sannipataj, kafaj pratishyaya |
|
|
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 katutrikadi churna in the management of Vataj
Pratishyaya with special reference to Allergic Rhinitis. |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
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 katutrikadi churna in management of Vataj
Pratishyaya.
3. To prepare katutrikadi churna as per vangsen samhita |
7 - 15 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
|
Phase 1 |
|
Date of First Enrollment (India)
|
20/01/2025 |
| 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="0"
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 Katutrikadi Churna in the management of Vataj Pratishyaya with special reference to Allergic Rhinitis
Primary objectives – To evaluate efficacy of katutrikadi churna in the management of 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 katutrikadi churna in management of Vataj Pratishyaya. 3. To prepare katutrikadi churna as per vangsen samhita.
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 Duration of treatment :- 7days Follow up:- 3rd ,5th ,7th day
Diagnostic phase Patient will be diagnosed on the basis of sign and symptoms of Vataj pratishaya as per Ayurvedic text book (Nasavrodh Kshavathu Nasasrava Shirshool etc ) Informed written consent will be taken prior to clinical study Case will be recorded on specially designed proforma
Assessment phase Subjective parameter : a) Nasavrodh b) Kshavathu c) Nasasrava d) Shirshool
Objective parameter : Absolute Eosinophil Count (if required)
After analyzing, data will be discussed in detail.
Conclusion will be drawn on the basis of data obtained and observation during study
Data will be summarized on the basis of observation and results
|