| CTRI Number |
CTRI/2024/09/074377 [Registered on: 25/09/2024] Trial Registered Prospectively |
| Last Modified On: |
25/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [classical] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical study to evaluate the effects of vyaghri haritaki avaleha and sribahusala guda in pratishyaya(Rhinitis) in children |
|
Scientific Title of Study
|
A Randomized Comparative Clinical Study to Evaluate the Effect of Vyaghri Haritaki Avaleha and Sribahusala guda in Pratisyaya With special reference to Intermittent Allergic Rhinitis in Children |
| 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 Elakkiyaselvi V |
| Designation |
PG Scholar |
| Affiliation |
Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital Kuthpady Udupi |
| Address |
Dr Elakkiyaselvi V Department of Kaumarabhritya Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital Kuthpady Udupi
Udupi
KARNATAKA
574118
India |
| Phone |
9655916530 |
| Fax |
|
| Email |
drelakkiyaselvi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prathviraj Puranik |
| Designation |
Professor and HOD department of Kaumarabhritya |
| Affiliation |
Shri Dharmasthala Manjunatheswara College of Ayurveda Kuthpady Udupi |
| Address |
Dr Prathviraj Puranik Professor and Head Of Department of Kaumarabhritya Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital Kuthpady Udupi
Udupi
KARNATAKA
574118
India |
| Phone |
9448745477 |
| Fax |
|
| Email |
drprathvirajpuranik@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Elakkiyaselvi V |
| Designation |
PG Scholar |
| Affiliation |
Sri Dharmasthala Manjunatheswara College of Ayurveda Kuthpady Udupi |
| Address |
Dr Elakkiyaselvi V PG Scholar Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital Kuthpady Udupi
Udupi
KARNATAKA
574118
India |
| Phone |
9655916530 |
| Fax |
|
| Email |
drelakkiyaselvi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Dharmasthala manjunatheshwara college of ayurveda and hospital kuthpady udupi 574118 |
|
|
Primary Sponsor
|
| Name |
Sri Dharmasthala Manjunatheshwara College of Ayurveda |
| Address |
Sri Dharmasthala Manjunatheswara College of Ayurveda Kuthpady Udupi 574118 Karnataka India
College phone 08202520332
email id sdmcau@sdmayurvedacollegeudupi |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Elakkiyaselvi V |
Sri Dharmasthala Manjunatheswara Ayurveda Udupi |
OPD number 11 Department of Kaumarabhritya
Udupi
KARNATAKA |
09655916530
drelakkiyaselvi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Dharmasthala Manjunatheshwara college of Ayurveda, Udupi Institutional ethical clearence committe human |
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 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Vyaghri Haritaki Avaleha, Reference: Bhaisajya ratnavalli, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 8(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Milk), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Sri Bahusala Guda, Reference: Cakradatta, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 8(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Milk), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
The age group between 5 to 10 years.
Patients with any 2 or more features of all the Tridoshaja Pratisyaya. |
|
| ExclusionCriteria |
| Details |
Patients with symptoms of Raktaja, and Dusta Pratisyaya.
Pratisyaya associated with systemic diseases.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| changes in symptoms of Prathisyaya |
oth day, 30th day, 45th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| changes in AEC value |
oth day, 30th day |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
07/10/2024 |
| 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="2"
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
|
A Randomixed comparative clinical study to evaluvate the effect of Vyaghri haritaki avaleha and Sribahusala guda in Pratisyaya w.s.r to intermittent allergic rhinitis in children. The study is conducted in SDM Ayurveda Hospital, Udupi. Among 30 children made into 2 groups A and B. Age group 5 to 10 years with dose of 15gram/day in divided dose for total 2month of assessment duration, belong to Nasasrava (nasal discharge), Ghranavarodha (nasal obstruction), Kshavathu (sneezing), Angamarda (body pain), Kasa (cough), Shirasoola (headache), Kandu (itching) and Absolute Esinophil Count. |