| CTRI Number |
CTRI/2024/06/068745 [Registered on: 12/06/2024] Trial Registered Prospectively |
| Last Modified On: |
07/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study on the Efficacy of Pratishyayahara Vati on Vataja Pratishyaya, Allergic Rhinitis in Children age 6-12 years for a period of 15 days. |
|
Scientific Title of Study
|
Study on the Efficacy of Pratishyayahara Vati on Vataja Pratishyaya, Allergic Rhinitis in Children - An Open Label Randomised Controlled Clinical 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 Meghana S K |
| Designation |
PG Scholar |
| Affiliation |
Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, Bangalore |
| Address |
Department of Kaumarabhritya
OPD No.7,8,9,22,23
Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, SH17, Anchepalya, Challegatta, Bangalore 560074, Karnataka, India.
Bangalore
KARNATAKA
560074
India |
| Phone |
9060541745 |
| Fax |
|
| Email |
drmeghanask@sdmayurbangalore.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Girish Kumar S V |
| Designation |
Associate Professor |
| Affiliation |
Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, Bangalore |
| Address |
Department of Kaumarabhritya
OPD No.7
Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, SH17, Anchepalya, Challegatta, Bangalore 560074, Karnataka, India.
Bangalore
KARNATAKA
560074
India |
| Phone |
9449577136 |
| Fax |
|
| Email |
drgirishkumargowda@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Meghana S K |
| Designation |
PG Scholar |
| Affiliation |
Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, Bangalore |
| Address |
Department of Kaumarabhritya
OPD No.7,8,9,22,23
Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, SH17, Anchepalya, Challegatta, Bangalore 560074, Karnataka, India.
Bangalore
KARNATAKA
560074
India |
| Phone |
9060541745 |
| Fax |
|
| Email |
drmeghanask@sdmayurbangalore.in |
|
|
Source of Monetary or Material Support
|
| Department of Kaumarabhritya
OPD No.7,8,9,22,23
Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, SH17, Anchepalya, Challegatta, Bangalore 560074, Karnataka, India. |
|
|
Primary Sponsor
|
| Name |
Dr Meghana S K |
| Address |
Department of Kaumarabhritya
OPD No.7,8,9,22,23
Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, SH17, Anchepalya, Challegatta, Bangalore 560074, Karnataka, 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 Meghana S K |
Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, Bangalore |
Department of Kaumarabhritya
OPD No.7,8,9,22,23
Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, SH17, Anchepalya, Challegatta, Bangalore 560074, Karnataka, India.
Bangalore
KARNATAKA |
9060541745
drmeghanask@sdmayurbangalore.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Sri Dharmasthala Manjunatheshwara Ayurveda and Hospital |
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: Pratishyayahara Vati, Reference: Rasatantrasara Va Siddhaprayoga Sangraha, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: warm water), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Tryushanadi Vati, Reference: Vangasena Samhitha, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: warm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Patients with age group of 6 to 12 years fulfilling the diagnostic criteria, irrespective of gender, religion, socio economic status.
Children with clinical features of Vataja Pratishyaya with duration less than 15 days. |
|
| ExclusionCriteria |
| Details |
Children of age below 6 years and above 12 years.
All other types of Pratishyaya, except Vataja Pratishyaya.
Children suffering from any chronic debilitating or infectious diseases like Deviated Nasal Septum, Nasal polyp, Sinusitis, fever(temp more than 100F), Tuberculosis, COPD, Congenital lung and cardiac anomalies etc which may interfere with present clinical trial. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in the clinical symptoms of Vataja Pratishyaya based on
1. Vataja Pratishyaya Gradation index.
2. TNSS (Total Nasal Symptom Score-Questionnaire) |
Baseline, 15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Significant clinical relief in signs and symptoms of Vataja pratishyaya based on
1. RCAT (Rhinitis Control Assessment Test) |
Baseline, 15 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
20/06/2024 |
| Date of Study Completion (India) |
25/07/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
An open label randomised controlled clinical trial
on the efficacy of Pratishyayahara vati on Vataja Pratishyaya, allergic
rhinitis in children of age group 6-12 years for a period of 15 days. During
this study period, 40 children will be recruited and divided into two groups,
Group A (Trial drug) and Group B (Control drug), 20 children each. Group
A(Trial drug) children will be administered Pratishyayahara Vati (500mg BID AF)
and Group B(Control drug) children will
be administered Tryushanadi Vati (500mg BID AF) for a
period of 15 days. Clinical assessment will be done for both subjective &
objective criteria on 0th day, 7th day & 15th day. Statistical
analysis will be done through data obtained on 0 day(BT) and 15th
day(AT). |